Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

Comparison of Continuous Subcutaneous Insulin Infusion (CSII) With Multiple Daily Injections (MDI) for the Treatment of Pregestational Diabetes During Pregnancy

This study is investigating whether insulin treatment with the insulin pump or with multiple daily injections (MDI) gives better outcomes for mother and baby in pregnant women with pregestational diabetes. Participants will be randomized to use either the insulin pump or MDI.

Primary outcome is a composite of Cesarian section, instrumental delivery, maternal hypertension, LGA infant, neonatal hypoglycemia or SCN admission.

Inclusion Criteria:

• subjects are attending the Diabetes Pregnancy Clinic at participating hospitals
• have had type 1 or type 2 diabetes for at least one year
• are in the first trimester or are actively attempting pregnancy
• have a singleton pregnancy
• are receiving intensive insulin therapy
• are judged by clinic staff to be capable of using an insulin pump
• are age 19 or older
• are willing to adhere to the study protocol including monitoring blood glucose levels
• are willing to take folic acid before pregnancy and during the first trimester
• are willing to discontinue any medication contraindicated in pregnancy prior to conception
• weigh less than 100 kg (220 lb) prior to becoming pregnant
• use less than 100 units of insulin per day

Exclusion Criteria:

• current or previous use of an insulin pump
• use of fertility treatments
• have a multiple pregnancy
• have had children born with major birth defects
• have experienced stillbirth or multiple early pregnancy losses
• have significant diabetes complications or a serious medical issue