Time Spent In Target Glucose Range in Women With T2D Diabetes in Pregnancy
Time Spent In the Target Glucose Range and MatErnaL and Neonatal Effects in Women With tYpe 2 Diabetes in Pregnancy (TIMELY)
Mount Sinai Hospital, Canada
50 participants
Mar 1, 2023
OBSERVATIONAL
Conditions
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
Inclusion Criteria6
- 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.
- ≤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 Criteria7
- Non-type 2 diabetes
- Current treatment with drugs known to interfere with glucose metabolism as judged by the investigator such as high dose systemic corticosteroids
- Known or suspected allergy against insulin
- 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
- Severe visual or hearing impairment, as judged by the investigator to impact treatment compliance
- Unable to communicate effectively in English as judged by the investigator
- Any reason judged by the investigator that would likely interfere with the normal conduct of the study and interpretation of study results
Interventions
A continuous glucose monitor (CGM) is a wearable device that tracks blood glucose (sugar) every few minutes, throughout the day and night. The readings are relayed in real time to a device which can be read by the patient, caregiver or health-care provider, even remotely
Locations(1)
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NCT06147466