A randomised controlled trial of insulin lispro given before or after meals in pregnant women with Type 1 diabetes—the effect on glycaemic excursion

Abstract

In order to study the glucose excursion associated with pre- and postprandial administration a randomised controlled trial with patients randomised to receive insulin lispro (IL) immediately before or after a standardised meal was performed. Pregnant women with diabetes who were treated with IL as part of a basal bolus regime were asked to bring their own usual lunch and administer their own IL. Maternal glycaemia was monitored preprandially and then at 15-minute intervals for 3 hours following the first bite of lunch. Glucose excursions were calculated by subtracting the preprandial glucose level from the subsequent values at each time point. Each woman was invited to attend on four occasions. On two random occasions she was asked to administer her IL after completing her meal and on two occasions IL was administered immediately before her meal. Nine women completed a total of 27 meals (14 preprandial IL and 13 postprandial IL). There was no significant difference between the mean (SD) fasting values between the two groups, before 5.8 (2.8) and after 5.7 (2.0) mmol/l. At each time-point there was no significant difference between the mean blood glucose excursion in the two groups. No patient suffered a hypoglycaemic attack and there was no evidence of fetal compromise. In the two groups there was a marked similarity in the glycemic excursion following a standard meal, whether or not IL was given before or after eating. Postprandial administration of IL may increase the flexibility of IL usage in pregnant women with diabetes.

Targeting postprandial hyperglycemia

“…Short-acting insulin can be used to aggressively control postprandial glucose. Lispro insulin can be used in diabetic pregnancies [346,347]. There is no increase in congenital anomaly rates in pregnancies where lispro insulin is used [348].…”

A core outcome set for the treatment of pregnant women with pregestational diabetes: an international consensus study

“…The results of the systematic review are shown in Figure S1. Of the 1475 potentially relevant studies, 67 16,17,23–87 fulfilled the inclusion criteria (Table 1). Two hundred and ten outcomes were extracted from the studies.…”

Insulin analogues in the treatment of diabetes in pregnancy

“…The safety and efficacy of Insulin lispro was shown in some trials, and in some case reports performed with pregnant women with gestational diabetes (22,23,25) and type 1 diabetes (24,26,27,(29)(30)(31)(32). It was also found not to cross the placenta (36).…”

“…Finally, it should be stated that many studies and case reports, most of them with small number of patients, have been conducted with the rapid-acting ana-logues lispro and aspart, which have shown to be safe and effective in the treatment of pregnant women with gestational and type 1 diabetes (22)(23)(24)(25)(26)(27)(28)(29)(30)(31)(32)(33)(34)(35). Table 1 shows the results of fourteen articles reporting on 2,069 pregnant diabetic women, 1,794 with type 1 diabetes, and 275 cases of gestational diabetes.…”