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Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

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ClinicalTrials.gov Identifier: NCT02064023
Recruitment Status : Terminated (Some sites withdrew because no contract with insulin pump supplier)
First Posted : February 17, 2014
Last Update Posted : October 30, 2017
Sponsor:
Information provided by (Responsible Party):
David Thompson, 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Type 2 Diabetes Pregnancy Device: insulin pump Other: multiple daily insulin injection Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Continuous Subcutaneous Insulin Infusion (CSII) With Multiple Daily Injections (MDI) for the Treatment of Pregestational Diabetes During Pregnancy
Study Start Date : April 2014
Actual Primary Completion Date : December 4, 2015
Actual Study Completion Date : December 4, 2015

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.



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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02064023


Locations
Canada, British Columbia
Jim Pattison Outpatient Care and Surgery Centre
Surrey, British Columbia, Canada, V3T 0G9
B.C. Women's Hospital
Vancouver, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
Investigators
Principal Investigator: David M Thompson, MD University of British Columbia

Responsible Party: David Thompson, Principal Investigator, University of British Columbia
ClinicalTrials.gov Identifier: NCT02064023     History of Changes
Other Study ID Numbers: H12-02375
First Posted: February 17, 2014    Key Record Dates
Last Update Posted: October 30, 2017
Last Verified: October 2017

Keywords provided by David Thompson, University of British Columbia:
insulin pump
CSII
multiple daily injections
MDI
type 1 diabetes
type 2 diabetes
pregnancy

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pregnancy Complications
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs