Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

NCT02064023 | Terminated

• 1 other identifier: H12-02375
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes; Pregnancy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 42 weeks

Secondary Outcomes (1)

• Mean maternal HbA1c during pregnancy

  up to 42 weeks

Other Outcomes (1)

• Number of episodes of severe hypoglycemia

  up to 42 weeks

Study Arms (2)

insulin pump

EXPERIMENTAL

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

Multiple Daily Insulin injections

ACTIVE COMPARATOR

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

Other: multiple daily insulin injection

Interventions

insulin pump DEVICE

subjects in the experimental arm will administer insulin using a pump

insulin pump

multiple daily insulin injection OTHER

Subjects will continue with usual insulin injections

Multiple Daily Insulin injections

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (2)

Jim Pattison Outpatient Care and Surgery Centre

Surrey, British Columbia, V3T 0G9, Canada

Location

B.C. Women's Hospital

Vancouver, British Columbia, Canada

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Interventions

Insulin Infusion Systems

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Drug Delivery Systems; Drug Therapy; Therapeutics; Infusion Pumps; Equipment and Supplies; Artificial Organs; Surgical Equipment

Study Officials

• David M Thompson, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2014
• First Posted: February 17, 2014
• Study Start: April 1, 2014
• Primary Completion: December 4, 2015
• Study Completion: December 4, 2015
• Last Updated: October 30, 2017

Record last verified: 2017-10

Locations

CA (2)