Status:
RECRUITING
Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy
Lead Sponsor:
Mount Sinai Hospital, Canada
Collaborating Sponsors:
University of Manitoba
Women's College Hospital
Conditions:
Diabete Type 2
Pregnancy in Diabetic
Eligibility:
FEMALE
18+ years
Brief Summary
Prospective cohort study to determine to what extent women with type 2 diabetes are achieving the time in the target range outlined for women with type 1 diabetes (70-140 mg/dl or 3.5-7.8 mmol/l), ove...
Eligibility Criteria
Inclusion
- Women with type 2 diabetes diagnosed prior to pregnancy or prior to 20 weeks gestation with either a HbA1c of \>6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75g OGTT. To make the diagnosis in pregnancy one needs 2 values equal to or greater than the values above.
- ≤14 weeks gestation,
- age ≥18 years
- Willingness to use the study devices a minimum of 10 days per trimester
- Able to provide informed consent
- Have access to email
Exclusion
- Non-type 2 diabetes
- Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
- Known or suspected allergy against insulin
- Women with nephropathy (eGFR\<30), severe autonomic neuropathy, uncontrolled gastroparesis that, as judged by the investigator, is likely to interfere with the normal conduct of the study and interpretation of study results
- Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance
- Unable to communicate effectively in English as judged by the investigator
- Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results
Key Trial Info
Start Date :
March 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06147466
Start Date
March 1 2023
End Date
June 1 2026
Last Update
March 20 2024
Active Locations (1)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada