Time Spent In the Target Glucose Range and MatErnaL and Neonatal Effects in Women With tYpe 2 Diabetes in Pregnancy (TIMELY)
Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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), overall and by trimester, by standard CGM measures and functional data analysis
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: t
View:
• 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
Locations
Other Locations
Canada
Mount Sinai Hospital
RECRUITING
Toronto
Contact Information
Primary
Denice Feig, MD, MSc, FRCPC
Denice.Feig@sinaihealth.ca
416-586-8590
Backup
Silva Darrouj, HBSc
silva.darrouj@sinaihealth.ca
416-586-4800
Time Frame
Start Date: 2023-03-01
Estimated Completion Date: 2026-06-01
Participants
Target number of participants: 50
Related Therapeutic Areas
Sponsors
Collaborators: University of Manitoba, Women's College Hospital
Leads: Mount Sinai Hospital, Canada