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NCT06057805: PPCMS

The PPCGMS Intervention After GDM Trial

Terminated NA Last updated 18 October 2024
What this trial tests

NA trial testing Blinded Dexcom G7 CGM in Postpartum Gestational Diabetes Mellitus in 39 participants. Terminated before completion.

Timeline
6 February 2024
Primary endpoint
16 October 2024
16 October 2024

Quick facts

Lead sponsorWoman's
PhaseNA
StatusTerminated
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment39
Start date6 February 2024
Primary completion16 October 2024
Estimated completion16 October 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Woman's — full company profile →

Who can join

Adults 18 to 45, female only, with Postpartum Gestational Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Among women who experience glucose abnormalities during pregnancy, screening during the postpartum period offers a window of opportunity for early identification of diabetes and prediabetes. The rates of postpartum type 2 diabetes (T2D) screening with an OGTT for women with GDM are not optimal given the majority of women with GDM fail to return for postpartum glucose testing. Continuous glucose monitoring (CGM) systems have been recognized as an ideal method of monitoring glycemic control in diabetic patients. CGM has been used in diabetic patients primarily as a management tool allowing a more acceptable and reliable glucose reading and control than self-monitoring of blood glucose (SMBG). There is a need to improve diabetes testing after childbirth in women who experienced gestational diabetes. This will allow investigators to target their efforts to improve the early diagnosis and treatment of diabetes following GDM. No studies conducted to date have not comprehensively examined whether CGM after delivery can be used in women with a recent history to predict their risk of diabetes. This research study is being done to assess the acceptability, feasibility, and accuracy of using a glucose sensor (also known as a continuous glucose monitor or CGM) after childbirth as a diagnostic test that can help identify women who are at risk of developing diabetes after having gestational diabetes and explore its correlation to the standard postpartum oral glucose tolerance test as well as a HbA1c and fructosamine test.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Continuous glucose monitoring predicts glycemic status in postpartum women with a recent history of gestational diabetes.
    Elkind-Hirsch KE, Armatta ML, Hames KC, Veillon EW. · · 2026 · PMID 41422557 · DOI 10.1080/17434440.2025.2607631

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06057805.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing