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

Launched by MOUNT SINAI HOSPITAL, CANADA · Nov 21, 2023

Keywords

ClinConnect Summary

This clinical trial, titled "Time Spent In Target Glucose Range in Women With Type 2 Diabetes in Pregnancy," is looking to understand how well women with type 2 diabetes are able to keep their blood sugar levels within a healthy range during pregnancy. The goal is to see how much time these women spend with their blood sugar between 70-140 mg/dl (or 3.5-7.8 mmol/l), which is the recommended target for women with type 1 diabetes. Researchers will collect data using continuous glucose monitoring (CGM) devices and analyze the information throughout the different stages of pregnancy.

To be eligible for this study, women must be at least 18 years old and diagnosed with type 2 diabetes before or during early pregnancy. They should also be willing to use the study devices for at least 10 days during each trimester and have access to email. Unfortunately, women with certain health issues, such as severe kidney problems or those taking specific medications that affect blood sugar, cannot participate. If you join the study, you can expect to wear a device that tracks your blood sugar levels and be part of a supportive environment aimed at improving health outcomes for you and your baby.

Gender

FEMALE

Eligibility criteria

• 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