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The aim of this work was to assess the accuracy of automatic macronutrient and calorie counting based on voice descriptions of meals provided by people with unstable type 1 diabetes using the developed expert system (VoiceDiab) in comparison with reference counting made by a dietitian, and to evaluate the impact of insulin doses recommended by a physician on glycemic control in the study’s participants. We also compared insulin doses calculated using the algorithm implemented in the VoiceDiab system. Meal descriptions were provided by 30 hospitalized patients (mean hemoglobin A1c of 8.4%, i.e., 68 mmol/mol). In 16 subjects, the physician determined insulin boluses based on the data provided by the system, and in 14 subjects, by data provided by the dietitian. On one hand, differences introduced by patients who subjectively described their meals compared to those introduced by the system that used the average characteristics of food products, although statistically significant, were low enough not to have a significant impact on insulin doses automatically calculated by the system. On the other hand, the glycemic control of patients was comparable regardless of whether the physician was using the system-estimated or the reference content of meals to determine insulin doses.

The aim of this review was to investigate existing guidelines and scientific evidence on determining insulin dosage in people with type 1 and type 2 diabetes, and in particular to check whether the prandial insulin dose should be calculated based on glycemia or the meal composition, including the carbohydrates, protein and fat content in a meal. By exploring the effect of the meal composition on postprandial glycemia we demonstrated that several factors may influence the increase in glycemia after the meal, which creates significant practical difficulties in determining the appropriate prandial insulin dose. Then we reviewed effects of the existing insulin therapy regimens on glycemic control. We demonstrated that in most existing algorithms aimed at calculating prandial insulin doses in type 1 diabetes only carbohydrates are counted, whereas in type 2 diabetes the meal content is often not taken into consideration. We conclude that prandial insulin doses in treatment of people with diabetes should take into account the pre-meal glycemia as well as the size and composition of meals. However, there are still open questions regarding the optimal way to adjust a prandial insulin dose to a meal and the possible benefits for people with type 1 and type 2 diabetes if particular parameters of the meal are taken into account while calculating the prandial insulin dose. The answers to these questions may vary depending on the type of diabetes.

Purpose The objective was to assess glucose, lactate, glycerol, and pyruvate concentrations in the interstitial fluid of the adipose tissue as well as the glucose relative recovery coefficient in reference to capillary blood (RC) during the first two days of the standard treatment of diabetic ketoacidosis (DKA) in patients with type 1 and type 2 diabetes. Materials and Methods The study group consisted of 19 patients (12 with type 1 diabetes and 7 with type 2 diabetes). The metabolic state of the patients was monitored using the microdialysis technique. The analysis of variance was used to investigate whether the type of diabetes and the duration of treatment influenced the assessed parameters. Results Concentrations of all the monitored components were stable after the initial 12 h of treatment. Glucose concentration was higher and concentrations of all the other components were lower (pConclusions The results suggest that the standard treatment of DKA is effective in stabilizing a concentration of the studied metabolic components in the interstitial fluid in patients with type 1 and type 2 diabetes despite differences in the glucose concentration at the beginning of the treatment.

Introduction Lactic acidosis is a relatively rare complication diagnosed in patients with diabetes. Objectives The aim of this study was to identify causes of lactic acidosis in patients with diabetes and to measure the extent of metabolic disturbances based on the available laboratory test results. Patients and methods A total of 29 diabetic patients aged 20-87 years were admitted to the Intensive Diabetes Care Unit of the Warsaw Medical University in the years 2007-2012 with the diagnosis of lactic acidosis (lactate level >5 mmol/l). A detailed medical history was taken from all patients or their caregivers. Lactate levels, glycemia, acetonuria, and gasometry were measured on admission. Results Eight patients with type 1 diabetes, 18 patients with type 2 diabetes, and 3 patients with other types of diabetes were hospitalized with the diagnosis of lactic acidosis. Lactic acidosis (lactate levels, 5.2-27 mmol/l) was associated with increased glycemia (13.3-91.7 mmol/l) and low pH (6.73-7.28). Alcohol abuse was reported in 12 subjects based on medical history. In 3 women, acute diabetic complication was caused by psychogenic eating disorders. There were 5 fatal cases including 3 cases of metformin treatment. Conclusions Alcohol abuse and its effects on health seem to be the main cause of lactic acidosis in diabetic patients. Metformin-treated patients, especially elderly ones, are at a risk of sudden deterioration of renal function, which in turn may increase the risk of lactic acidosis.

Diabetic foot ulcer area is a basic parameter used for monitoring the wound healing and effectiveness of the treatment applied. TeleDiaFoS (developed earlier in collaboration with the Department and Clinic of Gastroenterology and Metabolic Diseases, Medical University of Warsaw, Warsaw, Poland) is one of just a few systems available that make possible monitoring of the wound size remotely based on the foot scans transmitted to the physician from a patient's home. The aim of this study was to compare the diabetic foot ulcer areas measured using TeleDiaFoS with the results obtained using three reference methods.The reference measurements were conducted using the elliptical method with a ruler, the wound tracing method and planimetrics with the Visitrak (SmithNephew, London, UK) system, and the pattern-coded structured light method with the Silhouette (ARANZ Medical, Christchurch, New Zealand) system. Regression and Bland-Altman analyses were performed. The study group consisted of 23 diabetes patients with plantar foot ulcers.Thirty-three wounds were successfully examined. The measurement method influenced the measured area significantly (P=0.00005). The correlation coefficients between TeleDiaFoS and the ruler, Visitrak, and Silhouette methods were 0.949, 0.985, and 0.987, and the limits of agreement equaled -1.3±5.5 cm(2), -0.4±2.2 cm(2), and -0.6±2.1 cm(2), respectively. The strong linear relationships obtained can be used to convert the wound area measured with TeleDiaFoS to the corresponding value of each of the reference methods.The results indicate that the wound area of plantar ulcers in diabetes might be monitored effectively using the TeleDiaFoS system based on the foot scans that the patient can produce at home with no assistance of other persons.

Glycated hemoglobin A1c (HbA1c) concentration in blood is an index of the glycemic control widely used in diabetology. The aim of the work was to validate two mathematical models of HbA1c formation (assuming irreversible or reversible glycation, respectively) and select a model, which was able to predict changes of HbA1c concentration in response to varying glycemia courses with higher accuracy. The experimental procedure applied consisted of an original combination of: in vivo continuous glucose concentration monitoring, long-term in vitro culturing of the human erythrocytes and mathematical modeling of HbA1c formation in vivo and in vitro with HbA1c values scaled according to the most specific analytical methods. Sixteen experiments were conducted in vitro using blood samples collected from healthy volunteer and stable type 1 diabetic patients whose glycemia was estimated beforehand based on long-term monitoring. The mean absolute difference of the measured and predicted HbA1c concentrations for the in vitro experiments were equal to 0.64 +/- 0.29% and 1.42 +/- 0.16% (p = 0.0007) for irreversible and for reversible model, respectively, meaning that the irreversible model was able to predict the glycation kinetics with a higher accuracy. This model was also more sensitive to a deviation of the erythrocytes life span.

Background: Glycated hemoglobin A1c (HbA1c) has been used as an index of glycemic control in the management, guidance, and clinical trials of diabetic patients for the past 35 years. The aim of this study was to validate the HbA1c model in patients with type 1 and type 2 diabetes and to use it to support interpretation of HbA1c in different clinical situations. Methods: The HbA1c model was identified in 30 patients (15 with type 1 diabetes and 15 with type 2 diabetes) by estimating the overall glycation rate constant (k), based on results of continuous glucose monitoring. The model was validated by assessing its ability to predict HbA1c changes in cultures of erythrocytes in vitro and to reproduce results of the A1C-Derived Average Glucose (ADAG) study. The model was used to simulate the influence of different glucose profiles on HbA1c. Results: The mean k was equal to 1.296±0.216×10 �9 lm mol �1 s �1 with no difference between type 1 and type 2 diabetes. The mean coefficient of variation of k was equal to 16.7%. The model predicted HbA1c levels in vitro with a mean absolute difference less than 0.3% (3.3 mmol/mol). It reproduced the linear relationship of HbA1c and mean glucose levels established in the ADAG study. The simulation experiments demonstrated that during periods of unstable glycemic control, glycemic profiles with the same mean glucose might result in much different HbA1c levels. Conclusions: Patients with type 1 and type 2 diabetes are characterized by the same mean value of k, but there is considerable interindividual variation in the relationship of HbA1c and mean glucose level. Results suggest that reciprocal changes in glycation rate and the life span of erythrocytes exist in a wide range of HbA1c values. Thus, for an average patient with diabetes, no modifications of parameters of the glycation model are required to obtain meaningful HbA1c predictions. Interpreting HbA1c as a measure of the mean glucose is fully justified only in the case of stable glycemia. The model and more frequent tests of HbA1c might be used to decrease ambiguity of interpreting HbA1c in terms of glycemic control.

Existing standards of the management of the diabetic patients are not efficient enough, and further improvement is needed. The major objective of this paper is to present and discuss the therapeutic effectiveness of an intensive care telematic system designed and applied for intensive treatment of pregnant type 1 diabetic women. The developed system operates automatically, every night transferring all the data recorded during the day in the patient's glucometer memory to a central clinical unit. In order to assess the efficiency of the designed and developed system, a 3-year randomized prospective clinical trial was conducted, using the study group and the control group, each consisting of 15 pregnant type 1 diabetic women. All patients were treated by the same diabetologist. In the presented analysis, two indices calculated weekly were used for the assessment of glycemic control: MBG represents mean blood glucose level, and the universal J-index is sensitive to the glycemic level and glycemic variations. The most important results from the study concern: (a) better glycemic control in the study group in comparison with the control group during the course of treatment, as assessed by the average differences of the MBG and J indices calculated weekly (n = 24) (deltaMBG = -3.2 +/- 4.3 mg/dL, p = 0.0016, deltaJ = -1.4 +/- 2.3, p = 0.0065); (b) much more similar results in glycemic control among members of the study group compared to each other, than among members of the control group compared to each other, as indicated by significantly lower variations of the applied glycemic control indices (SDMBG: 11.9 vs. 18.7 mg/dL, p = 0.0498; SDJ: 6.5 vs. 10.9, p = 0.0318); (c) the observed tendency of a better glycemic control for patients with a lower level of intelligence (IQ100) supported by the telematic system in comparison with all other assessed groups of patients. The last result was not statistically significant (p0.05). This telematic intensive care system improved the effectiveness of diabetes treatment during pregnancy. It also allows the diabetologist's strategy to be much more precise than if it were conducted without telematic support. This telematic system is inexpensive and simple in use.

A telematic system supporting intensive insulin treatment of pregnant type 1 diabetic out-clinic patients was implemented and technical efficiency of the system was evaluated over long-term ambulatory application. The system consists of a patient teletransmission module (PTM) and a central clinical control unit (CCU). The PTM contains a one-box blood glucose meter and electronic logbook, a modem and a dial-up or cellular phone set. The CCU consists of a PC computer with a modem and DIAPRET – an original program designed to monitor the intensive insulin treatment. The system was installed in the Clinic of Gastroenterology and Metabolic Disease, MA Warsaw and was tested for 166 ± 24 days on 15 pregnant type 1 diabetic women. Telemonitoring of the patient data was done automatically. No major technical problems with proper operation or handling of the system was noted. Total effectiveness was 69.3 ± 13.0% and technical effectiveness 91.5 ± 6.1%. The efficacy of the system was not significantly influenced by patient intelligence level, education level or place of residence (p < 0.05). Significant improvement of metabolic control was noted during application of the system. In conclusion, the telematic system we developed and implemented should have a positive influence on the quality of diabetes treatment during pregnancy.

The objectives were as follows: (1) estimating mean value of the overall hemoglobin glycation rate constant (k); (2) analyzing inter-individual variability of k; (3) verifying ability of the hemoglobin A1c (HbA1c) formation model to predict changes of HbA1c during red blood cells cultivation in vitro and to reproduce the clinical data. The mean k estimated in a group of 10 non-diabetic subjects was equal to 1.257 ± 0.114 × 10(-9) L mmol(-1) s(-1). The mean k was not affected by a way of estimation of glycemia. The mean k differed less than 20% from values reported earlier and it was almost identical to the mean values calculated on basis of the selected published data. Analysis of variability of k suggests that inter-individual heterogeneity of HbA1c formation is limited or rare. The HbA1c mathematical model was able to predict changes of HbA1c in vitro resulting from different glucose levels and to reproduce a linear relationship of HbA1c and average glucose obtained in the A1C-Derived Average Glucose Study. This study demonstrates that the glycation model with the same k value might be used in majority of individuals as a tool supporting interpretation of HbA1c in different clinical situations.

Basal-bolus insulin therapy is a standard method of intensifying diabetes treatment. A common adverse effect of such treatment is hypoglycemia. Data on frequency of hypoglycemia when fast-acting insulin analogue is used in everyday clinical practice is scarce.The aim of the study was to investigate the risk of hypoglycemia after the use of insulin aspart in basal-bolus therapy in patients with type 1 and 2 diabetes.It was a multicenter, open-label, noninterventional study. It involved 950 patients with type 1 and 1332 patients with type 2 diabetes who started preprandial insulin aspart in basal-bolus regimen. Patients were followed for 13 weeks. The primary endpoint was the incidence of major daytime and nocturnal hypoglycemic events assessed on the basis of patients' self-reports during follow-up compared with a 4-week period before the baseline visit. Secondary endpoints were: incidence of minor daytime and nocturnal hypoglycemia, hemoglobin A1c (HbA1c), fasting and postprandial glycemia.The rate of major hypoglycemia decreased in patients with type 1 diabetes--the incidence rate ratio (IRR) was 0.14 for daytime and 0.03 for nocturnal episodes (P0.0001) and did not change in patients with type 2 diabetes. The rate of minor episodes decreased in patients with type 1 diabetes (IRR = 0.44 for daytime and IRR = 0.24 for nocturnal episodes, P0.0001) and in patients with type 2 diabetes (IRR= 0.57, P0.0001 for daytime and IRR = 0.89, P0.05 for nocturnal episodes). HbA1c decreased by 1.28 ± 1.64% in type 1 and 1.25 ± 1.10% in type 2 diabetes (both P0.0001). Self-measured fasting and postprandial blood glucose levels were significantly lower at the final visit compared with baseline, irrespective of diabetes type.In clinical practice, treatment with insulin aspart in basal-bolus regimen is associated with low risk of hypoglycemia and leads to a significant improvement in glucose control, irrespective of diabetes type.

The objective of the study was to establish the quasi-continuous courses, using microdialysis technique, of glucose, lactate, and glycerol concentrations in interstitial fluid of abdominal adipose tissue during the standard treatment of acute diabetes complications. Clinical studies were carried out on 31 diabetic patients during the initial 48 h of the treatment. In all but two obese female patients with hyperglycemic hyperosmolar state (HHS) did glucose concentration in perfusion fluid (PF) reflect concentration in capillary blood. The recovery of glucose correlated with patients' body mass index (r = 0.55). It was significantly higher in lean and overweight patients (91 +/- 15%) than in obese patients (55 +/- 31%). The course of lactate concentration in PF coincided with the course in venous blood (2.1 +/- 0.3 mmol/L vs. 2.0 +/- 0.5 mmol/L, P = 0.35). Glycerol concentration was 267 +/- 41 micromol/L and 133 +/- 40 micromol/L in PF and venous blood, respectively (P = 0.004). The study indicated that microdialysis may be an effective tool to monitor concentration of different metabolites in interstitial fluid of the adipose tissue during treatment of the acute complications of diabetes. Applicability of the technique in the monitoring of HHS, especially in obese female patients, needs further investigation.

The aim of the work was to develop and to evaluate the clinical efficiency of a mobile telecare system implementing teleconsultations based on the continuous transmission of patient-collected data directly to the physician and to the clinic. The developed TeleMed system consists of the patients' and the diabetologist's mobile units, the diabetologist's clinic and home workstations and the clinical server. The evaluation of the system was performed on a group of 13 newly diagnosed type 1 diabetic patients, during a single-arm study with 3-days run-in period, including a one-day intensive educational program, and 3-week study period, when the intensive insulin treatment was conducted without visits of patients to the clinic. The MBG dropped from 7.2 ± 1.7 mmol/L before the study to 6.1 ± 1.0 mmol/L in the third week of the study (P = 0.02) and the J-index from 30.2±19.2 to 19.7±7.7 (P = 0.04). Hemoglobin A1c decreased from 11.8 ± 3.3% to 8.6 ± 1.2% (P = 0.0002) in one month. The total daily insulin dose declined from 39.9 ± 8.5 U to 20.0 ± 9.6 U (P = 0.000006). The number of hypoglycemia episodes per patient per day decreased by 66% (P = 0.08) and the number of hyperglycemia episodes was reduced by 47% (P < 0.0001). The TeleMed facilitates not only efficient realization of the intensive insulin treatment but also successful remote patient training and education. No formal patient satisfaction study was done. However, some of the findings indicate that the application of the developed system increases patient self-confidence and quality of life. (Int J Artif Organs 2006; 29: 1074–81)