Pilot Study of Continuous Glucose Monitoring for Postpartum Glucose Screening

Wake Forest University (WFU)

Status: Begins enrollment this month

Conditions: Gestational Diabetes

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07332416

P30DK124723 (U.S. NIH Grant/Contract)

IRB00143138

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,300 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,300 participants in 3 patient groups

Postpartum CGM

Active Comparator group

Description:

Postpartum continuous glucose monitoring

Treatment:

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

Postpartum OGTT

No Intervention group

Description:

Postpartum oral glucose tolerance test

No screening

No Intervention group

Description:

No postpartum glucose screening