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Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening

Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07332416
Enrollment
1300
Registered
2026-01-12
Start date
2026-07-06
Completion date
2027-01-01
Last updated
2026-07-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gestational Diabetes

Keywords

Continuous glucose monitoring, Postpartum glucose screening, Dysglycemia

Brief summary

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

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.

Interventions

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

Postpartum CGM

Sponsors

Wake Forest University Health Sciences
Lead SponsorOTHER
Medstar Health Research Institute
CollaboratorOTHER
University of North Carolina, Chapel Hill
CollaboratorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Continuous Glucose Monitor (CGM) uptake - Percentage of CGM-eligible patients20 weeks postpartumPercentage of CGM-eligible patients that return a used CGM sensor

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORKatherine A Sauder, MD

Wake Forest University Health Sciences

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 11, 2026