Last updated: March 19, 2024
Sponsor: Mount Sinai Hospital, Canada
Overall Status: Active - Recruiting
Phase
N/A
Condition
Diabetes Mellitus, Type 2
Treatment
Dexcom Continuous Glucose Monitoring
Clinical Study ID
NCT06147466
21-0065-E
Ages > 18 Female Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Women with type 2 diabetes diagnosed prior to pregnancy or prior to 20 weeks gestationwith either a HbA1c of >6.5%, fasting glucose ≥7.0, or 2 hr glucose ≥11.1 on a 75gOGTT. To make the diagnosis in pregnancy one needs 2 values equal to or greater thanthe 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
Exclusion Criteria:
- Non-type 2 diabetes
- Current treatment with drugs known to interfere with glucose metabolism as judged bythe investigator such as high dose systemic corticosteroids
- Known or suspected allergy against insulin
- Women with nephropathy (eGFR<30), severe autonomic neuropathy, uncontrolledgastroparesis that, as judged by the investigator, is likely to interfere with thenormal conduct of the study and interpretation of study results
- Severe visual or hearing impairment, as judged by the investigator to impact treatmentcompliance
- Unable to communicate effectively in English as judged by the investigator
- Any reason judged by the investigator that would likely interfere with the normalconduct of the study and interpretation of study results
Study Design
Total Participants: 50
Treatment Group(s): 1
Primary Treatment: Dexcom Continuous Glucose Monitoring
Phase:
Study Start date:
March 01, 2023
Estimated Completion Date:
June 01, 2026
Connect with a study center
Mount Sinai Hospital
Toronto, Ontario
CanadaActive - Recruiting
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