172 results on '"Selam JL"'
Search Results
2. Combined improvements in implantable pump technology and insulin stability allow safe and effective long term intraperitoneal insulin delivery in type 1 diabetic patients: the EVADIAC experience
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Gin, H, Renard, E, Melki, V, Boivin, S, Schaepelynck-Bélicar, P, Guerci, B, Selam, JL, Brun, JM, Riveline, JP, Estour, B, and Catargi, B
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- 2003
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3. Effects of dipeptide administration on hypoglycaemic counterregulation in type 1 diabetes
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M'Bemba, J, Cynober, L, De Bandt, P, Taverna, M, Chevalier, A, Bardin, C, Slama, G, and Selam, JL
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- 2003
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4. Accuracy of the continuous glucose monitoring system in inpatient and outpatient conditions
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Djakouré-Platonoff, C, Radermercker, R, Reach, G, Slama, G, and Selam, JL
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- 2003
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5. Implantable insulin pumps
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Selam, JL
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Insulin pumps -- Usage - Published
- 1999
6. HL-A in Graves’Disease and in Diabetes Mellitus Insulin-Dependent
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Lapinski H, J Seignalet, Jaffiol C, Selam Jl, and Mirouze J
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medicine.medical_specialty ,business.industry ,Graves' disease ,Immunology ,General Medicine ,medicine.disease ,Biochemistry ,Endocrinology ,Diabetes mellitus ,Internal medicine ,Genetics ,Immunology and Allergy ,Medicine ,business ,Insulin dependent - Published
- 2008
7. Implantable insulin pumps: diagnosis and management of decreased flow rates using radionuclide investigation
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Boulahdour H, Selam Jl, Behar A, and Haardt Mj
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Implantable Pump ,Radionuclide ,business.industry ,Insulin ,medicine.medical_treatment ,Biomedical Engineering ,Medicine (miscellaneous) ,Bioengineering ,General Medicine ,Volumetric flow rate ,Biomaterials ,Medicine ,Radionuclide imaging ,business ,Nuclear medicine ,Biomedical engineering - Abstract
The aim of this study was to develop a diagnostic procedure for pumping unit malfunction by radionuclide imaging (RI) and to validate the method by comparing the results with those obtained using more conventional methods. Fifteen radionuclide investigations were performed in 11 patients with intraperitoneal implantable insulin pumps. One mCi of 99 mTc in 1 ml isotonic sodium chloride was injected into the reservoir. The results based on catheter visualization and peritoneal accumulation were compared blindly to the efficacy of alkaline rinses and laparoscopic findings. In all RI stoppage cases except one alkaline rinses failed to restore flow. Where laparoscopy was performed, comparisons were concordant i.e. no outflow from the tip of the catheter. The RI images obtained were reproduced in vitro using a pump under normal flow conditions and complete proximal and distal catheter obstruction. RI is a safe, quick non invasive method which allows the location of the site of pump/catheter malfunction within a one step procedure and the prediction of the efficacy of sodium hydroxide rinses.
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- 1996
8. Insulin degludec, an ultra-longacting basal insulin, versus insulin glargine in basal-bolus treatment with mealtime insulin aspart in type 2 diabetes (BEGIN Basal-Bolus Type 2): a phase 3, randomised, open-label, treat-to-target non-inferiority trial
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Garber, Aj, King, Ab, Del Prato, S, Sreenan, S, Balci, Mk, Muñoz Torres, M, Rosenstock, J, Endahl, La, Francisco, Am, Hollander, P, Protich, M, Ivanov, V, Veleva, N, Pichmanova, M, Guerenova, J, Hristozov, K, Slavcheva, A, Petrova, Gancheva, Prakova Teneva, Z, Böhmer, M, Clever, Hu, Kaiser, M, Peter Kempe, H, Mölle, A, Paulus, R, Rose, L, Sauter, J, Kinsley, B, Nolan, J, Hayes, F, Joshi, P, Khutsoane, Dt, Reddy, J, Mayet, L, Burgess, Lj, Raya, Pm, Cros, Mr, Calle, A, Candil, Sd, Soto, A, Francisco, J, Torres, M, Dominguez, Jr, Mesa, J, Mur, Al, Filetti, S, Piatti, P, Vespasiani, G, Santeusanio, F, Fanelli, Carmine Giuseppe, Mannucci, E, Consoli, A, Pata, P, Cignarelli, M, Borzì, V, Trevisan, R, Serban, V, Catrinoiu, D, Creteanu, G, Pop, L, Coman, A, Dogadin, S, Dvoryashina, I, Karpova, I, Lysenko, T, Smirnova, E, Yakusevich, V, Fábry, J, Ilavská, A, Tomášová, L, Tošerová, E, Chow, Fc, Karsidag, K, Erguney, M, Akbay, E, Balçi, Mk, Anderson, C, Baker, C, Berbano, R, Blevins, T, Broadstone, V, Brody, M, Brunner, J, Brusco, O, Case, C, Cherlin, R, Chuck, L, Clower, J, Connor, G, Cooperman, M, Paysinger, A, Early, M, Elliott, S, Fitz Patrick, D, Furlong, K, Garber, A, Glaser, L, Albert, S, Griffing, G, Handke, L, Harris, R, Hermayer, K, Huntley, R, Kaye, W, Kennedy, J, King, A, Klein, E, Lipetz, R, Snell, P, Morawski, E, Nurnberg, R, Orr, R, Osei, K, Palace, E, Raad, G, Rasmussen, B, Reeves, M, Roberts, V, Rodbard, H, Rosenblit, P, Selam, Jl, Shaw, S, Shelmet, J, Simon, H, Smith, M, Stringam, S, Sussman, A, Testa, J, Mazza, A, Varano, S, Warren, M, Winkle, P, Wise, J, Aroda, V, Strzinek, R, Wong, M, Pollock, J, and Bode, B.
- Published
- 2012
9. Comparison of a multiple daily insulin injection regimen (basal once-daily glargine plus mealtime lispro) and continuous subcutaneous insulin infusion (lispro) in type 1 diabetes: a randomized open parallel multicenter study.
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Bolli GB, Kerr D, Thomas R, Torlone E, Sola-Gazagnes A, Vitacolonna E, Selam JL, Home PD, Bolli, Geremia B, Kerr, David, Thomas, Reena, Torlone, Elisabetta, Sola-Gazagnes, Agnès, Vitacolonna, Ester, Selam, Jean Louis, and Home, Philip D
- Abstract
Objective: Insulin pump therapy (continuous subcutaneous insulin infusion [CSII]) and multiple daily injections (MDIs) with insulin glargine as basal insulin and mealtime insulin lispro have not been prospectively compared in people naïve to either regimen in a multicenter study. We aimed to help close that deficiency.Research Design and Methods: People with type 1 diabetes on NPH-based insulin therapy were randomized to CSII or glargine-based MDI (both otherwise using lispro) and followed for 24 weeks in an equivalence design. Fifty people were correctly randomized, and 43 completed the study.Results: Total insulin requirement (mean +/- SD) at end point was 36.2 +/- 11.5 units/day on CSII and 42.6 +/- 15.5 units/day on MDI. Mean A1C fell similarly in the two groups (CSII -0.7 +/- 0.7%; MDI -0.6 +/- 0.8%) with a baseline-adjusted difference of -0.1% (95% CI -0.5 to 0.3). Similarly, fasting blood glucose and other preprandial, postprandial, and nighttime self-monitored plasma glucose levels did not differ between the regimens, nor did measures of plasma glucose variability. On CSII, 1,152 hypoglycemia events were recorded by 23 of 28 participants (82%) and 1,022 in the MDI group by 27 of 29 patients (93%) (all hypoglycemia differences were nonsignificant). Treatment satisfaction score increased more with CSII; however, the change in score was similar for the groups. Costs were approximately 3.9 times higher for CSII.Conclusions: In unselected people with type 1 diabetes naïve to CSII or insulin glargine, glycemic control is no better with the more expensive CSII therapy compared with glargine-based MDI therapy. [ABSTRACT FROM AUTHOR]- Published
- 2009
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10. Improving glycemic control with insulin detemir using the 303 Algorithm in insulin naïve patients with type 2 diabetes: a subgroup analysis of the US PREDICTIVE 303 study.
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Selam JL, Koenen C, Weng W, Meneghini L, Selam, Jean-Louis, Koenen, Christoph, Weng, Wayne, and Meneghini, Luigi
- Abstract
Objective: PREDICTIVE 303 was a 26-week, prospective, randomized, open-label, multi-center study in patients with type 2 diabetes that investigated whether patient-driven adjustments of insulin detemir doses using the 303 Algorithm achieved similar glycemic control compared to standard-of-care, physician-driven adjustments in doses. This post hoc sub-analysis evaluates insulin naïve patients on oral anti-diabetic drugs (OADs) who were directed to start on once-daily insulin detemir as add-on therapy to any other glucose-lowering regimens.Methods: Patients in the 303 Algorithm group were instructed to adjust their detemir dose every 3 days based on mean fasting plasma glucose (FPG) values using a simple algorithm: mean FPG < 80 mg/dL, reduce dose by 3 units; between 80-110mg/dL, no change; > 110mg/dL, increase by 3 units. Physicians adjusted the detemir dose for patients in the Standard-of-care group according to their usual practice. No control insulin was used for comparison to insulin detemir.Results: Reductions in glycosylated hemoglobin (HbA(1c)) from baseline were similar between those patients in the 303 Algorithm and Standard-of-care groups (-1.1 and -1.0%, respectively; between group p = 0.0933); patients in the 303 Algorithm group achieved a greater reduction in FPG. Patients in both groups experienced a similar, low rate of hypoglycemia. Over 95% and 92% of patients, respectively, used detemir once daily.Conclusion: These data indicate that patients with type 2 diabetes naïve to insulin can effectively implement the 303 Algorithm to initiate and adjust a once-daily dose of insulin detemir to achieve improvements in glycemic control. [ABSTRACT FROM AUTHOR]- Published
- 2008
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11. Beneficial effect of glycaemic improvement in non-ischaemic forms of diabetic retinopathy: a 3-year follow-up
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P. Millet, Selam Jl, Mirouze J, Zaluski S, and S. Saeidi
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Adult ,Blood Glucose ,Male ,medicine.medical_specialty ,Time Factors ,Endocrinology, Diabetes and Metabolism ,Eye disease ,medicine.medical_treatment ,Gastroenterology ,Ophthalmoscopy ,Endocrinology ,Insulin Infusion Systems ,Internal medicine ,Diabetes mellitus ,Internal Medicine ,medicine ,Humans ,Insulin ,Fluorescein Angiography ,Diabetic Retinopathy ,medicine.diagnostic_test ,business.industry ,Diabetic retinopathy ,Middle Aged ,medicine.disease ,Fluorescein angiography ,Surgery ,Diabetes Mellitus, Type 1 ,Metabolic control analysis ,Female ,business ,Retinopathy ,Follow-Up Studies - Abstract
Recent studies have suggested that optimal glucose control fails to arrest or even worsens background retinopathy possibly by aggravating retinal ischaemia. Fourteen insulin-dependent diabetic patients, aged 34 +/- 11 years (mean +/- SD) treated by long-term intraperitoneal insulin infusion using portable pumps, were followed for 3 years. Preproliferative or proliferative lesions on ophthalmoscopy and large non-perfused areas on fluorescein angiography were exclusion criteria. Six patients were found to have minimal and 8 mild background retinopathy. The patients were retrospectively assigned to two comparable groups except for their glycaemic equilibrium under insulin infusion: average control (n = 6) and excellent control (n = 8), although glycaemic control was significantly improved in all cases when compared to previous conventional therapy. Fluorescein changes were scored blindly and independently by 3 ophthalmologists according to modifications of fluorescein diffusion and capillary abnormalities. The two types of retinal lesions improved gradually in 10 patients and deteriorated in only 1 patient, although not progressing to proliferative retinopathy. Structural improvements were significantly more frequent in the excellently controlled group. We conclude that non-ischaemic lesions may still be arrested and even improved by tight metabolic control.
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- 1986
12. Development of implantable insulin pumps: long is the road
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Selam Jl
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medicine.medical_specialty ,Clinical Trials as Topic ,business.industry ,Endocrinology, Diabetes and Metabolism ,Insulin ,medicine.medical_treatment ,Bioinformatics ,medicine.disease ,Endocrinology ,Diabetes Mellitus, Type 1 ,Insulin Infusion Systems ,Diabetes mellitus ,Insulin dependent diabetes ,Internal medicine ,Internal Medicine ,medicine ,Diabetes Mellitus ,Humans ,business - Published
- 1988
13. Experience with long-term peritoneal insulin infusion from external pumps
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Richard Jl, S. Saeidi, Selam Jl, Slingeneyer A, Mirouze J, Rodier M, Daynes B, and Lapinski H
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Adult ,Blood Glucose ,Male ,medicine.medical_specialty ,Time Factors ,Endocrinology, Diabetes and Metabolism ,medicine.medical_treatment ,Peritonitis ,Medical care ,Insulin infusion ,Endocrinology ,Insulin Infusion Systems ,Internal Medicine ,medicine ,Glycosylated haemoglobin ,Humans ,Normal range ,business.industry ,Insulin ,medicine.disease ,Surgery ,Catheter ,Diabetes Mellitus, Type 1 ,Intraperitoneal insulin ,Female ,Peritoneum ,business - Abstract
The long-term acceptability and feasibility of continuous peritoneal insulin infusion (CPII) from external pumps was evaluated in 40 insulin-dependent diabetic patients continuously treated for 1-27 months (mean 12 months). Blood glucose control was satisfactory and did not deteriorate with time (glycosylated haemoglobin 8.1 +/- 1.1%, mean +/- S.D., normal range 5.5-7.5%). Major problems included 1 episode of local peritonitis, 12 hypoglycaemic comas, 7 severe hyperglycaemic episodes, all cured without sequelae. Minor problems were frequent, mostly pump and catheter-related. Pump and catheter survival rates were 46% and 70% at one year, respectively. No peritoneal reaction was noted apart from occasional tissue growth around the catheter. This method of insulin treatment was judged satisfactory and acceptable by most of the subjects. Only one patient dropped out, after 1.5 years. These results were achieved through stringent selection of patients, intensive education with strict instructions, careful medical care, and possibly through the inherent physiological advantages of intraperitoneal insulin infusion.
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- 1985
14. Changes in Thyroid Hormone Levels During the Treatment of Ketotic Diabetes
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Baldet L, Selam Jl, Mendoza E, Jaffiol C, J Mirouze, and Pham Tc
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Thyroid Hormones ,medicine.medical_specialty ,business.industry ,Endocrinology, Diabetes and Metabolism ,Biochemistry (medical) ,Clinical Biochemistry ,Thyroid ,General Medicine ,medicine.disease ,Biochemistry ,Diabetic Ketoacidosis ,Endocrinology ,Text mining ,medicine.anatomical_structure ,Diabetes mellitus ,Internal medicine ,medicine ,Humans ,business ,Endocrine gland ,Hormone - Published
- 1981
15. CSII in Europe: where are we, where are we going? An analysis of articles published in Infusystems International.
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Selam JL
- Abstract
The use of CSII is progressively growing throughout the world, however a number of factors interfere with its diffusion and produce wide disparity between different countries. In USA around 20-25% of the population of Type 1 diabetics is treated with CSII, while in Europe the application ranges from nearly 0% in countries like UK and Denmark and 10% in Sweden, the Netherlands and Germany. The reasons for such differences are mostly economic and are likely to be even more accentuated in the next future due to the expected introduction in the market of more sophisticated and expensive instruments. A strong educational action seems to be necessary in order to convince the relevant payers to reimburse CSII as it has already proven its efficacy and effectiveness in improving the metabolic control and the quality of life of a well defined fraction of people with Type 1 diabetes. [ABSTRACT FROM AUTHOR]
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- 2006
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16. Basal insulin peglispro versus insulin glargine in insulin-naïve type 2 diabetes: IMAGINE 2 randomized trial.
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Davies MJ, Russell-Jones D, Selam JL, Bailey TS, Kerényi Z, Luo J, Bue-Valleskey J, Iványi T, Hartman ML, Jacobson JG, and Jacober SJ
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- Administration, Oral, Aged, Blood Glucose drug effects, Blood Glucose metabolism, Circadian Rhythm, Diabetes Mellitus, Type 2 blood, Double-Blind Method, Drug Therapy, Combination, Fasting blood, Female, Humans, Hypoglycemic Agents adverse effects, Insulin Glargine adverse effects, Insulin Lispro administration & dosage, Insulin Lispro adverse effects, Male, Middle Aged, Polyethylene Glycols adverse effects, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemic Agents administration & dosage, Insulin Glargine administration & dosage, Insulin Lispro analogs & derivatives, Polyethylene Glycols administration & dosage
- Abstract
Aims: To compare, in a double-blind, randomized, multi-national study, 52- or 78-week treatment with basal insulin peglispro or insulin glargine, added to pre-study oral antihyperglycaemic medications, in insulin-naïve adults with type 2 diabetes., Material and Methods: The primary outcome was non-inferiority of peglispro to glargine with regard to glycated haemoglobin (HbA1c) reduction (margin = 0.4%). Six gated secondary objectives with statistical multiplicity adjustments focused on other measures of glycaemic control and safety. Liver fat content was measured using MRI, in a subset of patients., Results: Peglispro was non-inferior to glargine in HbA1c reduction [least-squares (LS) mean difference: -0.29%, 95% confidence interval (CI) -0.40, -0.19], and had a lower nocturnal hypoglycaemia rate [relative rate 0.74 (95% CI 0.60, 0.91); p = .005), more patients achieving HbA1c <7.0% without nocturnal hypoglycaemia [odds ratio (OR) 2.15 (95% CI 1.60, 2.89); p < .001], greater HbA1c reduction (p < .001), and more patients achieving HbA1c<7.0% [OR 1.97 (95% CI 1.57, 2.47); p < .001]. Total hypoglycaemia rate and fasting serum glucose did not achieve statistical superiority. At 52 weeks, peglispro-treated patients had higher triglyceride (1.9 vs 1.7 mmol/L). alanine transaminase (34 vs 27 IU/L), and aspartate transaminase levels (27 vs 24 IU/L). LS mean liver fat content was unchanged with peglispro at 52 weeks but decreased 3.1% with glargine [difference: 2.6% (0.9, 4.2); p = .002]. More peglispro-treated patients experienced adverse injection site reactions (3.5% vs 0.6%, p < .001)., Conclusions: Compared with glargine at 52 weeks, peglispro resulted in a statistically superior reduction in HbA1c, more patients achieving HbA1c targets, less nocturnal hypoglycaemia, no improvement in total hypoglycaemia, higher triglyceride levels, higher aminotransferase levels, and more injection site reactions., (© 2016 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)
- Published
- 2016
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17. Similar HbA1c reduction and hypoglycaemia with variable- vs fixed-time dosing of basal insulin peglispro in type 1 diabetes: IMAGINE 7 study.
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Garg S, Selam JL, Bhargava A, Schloot N, Luo J, Zhang Q, Jacobson JG, and Hoogwerf BJ
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- Adult, Blood Glucose metabolism, Cross-Over Studies, Diabetes Mellitus, Type 1 metabolism, Drug Administration Schedule, Female, Glycated Hemoglobin metabolism, Humans, Insulin Lispro administration & dosage, Least-Squares Analysis, Male, Middle Aged, Treatment Outcome, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemia chemically induced, Hypoglycemic Agents administration & dosage, Insulin Lispro analogs & derivatives, Polyethylene Glycols administration & dosage
- Abstract
Aims: To compare 24-hour fixed-time basal insulin peglispro (BIL) dosing with 8- to 40-hour variable-time BIL dosing for glycaemic control and safety in patients with type 1 diabetes. Primary outcome was non-inferiority of BIL variable-time dosing compared with fixed-time dosing for glycated haemoglobin (HbA1c) change after 12-week treatment (margin = 0.4%)., Materials and Methods: This Phase 3, open-label, randomized, cross-over study (N = 212) was conducted at 20 centres in the United States. During the 12-week lead-in phase, patients received BIL daily at fixed-times. Two 12-week randomized cross-over treatment phases followed, where patients received BIL dosed at either fixed- or variable-times. During the 4-week safety follow-up, patients received conventional insulins., Results: During the lead-in period, least-squares mean HbA1c decreased from 7.5% to 6.8%. For BIL, variable-time dosing was non-inferior to fixed-time dosing for HbA1c change [least-squares mean difference = 0.06%, 95% confidence interval (-0.01, 0.13)]. In both regimens, HbA1c increased slightly during the cross-over periods, but remained significantly below baseline. Variable- and fixed-time dosing regimens had similar rates of total hypoglycaemia (10.4 ± 0.62 and 10.5 ± 0.67 events/patient/30 days, P = .947) and nocturnal hypoglycaemia (1.3 ± 0.11 and 1.5 ± 0.13 events/patient/30days, P = .060). Comparable proportions of patients achieved HbA1c < 7.0% with variable- [91 (54.5%)] and fixed-time dosing [101 (60.5%)]., Conclusions: Treatment with BIL allows patients to use flexible dosing intervals from 8 to 40 hours. Glycaemic efficacy (HbA1c), glycaemic variability and hypoglycaemia are similar to fixed-time dosing, suggesting that BIL could potentially provide flexibility in dosing for patients who miss their daily basal insulin., (© 2016 John Wiley & Sons Ltd.)
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- 2016
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18. Skin collagen pentosidine and fluorescence in diabetes were predictors of retinopathy progression and creatininemia increase already 6years after punch-biopsy.
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Sternberg M, M'bemba J, Urios P, Borsos AM, Selam JL, Peyroux J, and Slama G
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- Adult, Albuminuria blood, Albuminuria metabolism, Albuminuria pathology, Arginine chemistry, Arginine metabolism, Biomarkers analysis, Biopsy, Case-Control Studies, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 metabolism, Diabetes Mellitus, Type 1 pathology, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 metabolism, Diabetes Mellitus, Type 2 pathology, Diabetic Angiopathies blood, Diabetic Angiopathies metabolism, Diabetic Angiopathies pathology, Diabetic Nephropathies blood, Diabetic Nephropathies metabolism, Diabetic Nephropathies pathology, Diabetic Retinopathy blood, Diabetic Retinopathy pathology, Disease Progression, Female, Fluorescence, Humans, Longitudinal Studies, Lysine chemistry, Lysine metabolism, Male, Middle Aged, Skin pathology, Spectrometry, Fluorescence, Arginine analogs & derivatives, Collagen metabolism, Creatinine blood, Diabetic Retinopathy metabolism, Lysine analogs & derivatives, Skin metabolism
- Abstract
Objective: Advanced glycation end products (AGEs) of collagens appear to contribute to microvascular complications in diabetes. Do high concentrations of AGEs in skin collagen predict accelerated progression of these complications after 6 years and indicate the need for tighter anti-diabetic treatment?, Design and Methods: We measured two AGE parameters in collagen extracted from skin punch-biopsies: pentosidine and fluorescence at 370/440nm, as markers and predictors of microvascular complications, in 30 patients with diabetes (14 type-1, 16 type-2) without renal insufficiency, and in age- and gender-matched normoglycemic controls, followed at Hôtel-Dieu in Paris., Results: At the time of biopsy, marked increases in pentosidine (p=0.0014) and fluorescence (p=0.0001) expressed per collagen hydroxyproline, were found in the patients with diabetes versus the controls. A significant effect of age was found for pentosidine, but not fluorescence, measurements in the normoglycemic controls. Therefore pentosidine but not fluorescence results were corrected for age in the patients. Pentosidine and fluorescence were correlated with diabetes duration. Fluorescence was significantly dependent on retinopathy presence and score in type-1 and type-2 diabetes, whereas pentosidine was not. Fluorescence was correlated with microalbuminuria only in type-1 diabetes. Neither fluorescence nor pentosidine were correlated with creatininemia. Already six years after biopsy, retinopathy score progression and creatininemia increase were significantly correlated with initial pentosidine and fluorescence measurements., Conclusions: These AGEs are good predictors of progression of microvascular complications and appear to be pathogenic. High skin concentrations of AGEs should induce tighter anti-diabetic treatment., (Copyright © 2015 The Canadian Society of Clinical Chemists. Published by Elsevier Inc. All rights reserved.)
- Published
- 2016
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19. Evolution of diabetes insulin delivery devices.
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Selam JL
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- Diabetes Mellitus economics, Humans, Hypoglycemic Agents economics, Insulin economics, Medication Adherence, Patient Preference, Self Administration economics, Self Administration instrumentation, Self Administration methods, Syringes economics, Diabetes Mellitus drug therapy, Hypoglycemic Agents administration & dosage, Insulin administration & dosage, Insulin Infusion Systems adverse effects, Insulin Infusion Systems economics, Insulin Infusion Systems statistics & numerical data
- Abstract
The first manufactured insulin pump was introduced in the 1970s and the first insulin pens in 1985; since then, many improvements have been made to both devices. The advantages of pens over syringes have been confirmed in numerous studies and include greater accuracy, ease of use, patient satisfaction, quality of life, and adherence. United States claims database analyses indicate that the improved adherence made possible by use of an insulin pen has the potential to reduce diabetes care costs when compared with using a vial and syringe. Features of certain advanced pump models include the ability to connect wirelessly to a blood glucose meter or to a subcutaneous interstitial glucose sensor for semicontinuous glucose-driven insulin rate adjustment. A new trend in the design of insulin pumps is the tubing-free patch pump that adheres directly to the skin. The low rate of insulin pen usage in the United States compared with European countries and the fact that many patients report that they are not offered the option of an insulin pen by their physician suggest that there is a need to increase patient and provider awareness of the currently available devices for insulin administration., ((c) 2010 Diabetes Technology Society.)
- Published
- 2010
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20. Lacosamide in painful diabetic neuropathy: an 18-week double-blind placebo-controlled trial.
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Shaibani A, Fares S, Selam JL, Arslanian A, Simpson J, Sen D, and Bongardt S
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- Acetamides administration & dosage, Acetamides adverse effects, Analgesics, Non-Narcotic administration & dosage, Analgesics, Non-Narcotic adverse effects, Diabetic Neuropathies physiopathology, Double-Blind Method, Female, Humans, Lacosamide, Male, Middle Aged, Pain Measurement, Statistics, Nonparametric, Time Factors, Acetamides therapeutic use, Analgesics, Non-Narcotic therapeutic use, Diabetic Neuropathies drug therapy, Pain drug therapy
- Abstract
Unlabelled: The efficacy and tolerability of oral lacosamide (200, 400, and 600 mg/day) was evaluated in patients with painful diabetic neuropathy in a double-blind, randomized, placebo-controlled trial. The primary target dose to be confirmed was lacosamide 400 mg/day. Efficacy was assessed by changes in pain scale scores from baseline, with changes over the last 4 weeks of the 12-week maintenance period regarded as the primary endpoint. Endpoint reductions in mean pain score were higher with all doses of lacosamide, reaching the level of significance with 400 mg/day (P = .05). Over the treatment period (titration + maintenance), pain relief was significantly higher than placebo with lacosamide 400 (P = .02) and 600 mg/day (P = .03). Lacosamide had an early-onset effect with significant reductions over placebo during the titration period. Nonparametric and mixed-model analysis approaches gave similar results, supporting significant efficacy at 400 mg/day. Secondary criteria such as Patient's Global Impression of Change, responder rates, and pain-free days provided additional support. Adverse events included dizziness, nausea, and headache. Incidence of cognitive and behavioral adverse events was low. This trial suggests that lacosamide has beneficial effects and may be a suitable treatment option for patients with diabetic neuropathic pain., Perspective: This study presents efficacy and safety results of a phase 3, double-blind, placebo-controlled trial of the anticonvulsant drug lacosamide in patients with painful diabetic neuropathy. Lacosamide treatment at a dose of 400 mg/day reduced diabetic neuropathic pain with a favorable safety and tolerability profile that may be suitable for patients with diabetes.
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- 2009
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21. Basal-bolus therapy with insulin detemir using the 303 algorithm in the US PREDICTIVE 303 trial.
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Selam JL and Meneghini LF
- Subjects
- Aged, Blood Glucose drug effects, Blood Glucose metabolism, Blood Glucose Self-Monitoring, Body Weight drug effects, Diabetes Mellitus, Type 2 metabolism, Drug Administration Schedule, Drug Monitoring methods, Female, Glycated Hemoglobin drug effects, Glycated Hemoglobin metabolism, Humans, Insulin administration & dosage, Insulin pharmacology, Insulin Detemir, Insulin, Long-Acting, Linear Models, Male, Middle Aged, Practice Guidelines as Topic, Safety, Treatment Outcome, United States, Algorithms, Diabetes Mellitus, Type 2 drug therapy, Insulin analogs & derivatives, Physician's Role, Self Administration methods
- Abstract
Introduction: The aim of this study was to compare a simplified patient-driven algorithm (303 Algorithm) to physician-driven adjustments in a subset of 193 patients with type 2 diabetes from the PREDICTIVE 303 study who were using basal-bolus insulin therapy., Methods: PREDICTIVE 303 was a 26-week, randomized, phase 4 study, in which subjects were either instructed to adjust their insulin detemir dose every 3 days by +/-3 units if mean fasting plasma glucose (FPG) values were above 110 mg/dL or below 80 mg/dL (303 Algorithm), or had physicians adjust the insulin detemir dose according to usual practice (Standard-of-care)., Results: Patients in both groups achieved similar reductions in glycated hemoglobin (-0.2% and -0.3% for 303 Algorithm and Standard-of care groups, respectively; between groups P=0.60). 303 Algorithm group patients achieved a greater reduction in FPG (-21.3 mg/dL vs. 0.2 mg/dL; between groups P=0.03). Both 303 Algorithm and Standard-of care groups experienced a similar rate of overall hypoglycemia, and similar weight reduction (-1.7 kg and -0.4 kg, respectively; between groups P=0.07). Over 82% of patients in both groups used insulin detemir once daily., Conclusions: Adjustments of a once-daily detemir dose by patients using the 303 Algorithm in a basal-bolus setting is equally effective in improving glycemic control in patients with type 2 diabetes compared with physician-directed basal dose adjustments.
- Published
- 2009
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22. The usage of a simplified self-titration dosing guideline (303 Algorithm) for insulin detemir in patients with type 2 diabetes--results of the randomized, controlled PREDICTIVE 303 study.
- Author
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Meneghini L, Koenen C, Weng W, and Selam JL
- Subjects
- Blood Glucose analysis, Diabetes Mellitus, Type 2 drug therapy, Dose-Response Relationship, Drug, Drug Administration Schedule, Female, Humans, Insulin metabolism, Insulin pharmacology, Insulin therapeutic use, Insulin Detemir, Insulin, Long-Acting, Male, Middle Aged, Treatment Outcome, Hypoglycemic Agents therapeutic use, Insulin analogs & derivatives
- Abstract
The Predictable Results and Experience in Diabetes through Intensification and Control to Target: An International Variability Evaluation 303 (PREDICTIVE 303) Study (n = 5604) evaluated the effectiveness of insulin detemir, a long-acting basal insulin analogue, using a simplified patient self-adjusted dosing algorithm (303 Algorithm group) compared with standard-of-care physician-driven adjustments (Standard-of-care group) in a predominantly primary care setting, over a period of 6 months. Insulin detemir was to be started once-daily as add-on therapy to any other glucose-lowering regimens or as a replacement of prestudy basal insulin in patients with type 2 diabetes. Investigator sites rather than individual patients were randomized to either the 303 Algorithm group or the Standard-of-care group. Patients from the 303 Algorithm group sites were instructed to adjust their insulin detemir dose every 3 days based on the mean of three 'adjusted' fasting plasma glucose (aFPG) values (capillary blood glucose calibrated to equivalent plasma glucose values) using a simple algorithm: mean aFPG < 80 mg/dl (<4.4 mmol/l), reduce dose by 3 U; aFPG between 80 and 110 mg/dl (4.4-6.1 mmol/l), no change; and aFPG > 110 mg/dl (>1.1 mmol/l), increase dose by 3 U. The insulin detemir dose for patients in the Standard-of-care group was adjusted by the investigator according to the standard of care. Mean A1C decreased from 8.5% at baseline to 7.9% at 26 weeks for the 303 Algorithm group and from 8.5 to 8.0% for the Standard-of-care group (p = 0.0106 for difference in A1C reduction between the two groups). Mean FPG values decreased from 175 mg/dl (9.7 mmol/l) at baseline to 141 mg/dl (7.8 mmol/l) for the 303 Algorithm group and decreased from 174 mg/dl (9.7 mmol/l) to 152 mg/dl (8.4 mmol/l) for the Standard-of-care group (p < 0.0001 for difference in FPG reduction between the two groups). Mean body weight remained the same at 26 weeks in both groups (change from baseline 0.1 and -0.2 kg for the 303 Algorithm group and the Standard-of-care group respectively). At 26 weeks, 91% of the patients in the 303 Algorithm group and 85% of the patients in the Standard-of-care group remained on once-daily insulin detemir administration. The rates of overall hypoglycaemia (events/patient/year) decreased significantly from baseline in both groups [from 9.05 to 6.44 for the 303 Algorithm group (p = 0.0039) and from 9.53 to 4.95 for the Standard-of-care group (p < 0.0001)]. Major hypoglycaemic events were rare in both groups (0.26 events/patient/year for the 303 Algorithm group and 0.20 events/patient/year for the Standard-of-care group; p = 0.2395). In conclusion, patients in the 303 Algorithm group achieved comparable glycaemic control with higher rate of hypoglycaemia as compared with patients in the Standard-of-care group, possibly because of more aggressive insulin dose adjustments. The vast majority of the patients in both groups were effectively treated with once-daily insulin detemir therapy. The use of insulin detemir in this predominantly primary care setting achieved significant improvements in glycaemic control with minimal risk of hypoglycaemia and no weight gain.
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- 2007
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23. Cyclic relationships between diabetic nephropathy and cardiovascular risk factors.
- Author
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Charles MA and Selam JL
- Abstract
The most common cause of death in diabetes is cardiovascular. Diabetic nephropathy has an important role in cardiovascular disease among susceptible diabetic patients. What is not well appreciated is that independent cardiovascular death risk factors (e.g., hypertension, hyperglycemia, dyslipidemias and microalbuminuria) may each have a cyclic relationship with diabetic nephropathy. Thus, as discussed in this review, each risk factor may aggravate diabetic nephropathy, increasing the likelihood of end-stage renal disease. Diabetic nephropathy in turn may aggravate each of the risk factors, increasing the likelihood of a cardiovascular event. These cardiovascular risk factors, amplified by vicious cycles with diabetic nephropathy, may then lead to accelerated cardiovascular morbidity and mortality.
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- 2005
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24. Association between a protein polymorphism in the start codon of the vitamin D receptor gene and severe diabetic retinopathy in C-peptide-negative type 1 diabetes.
- Author
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Taverna MJ, Selam JL, and Slama G
- Subjects
- Adult, C-Peptide blood, Case-Control Studies, Codon, Initiator, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 epidemiology, Diabetic Nephropathies blood, Diabetic Nephropathies epidemiology, Diabetic Nephropathies genetics, Diabetic Retinopathy blood, Diabetic Retinopathy epidemiology, Female, Glycated Hemoglobin metabolism, Humans, Male, Middle Aged, Risk Factors, Severity of Illness Index, White People genetics, Diabetes Mellitus, Type 1 genetics, Diabetic Retinopathy genetics, Polymorphism, Genetic, Receptors, Calcitriol genetics
- Abstract
Context: The vitamin D (VD) receptor (VDR) is extensively expressed in retina. The plasma concentration of 1,25-dihydroxyvitamin D3 has been inversely correlated with the severity of diabetic retinopathy (DR), which raises the possibility that VD, through its antiinflammatory, antioxidant, antiproliferative, and antiangiogenic properties, may protect diabetic retina. The TaqI VDR polymorphism has been associated with severe DR. The FokI VDR polymorphism is a T-to-C substitution in the first codon (f allele), abolishing the first translation initiation site and resulting in a peptide lacking three amino acids (F allele), which increases the transcriptional activity of VDR., Objective and Design: To examine whether FokI polymorphism is involved in severe DR, 254 Caucasians with longstanding C-peptide-negative type 1 diabetes, 128 patients with absent/mild DR (control group), and 126 patients with preproliferative/proliferative DR (study group) were genotyped using PCR-restriction fragment length polymorphism analysis., Results: The genotype distribution was in Hardy-Weinberg equilibrium and was different between groups (P = 0.046). The frequency of F allele was significantly higher in the control (66.4%) than in the study group (56%, odds ratio = 0.64, 95% confidence interval 0.44-0.92, P = 0.016). In subjects with fewer than 25 yr of diabetes duration (median value, n = 134), this association was strongly increased (P = 0.0008)., Conclusions: In conclusion, we observed, in a cohort of Caucasians with C-peptide-negative type 1 diabetes, a novel association between the functional FokI VDR polymorphism and severe DR, especially among subjects with fewer than 25 yr of diabetes duration.
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- 2005
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25. The T-786C and C774T endothelial nitric oxide synthase gene polymorphisms independently affect the onset pattern of severe diabetic retinopathy.
- Author
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Taverna MJ, Elgrably F, Selmi H, Selam JL, and Slama G
- Subjects
- Adult, Age of Onset, Case-Control Studies, Diabetes Mellitus, Type 1 complications, Diabetes Mellitus, Type 1 genetics, Female, Genotype, Humans, Male, Middle Aged, Nitric Oxide Synthase Type III, Diabetic Retinopathy genetics, Nitric Oxide Synthase genetics, Polymorphism, Genetic
- Abstract
Genetic factors could be implicated in the pathogenesis of severe diabetic retinopathy (DR). Recently, we reported a strong association between the eNOS4b/a endothelial nitric oxide synthase (eNOS) polymorphism and severe DR. To examine whether T-786C and C774T eNOS polymorphisms are involved in severe DR, 254 Caucasians with longstanding C-peptide-negative type 1 diabetes, 128 patients with absent/mild DR (control group), and 126 patients with preproliferative/proliferative DR (study group) were genotyped. The distribution of T-786C and C774T eNOS polymorphisms was in Hardy-Weinberg equilibrium and did not differ between the study and control groups. However, in case patients (n=126), T-786C and C774T polymorphisms influenced the onset pattern of severe DR (P=0.0169 and P=0.0257, respectively). The C-786C genotype was associated with early-onset severe DR (duration of diabetes: 15.2+/-5.9 vs. 19.4+/-6.3 years, P=0.0105), and the homozygous T774T genotype was associated with late-onset severe DR (24.3+/-7.0 vs. 18.4+/-6.2 years, P=0.0067). In the case of patients with high glycosylated hemoglobin levels (HbA1c >8%, n=88), the association between the T-786C polymorphism and early-onset severe DR was stronger (P=0.0068). Case patients carrying the C-786C genotype had higher HbA1c values (9.61+/-1.89%) than those carrying the T-786T genotype (8.93+/-1.47%, P=0.0173). Multivariate analysis showed that T-786C polymorphism was the best independent factor for onset pattern of severe DR (P<0.001). These findings, supported by previous associations between eNOS4b/a polymorphism and DR, suggest that T-786C and C774T eNOS polymorphisms affect the onset pattern of severe DR.
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- 2005
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26. Insulin detemir used in basal-bolus therapy in people with type 1 diabetes is associated with a lower risk of nocturnal hypoglycaemia and less weight gain over 12 months in comparison to NPH insulin.
- Author
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De Leeuw I, Vague P, Selam JL, Skeie S, Lang H, Draeger E, and Elte JW
- Subjects
- Adult, Blood Glucose analysis, Blood Glucose metabolism, Body Weight drug effects, Diabetes Mellitus, Type 1 blood, Drug Administration Schedule, Female, Glycated Hemoglobin analysis, Humans, Insulin therapeutic use, Insulin Detemir, Insulin, Isophane therapeutic use, Insulin, Long-Acting, Male, Diabetes Mellitus, Type 1 drug therapy, Insulin administration & dosage, Insulin analogs & derivatives, Insulin, Isophane administration & dosage
- Abstract
Aim: The aim of this study was to compare the long-term safety and efficacy of twice-daily insulin detemir or NPH insulin as the basal component of basal-bolus therapy in people with type 1 diabetes., Methods: A multicentre, open-label, parallel-group study was conducted over 12 months and completed by 308 people (from an original randomized cohort of 428). Patients were randomized in a 2:1 ratio to receive insulin detemir or NPH insulin before breakfast and dinner, with insulin aspart at mealtimes., Results: Glycaemic control improved in both groups with HbA(1c) decreasing by 0.64 and 0.56% point in the insulin detemir and NPH insulin groups, reaching baseline-adjusted final values of 7.53 +/- 0.10% and 7.59 +/- 0.13%, respectively. No significant difference was apparent between treatments in terms of HbA(1c), fasting plasma glucose or 9-point blood glucose profiles. Fewer hypoglycaemic events (major and minor) occurred in association with insulin detemir compared with NPH insulin, but the overall hypoglycaemic risk did not differ statistically significantly (RR for detemir, 0.78 [0.56-1.08]). However, the risk of nocturnal hypoglycaemia during the maintenance phase (month 2-12) was 32% lower in the detemir group (p = 0.02) and lower in every month. This risk reduction remained statistically significant after correction for HbA(1c). After 12 months, baseline-adjusted mean body weight was significantly lower in the insulin detemir group than in the NPH insulin group (p < 0.001)., Conclusions: In long-term basal-bolus therapy, insulin detemir with insulin aspart as mealtime insulin is well tolerated and reduces the risks of nocturnal hypoglycaemia and weight gain compared to NPH insulin.
- Published
- 2005
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27. Benefits and risks of solitary islet transplantation for type 1 diabetes using steroid-sparing immunosuppression.
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Charles MA and Selam JL
- Subjects
- Adrenal Cortex Hormones therapeutic use, Diabetes Mellitus, Type 1 immunology, Humans, Immunosuppression Therapy adverse effects, Immunosuppression Therapy methods, Risk Assessment, Diabetes Mellitus, Type 1 surgery, Islets of Langerhans Transplantation adverse effects, Islets of Langerhans Transplantation mortality
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- 2004
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28. Inhaled insulin for the treatment of diabetes: projects and devices.
- Author
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Selam JL
- Subjects
- Administration, Inhalation, Humans, Nebulizers and Vaporizers, Diabetes Mellitus drug therapy, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents therapeutic use, Insulin administration & dosage, Insulin therapeutic use
- Abstract
A non-invasive alternative to insulin injections would represent a major improvement for Type 1 and 2 insulin-treated patients. The lung is the only route which allows bio-availability of insulin, approaching 10% without absorption enhancers. However, the reproducibility of the plasma response to the pulmonary insulin is similar to subcutaneous insulin analogues, that is to say, relatively poor. In the Exubera Project, the device is a dry powder inhaler. The insulin powder (Aventis) is packaged into a single dose blister containing 1 or 3 mg; the 1 mg blister corresponding to approximately 3 U of insulin. Phase II studies have shown similar efficacy than regular insulin. Data are available on 328 Type 1 and 309 Type 2 patients after 6 months of Phase III trials. The inhaled insulin group developed increased insulin antibodies. A total of 25% of the patients experienced cough after inhalation. The number of overall and severe hypoglycaemic episodes were similar in the two groups. Pulmonary function tests remained stable and normal except for minor reductions of carbon monoxide diffusion capacity. The AERx IDMS system is a microprocessor-controlled, aqeous mist inhaler. The insulin (regular 100 U/ml, Novo Nordisk) is delivered by 1 U increments. The clinical experience reported with this system so far is limited to 107 Type 2 insulin-treated patients. The results are similar to those obtained in the Exubera trials. In the Alkermes project, large, porous, regular insulin of low-mass density have been developed by the Advanced Inhalation Project. Results from human studies in normal subjects show similar pharmacokinetics as the two other devices above. Other projects seem less advanced than the projects cited above e.g., Aerodos and Oralin. Current clinical experience with inhaled insulin seems promising. It represents currently the only viable non-invasive alternative to insulin injections. However, long-term local tolerance of the pulmonary tissue is a crucial issue.
- Published
- 2003
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29. [Type I diabetes in adults and children].
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Selam JL
- Subjects
- Adult, Age Distribution, Child, Diagnosis, Differential, Diet, Diabetic, Disease Progression, Exercise, France epidemiology, Genetic Predisposition to Disease genetics, Global Health, Humans, Hypoglycemic Agents therapeutic use, Life Style, Risk Factors, Diabetes Mellitus, Type 1 diagnosis, Diabetes Mellitus, Type 1 epidemiology, Diabetes Mellitus, Type 1 etiology, Diabetes Mellitus, Type 1 therapy
- Published
- 2003
30. Insulin detemir is associated with more predictable glycemic control and reduced risk of hypoglycemia than NPH insulin in patients with type 1 diabetes on a basal-bolus regimen with premeal insulin aspart.
- Author
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Vague P, Selam JL, Skeie S, De Leeuw I, Elte JW, Haahr H, Kristensen A, and Draeger E
- Subjects
- Adult, Body Weight, Carrier Proteins adverse effects, Diabetes Mellitus, Type 1 blood, Eating, Female, Glycated Hemoglobin analysis, Humans, Hypoglycemia epidemiology, Hypoglycemic Agents administration & dosage, Incidence, Insulin analogs & derivatives, Insulin Aspart, Insulin Detemir, Insulin, Isophane administration & dosage, Insulin, Long-Acting, Male, Middle Aged, Risk Factors, Blood Glucose metabolism, Carrier Proteins administration & dosage, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemia chemically induced, Hypoglycemic Agents adverse effects, Insulin administration & dosage, Insulin adverse effects, Insulin, Isophane adverse effects
- Abstract
Objective: Insulin detemir is a soluble basal insulin analog with a unique mechanism of protracted action designed to reduce the variability associated with conventional basal insulins. This trial compared the glycemic control, risk of hypoglycemia, and effect on body weight of insulin detemir and NPH insulin in patients with type 1 diabetes treated with rapid-acting insulin aspart at meals., Research Design and Methods: This study was a 6-month multinational open parallel-group comparison conducted at 46 centers in five countries and included 448 patients with type 1 diabetes randomized 2:1 to insulin detemir or NPH insulin, respectively., Results: After 6 months, comparable HbA(1c) levels were found between the two treatment groups. Fasting plasma glucose tended to be lower in patients treated with insulin detemir, but this difference was not statistically significant (-0.76 mmol/l, P = 0.097). Within-subject variation in self-measured fasting blood glucose was lower with insulin detemir than with NPH insulin (SD 3.37 vs. 3.78 mmol/l, P < 0.001). Risk of hypoglycemia was 22% lower with insulin detemir than with NPH insulin (P < 0.05) and 34% lower for nocturnal (2300-0600) hypoglycemia (P < 0.005). Nightly plasma glucose profiles were smoother and more stable with insulin detemir (P = 0.05). Body weight was significantly lower with insulin detemir at the end of the trial (P < 0.001)., Conclusions: Treatment with insulin detemir resulted in more predictable glycemic control, with smoother plasma glucose profiles than NPH insulin and a significant reduction in the risk of hypoglycemia. The reduction in body weight with insulin detemir is a potential additional advantage. Regimens optimized for insulin detemir may be able to improve glycemic control beyond that possible with NPH insulin.
- Published
- 2003
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31. eNOS4 polymorphism of the endothelial nitric oxide synthase predicts risk for severe diabetic retinopathy.
- Author
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Taverna MJ, Sola A, Guyot-Argenton C, Pacher N, Bruzzo F, Chevalier A, Slama G, Reach G, and Selam JL
- Subjects
- Adult, Age of Onset, Alleles, DNA Primers, Databases, Factual, Diabetes Mellitus, Type 1 complications, Diabetic Retinopathy epidemiology, Endothelium, Vascular enzymology, Female, France, Genetic Carrier Screening, Genotype, Humans, Male, Middle Aged, Nitric Oxide Synthase Type III, Odds Ratio, Predictive Value of Tests, Risk Factors, White People genetics, Diabetes Mellitus, Type 1 genetics, Diabetic Retinopathy genetics, Nitric Oxide Synthase genetics, Polymorphism, Genetic
- Abstract
Background: Genetic factors may be involved in the development, and particularly in the severity, of diabetic retinopathy (DR), in addition to chronic hyperglycaemia. Increased nitric oxide generation has been suggested to play a significant role in the pathogenesis of DR., Aims and Methods: To examine whether the eNOS4 is involved in the risk of severe DR, 200 unrelated Caucasian Type 1 diabetic patients of long duration were randomly selected (M/F 103/97, age 44.4 +/- 12.4 years, diabetes duration 27.7 +/- 10.0 years, body mass index 24.3 +/- 3.4 kg/m2, HbA1c 8.6 +/- 1.3%). The eNOS4 polymorphism was analysed by polymerase chain reaction, and DR by retinal angiography and classified as presence (n = 101) or absence (n = 99) of severe (proliferative or pre-proliferative) DR., Results: The genotype distribution of eNOS4b/b (wild-type), eNOS4b/a (heterozygous) and eNOS4a/a (homozygous) was 72%, 24.5% and 3.5%, respectively. Frequency of eNOS4a/a was significantly lower in patients with severe DR (n = 0) when compared with controls (n = 7, odds ratio (OR) = 0 (95% confidence interval (CI) = 0.5-0.74), P = 0.02). eNOS4b/b was more frequent in patients with severe DR (n = 80) when compared with controls (n = 64, OR = 2.1 (95% CI = 1.1-4.12), P = 0.032). Frequency of eNOS4b/a was not different between the study (n = 21) and control groups (n = 28, ns). The allelic frequencies between the study and control groups were different (4b: n = 181 vs. n = 156, respectively, OR = 2.3 (95% CI = 1.27-4.25), P = 0.005; 4a: n = 21 vs. n = 42, respectively, OR = 0.4 (95% CI = 0.24-0.79), P = 0.005)., Conclusions: We demonstrate in Caucasians with Type 1 diabetes that (i) eNOS4a/a is associated with absent or non-severe DR, and (ii) eNOS4b/b is associated with severe DR.
- Published
- 2002
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32. Taq I polymorphism of the vitamin D receptor and risk of severe diabetic retinopathy.
- Author
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Taverna MJ, Sola A, Guyot-Argenton C, Pacher N, Bruzzo F, Slama G, Reach G, and Selam JL
- Subjects
- Adult, Age of Onset, C-Peptide blood, DNA blood, DNA genetics, Diabetes Mellitus, Type 1 blood, Female, Genotype, Humans, Male, Middle Aged, Polymerase Chain Reaction, Reference Values, Restriction Mapping, Risk Factors, Deoxyribonucleases, Type II Site-Specific genetics, Diabetes Mellitus, Type 1 genetics, Diabetic Retinopathy epidemiology, Polymorphism, Genetic, Receptors, Calcitriol genetics
- Abstract
Aims/hypothesis: Vitamin D, a molecule with antiproliferative, antiangiogenic, antioxidant and immunosuppressive effects, could play a role in the pathogenesis of severe diabetic retinopathy. We examined whether Taq I polymorphism of the vitamin D receptor is involved in the development of severe diabetic retinopathy., Methods: 200 unrelated C-peptide-negative French Type I diabetic patients were randomly selected (male:female, 103:97, age 44.4 +/- 12.4 years, diabetes duration: 27.7 +/- 10.0 years, BMI: 24.3 +/- 3.4 kg/m(2), HbA(1c): 8.6 +/- 1.3 %). The Taq I site was analysed by PCR followed by digestion with Taq I enzyme. Diabetic retinopathy was assessed by retinal angiography and classified as presence (n = 101) or absence (n = 99) of severe (preproliferative or proliferative) diabetic retinopathy., Results: Frequency of wild-type genotype TT was lower in patients with severe diabetic retinopathy (n = 27) when compared with control subjects (n = 42, OR = 0.5, p = 0.028). Allele frequencies were not different between patients (T: n = 112 and t: n = 90) and control subjects (T: n = 128, and t: n = 70, p = 0.075). Global chi(2) (df = 2): p = 0.064. In subjects with diabetes duration of more than 25 years, TT was lower in severe diabetic retinopathy (n = 14) than control subjects (n = 18, OR = 0.3, p = 0.01). Allele frequencies were different between patients (T: n = 68 and t: n = 66) and control subjects (T: n = 52, OR = 0.5, and t: n = 26, OR = 1.9, p = 0.034). Global chi(2) (df = 2): p = 0.024. In subjects with HbA(1c) over 9 %, Tt was higher in patients (n = 28) than control subjects (n = 15, OR = 3.1, p = 0.019). Allele frequencies were not different between patients (T: n = 52 and t: n = 38) and control subjects (T: n = 57, and t: n = 29, p = 0.31). Global chi(2) (df = 2): p = 0.035., Conclusion/interpretation: In French Type I (insulin-dependent) diabetic patients, we demonstrate an association between TT form (VDR) and low risk for severe diabetic retinopathy, especially in patients with long duration, and between Tt variant and high risk for severe diabetic retinopathy in subjects with poor glycaemic control.
- Published
- 2002
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33. [Inhaled insulin: clinical results in type 2 diabetic patients].
- Author
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Selam JL
- Subjects
- Administration, Inhalation, Clinical Trials as Topic, Hypoglycemic Agents adverse effects, Hypoglycemic Agents pharmacokinetics, Hypoglycemic Agents therapeutic use, Insulin adverse effects, Insulin pharmacokinetics, Insulin therapeutic use, Pulmonary Circulation, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemic Agents administration & dosage, Insulin administration & dosage
- Abstract
French type 2 diabetic patients are underinsulinised mainly because of fear of injections. Among all alternatives to the subcutaneous route, only the lung has a sufficient bioavailability of 10% without addition of promoters. This is made possible by the large surface and thinness of the alveolo-capillary barrier, and only if insulin particles have an ideal size (2-3 microns). The Pfizer-Aventis-Inhale project utilises powder aerosolisation, whether the Novo-Aradigm project utilises liquid nebulization. In the former project, phase 1 studies have shown plasma kinetics similar to subcutaneous lispro, and intrasubject reproducibility non significantly different from rapid and lispro insulins. Phase 2 studies, performed on more than 200 insulin-treated and non insulin-treated subjects have shown an efficacy similar to subcutaneous insulin, with no difference in terms of side-effects (hypoglycaemia, weight gain) and a satisfactory 1-year local tolerance, as evaluated by functional tests. Phase 3 studies, performed on 1400 subjects have just been completed and are not published yet. Though results are promising, some important questions remain to be clarified: long term tolerance, miniaturisation of the inhaler, overcost, and long-term acceptability, especially in type 2 patients. It already appears that the major potential indications may be "functional" (flexible) insulin therapy of type 1 diabetes and early insulinisation of type 2 patients with oral drugs failure.
- Published
- 2001
34. Sildenafil citrate for the treatment of erectile dysfunction in men with Type II diabetes mellitus.
- Author
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Boulton AJ, Selam JL, Sweeney M, and Ziegler D
- Subjects
- 3',5'-Cyclic-GMP Phosphodiesterases antagonists & inhibitors, Adult, Aged, Aged, 80 and over, Diabetes Mellitus, Type 2 blood, Double-Blind Method, Glycated Hemoglobin analysis, Humans, Male, Middle Aged, Placebos, Purines, Sildenafil Citrate, Sulfones, Treatment Outcome, Diabetes Mellitus, Type 2 complications, Erectile Dysfunction drug therapy, Erectile Dysfunction etiology, Phosphodiesterase Inhibitors therapeutic use, Piperazines therapeutic use
- Abstract
Aims/hypothesis: Ninety percent of all men with diabetes have Type II (non-insulin-dependent) diabetes mellitus, and erectile dysfunction (ED) is common in this patient group. This study evaluated the effects of sildenafil on men with erectile dysfunction and Type II diabetes and compared the results with glycated haemoglobin concentrations and chronic diabetic complications., Methods: Patients (mean age, 59 years) in this double-blind, placebo-controlled trial were randomised to sildenafil (25-100 mg; n = 110) or matching placebo (n = 109) for 12 weeks. Primary criteria for efficacy included questions 3 (achieving an erection) and 4 (maintaining an erection) from the International Index of Erectile Function (IIEF, score range, 0-5). Secondary outcome measures included a global efficacy question (GEQ), patient event logs, a life satisfaction checklist, and the remaining IIEF questions., Results: After 12 weeks, the mean scores for questions 3 and 4 had improved significantly in patients receiving sildenafil (3.42 +/- 0.23 and 3.35 +/- 0.24) compared with placebo (1.86 +/- 0.22 and 1.84 +/- 0.23; p < 0.0001). Similarly, the GEQ score was higher in the sildenafil (64.6 %) than the placebo group (10.5 %). Even when correlating efficacy with glycated haemoglobin concentrations ( < or = 8.3 % or > 8.3 %, the median concentration found in this study) or the number of diabetic complications (0 or > or = 1), the mean scores for the GEQ and questions 3 and 4 from the IIEF remained higher for all the sildenafil groups compared with the placebo groups (p < 0.0001)., Conclusion/interpretation: Sildenafil was well-tolerated and effective in improving erectile dysfunction in men with Type II diabetes, even in patients with poor glycaemic control and chronic complications.
- Published
- 2001
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35. Efficacy and tolerance of intranasal insulin administered during 4 months in severely hyperglycaemic Type 2 diabetic patients with oral drug failure: a cross-over study.
- Author
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Lalej-Bennis D, Boillot J, Bardin C, Zirinis P, Coste A, Escudier E, Chast F, Peynegre R, Selam JL, and Slama G
- Subjects
- Adult, Aged, Cross-Over Studies, Diabetes Mellitus, Type 2 blood, Glycated Hemoglobin metabolism, Humans, Insulin blood, Insulin, Isophane adverse effects, Insulin, Isophane pharmacokinetics, Insulin, Isophane therapeutic use, Middle Aged, Patient Selection, Treatment Failure, Administration, Intranasal, Diabetes Mellitus, Type 2 drug therapy, Hyperglycemia blood, Hypoglycemic Agents therapeutic use, Insulin, Isophane administration & dosage
- Abstract
Aims: We have evaluated the local tolerance and the metabolic efficacy of a lyophilized nasal insulin preparation in 10 severely hyperglycaemic Type 2 diabetic patients., Methods: The study included two 4-month randomized periods: (A) three preprandial doses of nasal insulin secondarily combined with one evening subcutaneous NPH if the desired glycaemic control was not achieved; (B) two NPH injections daily. We assessed: (i) diabetes control on monthly HbA1c levels and occurrence of hypoglycaemic events; (ii) local tolerance on clinical symptoms, rhinoscopy, nasal muco-ciliary clearance and nasal biopsies; (iii) insulin absorption at months 0 and 4., Results: One patient was withdrawn because of cough and dizziness after each nasal application. HbA1c was not significantly different at month 4 (9.4 +/- 0.5% vs. 8.8 +/- 0.2%, A vs. B). Blood glucose control remained only fair in the majority of our patients. Nasal insulin was able to replace the daytime fraction of the subcutaneous insulin with a 18% efficacy. Side-effects included transient nasal hyperactivity (pruritus, sneezing and rhinorrhoea) and chronic persistence of nasal crusts. Plasma insulin profiles were not significantly different between months 0 and 4., Conclusions: The utilization of nasal insulin (with or without NPH) was associated with similar diabetes control compared with NPH twice daily. Nasal insulin alone was able to achieve an adequate glycaemic control in three of the 10 patients.
- Published
- 2001
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36. Beta-cell function evaluated by HOMA as a predictor of secondary sulphonylurea failure in Type 2 diabetes.
- Author
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Taverna MJ, Pacher N, Bruzzo F, Slama G, and Selam JL
- Subjects
- Biomarkers blood, Calibration, Diabetes Mellitus, Type 2 drug therapy, Female, Glyburide therapeutic use, Humans, Insulin metabolism, Insulin Secretion, Male, Middle Aged, Predictive Value of Tests, Sensitivity and Specificity, Treatment Failure, Blood Glucose metabolism, Diabetes Mellitus, Type 2 blood, Glycated Hemoglobin analysis, Insulin blood, Insulin therapeutic use, Islets of Langerhans metabolism, Sulfonylurea Compounds therapeutic use
- Abstract
Background and Aims: Secondary failure to oral hypoglycaemic agents, a common evolution of long-standing Type 2 diabetes, is usually assessed by non-standardized indices requiring fine clinical assessment, including hyperglycaemia resistant to maximum doses of sulphonylureas despite appropriate diet and follow-up. The goal of this study was to evaluate if HOMA, a modelized plasma insulin/glucose ratio allowing simple evaluation of residual insulin secretion and sensitivity, is a better predictor of the insulin requiring stage than clinical indices., Materials and Methods: HOMA was measured in 84 Type 2 diabetic patients aged 58 +/- SD 6 years, with diabetes duration 11 +/- 4 years, hospitalized because of hyperglycaemia resistant to maximal doses of sulphonylureas (e.g. glibenclamide > or = 15 mg/day), with no apparent external reason for hyperglycaemia. Despite reinforced appropriate diet recommendations, 62 of these patients remained hyperglycaemic (insulin-requiring group)., Results: Age, duration of diabetes, body mass index (BMI) and HOMA value for insulin sensitivity (71 +/- 6% vs. 76 +/- 7%, normal values 59-161%) were comparable in the two groups. HbA(1c) was higher (10.0 +/- 0.2% vs. 8.3 +/- 0.3%, P < 0.001) and HOMA insulin secretion values lower (25 +/- 2% vs. 43 +/- 6%, normal values 70-150%, P < 0.01) in the insulin-requiring group. Of the following potential predictors: HbA(1c) > 8%, duration of diabetes > or = 10 years, HbA(1c) combined with diabetes duration, insulin sensitivity < or = 40%, insulin secretion < or = 20%, the latter showed the best positive predictivity (86% patients with low insulin secretion were insulin-requiring)., Conclusions: (i) HOMA is a simple and good predictor of the insulin-requiring stage in Type 2 diabetes mellitus; (ii) this stage of diabetes is characterized by a further decline of insulin secretion rather than of insulin sensitivity. Diabet. Med. 18, 584-588 (2001)
- Published
- 2001
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37. Six month administration of gelified intranasal insulin in 16 type 1 diabetic patients under multiple injections: efficacy vs subcutaneous injections and local tolerance.
- Author
-
Lalej-Bennis D, Boillot J, Bardin C, Zirinis P, Coste A, Escudier E, Chast F, Peynegre R, Slama G, and Selam JL
- Subjects
- Administration, Intranasal, Adult, Cross-Over Studies, Diabetes Mellitus, Type 1 blood, Drug Administration Schedule, Glycated Hemoglobin analysis, Humans, Hyperglycemia epidemiology, Hypoglycemic Agents administration & dosage, Hypoglycemic Agents adverse effects, Hypoglycemic Agents therapeutic use, Inflammation, Injections, Subcutaneous, Insulin, Isophane adverse effects, Insulin, Isophane therapeutic use, Nasal Mucosa drug effects, Nasal Mucosa pathology, Sinusitis etiology, Diabetes Mellitus, Type 1 drug therapy, Insulin, Isophane administration & dosage
- Abstract
Objective: Nasal insulin administration is a potential route for intensive insulin management, less invasive and more rapid than subcutaneous injections. Previous studies have shown poor bioavailability (less than 15%) with nasal insulin administration with various absorption enhancers. The aim of the study was to evaluate in type 1 diabetic patients, the metabolic efficacy and local tolerance of a new gelified sprayed nasal insulin containing glychocolate and methylcellulose as absorption promoters., Material and Methods: The study was conducted in 16 type 1 diabetic patients (HbA1c 8.6+/-0.2%) in a cross-over trial including 2 six month randomized periods: a) NPH twice daily + 3 pre-prandial nasal insulin doses + nasal supplementation in case of unexpected hyperglycaemia; b) NPH twice daily + 3 pre-prandial regular insulin injections. End points were HbA1c levels, hypoglycaemic episodes and tolerance evaluated at month 0, 2, 6 and 8 on clinical symptoms and objective nasal assessments., Results: Four patients were withdrawn because of nasal burning (3 cases) and persistent sinusitis (1 case), and one patient had purulent sinusitis at the month 6 examination. At month 6, HbA1c levels were comparable (8.3 +/- 0.1 vs 8.6 +/- 0.1%, m +/- SEM, NS) for nasal and subcutaneous period respectively. The number of hypoglycaemic events was identical during the 2 periods (88 episodes). Nasal tolerance with the gelified form was better than with the already reported lyophilized form but, when present, symptoms were more marked, suggesting a potentiating additional role of methylcellulose excipient on nasal intolerance., Conclusions: 1) Gelified nasal insulin is as efficient as subcutaneous regular insulin in type 1 diabetic patients. 2) Other galenic forms should be investigated to improve nasal tolerance and bioavailability.
- Published
- 2001
38. External and implantable insulin pumps: current place in the treatment of diabetes.
- Author
-
Selam JL
- Subjects
- Equipment Design, Humans, Infusion Pumps, Prostheses and Implants, Diabetes Mellitus drug therapy, Insulin administration & dosage
- Abstract
External insulin infusion (CSII) pumps have regained interest since DCCT, the number of patients approaching 100,000 in the USA. Only 2 manufacturers (Minimed, Disetronic) and 2 insulins (lispro, insuman) are sharing the market. The major advantages over multiple s.c. injections (MDI) are a reduction of nightly instability and hypoglycemia, and time flexibility. Patients poorly controlled under MDI and/or with recurrent hypoglycemias thus represent the best indications. Pumps are predicted to expand in some european countries e.g. France with changes in reimbursement regulations. Implantable insulin pumps are still not commercialized except in few countries e.g. France. Therefore only 1065 pumps have been implanted worldwide so far. The only material available is the Minimed 2007 pump, with the Aventis Genapol insulin. The catheter is intraperitoneal for portal insulin absorption. Metabolic results are better than CSII in terms of glycemic fluctuations and hypoglycemias. Adverse events are limited to catheter obstructions (15% per patient-year). Ideally, indications should be restricted only to patients with recurrent severe hypoglycemias and/or poor control with CSII because of high cost of the pump ($ 15,000).
- Published
- 2001
- Full Text
- View/download PDF
39. [How to prescribing Viagra in practice...].
- Author
-
Lalej-Bennis D, Sellam R, Selam JL, and Slama G
- Subjects
- Cardiovascular Diseases complications, Cardiovascular Diseases physiopathology, Contraindications, Diabetes Complications, Diabetic Angiopathies physiopathology, Erectile Dysfunction etiology, Humans, Male, Myocardial Ischemia complications, Myocardial Ischemia physiopathology, Purines, Sildenafil Citrate, Sulfones, Diabetes Mellitus physiopathology, Erectile Dysfunction drug therapy, Phosphodiesterase Inhibitors therapeutic use, Piperazines therapeutic use
- Abstract
Diabetes can induce sexual disorders by different mechanisms. These troubles are more frequent in diabetics subjects. Thus, management of sexual impotence is an important aspect of diabetes care. However, most diabetologists are not trained to treat sexual disorders. The recent availability of oral drugs, i. e. Sildenafil (Viagra), has partly simplified the treatment of sexual impotence, particularly in diabetic patients. However, Viagra is efficient in only 60% cases in diabetic subjects. In the remaining cases, intracavernosal injections or vacuum can be used. Since Viagra has been available, more diabetic patients complained with sexual disorders, and ask for treatment of impotence. Cardio-vascular diseases must retain more attention in diabetic patients who are exposed to silencious myocardial ischemia. In such subjects, Viagra is not contra-indicated, but must be used after myocardial explorations, especially if the patients have cardio-vascular risk factors. However, patients and their doctors have been threatened by death cases reported with Viagra in United States. The lack of detailed informations has restrained Viagra's prescription. The following explains how to manage sexual disorders as part of diabetes care, and suggests rules for Viagra's prescription in diabetic patients.
- Published
- 2000
40. [How to measure glycemic instability?].
- Author
-
Selam JL
- Subjects
- Blood Glucose analysis, Blood Glucose Self-Monitoring methods, Evaluation Studies as Topic, Humans, Reproducibility of Results, Blood Glucose metabolism, Blood Glucose Self-Monitoring standards, Diabetes Mellitus, Type 1 blood
- Abstract
Instability of glycemic levels is "normal" in type 1 diabetes, with different levels of severity, up to the restrictive definition of brittle diabetes (repeated ketoacidosis and/or severe hypoglycemias). Quantification of glycemic instability, in terms of intraday variability and day-to-day reproducibility, is advisable. Standard deviation of blood glucose, though a simple index does not discriminate between slow and brutal variations. Repartition of blood glucose values also only indicates dispersion. M values compares the patient values to an ideal blood glucose level, emphasizing the role of low values. The MAGE index measures the amplitude of the largest glucose excursions, thus evaluating appropriately glycemic variability. The Low Blood Glucose Index (LBGI) is a new index of variability emphasising (as the M value) the low glycemias. Each glycemia is given a value from O (if >=110 mg/dl) to 100 (if 20 mg/dl). It thus integrates the frequency and severity of hypoglycemias. According to its authors the LBGI would be the best indicator of severe hypoglycemias. The Mean of Daily Differences (MODD) evaluates the day-to-day reproducibility of blood glucose values. All the above indexes could easily be incorporated in the programmes of large memory glucose meters.
- Published
- 2000
41. Insufficient adaptation of hypoglycaemic threshold for cognitive impairment in tightly controlled type 1 diabetes.
- Author
-
Taverna MJ, M'Bemba J, Sola A, Chevalier A, Slama G, and Selam JL
- Subjects
- Adult, Awareness, Blood Glucose analysis, Diabetes Mellitus, Type 1 psychology, Epinephrine blood, Female, Glucagon blood, Glycated Hemoglobin analysis, Human Growth Hormone blood, Humans, Hydrocortisone blood, Hypoglycemia chemically induced, Hypoglycemic Agents adverse effects, Hypoglycemic Agents blood, Insulin adverse effects, Insulin blood, Male, Middle Aged, Norepinephrine blood, Cognition, Diabetes Mellitus, Type 1 blood, Diabetes Mellitus, Type 1 physiopathology, Hypoglycemia diagnosis
- Abstract
Unlabelled: It is well known that hypoglycaemic thresholds for hormones and symptoms occur at lower plasma glucose levels in patients with strict glycaemic control. However, whether the threshold for cognitive impairment also shifts is still an unresolved question. We studied 19 type 1 diabetic patients, including 8 with hypoglycaemia unawareness, aged 37.0 +/- 7.4 y.r., with diabetes duration 15.2 +/- 10.7 yr, and HbA1c 7.6 +/- 1.1%. Hypoglycaemic thresholds for hormones, symptoms, awareness and cognitive function using the 4-choice reaction time test (4RT), were measured every 30 min during a 150 min stepped 4.4 to 2.2 mM hypoglycaemic hyperinsulinemic clamp. We found that 4RT- accuracy deteriorated earlier than 4RT-time (3.2 and 2.7 mM, respectively, p<0.01), and that both correlated poorly with HbA1C before and after adjustment for age and diabetes duration (r=0.11, and 0.18, respectively). On the opposite, adrenaline, autonomic and neuroglycopenic symptoms, and awareness significantly correlated with HbA1c values (r=0.56, 0.70, 0.61, and 0.63, after adjustment, respectively). Furthermore, after allocating the patients into two subgroups according to HbA1c values (<8% n=12, and >=8% n=7), we found that, as opposed to other thresholds, accuracy and 4RT-time were minimally and not significantly influenced by glycaemic control, therefore exhibiting the smaller glucose thresholds shifts (- 0.2 and - 0.5 mM for accuracy and time, respectively, vs. 0.6 -0.8 for other thresholds)., In Conclusion: 1) the hypoglycaemic thresholds for cognitive dysfunction shift with strict glycaemic control, but not significantly and less than other thresholds, 2) as opposed to other reports, accuracy deteriorates earlier than speed during the 4RT test, and 3) these "maladapted" reactions may contribute to the higher risk for severe hypoglycaemia in subjects with tight glycaemic control.
- Published
- 2000
42. [Drug therapy of type 2 diabetes with 1.26g/l fasting blood glucose (see above)].
- Author
-
Slama G, Selam JL, Elgrably F, and Reach G
- Subjects
- Diabetes Mellitus, Type 2 diagnosis, Humans, Blood Glucose analysis, Diabetes Mellitus, Type 2 blood, Diabetes Mellitus, Type 2 drug therapy, Hypoglycemic Agents therapeutic use
- Published
- 1999
43. [Lispro (humalog) insulin in practice].
- Author
-
Selam JL and Slama G
- Subjects
- Contraindications, Humans, Insulin therapeutic use, Insulin Lispro, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemic Agents therapeutic use, Insulin analogs & derivatives
- Published
- 1998
44. [Cognitive risk from recurrent hypoglycemia in the diabetic].
- Author
-
Selam JL
- Subjects
- Chronic Disease, Humans, Recurrence, Risk Factors, Cognition Disorders etiology, Diabetes Mellitus, Type 1 drug therapy, Hypoglycemia psychology, Hypoglycemic Agents adverse effects, Insulin adverse effects
- Published
- 1998
45. [A new strategy for education and management of insulin-dependent diabetics].
- Author
-
Traynard PY, Elgrably F, Selam JL, and Slama G
- Subjects
- Health Services, Humans, Patient Compliance, Diabetes Mellitus, Type 1 therapy, Patient Education as Topic
- Published
- 1998
46. [Reevaluation of hypoglycemic risk in the course of intensive insulin therapy].
- Author
-
Selam JL
- Subjects
- Evaluation Studies as Topic, Humans, Risk Factors, Hypoglycemia chemically induced, Hypoglycemic Agents adverse effects, Insulin adverse effects
- Published
- 1998
47. Extreme insulin resistance: clinical management by external subcutaneous insulin infusion.
- Author
-
Lalej-Bennis D, Selam JL, Fluteau-Nadler S, M'Bemba J, Reach G, Sorel G, Bardin C, Zirinis P, Chast F, Elgrably F, and Slama G
- Subjects
- Adult, Blood Glucose metabolism, Body Weight, Diabetes Mellitus, Type 1 physiopathology, Female, Glycated Hemoglobin analysis, Glycosuria, Humans, Infusions, Intravenous, Injections, Subcutaneous, Insulin therapeutic use, Plasma Exchange, Diabetes Mellitus, Type 1 drug therapy, Insulin administration & dosage, Insulin Infusion Systems, Insulin Resistance
- Abstract
Management of very high insulin requirements in rare extreme insulin resistance syndromes is difficult and poorly documented. We report a case of a type B insulin-resistant patient requiring approximately 10,000 units of insulin per day, i.e. beyond the possibilities of current insulin formulations and delivery devices. Only the Panomat C10 portable pump model (Disetronic) and U500 Humulin (Lilly) allowed the required rate of 400 units per hour to be attained only when the reservoir was changed twice daily and the site and catheter were changed once daily. Three months after discharge, the patient was in good general and local condition, but with only fair diabetes control (glycated haemoglobin 9.5%).
- Published
- 1997
48. [Pharmacokinetics of hypoglycemic sulfonamides: Ozidia, a new concept].
- Author
-
Selam JL
- Subjects
- Administration, Oral, Circadian Rhythm, Diabetes Mellitus, Type 2 drug therapy, Glipizide administration & dosage, Glipizide therapeutic use, Humans, Hypoglycemic Agents therapeutic use, Islets of Langerhans drug effects, Islets of Langerhans metabolism, Liver drug effects, Liver metabolism, Diabetes Mellitus, Type 2 physiopathology, Glipizide pharmacokinetics, Hypoglycemic Agents pharmacokinetics
- Abstract
Hypoglycaemic sulfonamides differ in their properties, which vary in clinical importance. The potency of sulfonamide has increased with the generations. However, this potency is compensated in practice by the dose prescribed, which is much smaller for recent generations. The half-life is a far more important property. The effective action period is correlated with half-life but is much longer. The action period for "short-term" sulfonamides is < or = 24 h (tolbutamide, glipizide) and can exceed 24 h for "long-term" sulfonamides (e.g. glibenclamide). Metabolism and elimination reduce the risk of accumulation. All sulfonamides are metabolised more than 95% by the liver. The metabolites are inactive except for one from glibenclamide. As a function of their action period and possibly of intrinsic properties, some sulfonamides more than others (e.g. glibenclamide) affect fasting hepatic glucose production, which is particularly increased early in the day in non-insulin-dependent diabetic patients because of a circadian drop in insulin sensitivity (dawn phenomenon). Finally, in chronic administration, all sulfonamides cause a progressive desensitisation of the beta cell, which responds by an insulin secretion peak only during food intake. This condition indicates the unuselessness of sulfonamide fractionation and, contrary to the classic notion, the low risk of hypoglycaemia after a meal is skipped. The ideal product would be a sulfonamide with high potency and an ultra-short half-life, but capable of maintaining plasma concentrations for 24 h (which might seem incompatible except in continuous administration). Moreover, it would exert its action at relatively low levels of insulinaemia and be completely metabolisable. Glipizide in its osmotic oral form (Ozidia) satisfies all these conditions since it is a very potent sulfonamide with a quite short half-life but with intestinal delivery up to 16 h after administration because of its osmotic principle. It controls fasting glycaema better than ordinary glipizide and at least as well as glibenclamide by acting on hepatic glucose production. Compared to glibenclamide, it has the advantage of generation this effect at lower levels of insulinaemia. In comparison with normal glipizide, it allows identical control for lower postprandial inslinaemias, which is proof of its powerful inductive effect on insulin sensitivity.
- Published
- 1997
49. Evaluation of a structured 4-day educational programme for intensive insulin therapy.
- Author
-
Jullien V, Elgrably F, Traynard PY, Slama G, and Selam JL
- Subjects
- Adult, Aged, Blood Glucose metabolism, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1 blood, Female, Glycated Hemoglobin analysis, Humans, Hypoglycemia epidemiology, Inpatients, Insulin administration & dosage, Insulin adverse effects, Male, Middle Aged, Patient Compliance, Reinforcement, Psychology, Retrospective Studies, Diabetes Mellitus, Type 1 drug therapy, Diabetes Mellitus, Type 1 rehabilitation, Insulin therapeutic use, Patient Education as Topic, Self Care
- Published
- 1997
- Full Text
- View/download PDF
50. [From the concept of fast acting analogs to the properties of the insulin Lispro].
- Author
-
Selam JL
- Subjects
- Humans, Hyperglycemia drug therapy, Hypoglycemia etiology, Hypoglycemic Agents pharmacokinetics, Insulin pharmacokinetics, Insulin therapeutic use, Insulin Lispro, Postprandial Period, Reproducibility of Results, Time Factors, Hypoglycemic Agents therapeutic use, Insulin analogs & derivatives
- Abstract
The difficulties of achieving good glycaemic control in insulin-dependent diabetes are due in large part to the inadequacies of subcutaneously administered insulin. In particular, resorption with the long acting form is variable from one subject to another and from one day to another and irregular over time, whereas the action of the rapid acting form is too late and prolonged. The slowness of absorption of the rapid acting form is attributable to the need for hexamer dissociation. The Lilly Laboratories, by inverting the amino acids lysine and proline in positions 28 and 29 in the B chain, have created an insulin (Lispro) which more rapidly dissociates into monomers after injection. The stability of Lispro is good, probably because of its phosphate buffer. In our experience, in conditions simulating use in portable insulin pumps, Lispro proved to be more stable than insulins specially intended for this use. The affinity in vitro was identical to that of insulin for its receptor. The affinity for insulin-like growth factor-I (IGF-I) receptor has been found to be 1.5 times as high as that of fast insulin in some models and comparable in others, and nearly 1,000 times less than that of IGF-1. Studies on in vivo potency and ex vivo cell growth, as well as of tolerance in the animal (mutagenicity, toxicity and carcinogenicity), have not shown a different effect from regular insulin (contrary to results for analogue Asp B10). The pharmacokinetics has shown an earlier and higher insulinaemic peak and a more rapid return to baseline values than regular insulin. On the basis of pharmacokinetic studies in normal subjects and diabetic patients, the characteristics retained by the licensing authorities are onset of action at 15 min, insulinemic peak between 30 and 70 min, and duration of action 2 to 5 h. Some clinical studies have shown a shortened action period of 1 to 3 h as compared to regular insulin and less influence of dose and injection site, notably with a return to normal insulin levels. The time required for normalisation is increased by 1 h if the injection is made in the thigh rather than the abdomen, as compared to 2 to 3 h for conventional insulin. This suggests that Lispro should be administered just before the meal (0 to 15 min). In some patients, an insulin with prolonged action can be added if the interval between injections is prolonged, i.e. always at the evening meal but possibly also at the noon meal. Lispro can be mixed with Umuline NPH or Umuline zinc without any alteration in its pharmacokinetics and potency if the injection is performed immediately. The few studies that have considered glycaemic stability and reproducibility have shown a tendency toward improvement in glycaemic excursions during the day, as measured by MAGE, and in insulinaemia variability expressed in area under the curve, which was reduced by half in the same individual or from one individual to another, with less marked impact on the variability from one day to another of glycaemic excursions. On the whole, Lispro provides faster kinetics, greater stability and possibly better reproducibility than fast insulin. These advantages, if confirmed by clinical experience, should allow an improvement in the comfort and glycaemic stability of diabetic patients.
- Published
- 1997
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