Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

October 27, 2017 updated by: David Thompson, University of British Columbia

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Surrey, British Columbia, Canada, V3T 0G9
        • Jim Pattison Outpatient Care and Surgery Centre
      • Vancouver, British Columbia, Canada
        • B.C. Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Device: insulin pump
subjects in the experimental arm will administer insulin using a pump
Active Comparator: Multiple Daily Insulin injections
subjects will continue their usual insulin treatment with multiple daily injections of sc insulin
Other: multiple daily insulin injection
Subjects will continue with usual insulin injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite obstetrical/perinatal endpoint consisting of specific elements (see description)
Time Frame: 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.
Up to 42 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean maternal HbA1c during pregnancy
Time Frame: up to 42 weeks
HbA1c will be measured at least every three months to provide information about overall glycemic control
up to 42 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of episodes of severe hypoglycemia
Time Frame: up to 42 weeks
Severe hypoglycemia is defined as capillary glucose < 3.3 mmol/L requiring the assistance of another person for treatment.
up to 42 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Investigators

  • Principal Investigator: David M Thompson, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2014

Primary Completion (Actual)

December 4, 2015

Study Completion (Actual)

December 4, 2015

Study Registration Dates

First Submitted

February 3, 2014

First Submitted That Met QC Criteria

February 14, 2014

First Posted (Estimate)

February 17, 2014

Study Record Updates

Last Update Posted (Actual)

October 30, 2017

Last Update Submitted That Met QC Criteria

October 27, 2017

Last Verified

October 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H12-02375

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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