Status:
COMPLETED
Closed-Loop Insulin in Mothers With Type 1 Diabetes and Baby Feeding Practices
Lead Sponsor:
University of Calgary
Collaborating Sponsors:
Calgary Health Trust
Medtronic
Conditions:
Diabetes Mellitus Type 1 Pre-Existing
Pregnancy Related
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief Summary
This study will is a parallel two-group randomized controlled trial that will use the MiniMed 670G hybrid closed-loop system's continuous glucose monitor (GCM) insulin pump and computer algorithm to d...
Detailed Description
Women work very hard prior during pregnancy to try to control their blood sugars. However, after delivery, women often feel they need a rest from the intense effort they have put into diabetes self-ca...
Eligibility Criteria
Inclusion
- Women aged 18 to 45, with at least a two year duration of type 1 diabetes, on intensive insulin therapy (at least 3 daily insulin injections or insulin pump) with a Hba1c during pregnancy \< 9.9 % at study entry who are confirmed by ultrasound, to have a viable singleton pregnancy between 12 and 32 weeks gestation and are not planning to conceive another pregnancy in the first 24 weeks postpartum.
Exclusion
- Non-type 1 diabetes
- Any other physical or psychological disease which, in the opinion of the investigator, is likely to interfere with the normal conduct and interpretation of the study results
- Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids, non-selective beta-blockers and MAO inhibitors.
- Known or suspected allergy against insulin.
- Women with advanced nephropathy (eGFR\<45), severe autonomic neuropathy, uncontrolled gastroparesis or severe proliferative retinopathy, as judged by the investigator, that is likely to interfere with the normal conduct of the study and interpretation of study results.
- Total daily insulin dose of less than 8 or greater than 250 units/day.
- Severe visual or hearing impairment
- Unable to speak and understand English (or French)
- Planning to conceive another pregnancy within the first six months postpartum
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 28 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04420728
Start Date
July 15 2020
End Date
February 28 2023
Last Update
May 23 2023
Active Locations (2)
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1
University of Calgary
Calgary, Alberta, Canada, T2T 5C7
2
Mount Sinai Hospital
Toronto, Ontario, Canada, M5T 3L9