Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy (NCT06147466) | Clinical Trial Compass
RecruitingNot Applicable
Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy
Canada50 participantsStarted 2023-03-01
Plain-language 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
Who can participate
Age range18 Years
SexFEMALE
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Inclusion criteria
ā. Women with type 2 diabetes diagnosed prior to pregnancy or prior to 20 weeks gestation with either a HbA1c of \>6.5%, fasting glucose ā„7.0, or 2 hr glucose ā„11.1 on a 75g OGTT. To make the diagnosis in pregnancy one needs 2 values equal to or greater than the values above.
ā. ā¤14 weeks gestation,
ā. age ā„18 years
ā. Willingness to use the study devices a minimum of 10 days per trimester
ā. Able to provide informed consent
ā. Have access to email
Exclusion criteria
ā. Non-type 2 diabetes
ā. Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
ā. Known or suspected allergy against insulin
ā. 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
ā. Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance
ā. Unable to communicate effectively in English as judged by the investigator