Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy

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

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 Criteria

Inclusion

Inclusion Criteria:

  1. 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.
  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

Exclusion Criteria:

  1. Non-type 2 diabetes
  2. Current treatment with drugs known to interfere with glucose metabolism as judged bythe investigator such as high dose systemic corticosteroids
  3. Known or suspected allergy against insulin
  4. 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
  5. Severe visual or hearing impairment, as judged by the investigator to impact treatmentcompliance
  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 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
    Canada

    Active - Recruiting

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