Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

Not Applicable

Terminated

• Conditions: Type 1 Diabetes; Type 2 Diabetes; Pregnancy
• Interventions: Other: multiple daily insulin injection; Device: insulin pump

• Registration Number: NCT02064023
• Lead Sponsor: University of British Columbia

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study First Submitted: 2014-02-03
• Study First Submitted QC: 2014-02-14
• Study First Posted: 2014-02-17
• Study Start: 2014-04
• Primary Completion: 2015-12-04
• Study Completion: 2015-12-04
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-27
• Last Update Posted: 2017-10-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Multiple Daily Insulin injections	multiple daily insulin injection	subjects will continue their usual insulin treatment with multiple daily injections of sc insulin
insulin pump	insulin pump	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

Primary Outcome Measures

Name	Time	Method
Composite obstetrical/perinatal endpoint consisting of specific elements (see description)	Up to 42 weeks	Composite obstetrical/perinatal endpoint consisting of one or more of pre-eclampsia, primary caesarian section, pre-term delivery, spontaneous abortion, termination for congenital anomaly or chromosomal abnormality, perinatal mortality, large-for-gestational age, shoulder dystocia, birth injury, major congenital anomaly, neonatal hypoglycemia, jaundice requiring phototherapy, or admission to neonatal intensive care nursery.

Secondary Outcome Measures

Name	Time	Method
Mean maternal HbA1c during pregnancy	up to 42 weeks	HbA1c will be measured at least every three months to provide information about overall glycemic control

Trial Locations

Locations (2)

Jim Pattison Outpatient Care and Surgery Centre; 🇨🇦 Surrey, British Columbia, Canada

B.C. Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada