An Effective Intervention for Diabetic Lipohypertrophy: Results of a Randomized, Controlled, Prospective Multicenter Study in France.

BACKGROUND: Lipohypertrophy (LH) is highly prevalent and is potentially harmful to insulin-injecting patients. METHODS: In this study, we assessed the impact of injection technique (IT) education, including use of a 4-mm pen needle on insulin-treated patients with clinically observed LH in a randomized, controlled, prospective multicenter study in France with follow-up of 6 months. Intensive education and between-visit reinforcement were given to the intervention group. Control patients received similar messages at study outset. RESULTS: A total of 123 patients were recruited (age 52.1 ± 15.7 years; men 70.7%; body mass index >30 kg/m2: 34.2%; type 1: 53.7%; years with diabetes mellitus: 18.1 ± 10.5), of which 109 patients were included in the final analysis. The intervention group (n = 53) showed a significant decrease of total daily dose of insulin (average at baseline: 54.1 IU) at 3 months (T-3) and 6 months (T-6), reaching just over 5 IU versus baseline (P = 0.035). Corresponding, although not significant, decreases occurred in controls (n = 56); between-group differences were not significant. There were significant decreases in HbA1c (up to 0.5%) at T-3 and T-6 in both groups, with no significant differences between groups. A significant number of intervention patients improved their IT habits; about half achieved ideal IT habits by T-3 versus a quarter of control patients. By T-6, 2/3 of intervention patients achieved either ideal or acceptable IT habits, while only 1/3 of control patients did. CONCLUSIONS: Our intervention was effective in both study arms, however, to a greater degree and more rapidly in the intervention group. Widespread application of this intervention could be highly cost-effective.

A recent survey confirms the efficacy and the safety of implanted insulin pumps during long-term use in poorly controlled type 1 diabetes patients.

BACKGROUND: This article reports a prolonged trial with insulin pumps implanted in patients with type 1 diabetes showing poor glucose control and a high rate of complications. METHODS: We reviewed data from 181 patients undergoing implanted insulin pump therapy. Analysis included hemoglobin A1c (HbA1c) values, body weight, and diabetes complications status. RESULTS: At implantation, the mean age was 43 (range, 19-72) years, mean duration of diabetes was 22.2 (2-52) years, and mean body weight was 68.6 (43-104) kg. The complication status involved retinopathy (62% of patients), neuropathy (34.6%), nephropathy (26%), and cardiovascular disease (14%). Patients' previous insulin treatment regimen was multiple daily injections (17.1%) or continuous subcutaneous insulin infusion (82.9%). HbA1c levels significantly dropped from 7.9 ± 1.2% to 7.6 ± 1.2% after 1 year (P < 0.01) and remained within the range of 7.5-7.6% for up to 5 years. No significant variation of body weight or complications status occurred. CONCLUSIONS: Implanted insulin pump therapy demonstrates long-term benefits in type 1 diabetes patients who have poor prognosis under intensive subcutaneous treatment.

Intraperitoneal insulin infusion versus islet transplantation: comparative study in patients with type 1 diabetes.

OBJECTIVE: The purpose of this article was to compare two strategies for insulin delivery in brittle type 1 diabetic patients: intraperitoneal insulin infusion (IPII) through an implantable pump and intraportal islet transplantation (IIT). METHODS: Thirteen consecutive patients (6 islet after kidney and 7 islet transplantation alone), treated with IIT according to the Edmonton protocol, were compared with 17 patients treated with IPII in the same center in a nonrandomized study. Both groups of patients were assessed for clinical profile, metabolic results, and adverse events during the 3-year period after implantation. RESULTS: Sex ratio, mean age, body mass index, diabetes duration, daily insulin need (DIN), blood creatinine, lipid and HbA1c levels, and frequency of diabetic complications did not differ significantly between the two groups before inclusion. The comparison of metabolic results 3, 6, and 12 months after IIT or IPII showed that while mean HbA1c significantly decreased over time in both groups, mean DIN, glycemia, and number of hypoglycemias less than 3.3 mmol/L per patient per week (Hypo) only significantly decreased in the IIT group versus baseline. At 12 months, mean DIN, HbA1c, and Hypo were significantly lower in the IIT versus IPII group. After 24 and 36 months, mean DIN, HbA1c, and Hypo remained significantly lower in the IIT group versus baseline, and mean HbA1c and DIN versus IPII. Adverse events were, however, fourfold more frequent with IIT versus IPII, though their numbers decreased over time. CONCLUSION: These results suggest that metabolic results improve with both methods, but were significantly better with IIT versus IPII, though with more frequent side effects.