Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02064023
• Other study ID #: H12-02375
• Status: Terminated
• Phase: N/A
• First received: February 3, 2014
• Last updated: October 27, 2017
• Start date: April 2014
• Est. completion date: December 4, 2015

Study information

• Verified date: October 2017
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: December 4, 2015
• Est. primary completion date: December 4, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• Pregnancy
• Type 1 Diabetes
• Type 2 Diabetes

Intervention

Device:
• insulin pump
subjects in the experimental arm will administer insulin using a pump

Other:
• multiple daily insulin injection
Subjects will continue with usual insulin injections

Locations

Country	Name	City	State
Canada	Jim Pattison Outpatient Care and Surgery Centre	Surrey	British Columbia
Canada	B.C. Women's Hospital	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of episodes of severe hypoglycemia	Severe hypoglycemia is defined as capillary glucose < 3.3 mmol/L requiring the assistance of another person for treatment.	up to 42 weeks
Primary	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	Mean maternal HbA1c during pregnancy	HbA1c will be measured at least every three months to provide information about overall glycemic control	up to 42 weeks