The PPCGMS Intervention After GDM Trial

Stopped early · Not applicable

Conditions studied: Postpartum Gestational Diabetes Mellitus

In brief

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.

Key facts

Study ID

NCT06057805

Run by

Woman's

People needed

39

Starts

2024-02-06

Expected to finish

2024-10-16

Last updated by the study team

2024-10-18

Who can join

Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• diagnosis of gestational diabetes during recent pregnancy (4-24 weeks)
• age 18 or older.
• written informed consent

You may not qualify if…

• pregestational diabetes (type 1 or type 2)
• include known known skin adhesive allergy which would prevent subject from wearing a CGM,
• history of bariatric surgery or other surgeries that induce malabsorption
• long-term use (>2 weeks) of systemic steroids during the testing interval
• inability or refusal to comply with protocol

Where it is running

• Karen Elkind-Hirsch — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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