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Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

NCT ID: NCT02064023

Last Updated: 2017-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2015-12-04

Brief Summary

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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

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

Conditions

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Type 1 Diabetes Type 2 Diabetes Pregnancy

Keywords

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insulin pump CSII multiple daily injections MDI type 1 diabetes type 2 diabetes pregnancy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

insulin pump

Intervention Type DEVICE

subjects in the experimental arm will administer insulin using a pump

Multiple Daily Insulin injections

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

Group Type ACTIVE_COMPARATOR

multiple daily insulin injection

Intervention Type OTHER

Subjects will continue with usual insulin injections

Interventions

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insulin pump

subjects in the experimental arm will administer insulin using a pump

Intervention Type DEVICE

multiple daily insulin injection

Subjects will continue with usual insulin injections

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of British Columbia

OTHER

Sponsor Role lead

Responsible Party

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David Thompson

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David M Thompson, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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Jim Pattison Outpatient Care and Surgery Centre

Surrey, British Columbia, Canada

Site Status

B.C. Women's Hospital

Vancouver, British Columbia, Canada

Site Status

Countries

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Canada

Other Identifiers

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H12-02375

Identifier Type: -

Identifier Source: org_study_id