Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening

NCT ID: NCT07332416

Last Updated: 2026-01-12

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

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

1300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-03-01

Study Completion Date

2027-01-31

Brief Summary

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The oral glucose tolerance test (OGTT) is the standard of care in the postpartum period to screen patients with gestational diabetes mellitus (GDM) for persistent dysglycemia. However, most patients find it burdensome and dread having to do it. Adherence rates are low (18-61%), impeding initiation of follow-up care to improve diabetes-related outcomes in subsequent pregnancies and long-term.

Detailed Description

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Continuous glucose monitoring (CGM) is an appealing alternative to the OGTT because it is a low-burden, fully remote, comprehensive assessment of glycemic status. Emerging data suggest that CGM is superior to the OGTT in identifying persistent dysglycemia at 2-5 months postpartum, and preferable to the OGTT among women willing to complete both assessments in the context of a research study. This study proposes a feasibility study of postpartum CGM among patients who do not complete the standard postpartum OGTT. The study will offer CGM in a telehealth (fully remote) context to determine if it can increase adherence to postpartum glycemic screening in real-world settings. This study will (a) evaluate uptake of CGM screening, (b) characterize patients who complete CGM, complete the OGTT, or do not complete screening, and (c) monitor initiation of follow-up care after abnormal results.

Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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Postpartum CGM

Postpartum continuous glucose monitoring

Group Type ACTIVE_COMPARATOR

Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott

Intervention Type OTHER

Postpartum CGM

Postpartum OGTT

Postpartum oral glucose tolerance test

Group Type NO_INTERVENTION

No interventions assigned to this group

No screening

No postpartum glucose screening

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott

Postpartum CGM

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 12-16 weeks postpartum
* Gestational diabetes Mellitus (GDM) diagnosis in most recent pregnancy
* Oral Glucose Tolerance Test (OGTT) order placed in the medical record

Exclusion Criteria

* Pre-gestational diabetes
* Non-English language
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Medstar Health Research Institute

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Katherine A Sauder, MD

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Central Contacts

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Katherine A Sauder, MD

Role: CONTACT

336-716-1280

Facility Contacts

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Katherine A Sauder, MD

Role: primary

336-716-1280

Other Identifiers

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P30DK124723

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00143138

Identifier Type: -

Identifier Source: org_study_id

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