Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

University of British Columbia

Status: Terminated

Conditions: Type 1 Diabetes; Type 2 Diabetes; Pregnancy

Treatments: Device: insulin pump; Other: multiple daily insulin injection

Study type: Interventional

Funder types: Other

Identifiers

NCT02064023

H12-02375

Details and patient eligibility

About

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.

Full description

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

Enrollment: 2 patients

Sex: Female

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

insulin pump

Experimental group

Description:

subjects will use an insulin pump for the duration of the pregnancy. The intervention is that they will control their diabetes using an insulin pump

Treatment:

Device: insulin pump

Multiple Daily Insulin injections

Active Comparator group

Description:

subjects will continue their usual insulin treatment with multiple daily injections of sc insulin

Treatment:

Other: multiple daily insulin injection