Impact of the "Diabetes Interactive Diary" telemedicine system on metabolic control, risk of hypoglycemia, and quality of life: a randomized clinical trial in type 1 diabetes.

BACKGROUND: Telemedicine systems based on mobile phones represent new promising educational tools. The "Diabetes Interactive Diary" (DID) is a carbohydrate/bolus calculator promoting the patient-physician communication via short message service. This study aimed to compare the efficacy of the DID versus usual care on metabolic control, hypoglycemia, and quality of life. PATIENTS AND METHODS: Patients with type 1 diabetes on a basal:bolus regimen with insulin glargine and insulin glulisine, not previously educated on carbohydrate (CHO) counting, were randomized to DID (Group A; n=63) or traditional education (Group B; n=64). Generalized hierarchical linear regression models for repeated measures were applied to compare changes between groups. Incidence of hypoglycemia was compared using Poisson regression models. RESULTS: Of 127 patients (age, 36.9±10.5 years; diabetes duration, 16.3±9.3 years), 15 (11.8%) dropped out. After 6 months, hemoglobin A1c (HbA1c) levels decreased by -0.49±0.11 in Group A and -0.48±0.11 in Group B (P=0.73). Group A showed a 86% lower risk of grade 2 hypoglycemia than Group B. Compared with usual care, DID improved the "perceived frequency of hyperglycemic episodes" scale of the Diabetes Treatment Satisfaction Questionnaire and the "social relations" and the "fear of hypoglycemia" dimensions of the Diabetes Specific Quality of Life Scale. Results obtained with DID markedly differ among patients and centers. CONCLUSIONS: DID is no more effective than traditional CHO counting education in reducing HbA1c levels. DID reduces the risk of moderate/severe hypoglycemia and improves quality of life. A better understanding of patients' and healthcare professionals' attitudes associated with an effective care supported by technology is essential to avoid waste of resources.

Rethink Organization to iMprove Education and Outcomes (ROMEO): a multicenter randomized trial of lifestyle intervention by group care to manage type 2 diabetes.

OBJECTIVE: A trial was performed to establish whether our group care model for lifestyle intervention in type 2 diabetes can be exported to other clinics. RESEARCH DESIGN AND METHODS: This study was a 4-year, two-armed, multicenter controlled trial in 13 hospital-based diabetes clinics in Italy (current controlled trials no. ISRCTN19509463). A total of 815 non-insulin-treated patients aged <80 years with > or =1 year known diabetes duration were randomized to either group or individual care. RESULTS: After 4 years, patients in group care had lower A1C, total cholesterol, LDL cholesterol, triglycerides, systolic and diastolic blood pressure, BMI, and serum creatinine and higher HDL cholesterol (P < 0.001, for all) than control subjects receiving individual care, despite similar pharmacological prescriptions. Health behaviors, quality of life, and knowledge of diabetes had become better in group care patients than in control subjects (P < 0.001, for all). CONCLUSIONS: The favorable clinical, cognitive, and psychological outcomes of group care can be reproduced in different clinical settings.

Better postprandial glucose stability during continuous subcutaneous infusion with insulin aspart compared with insulin lispro in patients with type 1 diabetes.

BACKGROUND: Persistent glucose variability is a frequent condition in type 1 diabetes. Continuous subcutaneous insulin infusion (CSII) is a rational option to overcome this clinical issue; however, no comparative studies have been reported for aspart and lispro insulin when used in CSII. This study compare the effects of aspart and lispro delivered by CSII on glycemic stability as measured using a continuous glucose monitoring system. METHODS: This single-center, randomized, controlled, 3-day crossover trial included 17 patients with type 1 diabetes. Patients were randomized to receive insulin aspart or insulin lispro. The next day, they received a standard meal at breakfast and lunch and a bolus of insulin aspart or lispro based on insulin:carbohydrate ratio. Patients were monitored for 8 h, after which they received a crossover treatment with insulin aspart or insulin lispro followed by the same procedure as previously. RESULTS: Postprandial blood glucose was more stable with insulin aspart than insulin lispro (absolute Deltaglucose 7.04 +/- 3.16 vs. 9.04 +/- 4.2, P < 0.0019). Daily blood glucose variability profiles (coefficient of variation and mean amplitude of glucose excursion) and frequency of hypoglycemic episodes (area under the curve <72 mg/dL) were similar with both treatments. CONCLUSIONS: Postprandial glucose was more stable when insulin aspart was infused as a pre-meal bolus compared with insulin lispro, indicating a more favorable effect of insulin aspart on postprandial glucose. No differences in overall daily glucose stability were observed between insulin aspart and insulin lispro when infused as basal rate insulin.