Progression of Retinopathy During Pregnancy in Type 1 Diabetic Women Treated With Insulin Lispro

Abstract

OBJECTIVE -To evaluate the progression of retinopathy during pregnancy and postpartum in (insulin-dependent) women with type 1 diabetes treated with insulin lispro or with regular human insulin. RESEARCH DESIGN AND METHODS-A prospective open study of 69 pregnant women with diabetes was performed. A total of 36 of the women were treated with insulin lispro (lispro group) and 33 were treated with conventional short-acting human insulin (regular insulin group). The retinopathy level was estimated by color fundus photography every trimester and postpartum. Glycemic control during pregnancy, hypoglycemia (blood glucose level Ͻ3 mmol/l) in 24-h glucose profile, blood pressure, and proteinuria were registered.RESULTS -HbA 1c values were similar at baseline in the first trimester but thereafter were lower in the lispro group than in the regular insulin group throughout pregnancy (P ϭ 0.022, repeated-measures ANOVA). The number of hypoglycemic episodes did not differ between the treatment groups. In multivariable logistic regression analysis with retinopathy severity (Diabetes Control and Complications Trial level) in the third trimester as the dependent variable, only nulliparity qualified as a predictor in the model [Exp(B) ϭ 4.0, 95% CI 1.1-13.7, P ϭ 0.030]. Factors such as duration of diabetes, type of insulin used, mean HbA 1c level throughout pregnancy, blood pressure (systolic or diastolic), preeclampsia in the current pregnancy, smoking, or prepregnancy planning did not explain the retinopathy progression.CONCLUSIONS -Insulin lispro improves glycemic control during diabetic pregnancy compared with regular insulin with no adverse impact on progression of diabetic retinopathy.

Maternal Glycemic Control and Hypoglycemia in Type 1 Diabetic Pregnancy

“…In clinical studies, compared with HI, IAsp provides superior postprandial glycemic control with less risk of major and nocturnal hypoglycemic episodes and small improvement in A1C (20 -24). Safety and efficacy of the use of insulin analogs during pregnancy has yet to be confirmed in randomized controlled trials, although observational studies have not identified cause for concern (25)(26)(27)(28)(29).…”

Systematic Literature Review of Basal Bolus Insulin Analogue Therapy during Pregnancy

“…As suggested by these results glycemic control measured by A1c was improved in lispro groups versus regular insulin in multiple studies [22,23,26,29], except for the Garcia-Dominguez et al [30] report showing greater A1c levels in the lispro group, p=0.022 [30].…”

“…They found lower, but non-significant, rates of maternal hypoglycemia (9 vs. 11 women, p=0.42) throughout pregnancy. A1c levels were significantly lower in the lispro group in T2 and T3, but not in T1 (p=0.022) [23].…”

“…However, Loukovaara et al [23] demonstrated that lispro had no impact on the progression of diabetic retinopathy [23]. Masson et al [17] similarly reported that none of the patients developed retinopathy de novo, but 6 patients with established retinopathy required laser therapy during pregnancy [17].…”

“…Loukovaara et al [23] conducted a randomized trial on women with T1DM (lispro, n=36 and regular insulin, n=33). They found lower, but non-significant, rates of maternal hypoglycemia (9 vs. 11 women, p=0.42) throughout pregnancy.…”