Search

Aims: Regional variations in the adoption of diabetes technology may be reflected in population-level metrics of glycaemic control. In this observational study, we aimed to assess the glycaemic impacts of transitioning from the Dexcom G5 Real-Time Continuous Glucose Monitoring (RT-CGM) System to the Dexcom G6 in three European countries., Methods: Anonymised RT-CGM data (uploaded to the Dexcom Clarity app) were from users in Germany, Sweden, and the United Kingdom (UK) who transitioned from G5 to G6 between 9-12 months after G6 launched in 2018. Primary endpoints were percent time in hypoglycaemia, percent time in range (TIR), user retention rates, device utilisation, and urgent low soon (ULS) alert utilisation. Metrics were computed for 3-month intervals in the 2-year study window., Results: In all three countries, the transition from G5 to G6 was associated with a clear decrease in hypoglycaemia. In months 0-3 after transitioning, the median percent time 〈3 mmol/L (54 mg/dL) and 〈3.9 mmol/L (70 mg/dL) decreased by [0.12-0.28] and [0.40-0.43] percentage points, respectively, with another [0.11-0.21] and [0.34-0.65] percentage point decrease in months 3-6 in the three countries analysed. TIR and CGM utilisation were sustained or improved slightly across all countries. At the end of the study window, the retention rate was [88.8-94.8%] and ULS utilization was [83.9-86.9%] in the three countries analysed., Conclusions: Similar RT-CGM trends were observed across Germany, Sweden, and the UK. Improvements in hypoglycaemia occurred in all countries. The high retention of users may lead to sustained glycaemic benefits associated with RT-CGM use., (© 2022 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

Background: The presence of chronic kidney disease (CKD) influences the type of antiglycaemic therapy and the risk for hypoglycaemia., Methods: In 2006, 2011 and 2016 health insurance data of people with diabetes type 2 were screened for CKD and the presence of severe hypoglycaemia (sHypo). The type of antihyperglycaemic therapy was recorded due to Anatomical Therapeutic Chemical (ATC) codes up to 3 months before suffering sHypo., Results: The prevalence of CKD increased from 5.3% in 2006 to 7.3% in 2011 and 11.2% in 2016. Insulin-based therapies were used in 39.0, 39.1, and 37.9% of patients with, but only in 17.7, 17.4, and 18.8% of patients without CKD. Although the proportion of the CKD stages 1, 2 and 5 decreased, CKD stages 3 and 4 increased. The proportion of sHypo in CKD declined from 2006 (3.5%) to 2011 (3.0%) and 2016 (2.2%) but was still more than 10 times higher as compared to type 2 diabetic patients without CKD (0.3/0.2/0.2%) conferring a significantly higher probability of sHypo (OR 9.30, 95%CI 9.07-9.54) in CKD. The probability of sHypo was significantly lower in 2016 than in 2006 both in patients with (OR 0.58; CI 0.55-0.61) and without CKD (OR 0.70; CI 0.68-0.73)., Conclusion: The prevalence of CKD increased from 2006 to 2016. Patients with CKD exhibited a 9-fold increased probability of sHypo, especially in patients treated with insulin plus oral anti-diabetic drugs. However, the rate and risk for sHypo decreased over time, probably as a consequence of new antidiabetic treatment options, better awareness of sHypo, and changed therapy goals., Competing Interests: The authors declare that they have no conflict of interest., (Thieme. All rights reserved.)

Background: Studies on acute complications in adult T1D were previously reported from the United States (U.S.) and from Germany. The aim was to compare demographic characteristics and patterns of severe hypoglycaemia (SH) and diabetic ketoacidosis (DKA) between Germany and the U.S., Methods: Descriptive comparison on individuals aged ≥18 years, with T1D duration ≥2 years were made between the German diabetes-patient registry (DPV) and the U.S. electronic-health-record database (T1PCO). Individuals in both databases were divided into patients with haemoglobin A1c (HbA1c) <7% and HbA1c ≥7%., Results: 5190 (DPV) and 31,430 individuals (T1PCO) fulfilled the inclusion criteria. DPV patients were younger, more often male and had lower body-mass index. In both databases, more males than females had HbA1c <7%. Individuals had higher HbA1c in T1PCO compared to DPV. The relationship between HbA1c and DKA was similar in both databases. SH revealed a U-shaped curve in T1PCO, but no clear pattern was present in DPV. SH events increased with higher age in DPV, but not in T1PCO., Conclusion: Patterns of SH differ between Germany and U.S. Differences in capture of SH among the databases cannot be excluded, but differences in health care including patient education and level of care by specialists are likely., Competing Interests: Declaration of competing interest J.H.P. is a consultant for Diasome, Insulet, Lexicon, Lilly, MannKind, Novo Nordisk, Sanofi and Senseonics. F.L.Z. is an employee and stockholder of Sanofi. S.V.E. is a medical advisor for AstraZeneca, BrightSight, InPen, Lexicon, Lilly USA LLC, MannKind, Merck, Novo Nordisk and Sanofi; is a speaker for AstraZeneca, Lilly USA LLC, MannKind, Merck and Sanofi; and is an advisory board member for Senseonics and TeamType1. No other potential conflicts of interest relevant to this article were reported., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Aim: To investigate the incidence of severe hypoglycaemia over the past 10 years, taking into account changes in anti-hyperglycaemic therapy., Methods: This retrospective population-based study used German health insurance data. All adults diagnosed with documented type 2 diabetes (extrapolated to the German population: 6.6 million in 2006; 7.9 million in 2011; 8.86 million in 2016) were screened for severe hypoglycaemia. Anti-hyperglycaemic agents were identified by Anatomical Therapeutic Chemical (ATC) code., Results: The event rate for severe hypoglycaemia was 460 per 100 000 people in 2006, 490 per 100 000 in 2011 and 360 per 100 000 in 2016. The proportion of people with severe hypoglycaemia receiving sulfonylureas, as well as receiving combination therapy of metformin and sulfonylureas decreased from 2006 to 2016 (23.6% vs. 6.2%) Among those with severe hypoglycaemia in 2006, there were no prescriptions for dipeptidyl peptidase-4 (DPP-4) inhibitors, glucagon-like peptide-1 (GLP-1) receptor agonists or sodium-glucose co-transporter 2 (SGLT2) agonists. The proportions of people with severe hypoglycaemia receiving DPP-4 inhibitors, GLP-1 receptor agonists or SGLT2 agonists in 2011 and 2016 were low. The proportion of people receiving human insulin also decreased (from 11.3% in 2006 to 10.3% in 2011 and 4.3% in 2016); the proportion of people receiving insulin analogues increased from 5.4% in 2006 to 11.5% in 2016. Therapy with mixed insulins was used by 19.7% of people with severe hypoglycaemia in 2006, by 14.0% in 2011 and by 7.3% in 2016. People undergoing therapy with insulin analogues have the highest risk of severe hypoglycaemia adjusted by age, gender, nephropathy diagnosis and year of survey [odds ratio (OR) 14.4, 95% confidence interval (95% CI) 13.5-15.5]., Conclusion: The incidence of severe hypoglycaemic events in Germany increased between 2006 and 2011, and decreased in 2016., (© 2020 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

Aims: We aimed to analyze the relationship between epilepsy and glutamic acid decarboxylase autoantibodies (GADA) in patients with type 1 diabetes mellitus (T1DM) and the impact of GADA on demographic, clinical, and metabolic data in T1DM patients with epilepsy., Methods: We searched for patients with T1DM ≤20 years and GADA measurements, and within this group for patients with epilepsy. We formed groups: T1DM + Epilepsy + GADA positive; T1DM + Epilepsy + GADA negative; T1DM + GADA positive; T1DM + GADA negative. We used logistic regression to analyze the relationship between epilepsy and GADA with odds ratio adjusted for sex, duration of diabetes (DOD), and age at diabetes onset (ADO). We used logistic regression with odds ratio adjusted for DOD and ADO onset using epilepsy as a dependent variable and GADA, HbA1c, ketoacidosis, severe hypoglycemia (SH), sex, celiac disease, and autoimmune thyroiditis as independent variables. We conducted regression analyses adjusted for sex, DOD, and ADO to analyze differences in clinical/metabolic parameters between the groups., Results: Epilepsy was not more frequent in GADA-positive patients (GPP). Logistic regression including all patients with GADA measurements showed that hypoglycemia with coma (HC) correlated with epilepsy when compared to no SH. We found no differences in clinical and metabolic data between GPP and GADA-negative patients (GNP) with epilepsy. SH occurred more often in GPP with epilepsy in comparison to GPP without epilepsy. GNP with epilepsy had a higher rate of HC than GPP without epilepsy., Conclusion: We found no relationship between epilepsy and GADA. A relationship between T1DM and epilepsy might be explainable by SH., (© 2020 The Authors. Pediatric Diabetes published by John Wiley & Sons Ltd.)

Objective: To estimate the prevalence of diabetes due to diseases of the exocrine pancreas (DEP) using data of the multicentre diabetes patient follow-up registry. Moreover, we aimed at comparing individuals with diabetes due to DEP to individuals with type 1 and type 2 diabetes., Methods: Individuals with DEP, type 1 or type 2 diabetes ≥18 years of age were studied. We aggregated the most recent treatment year per patient and used propensity scores to match diabetes due to DEP to type 1 and type 2 diabetes. Matching was conducted one-to-one with sex, age, diabetes duration, migration background and the German index of socioeconomic deprivation as covariates., Results: We identified 7,093 (1.6%) individuals with diabetes due to DEP. In the matched cohort DEP-type 1 diabetes we observed a similar daily insulin dose (0.62 IU/kg (95% confidence interval:0.60-0.63), 0.60 IU/kg (0.58-0.62)) and significant differences regarding microvascular (41.0% (39.7-42.2), 45.3% (44.0-46.6)), and macrovascular disease (16.6% (15.7-17.6), 14.7% (13.8-15.6)). HbA1c (8.2% (8.1-8.3), 7.9% (7.8-8.0)), daily insulin dose (0.60 IU/kg (0.58-0.62), 0.56 IU/kg (0.54-0.58)) and event rates of severe hypoglycemia (23.9 events/100 PY (21.4-26.8), (9.5 events/100 PY (8.0-11.2)) were significantly higher in individuals with diabetes due to DEP compared to type 2 diabetes., Conclusions: Using registry data, rare diabetes types such as diabetes due to DEP can be studied with a significant sample size. Our study identified differences and similarities between adult individuals with DEP related diabetes and type 1 or type 2 diabetes., Competing Interests: Declaration of competing interest The authors declare that there is no duality of interest associated with this manuscript., (Copyright © 2020 IAP and EPC. Published by Elsevier B.V. All rights reserved.)

Objective: To investigate temporal trends in glycemic control and severe hypoglycemia rates for pediatric patients with type 1 diabetes from 1995 to 2016 by analyzing data from the longitudinal, prospective, population-based German/Austrian (Diabetes Patient History Documentation [DPV]) and Western Australian (Western Australian Children's Diabetes Database [WACDD]) diabetes registries., Research Design and Methods: Patients diagnosed with type 1 diabetes aged <15 years were identified from the DPV ( N = 59,883) and WACDD ( N = 2,595) registries and data extracted for all clinic visits occurring between 1995 and 2016, inclusive. Mean HbA 1c and severe hypoglycemia (self-reported loss of consciousness/convulsion) rates were calculated per 100 patient-years., Results: Between 1995 and 2016, the annual mean HbA 1c decreased from 8.3 to 7.8% in the DPV cohort and from 9.2 to 8.3% in the WACDD cohort. Over the same period, the severe hypoglycemia rate decreased by an annual average of 2% (relative risk 0.983 [95% CI 0.981, 0.986]) in the DPV cohort and 6% (relative risk 0.935 [95% CI 0.934, 0.937]) in the WACDD cohort. Concomitant decreasing trends in both HbA 1c and severe hypoglycemia rates were observed in boys and girls, all age-groups, and injection therapy/pump regimen groups., Conclusions: Over the past two decades, there have been concurrent improvements in HbA 1c and decreasing severe hypoglycemia rates in two contemporary, longitudinal, population-based pediatric cohorts of type 1 diabetes. Translation of these data into clinical practice and patient education may reduce fear of hypoglycemia and enable better glycemic control., (© 2019 by the American Diabetes Association.)

Background: Self-monitoring of blood glucose (SMBG) using the ColourSure™ Technology to visualize target range showed improvement of metabolic control and overall diabetes self-management in insulin-treated patients. This economic analysis aimed to identify cost savings for the German health system resulting from an HbA1c reduction due to the utilization of user-friendly glucose meters., Methods: Patient data from a recently published observational study on SMBG were used for risk evaluations using the UKPDS risk engine. These values were integrated in an economic analysis regarding costs of myocardial infarctions (MIs) related to diabetes for the German health system. Based on an earlier assessment these calculations were combined with a 10% reduction of severe hypoglycemic episodes. In the current study, 0% severe hypoglycemic episodes were observed., Results: An HbA1c reduction of 0.69% over 6 months was associated with a 3% decreased risk of MI in 10 years. In this model the decrease led to cost savings of €4.90 per patient-year. Considering 2.3 million insulin-treated patients in Germany, this 3% reduction of MI could result in annual savings of €11.27 million. Combining this with a 10% reduction in severe hypoglycemic events, the cost savings would increase to €30.61 per patient-year or €70.4 million for 2.3 million insulin-treated patients in Germany., Conclusion: The improvement of metabolic control and diabetes self-management that was achieved with the ColourSure™ Technology has the potential to generate substantial cost savings for the German health system underlining the importance of user-friendly methods for SMBG.

Objective: To evaluate adrenal crises after the start of treatment up to the age of 6 years in children with classic congenital adrenal hyperplasia (CAH)., Design: Analysis of data extracted from a population-based prospective long-term follow-up study of children detected in neonatal screening., Methods: Data of 102 Bavarian children with classic CAH due to 21-hydroxylase deficiency were analyzed, using parental questionnaires and medical reports. Parent-reported hospital admissions of children diagnosed with acute health impairment were included in the analysis if salt loss (hyponatremia) or hypoglycemia was documented in the discharge summary., Results: A total of 74 children (72.5%) had no report of hospital admissions with salt loss or hypoglycemia during the observational period. However, in 27.5% of the children, 22 salt-wasting crises (seven of these also with low blood glucose) and 16 hypoglycemic episodes without salt loss were reported. Furthermore, the cumulative incidence for seizures was elevated; 13 children experienced seizures during hyponatremia or hypoglycemia. Most adrenal crises were triggered by infections, often with inappropriate emergency management, but in 11 cases hypoglycemia occurred unexpectedly, without evidence of severe illness and without any management errors. Frequency of adrenal crises was 6.5 per 100 patient years (95% CI: 4.6-8.8)., Conclusions: Crisis prevention remains a permanent challenge for families and physicians caring for children with classic CAH. Expert care and compliance with emergency recommendations are crucial. Further research on the interactions among glucocorticoid deficiency, adrenomedullary dysfunction, and glucose metabolism is necessary for the prevention of hypoglycemia, especially in young CAH patients., (© 2016 European Society of Endocrinology.)

Objective: To investigate rates and risk factors of hospital admission for diabetic ketoacidosis (DKA) or severe hypoglycemia in young patients with established type 1 diabetes., Design: In total, 31,330 patients with type 1 diabetes (median age 12.7 years) from the Diabetes Patienten Verlaufsdokumentation (DPV) Prospective Diabetes Registry treated between 2011 and 2013 in Germany were included., Methods: Admission rates for DKA (pH < 7.3 or bicarbonate <15 mmol/l) and severe hypoglycemia (requiring assistance from another person) were calculated by negative binomial regression analysis. Associations of DKA or hypoglycemia with patient and treatment characteristics were assessed by multivariable regression analysis., Results: The mean admission rate for DKA was 4.81/100 patient-years (95% CI, 4.51-5.14). The highest DKA rates were observed in patients with HbA1c ≥ 9.0% (15.83 (14.44-17.36)), age 15-20 years (6.21 (5.61-6.88)) and diabetes duration of 2-4.9 years (5.60 (5.00-6.27)). DKA rate was higher in girls than in boys (5.35 (4.88-5.86) vs 4.34 (3.95-4.77), P = 0.002), and more frequent in migrants than in non-migrants (5.65 (4.92-6.49) vs 4.57 (4.23-4.93), P = 0.008). The mean admission rate for severe hypoglycemia was 1.45/100 patient-years (1.30-1.61). Rates were higher in migrants compared to non-migrants (2.13 (1.72-2.65) vs 1.28 (1.12-1.47), P < 0.001), and highest in individuals with severe hypoglycemia within the preceding year (17.69 (15.63-20.03) vs patients without preceding hypoglycemia 0.42 (0.35-0.52), P < 0.001). Differences remained significant after multivariable adjustment., Conclusions: The identification of at-risk individuals for DKA (patients with high HbA1c, longer diabetes duration, adolescents, girls) and for severe hypoglycemia (patients with preceding severe hypoglycemia, migrants) may facilitate targeted diabetes counselling in order to prevent these complications., (© 2015 European Society of Endocrinology.)

Aims/hypothesis: This study investigated the accuracy of blood glucose meters for self-monitoring and its influence on glycated hemoglobin (HbA1c) levels and the frequency of hypoglycemic coma., Materials and Methods: Self-measured and simultaneously obtained laboratory blood glucose values from 9,163 patients with type 1 diabetes <18 years of age in the German/Austrian Diabetes Prospective Documentation Initiative registry were analyzed by investigating their compliance with the International Organization for Standardization (ISO) criteria (versions 2003 and 2013) and by error grid analyses. Regression models elucidated effects on glucose control and hypoglycemia rates., Results: Depending on the respective subgroup (defined by sex, age, duration of diabetes, mode of insulin therapy), 78.7-94.7% of the self-monitoring of blood glucose (SMBG) values met the old and 79.7-88.6% met the new ISO criteria. In Clarke and Parkes error grid analyses, the percentages of SMBG values in Zone A ranged between 92.8% and 94.6% (Clarke) and between 92.2% and 95.0% (Parkes). The patient group with SMBG devices measuring "far too low" (compared with the laboratory-obtained glucose levels) presented with a higher HbA1c level than those measuring "far too high," "too high," "identical/almost identical," or "too low" (based on quintiles of deviation). Performing "far too high" was associated with the highest rate of hypoglycemic coma in comparison with the other deviation quintiles., Conclusions: This study showed that current SMBG devices fulfilled neither the previous nor the new ISO criteria. Large deviations of the SMBG values from the "true" glucose levels resulted in higher HbA1c levels and markedly increased rates of hypoglycemic events.

Aims: To compare rates and predictors of documented hypoglycaemia in type 2 diabetes patients treated with either basal insulin supported oral therapy (BOT), conventional therapy (CT) or supplementary insulin therapy (SIT) in primary care., Methods: Data from 10,842 anonymous patients (mean age ± SD: 54 ± 8 yrs) on BOT, 2,407 subjects (56 ± 7 yrs) on CT, and 7,480 patients (52 ± 10 yrs) using SIT from 1,198 primary care practices were retrospectively analyzed (Disease Analyzer, Germany: 01/2005-07/2013). Stepwise logistic regression (≥1 documented hypoglycaemia: ICD code) was used to evaluate risk factors of hypoglycemia., Results: The unadjusted rates (95% CI) per 100 patient-years of documented hypoglycaemia were 1.01 (0.80-1.20) (BOT), 1.68 (1.10-2.30) (CT), and 1.61 (1.30-1.90) (SIT), respectively. The odds of having ≥1 hypoglycemia was increased for CT (OR; 95% CI: 1.71; 1.13-2.58) and SIT (1.55; 1.15-2.08) (reference: BOT). Previous hypoglycemia (OR: 11.24; 6.71-18.85), duration of insulin treatment (days) (1.06; 1.05-1.07), history of transient ischemic attack (TIA)/stroke (1.91; 1.04-3.50), and former salicylate prescriptions (1.44; 1.06-1.98) also showed an increased odds of having hypoglycemia. Higher age was associated with a slightly lower odds ratio (per year: 0.98; 0.97-0.99)., Conclusions: Insulin naïve type 2 diabetes patients in primary care, initiated with CT and SIT have an increased risk of hypoglycaemia compared to BOT, which is in line with previous randomized controlled trials. As hypoglycaemic events are associated with an increased mortality risk, this real-world finding is of clinical relevance.

Objective: In a randomized, multi-centre trial, the efficacy of a self-management-oriented education programme (PRIMAS) for people with type 1 diabetes was compared with an established education programme as control group (CG). Primary outcome was the effect on glycaemic control in a 6-month follow-up. Secondary outcomes were the impact on emotional aspects, self-management related aspects and hypoglycaemia problems., Methods: The study was conducted in an outpatient setting. 160 participants were randomized. Baseline characteristics in PRIMAS and CG were similar (age 45.1±13.5 vs. 45.9±13.1 years, p=.716; diabetes duration 18.8±12.3 vs. 19.8±13.4 years, p=.615; BMI 26.5±4.6 vs. 27.5±5.0kg/m(2), p=.236; HbA1c 8.3±1.1 vs. 8.1±1.0%, p=.236)., Results: At follow-up there was a significant 0.4 percentage points greater reduction of HbA1c in PRIMAS compared to CG (Δ -0.4±1.0% vs. Δ 0.0±0.6%; p=.012). Also, diabetes-related distress (Δ -0.3±0.7 vs. -0.1±0.4, p=.032) and dissatisfaction with diabetes treatment (Δ -3.3±6.9 vs. -1.9±5.6, p=.024) decreased more in PRIMAS. Diabetes empowerment (Δ 2.6±5.9 vs. 0.8±5.1, p=.037) and diabetes self-efficacy (Δ 1.4±3.6 vs. 0.2±4.0, p=.013) increased in PRIMAS. Incidence of severe hypoglycemia, hypoglycemia awareness, diabetes knowledge, and self-care behaviour improved in both groups with no significant differences between groups., Conclusion: PRIMAS is more effective in lowering HbA1c than a previously established education programmes and also showed superiority in reducing diabetes-related distress and increasing diabetes empowerment, diabetes self-efficacy and satisfaction with insulin therapy., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Aims: The purpose of this study was to explore the burden and impact of non-severe nocturnal hypoglycaemic events (NSNHEs) on diabetes management, patient functioning and well-being in order to better understand the role that NSNHEs play in caring for persons with diabetes and facilitate optimal diabetes treatment management strategies., Methods: A 20-min survey assessing the impact of NSNHEs was administered to patients with self-reported diabetes age 18 or older via the Internet in nine countries (USA, UK, Germany, Canada, France, Italy, Spain, The Netherlands and Sweden) who experienced an NSNHE in the last month. Questions captured reasons for and length of the event, and impacts on diabetes management, daily function, sleep and well-being., Results: A total of 20 212 persons with Type 1 diabetes mellitus (T1DM) and Type 2 diabetes mellitus (T2DM) were screened of which 2108 respondents were eligible. Respondents initiated, on average, an additional 3.6 glucose monitoring tests, and did not resume usual functioning for an average of 3.4 hours after the NSNHE. Of the respondents using insulin, 15.8% decreased their insulin dose over an average of 3.6 days. NSNHEs also impacted sleep, with 10.4% not returning to sleep that night. Next day functioning was affected with 60.3% (n = 1273) feeling the need to take a nap and/or rest (with 65.5% of those actually taking a nap/rest) and 40.2% (n = 848) wanting to go to bed earlier than usual. A total of 21.4% were restricted in their driving the next day. These events also resulted in decreased well-being with 39.6% of respondents feeling 'emotional low' the following day., Conclusions: NSNHEs have serious consequences for patients. Greater attention to patient and physician education regarding the burden of NSNHEs and incorporation of corrective actions in treatment plans is needed to facilitate patients reaching optimal glycaemic control., (© 2013 Blackwell Publishing Ltd.)

Aim: Elderly and old patients with Type 1 diabetes represent a growing population that requires thorough diabetes care. The increasing relevance of this subgroup, however, plays only a minor role in the literature. Here, we describe elderly patients with Type 1 diabetes on the basis of a large multi-centre database in order to point out special features of this population., Method: Data of 64609 patients with Type 1 diabetes treated by 350 qualified diabetes treatment centres were assessed and analysed by age group., Results: Compared with the age group ≤ 60 years, patients aged >60 years (n=3610 61-80 years and n=377 >80 years old) were characterized by a longer diabetes duration (27.7 vs. 7.7 years), an almost double risk for severe hypoglycaemia (40.1 vs. 24.3/100 patient-years), a lower level of HbA(1c) [60 vs. 67 mmol/mol (7.6 vs. 8.3%)] and higher percentages of microalbuminuria (34.5 vs. 15.6%), diabetic retinopathy (45.2 vs. 8.3%), myocardial infarction (9.0 vs. 0.4%) or stroke (6.8 vs. 0.3%). Elderly patients used insulin pumps less frequently (12.2 vs. 23.8%), but more often used conventional premixed insulin treatment (10.8 vs. 3.8%). Differences between elderly and younger patient groups were significant, respectively., Conclusion: Diabetes care of elderly patients with Type 1 diabetes involves individualized treatment concepts. Increased hypoglycaemia risk and functional impairment attributable to diabetes-associated and/or age-related disorders must be taken into account., (© 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.)

Background: Patients with type-2 diabetes are at risk for treatment- and disease-related complications. Little is known about the interrelation of hypoglycaemia and co-morbid vascular disease (VD), defined as coronary heart disease, stroke and peripheral arterial disease., Hypothesis: Hypoglycaemia is associated with co-morbid VD in diabetic patients., Methods: DiaRegis is a prospective registry that included patients with type-2 diabetes in 2009/2010. Metric variables are displayed as median and quartiles. For the comparison of patients with or without VD Odds Ratios (OR) were determined from univariate analyses and adjusted for differences in patient characteristics (multivariable analysis)., Results: Data on hypoglycaemia and VD within the last 12 months were available for 3741 patients (98.2%) with a median (IQR) age of 65.9 (57.6-72.9) years; 46.7% were female. VD patients (n = 909; 24.3%) were older (70.7 vs 63.9 years; p < 0.0001), less often female (33.6% vs 50.9%; p < 0.0001) and had had diabetes for a longer duration (6.4 vs 5.4 years; p < 0.0001). Mean cholesterol (total, HDL and LDL) was also slightly lower (p < 0.0001). Glycaemic control (HbA1c, fasting and postprandial glucose) was comparable. VD patients received less metformin (80.7 vs 85.2%; p < 0.01) and more sulfonylureas (31.8 vs 27.6%; p < 0.05). There was an increased incidence of symptomatic hypoglycaemia with or without requiring help and with a need for medical assistance. After adjusting a number of baseline variables the rates of symptomatic hypoglycaemias with help remained significantly increased (OR 3.73 (95% CI 1.31-10.65) in patients with VD., Conclusions: As hypothesized there is a strong association between the incidence of hypoglycaemia and vascular disease at comparable glycaemic control, which confirms prior randomized controlled trial data suggesting an interrelationship between hypoglycaemia and vascular disease.

Background: Patients with type 2 diabetes and heart failure are considered to be at high risk for hypoglycaemic complications. There is a considerable uncertainty with respect to the appropriate choice of antidiabetic pharmacotherapy in patients with type 2 diabetes and comorbid heart failure. Little is known about comorbidity, hypoglycaemia rates and selected pharmacotherapy in diabetic patients with heart failure in clinical practice., Methods: DiaRegis is a prospective registry in Germany including 3,810 patients with type 2 diabetes receiving antidiabetic treatment with oral mono or oral dual combination therapy in 2009/2010. Only patients for which adjustment of pharmacotherapy (including the introduction of insulin and GLP-1 analogues) was deemed necessary were enrolled. We examined the differences in comorbidity, hypoglycaemia and choice of anti-diabetic pharmacotherapy between diabetics with and without clinical heart failure in clinical practice in Germany., Results: For 3,746 patients, data on the presence of heart failure were available, median (IQR) age 65.9 (57.6-72.8) years and 46.8% were female. Patients with heart failure (n = 370; 9.9%) were older, had a higher BMI, were less physically active, and had more cardiovascular risk factors and a substantial comorbidity. Glycaemic control was comparable between groups. Of the patients with heart failure, 76.8% received metformin, 32.7% sulfonylureas, 2.2% glucosidase inhibitors, 4.3% glinides, 6.2% glitazones and 7.3% DPP-4 inhibitors at baseline before adjustment of therapy. In multivariate analyses, patients with heart failure received less metformin (odds ratio (OR) 0.58, 95% confidence interval (CI) 0.43-0.79) and sulfonylureas (OR 0.70, 95%CI 0.52-0.95) but not thiazolidinediones (OR 1.22, 95%CI 0.82-1.81) or other antidiabetic drugs. Hypoglycaemia was considerably more frequent in diabetic patients with heart failure than in those without (OR 1.96, 95%CI 1.47-2.61)., Conclusion: Patients with type 2 diabetes and heart failure had a substantially increased comorbidity burden compared to patients without heart failure. They more often suffered from episodes of hypoglycaemia, especially those requiring medical assistance. The diagnosis of heart failure did not impact the choice of antidiabetic pharmacotherapy in patients with type 2 diabetes. There was no differential use of thiazolidinediones despite evidence discouraging their use in patients with heart failure.

Objective: To determine frequency, duration, and relationship of continuous glucose monitoring (CGM) to glycemic control and rate of hypoglycemia in children and adults in Germany and Austria., Research Design and Methods: From 59,920 patients documented in the DPV (Diabetessoftware zur prospektiven Verlaufsdokumentation) database, 144,385 sensor days of 2874 patients using CGM between January 2008 and September 2010 were analyzed., Results: Overall, 4.8% of patients used CGM. In pediatric patients, study period (p = 0.0309), age (p = 0.0140), insulin dose (p < 0.0001), and use of insulin analogs (p < 0.0001) significantly influenced hemoglobin A1c (HbA1c), but duration of diabetes, sex, and CGM use did not. In contrast, adults with longer CGM use (>30 d) had significantly lower HbA1c (p < 0.0016). Severe hypoglycemia was not reduced in patients using CGM for <30 d., Conclusions: CGM is still rarely used in Germany and Austria. CGM use is associated with a significant reduction of HbA1c in adults but not in children. Hypoglycemic events were not reduced, irrespective of age., (© 2011 John Wiley & Sons A/S.)

Background: Patients with type 2 diabetes are at an increased risk for disease and treatment related complications after the initial approach of oral mono/dual antidiabetic therapy has failed. Data from clinical practice with respect to this patient group are however scarce. Therefore we set up a registry in primary care documenting the course and outcomes of this patient group., Methods: Diabetes Treatment Patterns and Goal Achievement in Primary Diabetes Care (DiaRegis) is a prospective, observational, German, multicenter registry including patients with type-2 diabetes in which oral mono/dual antidiabetic therapy has failed. Data were recorded at baseline and will be prospectively documented during visits at 6 ± 1, 12 ± 2 and 24 ± 2 months. The primary objective is to estimate the proportion of patients with at least 1 episode of severe hypoglycemia within one year., Results: 313 primary care offices included 4,048 patients between June 2009 and March 2010 of which 3,810 patients fulfilled the in- and exclusion criteria. 46.7% of patients were female; patients had a median diabetes duration of 5.5 years and most were obese with respect to BMI or waist circumference. HbA1c at baseline was 7.4%, fasting plasma glucose 142 mg/dl and postprandial glucose 185 mg/dl. Co-morbidity in this patient population was substantial with 17.9% having coronary artery disease, 14.4% peripheral neuropathy, 9.9% heart failure and 6.0% peripheral arterial disease. 68.6% of patients received oral monotherapy, 31.4% dual oral combination therapy. The most frequent antidiabetic agent used as monotherapy was metformin (79.0%) followed by sulfonylureas (14.8%)., Conclusions: DiaRegis is a large, prospective registry in primary diabetes care to document the course and outcomes of patients with type-2 diabetes in which the initial approach of oral mono/dual antidiabetic therapy has failed. The two year follow-up will allow for a prospective evaluation of these patients during multiple adjustments of therapy.

Objective: Severe sulfonylurea-induced hypoglycemia (SH) remains a life-threatening and under-reported condition. We investigated the incidence of SH and clinical characteristics of patients with type 2 diabetes mellitus (T2DM) to demonstrate typical risk constellations., Methods: In a prospective population-based observational study, all consecutive cases of SH in the period 2000 - 2009 in a German area with 200,000 inhabitants were registered. Severe hypoglycemia was defined as a symptomatic event requiring treatment with intravenous glucose and was confirmed by a blood glucose measurement of < 50 mg/dl., Results: A mean incidence of seven episodes of SH per year and 100,000 inhabitants was registered. The 139 hypoglycemic individuals had been treated with glimepiride (n = 98), glibenclamide (n = 40) or gliquidone (n = 1). No preparation showed a constant dose-effect relationship, SH occurring within a wide dose range. The patients were characterized as follows: age 77.5 + or - 9.4 years, duration of diabetes 11 + or - 7 years, body mass index 26.3 + or - 4.9 kg/m(2), HbA1c 6.6 + or - 1.3%, creatinine clearance 46 + or - 24 ml/min with renal insufficiency in 73% and co-medication 7 + or - 3 drugs. Two-thirds of all subjects lived independently at home whereas a third were cared for by a home nursing service or received care in nursing homes. In all, 30% had participated in diabetes education programs. In 31%, systematic blood glucose monitoring was performed., Conclusions: Uncritical prescription of sulfonylureas neglecting crucial contraindications - particularly renal insufficiency - and deficiencies of diabetes care contributed substantially to the risk of SH in the mainly geriatric patients. There is a need for alternative therapeutic concepts that minimize the risk of hypoglycemia in geriatric patients with T2DM.

The incidence of severe metabolic crises in medium chain acyl-CoA dehydrogenase deficiency (MCADD) patients homozygous for the common c.985A>G mutation, who had been identified by neonatal screening, was assessed prospectively and compared to retrospective cohort data in unscreened patients with identical genotypes. Logrank test showed a significant reduction of severe metabolic crises in the screened cohort (p<0.01). Neonatal screening appears to reduce the rate of severe metabolic crisis or death in the most prevalent subset of MCADD.

Introduction: Undiagnosed gestational diabetes mellitus (GDM) is associated with severe perinatal complications., Patients and Methods: Out of 970 women, infant and maternal morbidity was assessed in 114 mother-children-pairs with an infant birth weight over the 90th percentile (Voigt et al., 1996). It was the aim of this retrospective study to assess the number of mothers with undiagnosed GDM, who have born a macrosomic child., Results: The macrosomia rate in newborns was 12 % in this study excluding macrosomic infants of mothers with preexisting diabetes mellitus. Maternal data: Age 28.3 +/- 5.3 years, adipositas (body-mass-index > 30 kg/m) in 42.1 % vs. 30.4 % in the peer group (p < 0.02), increase in weight > 15 kg during pregnancy in 57.9 % of the mothers who have given birth to a macrosomic child vs. 30.9 % in the peer group (p < 0.0001), family history of diabetes mellitus (28.0 % vs. 11.3 % in the peer group, p = 0.006), preeclampsia in 8.8 % vs. 2.7 % in the peer group (p = 0.002), cervical insufficiency in 2.6 % vs. 0.4 % in the peer group (p = 0.02). After delivery HbA1c was elevated in 38.6 % of the women having born macrosomic infant (mean HbA1c: 5.0 % +/- 0.5). Infant data: neonatal jaundice 16.7 % vs. 4.5 % in the peer group, p < 0.0001. There were no statistically significant differences concerning perinatal condition and malformations. Neonatal hypoglycaemia occurred in 9.6 % of the macrosomic infants. Cord blood insulin levels were significantly elevated in comparison to the peer group of mothers without metabolic disorders and having born eutroph infants (8.4 mU/l [3.0 - 100.0] vs. 5.3 mU/l [3.0 - 30.7], p = 0.01). 11.4 % of all macrosomic infants had cord blood insulin levels above the normal range., Conclusion: More than one third of the mothers having born one or more macrosomic infants had an impairment of glucose metabolism immediately after birth. The elevated prevalence of preeclampsia in this group confirms the relationship of hypertension and impaired glucose metabolism during pregnancy. The detection of hyperinsulinaemia, postnatal hypoglycaemia, elevated prevalence of neonatal jaundice with need of further therapy and diabetic fetopathy in macrosomic infants of mothers, whose metabolism was not monitored during pregnancy, pinpoint the need for a diagnostic screening for GDM.

Aim: To determine the clinical characteristics of severe hypoglycaemia (SH) in a nonselected German population. SH was defined as an event requiring intravenous glucose or glucagon injection., Methods: The prospective population-based study screened sensitively for SH in a region with 200,000 inhabitants between 1997 and 2000. All 30,768 patients who presented to the regional central hospital emergency department, and 6,631 (85 %) of 7,804 patients attended by the emergency medical service in the region were given an initial blood glucose test to detect atypical hypoglycaemia., Results: Altogether, 264 cases of SH were registered, which occurred either spontaneously (n = 14; 5 %), in subjects with type 1 (n = 92; 35 %) or type 2 diabetes (n = 148; 56 %), or in subjects with a non-classified form of diabetes (n = 10; 4 %). On the basis of the estimated local number of diabetic patients the annual rate of SH was 1.5 episodes per 100 patients in insulin-treated type 2 diabetics compared with a rate of 0.4 episodes per 100 patients for the overall group of type 2 diabetic patients. Nocturnal hypoglycaemia accounted for 44 % of episodes in patients with type 1 diabetes on intensified therapy but for only 25 % in patients with type 2 diabetes. 26 % of the hypoglycaemic individuals with type 1 diabetes had an impaired awareness of hypoglycaemia and thus recurrent hypoglycaemic episodes. Irrespective of the treatment, the most frequent contributing factors for SH in type 2 diabetic patients were advanced age (76 +/- 12 years), multimorbidity (3.6 +/- 2.6 concomitant diseases)--in particular renal impairment (54 % [80/148])--and polypharmacy (4 +/- 2.7 concomitant drugs). 34 % (50/148) of the subjects with type 2 diabetes lived in nursing homes or were cared for by a home nursing service. With standardised treatment zero mortality of SH in diabetic patients was achieved, only one non-diabetic died due to hepatic failure., Conclusion: In elderly, multimorbid patients approaching the insulin-deficient end of the spectrum of type 2 diabetes the risk of developing SH increases considerably, nearing that in patients with type 1 diabetes. In order to avoid SH in geriatric patients, the treatment targets should be defined critically, taking into account individual quality of life and life expectancy. Hypoglycaemia unawareness is a major risk factor for SH in type 1 diabetes.

The purpose of the study was to specify the changes in blood glucose concentrations in the course of repeated tournament and practice matches, and to quantify the Incidence of hypoglycaemia in elite tennis players. The study consisted of two parts. In the first, 147 tournament players completed a questionnaire about the incidence of hypoglycaemic symptoms during repeated tennis matches. In the second part of the study, the players participated in two subsequent matches (one singles match followed by a doubles) under (T) tournament (n = 57) and (P) practice (n = 20) conditions. Of the 147 players consulted, 94 (63.9%) reported experiences with hypoglycaemic symptoms during a tennis tournament (n = 80) and/or tennis practice (n = 62). The warm-up period for the second match day was identified as the most sensitive point for the occurrence of hypoglycaemic symptoms (n = 29), compared to the final stages of the first (n = 11) or second match (n = 7). Under both practice and tournament conditions, a significant (p < 0.01) drop in blood glucose concentration was found during the warm-up period for the second match per day (T: from 5.8 +/- 1.4 mmol x L(-1) to 4.3 +/- 0.8 mmol x L(-1) and P: from 5.4 +/- 1.1 mmol x L(-1) to 4.1 +/- 1.5 mmol x L(-1)). In conclusion, precautions should be taken to prevent a sudden drop in blood glucose concentration and hypoglycaemic symptoms during the early stages of a player's second tennis match in one day.

Blood glucose testing plays an important role in emergency medicine. Although the use of visual reagent test strips is widely established in this setting, the accuracy of reflectometric blood glucose determinations under emergency conditions has rarely been investigated. In a prospective study, 522 of a total of 3,217 patients undergoing emergency blood glucose testing had parallel blood glucose measurements performed using a specific enzymatic method. These 522 patients (aged 61.4 years, 54% men, 90 cases of severe hypoglycemia) had an intravenous access placed at the scene of the emergency. Venous whole blood from the introducer needle of the access was applied to the test strip and the glucose measured with a GlucoTouch reflectometer (LifeScan, Inc.). A blood sample from the intravenous access was then immediately collected in a monovette for subsequent glucose determination in a chemical laboratory (hexokinase method) within 20 to 40 minutes. The emergency glucose measurements (mean: 7.3 mmol/L [95% confidence interval [CI] 6.9 to 7.7]; range: 0.55 to 27.7) correlated well with the reference laboratory results (Pearson's r = .98; linear regression analysis: slope 1.0, axial intercept 1.74). Error grid analysis also showed good agreement between corresponding measurements: zone A 96.7%, B 2.5%, C 0% and D 0.8%. The mean difference using the Bland-Altman method was 0.14 mmoVL; 2 SD 1.8 mmol/L; minimum -7.0 mmol/L; maximum 4.4 mmol/L. The accuracy of the rapid venous blood glucose determination by constantly changing emergency teams was high. Especially in 90 hypoglycemic patients, there were no deviations from the reference method that could have led to clinically relevant wrong decisions. The method of collecting whole blood directly from the venous access is simple and robust, and is independent of the hemodynamic status of the patient.

Intensification of insulin therapy in the Diabetes Control and Complications Trial led to an improvement in the quality of diabetes care, which was accompanied, however, by a threefold increase in the risk of severe hypoglycaemia. The present trial, a long-term evaluation of a structured 5-day treatment and teaching programme (DTTP) for intensified insulin therapy, was performed to clarify factors determining HbA1c, the incidence of severe hypoglycaemia, diabetes knowledge and quality of life. Ninety-four Type 1 diabetic patients were examined at baseline and 4 years after participation in a DTTP. Comparison of baseline data with measurements at the 4-year follow-up examination showed that relative HbA1c (= HbA1c/mean normal) improved (1.9 +/- 0.51 vs 1.55 +/- 0.3*, p < 0.001, *excluding 4 patients with diabetes manifestation at baseline) and that frequencies of daily insulin injections (3.73 +/- 1.23 vs 4.9 +/- 0.69*, p < 0.001) and weekly blood glucose self-tests (6.6 +/- 10.1 vs 25.5 +/- 8.7*, p < 0.001) increased, whereas the incidence of severe hypoglycaemia (intravenous glucose, glucagon injection) remained stable (0.19 vs 0.24, p = 0.48). Patients with less diabetes knowledge had higher HbA1c levels and a higher incidence of severe hypoglycaemia. In the group of patients with severe hypoglycaemia, certain crucial gaps in diabetes knowledge were identified concerning the effects of physical activity, nutrition and long-term complications of diabetes. In multivariate analysis. The most important factor associated with HbA1c was diabetes knowledge which, however, was not influenced by educational level or other factors. Interventions, such as the identification of psychosocial factors which may interact with diabetes knowledge, quality of life and successful self-management of diabetes by patients, are needed to improve the efficacy of DTTPs and to prevent severe side effects such as hypoglycaemia.

The objective of this study was to identify possible risk factors of severe hypoglycaemia (SH) in a prospective population based study of adult Type I (insulin-dependent) diabetic patients. A representative sample of 684 patients (41% women, mean +/- SD age 36 +/- 11, diabetes duration 18 +/- 11 years), living in the district of Northrhine (9.5 million inhabitants), Germany, were examined in their homes using a mobile ambulance. A comprehensive baseline assessment of possible predictors of SH included sociodemographic and disease related variables, hypoglycaemia awareness, diabetes management, and attitudes and behavioural aspects as expressed by the patients. After a mean of 19 +/- 6 months 669 (98%) patients were interviewed about events of SH since the baseline examination. Using the multiple Cox proportional hazards model, five risk factors of SH were identified: SH during the preceding year [hazard ratio (HR) 2.7, 95% confidence intervals (CI) 1.8-4.2], any history of SH (HR 1.9, CI 1.1-3.4), C-peptide negativity (HR 4.0, CI 1.2-12.7), social status (HR 0.8 for a difference of 5 units for a value range of 0-24, CI 0.6-0.9), and patients' determination to reach normoglycaemia (HR 0.7 for a difference of 1 unit for a value range of 1-6, CI 0.5-0.9), indicating that the lower the social status and the higher the patients' determination to reach normoglycaemia, the higher the risk of SH. After eliminating the history of hypoglycaemia from the model, impaired hypoglycaemia awareness and patients' inappropriate denial of SH as their particular problem became additional significant risk factors of SH. In conclusion, in this population based study of adult Type I diabetic patients, C-peptide negativity, a previous event of SH, patients' determination to reach normoglycaemia and social class were risk factors of SH.

Up to now all published experience with intensified insulin therapy has originated from specialized diabetes centres. However, even in diabetes centres and under research conditions intensification of insulin therapy may substantially increase the risk of severe hypoglycaemia. The aim of the present study was to demonstrate the feasibility of effectively and safely transferring intensified insulin therapy based upon a 5-day in-patient treatment and teaching programme from a University diabetes centre to non-specialized general hospitals. A total of nine general hospitals were recruited; the University diabetes centre served as a reference centre. From each general hospital a nurse and a dietitian were trained as diabetes educators, and a diabetes unit with about 10 beds was organized within each department of internal medicine. A total of 697 consecutively admitted Type 1 (insulin-dependent) diabetic patients (age 26 +/- 7 years, duration of diabetes 8 +/- 7 years) who participated in the programme either in one of the general hospitals (n = 579) or in the reference centre (n = 118) were re-examined after 1, 2 and 3 years. Insulin therapy was intensified to a similar extent in the reference centre and the general hospitals; at the 3-year follow-up about 80% of the patients injected insulin at least three times daily or used continuous subcutaneous insulin infusion (10%), and about 70% reported measuring blood glucose levels more than twice per day. HbA1 levels were lowered (p < 0.0001) to comparable levels, i.e. from 10.6% (reference centre) and 9.9% (general hospital), respectively, at baseline to 9.4% and 9.3%, respectively, at the 3-year follow-up.(ABSTRACT TRUNCATED AT 250 WORDS)