Podaż węglowodanów w diecie i kontrola glikemii u pacjentów leczonych za pomocą mieszanek insuliny ludzkiej

Wstęp. Leczenie mieszankami insuliny ludzkiej (PMHI, pre-mixed human insulin) jest na całym świecie jednym z najpopularniejszych modeli insulinoterapii. Jednak osiągnięcie dobrej kontroli glikemii u osób stosujących PMHI może być trudne, głównie ze względu na zmienne spożycie węglowodanów i podaż kalorii. Badanie przeprowadzono w celu oceny wpływu modyfikacji diety na stężenia glukozy u chorych na cukrzycę typu 2 (T2DM, type 2 diabetes mellitus) stosujących PMHI. Materiał i metody. Do tego prospektywnego badania przeprowadzonego w układzie naprzemiennym włączono 8 chorych na T2DM leczonych PMHI (średnie stężenie HbA1c 8,4%). U chorych zastosowano 2 diety, obie cechujące się stałą zawartością kalorii/węglowodanów: dieta A - 50% kalorii pochodzi z węglowodanów, 30% - z tłuszczów, 20% - z białek; dieta B - 40% kalorii pochodzi z węglowodanów, 30% - z tłuszczów i 30% - z protein. Badanie prowadzono w warunkach domowych, dostarczano chorym wszystkie posiłki. Każdy chory stosował dietę A przez 9 dni, a następnie po 7-dniowym okresie wypłukiwania przez 9 dni stosował dietę B. Profile glukozy oceniano przy użyciu systemu ciągłego monitorowania glikemii (CGMS, continuous glucose monitoring system, iPro, Medtronic, USA). Wyniki. Zmiana z diety A na dietę B spowodowała zmniejszenie średnich stężeń glukozy (dane z system CGMS) ze 145 mg/dl do 133 mg/dl (p = 0,0001), redukcję SD z 51 do 42 mg/dl (p = 0,0429) oraz skrócenie czasu, w którym glikemia utrzymywała się powyżej progowej wartości 180 mg/dl z 18% do 11% (p = 0,0006). Wnioski. W badaniu wykazano, że zapewnienie odpowiedniej i powtarzalnej podaży węglowodanów i kalorii z umiarkowanym ograniczeniem węglowodanów umożliwia poprawę kontroli glikemii u chorych na cukrzycę typu 2.Introduction. The treatment with pre-mixed human insulins (PMHI) is globally one of the most popular models of insulin therapy. Achieving good glycaemic control on PMHI may, however, be difficult, mostly due to inconsistent calorie and carbohydrate intake. The aim of the study was to examine the impact of dietary modification on glucose levels in patients with type 2 diabetes mellitus (T2DM) treated with PMHI. Materials and methods. In this prospective cross-over analysis we studied 8 T2DM PMHI treated individuals (mean HbA1c 8.4%). We exposed patients to 2 diets, both based on steady calorie/carbohydrate content: "A" - 50% calories from carbohydrates, 30% from fat, 20% from protein, "B" - 40% from carbohydrates, 30% from fat and 30% from protein. The study was performed in home settings, all the meals were delivered to the patients. Each patient was exposed to diet A for 9 days, than after 7 days of wash-out to 9 days of diet B. Glucose patterns were assessed with continuous glucose monitoring system (CGMS, iPro, Medtronic, USA). Results. Switching from diet A to diet B resulted in a decrease in mean glucose levels (CGMS data) from 145 mg/dL to 133 mg/dL (p = 0.0001), SD reduction from 51 to 42 mg/dL (p = 0.0429), and a decrease in time spent above the target of 180 mg/dL from 18% to 11% (p = 0.0006). Conclusions. The study demonstrates that consistent and repeatable carbohydrate (CH) and calorie intake with moderate restriction of CHs helps to improve glycaemic control in this group of patients

Efficacy, Safety, and Quality of Treatment Satisfaction of Premixed Human and Analogue Insulin Regimens in a Large Cohort of Type 2 Diabetic Patients: PROGENS BENEFIT Observational Study

Diabetes is a lifelong course disease, so insulin treatment has to be effective and safe, and patients should be satisfied with it. We aimed to compare efficacy, safety, and quality of treatment satisfaction of human and premixed analogue insulin among 3264 patients (53.58% women) with type 2 diabetes mellitus (T2DM) in a real-life environment. 2493 patients (62.77%) had been assigned to group I where before the inclusion into the study the treatment regimen has been changed from analogue to human premixed insulin and 771 patients (37.23%) to group II where the treatment with insulin analogue remained unchanged. At the end of the study, there was a reduction of HbA1c observed in both of the groups; however, Δ HbA1c was significantly higher in group 1 (−0.599 versus −0.406; P<0.001 at visit 3 versus visit 1). The number of hypoglycemic episodes during the study observation was insignificantly reduced in both groups. Diabetes treatment satisfaction measured with DTSQ increased at the end of the study and was significantly better in group I compared to group II (P<0.001). This observational study proved that both human and premixed analogue insulin are effective and safe, and patients are satisfied with the treatment

Diet-Related Knowledge and Physical Activity in a Large Cohort of Insulin-Treated Type 2 Diabetes Patients: PROGENS ARENA Study

There is no doubt that behavioral intervention is crucial for type 2 diabetes mellitus (T2DM) prevention and management. We aimed to estimate dietary habits and diet-oriented knowledge as well as the level of physical activity in 2500 insulin-treated Polish type 2 diabetes mellitus (T2DM) patients (55.4% women). The mean age of the study participants was 64.9 ± 9.3 years, mean BMI was 31.4 kg/m2 ± 4.5, mean diabetes duration was 12.4 ± 6.9 years, and mean baseline HbA1c was 8.5%  ± 1.2. At the study onset, all the patients completed a questionnaire concerning health-oriented behavior. Results showed a significant lack of diet-related knowledge. For example, only 37.5% recognized that buckwheat contains carbohydrates; the percentage of correct answers in questions about fruit drinks and pasta was 56.4% and 61.2%, respectively. As for the physical activity, only 57.4% of examined T2DM patients declared any form of deliberate physical activity. To conclude, the cohort of poorly controlled insulin-treated T2DM patients studied by us is characterized by insufficient diet-related knowledge and by a very low level of physical activity. Further studies on other populations of insulin-treated T2DM patients are required to confirm these findings

A Multicenter, Prospective, Observational, Open-Label Study of the Safety and Comfort of Gensulin® Delivery Device Use in a Large Cohort of Adult and Elderly Patients with Type 2 Diabetes

Insulin treatment is necessary for many patients with type 2 diabetes, and its delivery must be safe and comfortable. This study evaluated patients&rsquo; safety and comfort when using a Gensulin&reg; delivery device, GensuPen (Bioton), a reusable insulin pen device for injecting Gensulin&reg; insulin among adult and elderly patients with type 2 diabetes. This was a 4-week multicenter, prospective, observational, open-label study in patients with diabetes mellitus type 2 who have recently started using a GensuPen. Overall, 10,309 patients (mean age: 63 &plusmn; 12.0 years; 47.9% female) were analyzed in this study. Of these, 2.5% had used an insulin delivery device before, and for 97.5%, GensuPen was the first delivery device they had used. Most (87.8%) of the patients rated the GensuPen as very good in setting the dose, 92.0% in confirmation of successful insulin administration, 80.9% in trigger location, and 75.0% in force needed for injection. The overall safety of the GensuPen use was high since severe hypoglycemia occurred only in 0.2% of the studied patients. There were 0.6% adverse events, none of which were serious. This real-life observation data shows that the GensuPen was well accepted and safe in this large patient population of adult and elderly patients with type 2 diabetes