Monitoring glucose levels in pregnant women with type 2 diabetes
Time Spent In the Target Glucose Range and MatErnaL and Neonatal Effects in Women With tYpe 2 Diabetes in Pregnancy (TIMELY)
This study is testing how well pregnant women with type 2 diabetes can keep their blood sugar levels in a healthy range using a continuous glucose monitor.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Mount Sinai Hospital, Canada Academic / other |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT06147466 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess how well women with type 2 diabetes manage their glucose levels during pregnancy, specifically focusing on the time spent within the target glucose range of 70-140 mg/dl. Participants will use Dexcom Continuous Glucose Monitoring devices to track their glucose levels throughout their pregnancy, with data analyzed by trimester. The study seeks to understand the glycemic control of these women and its impact on neonatal outcomes.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with a diagnosis of type 2 diabetes prior to pregnancy or within the first 20 weeks of gestation.
Not a fit: Patients with non-type 2 diabetes or those with severe complications related to diabetes may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve glycemic control in pregnant women with type 2 diabetes, leading to better health outcomes for both mothers and their babies.
How similar studies have performed: Other studies have shown success in using continuous glucose monitoring to improve outcomes in diabetic pregnancies, indicating a promising approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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. 2. ≤14 weeks gestation, 3. age ≥18 years 4. Willingness to use the study devices a minimum of 10 days per trimester 5. Able to provide informed consent 6. Have access to email Exclusion Criteria: 1. Non-type 2 diabetes 2. Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids 3. Known or suspected allergy against insulin 4. 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 5. Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance 6. Unable to communicate effectively in English as judged by the investigator 7. Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results
Where this trial is running
Toronto, Ontario
- Mount Sinai Hospital — Toronto, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Denice Feig — Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital
- Study coordinator: Denice Feig, MD, MSc, FRCPC
- Email: Denice.Feig@sinaihealth.ca
- Phone: 416-586-8590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.