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

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

Recruiting
18 years and older
Female
Phase N/A

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Overview

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

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

Study details
    Diabete Type 2
    Pregnancy in Diabetic

NCT06147466

Mount Sinai Hospital, Canada

27 January 2024

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