Recruiting

Observational Study

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT06147466

Conditions

Diabete Type 2

Pregnancy in Diabetic

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

Interventions

Dexcom Continuous Glucose Monitoring

Study Details

Brief 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

Conditions

Diabete Type 2

Pregnancy in Diabetic

Study ID

NCT06147466

Start date

Mar 1, 2023

Status verified date

Mar, 2023

Completion date

Jun 1, 2026

Anticipated

Primary completion date

Mar 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

Dexcom Continuous Glucose Monitoring

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

Primary outcome measure

  • Time in target range [ Time Frame: 7-9 months ]

Central Contacts and Locations

Central contacts

Locations

Mount Sinai Hospital

Recruiting

Toronto, Ontario, Canada

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Mar 20, 2024

Last verified

Mar, 2023

Keywords

  • glucose range
  • neonatal outcomes
  • glycemic control
  • hypoglycemia
  • insulin resistance
  • preganant
  • pregnancy
  • CGM
  • Continuous Glucose Monitoring
  • Dexcom
  • maternal outcomes
  • Pregnancy in Diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2024-03-20.