| Registry | NCT07332416 |
|---|---|
| Status | Enrolling by invitation |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, screening |
| Enrollment | 1300 (Estimated) |
| Sponsor | Wake Forest University Health Sciences (Other); collaborators: Medstar Health Research Institute, University of North Carolina, Chapel Hill, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
| Conditions | Gestational Diabetes |
| Interventions | Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott (Other) |
| Dates | start 2026-07-06, primary completion 2027-01-01 (estimated), completion 2027-01-01 (estimated), first posted 2026-01-12, last updated 2026-07-10 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Gestational Diabetes All trials of Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Postpartum CGM | Active comparator | Other: Continuous glucose monitoring for 14 days using the Freestyle LibrePro by Abbott | Postpartum continuous glucose monitoring |
| Postpartum OGTT | No intervention | Postpartum oral glucose tolerance test | |
| No screening | No intervention | No postpartum glucose screening |
Sex: Female, ages: 18 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem, North Carolina | United States |
NIH grants: P30DK124723