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

NCT ID: NCT06147466

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-01

Study Completion Date

2026-06-01

Brief Summary

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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

Detailed Description

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Conditions

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Diabete Type 2 Pregnancy in Diabetic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Manitoba

OTHER

Sponsor Role collaborator

Women's College Hospital

OTHER

Sponsor Role collaborator

Mount Sinai Hospital, Canada

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Denice Feig

Role: PRINCIPAL_INVESTIGATOR

Lunenfeld-Tanenbaum Research Institute, Mount Sinai Hospital

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Denice Feig, MD, MSc, FRCPC

Role: CONTACT

416-586-8590

Silva Darrouj, HBSc

Role: CONTACT

416-586-4800 ext. 3946

Facility Contacts

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Denice Feig, MD

Role: primary

Other Identifiers

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21-0065-E

Identifier Type: -

Identifier Source: org_study_id

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