CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitorother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

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NCT04521712N/ACompleted
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Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia

University of Alabama at Birmingham·interventional·Posted Aug 20, 2020·Updated Dec 18, 2024

In Brief

A clinical study evaluating 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor for Gestational Diabetes. Completed, enrolled 40 participants across 2 sites.

Detailed Summary

GDM is characterized by decreased insulin sensitivity, decreased insulin secretion, or a combination of both. Women with GDM are at significant risk for overt T2DM later in life, and postpartum insulin sensitivity and secretion in women with GDM has not been quantified, limiting our ability to optimize screening for overt T2DM. In addition, compliance with currently recommended postpartum T2DM screening by OGTT is poor. Quantification of postpartum insulin sensitivity and secretion in women at high risk for T2DM will inform strategies to improve diagnostic strategies. Continuous glucose monitoring (CGM) is a new technology that may be useful to identify women with persistent hyperglycemia. Understanding maternal glycemia and physiology that drives glycemia in the postpartum period is limited. Completion of this study will define postpartum maternal glycemia, quantify insulin secretion versus insulin sensitivity defects, and demonstrate the feasiblity of using continuous glucose monitoring to identify women most at risk for overt T2DM.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsGestational Diabetes
CountriesUnited States
CollaboratorsUniversity of North Carolina, Chapel Hill

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedAug 20, 2020
Enrollment StartSep 17, 2021
Primary CompletionDec 10, 2024
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 5.9 years ago

Interventions

2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitorother

All women enrolled in this study will have a 2-hour 75-g oral glucose tolerance test performed immediately postpartum (within 4 days of delivery), at 4-6 weeks postpartum, and at 6 months postpartum. Enrolled women will also wear a continuous glucose monitor for 10 days at each of these time periods. Both women and their infants will have skin fold thickness measured at each of these 3 study visits to estimate body fat composition. Additionally umbilical cord blood and placental biopsies will be collected at delivery and stored for future research.