OBJECTIVE: To evaluate the safety and efficacy of the transition from a continuous subcutaneous insulin infusion (CSII) regimen with insulin lispro to 1 of 2 dose regimens of multiple daily injections (MDI) with insulin lispro and insulin glargine in patients with type 1 diabetes. METHODS: The study group consisted of 38 patients with type 1 diabetes who had been using CSII with insulin lispro for > or =6 months. These patients were randomized to receive insulin glargine at a dose equal to (group 1:1) or 1.2 times (group 1:1.2) the mean of their total daily CSII basal insulin dose. Data were obtained by continuous interstitial glucose measurement at baseline and for 7 days of MDI. RESULTS: The switch to MDI was associated with a transient deterioration in glycemic control on day 1 in the 1:1 treatment group, which stabilized thereafter. Glucose variability did not increase significantly from baseline in either group on days 1 and 2 after the switch in treatment but increased significantly on day 4 in the 1:1 group for mean amplitude of glucose excursion and in the 1:1.2 group for SD, M-value, and mean amplitude of glucose excursion. Rates of hypoglycemia did not change significantly in either study group after the switch in treatment, but the 1:1 group showed a trend toward less nocturnal hypoglycemia. There were no episodes of severe hypoglycemia, and patients in both groups experienced significantly less time at glucose values <70 mg/dL on day 1 after the switch in comparison with baseline. CONCLUSION:MDI with insulin glargine and insulin lispro provide a safe transition for patients taking "pump holidays" without clinically significant disruptions of glycemic control. The recommended dose of insulin glargine after the switch in treatment is equal to the total daily basal dose on CSII.
RCT Entities:
OBJECTIVE: To evaluate the safety and efficacy of the transition from a continuous subcutaneous insulin infusion (CSII) regimen with insulin lispro to 1 of 2 dose regimens of multiple daily injections (MDI) with insulin lispro and insulinglargine in patients with type 1 diabetes. METHODS: The study group consisted of 38 patients with type 1 diabetes who had been using CSII with insulin lispro for > or =6 months. These patients were randomized to receive insulinglargine at a dose equal to (group 1:1) or 1.2 times (group 1:1.2) the mean of their total daily CSII basal insulin dose. Data were obtained by continuous interstitial glucose measurement at baseline and for 7 days of MDI. RESULTS: The switch to MDI was associated with a transient deterioration in glycemic control on day 1 in the 1:1 treatment group, which stabilized thereafter. Glucose variability did not increase significantly from baseline in either group on days 1 and 2 after the switch in treatment but increased significantly on day 4 in the 1:1 group for mean amplitude of glucose excursion and in the 1:1.2 group for SD, M-value, and mean amplitude of glucose excursion. Rates of hypoglycemia did not change significantly in either study group after the switch in treatment, but the 1:1 group showed a trend toward less nocturnal hypoglycemia. There were no episodes of severe hypoglycemia, and patients in both groups experienced significantly less time at glucose values <70 mg/dL on day 1 after the switch in comparison with baseline. CONCLUSION:MDI with insulin glargine and insulin lispro provide a safe transition for patients taking "pump holidays" without clinically significant disruptions of glycemic control. The recommended dose of insulinglargine after the switch in treatment is equal to the total daily basal dose on CSII.