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Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

Primary Purpose

Type 1 Diabetes, Type 2 Diabetes, Pregnancy

Status

Terminated

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

insulin pump

multiple daily insulin injection

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring insulin pump, CSII, multiple daily injections, MDI, type 1 diabetes, type 2 diabetes, pregnancy

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Jim Pattison Outpatient Care and Surgery Centre
B.C. Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

insulin pump

Multiple Daily Insulin injections

Arm 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

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

Outcomes

Primary Outcome Measures

Composite obstetrical/perinatal endpoint consisting of specific elements (see description)

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

Mean maternal HbA1c during pregnancy

HbA1c will be measured at least every three months to provide information about overall glycemic control

Full Information

NCT ID

NCT02064023

First Posted

February 3, 2014

Last Updated

October 27, 2017

Sponsor

University of British Columbia

1. Study Identification

Unique Protocol Identification Number

NCT02064023

Brief Title

Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2017

Overall Recruitment Status

Terminated

Why Stopped

Some sites withdrew because no contract with insulin pump supplier

Study Start Date

April 2014 (undefined)

Primary Completion Date

December 4, 2015 (Actual)

Study Completion Date

December 4, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of British Columbia

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes, Type 2 Diabetes, Pregnancy

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

2 (Actual)

8. Arms, Groups, and Interventions

Arm Title

insulin pump

Arm Type

Experimental

Arm 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

Arm Title

Multiple Daily Insulin injections

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

insulin pump

Intervention Description

subjects in the experimental arm will administer insulin using a pump

Intervention Type

Other

Intervention Name(s)

multiple daily insulin injection

Intervention Description

Subjects will continue with usual insulin injections

Primary Outcome Measure Information:

Title

Composite obstetrical/perinatal endpoint consisting of specific elements (see description)

Description

Time Frame

Up to 42 weeks

Secondary Outcome Measure Information:

Title

Mean maternal HbA1c during pregnancy

Description

HbA1c will be measured at least every three months to provide information about overall glycemic control

Time Frame

up to 42 weeks

Other Pre-specified Outcome Measures:

Title

Number of episodes of severe hypoglycemia

Description

Severe hypoglycemia is defined as capillary glucose < 3.3 mmol/L requiring the assistance of another person for treatment.

Time Frame

up to 42 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David M Thompson, MD

Organizational Affiliation

University of British Columbia

Official's Role

Principal Investigator

Facility Information:

Facility Name

Jim Pattison Outpatient Care and Surgery Centre

City

Surrey

State/Province

British Columbia

ZIP/Postal Code

V3T 0G9

Country

Canada

Facility Name

B.C. Women's Hospital

City

Vancouver

State/Province

British Columbia

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

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