The PPCGMS Intervention After GDM Trial

NCT06057805 | Terminated FDA Device

• 1 other identifier: RP23-010
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Postpartum Gestational Diabetes Mellitus

Keywords

postpartum; continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• CGM metric of mean glucose compared to OGTT result

  CGM metric of mean glucose will be compared to standard 75-gram postpartum OGTT result

  up to 10 days

Secondary Outcomes (8)

• CGM variability metric of time in range will be compared to OGTT result

  up to 10 days

• CGM variability measure MAGE will be compared to be compared to OGTT result

  up to 10 days

• CGM metric of mean glucose compared to hemoglobin A1C result

  up to 10 days

• CGM variability metric of time in range will be compared to hemoglobin A1C test

  up to 10 days

• CGM variability measure MAGE will be compared to hemoglobin A1C test

  up to 10 days

Other Outcomes (1)

• Tolerability to dexcom adhesive

  up to 10 days

Study Arms (1)

Blinded CGM

EXPERIMENTAL

Blinded continuous glucose monitor Dexcom G7

Device: Blinded Dexcom G7 CGM

Interventions

Blinded Dexcom G7 CGM DEVICE

CGM that records blood glucose but not visible to patient or provider in real time

Also known as: Blinded continuous glucose monitor Dexcom G7

Blinded CGM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Participant postpartum 4-24 weeks after having gestational diabetes during prior pregnancy
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

Sponsors & Collaborators

• Woman's: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Karen Elkind-Hirsch

Baton Rouge, Louisiana, 70817, United States

Location

Related Publications (1)

• Elkind-Hirsch KE, Armatta ML, Hames KC, Veillon EW Jr. Continuous glucose monitoring predicts glycemic status in postpartum women with a recent history of gestational diabetes. Expert Rev Med Devices. 2026 Jan;23(1):99-105. doi: 10.1080/17434440.2025.2607631. Epub 2025 Dec 26.

  PMID: 41422557 DERIVED

Study Officials

• Karen Elkind-Hirsch, PhD

  Woman's Hospital, Louisiana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Blinded continuous glucose monitor will be compared with routine blood testing postpartum

Study Record Dates

• First Submitted: September 11, 2023
• First Posted: September 28, 2023
• Study Start: February 6, 2024
• Primary Completion: October 16, 2024
• Study Completion: October 16, 2024
• Last Updated: October 18, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)