Objective: To compare insulin lispro with regular human insulin with respect to blood glucose control and frequency of hypoglycaemia in patients with type 1 diabetes who wished to fast during the month of Ramadan.
Research design and methods: Insulin lispro or regular human insulin was given together with NPH insulin, twice daily before the morning and evening meals, for two weeks each in an open-label, randomised, cross-over design, and 64 patients completed the protocol. Blood glucose was self-monitored at fasting morning and evening, and 1-h and 2-h after the post-sunset meal on three consecutive days at the end of each treatment period.
Results: The 2-h blood glucose excursion after the post-sunset meal was significantly (p=0.026) lower with insulin lispro (2.50 +/- 0.46 mmol/l) than with regular human insulin (3.47 +/- 0.49 mmol/l). Daily insulin doses did not differ between treatments but compliance with recommended time of injection was better with insulin lispro. Hypoglycaemia incidence (insulin lispro, 15 (23.4%) patients; regular human insulin 31 (48.4%) patients; p=0.004) and frequency (insulin lispro, 0.70 +/- 0.19; regular human insulin 2.25 +/- 0.36 episodes/patient/30 days; p<0.001) were lower with insulin lispro. Five (22.7%) of the episodes during insulin lispro occurred during the nocturnal period compared with 27 (36.5%) of the episodes while on regular human insulin.
Conclusions: Glycaemic control, measured by postprandial glycemic excursions, was improved and hypoglycaemia was significantly reduced with insulin lispro compared with regular human insulin. Patients with type 1 diabetes who insist on fasting during Ramadan may be better managed with insulin lispro.