Continuous Glucose Monitoring in Women With Type 1 Diabetes in Pregnancy Trial

Completed · Not applicable

Conditions studied: Type 1 Diabetics Who Are Pregnant or Planning Pregnancy

In brief

The primary objective of the study is to determine if RT CGM (Real Time-Continuous Glucose Monitoring) can improve glycemic control in women with T1D who are pregnant or planning pregnancy.

Key facts

Study ID

NCT01788527

Run by

Mount Sinai Hospital, Canada

People needed

325

Starts

2013-03-01

Expected to finish

2016-03-01

Last updated by the study team

2017-07-19

Who can join

Age: 18 and older, up to 40. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Clinical diagnosis of type 1 diabetes and using daily insulin therapy for at least one year
• Age 18-40 years
• Insulin regimen involves either the use of an insulin pump or multiple daily injections of insulin (at least 3 shots per day). Subjects using premixed fixed doses of insulin at the time of enrolment will not be eligible. Insulin regimen must be stable for at least 4 weeks (i.e. on multiple insulin injections or on insulin pump) prior to randomization.
• No expectation that subject will be moving out of the area of the clinical center during the next year, unless the move will be to an area served by another study center
• Informed Consent Form signed by the subject
• In addition, specific eligibility criteria apply to the respective groups:
• Pre-pregnancy Group:
• Patients who are planning pregnancy and wish to optimise glycemic control before conception
• Pregnancy Group:
• Pregnancy gestation ≤13 weeks, 6 days at time of randomization
• Live singleton fetus
• Dating ultrasound (US) done to confirm gestational age, viability and rule out multiples. Gestational age will be based on the last menstrual period (LMP) provided there is a ≤5 day discrepancy with US dates in the first trimester and ≤10 day discrepancy with US dates in the second trimester. If the dates from LMP are outside these limits, the US dates will be used as the best estimate of gestational age.

You may not qualify if…

• Type 2 diabetes
• Gestational diabetes
• Previous participation in the study
• Estimated GFR <60 ml/min/1.73
• The presence of a significant medical disorder or use of a medication such as oral glucocorticoids that in the judgment of the investigator will affect the wearing of the sensors or the completion of any aspect of the protocol.
• If the investigator is uncertain whether the patient would be eligible; i.e. if the medical disorder would constitute an exclusion, the Steering Committee will be asked to make the decision.
• Inpatient psychiatric treatment in the past 6 months
• Subjects using premixed fixed doses of insulin at the time of enrolment
• In addition, specific exclusion criteria apply to the respective groups:
• Pre-pregnancy Group:
• HbA1c <7.0% or >10.0%
• Pregnancy Group:
• HbA1c <6.5% or >10.0%
• Known current higher order pregnancies (twins, triplets, etc.) These women will be excluded as they have a higher rate of adverse outcomes and could lead to inequalities if they are unequally distributed between the groups.
• Known potentially major fetal anomaly (as per EUROCAT criteria).

Where it is running

• Sansum Diabetes Research Institute — Santa Barbara, California, United States
• Alberta Health Services - Calgary Zone — Calgary, Alberta, Canada
• IWK Health Centre — Halifax, Nova Scotia, Canada
• McMaster University — Hamilton, Ontario, Canada
• Kingston General Hospital — Kingston, Ontario, Canada
• St Joseph's Health Care — London, Ontario, Canada
• The Ottawa Hospital — Ottawa, Ontario, Canada
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada
• Mount Sinai Hospital — Toronto, Ontario, Canada
• St-Luc Hospital- Centre hospitalier de L'Universite de Montreal — Montreal, Quebec, Canada
• Chuq-Chul — Québec, Quebec, Canada
• Royal University Saskatoon — Saskatoon, Saskatchewan, Canada
• Galway University Hospital — Galway, Ireland
• Niguarda Ca' Granda Hospital — Milan, Italy
• Hospital De La Santa Creu I Sant Pau — Barcelona, Spain
• University of Aberdeen — Aberdeen, Scotland, United Kingdom
• Royal Infirmary of Edinburgh — Edinburgh, Scotland, United Kingdom
• Glasgow Royal Infirmary — Glasgow, Scotland, United Kingdom
• Russells Hall Hospital — Dudley, West Midlands, United Kingdom
• Addenbrooke's Hospital — Cambridge, United Kingdom
• Ipswich Hospital NHS Trust — Ipswich, United Kingdom
• St James University Hospital — Leeds, United Kingdom
• Guys & St. Thomas' — London, United Kingdom
• Kings College Hospital — London, United Kingdom
• Manchester University Hospital NHS Trust — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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