Postpartum Glycemia in Women At Risk for Persistent Hyperglycemia

The University of Alabama at Birmingham

Status: Completed

Conditions: Gestational Diabetes

Treatments: Diagnostic Test: 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor

Study type: Interventional

Funder types: Other

Identifiers

NCT04521712

300005510

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for early GDM women:

• Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
• Gestational diabetes mellitus identified at < 20 weeks' gestation requiring pharmacologic treatment (class A2)

Exclusion Criteria for early GDM women:

• History of prediabetes or polycystic ovarian syndrome
• History of pregestational type 2 diabetes mellitus
• Skin conditions which prevent wearing a continuous glucose monitor

Inclusion Criteria for 3rd trimester GDM women:

• Live singleton gestation with no fetal anomalies at 34-40 weeks gestation
• Gestational diabetes mellitus identified at >= 24 weeks' gestation requiring pharmacologic treatment (class A2)

Exclusion Criteria for 3rd trimester GDM women:

• History of prediabetes or polycystic ovarian syndrome
• History of pregestational type 2 diabetes mellitus
• Skin conditions which prevent wearing a continuous glucose monitor

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Postpartum GDM

Experimental group

Description:

Women with GDM diagnosed early (\< 20 weeks gestation) or with routine 3rd trimester screening (\>=24 weeks) will be enrolled in this longitudinal study. All enrolled women will complete a oral glucose tolerance test and wear a continuous glucose monitor for 10 days at the 3 designated study time points (0-4 days, 4-6 weeks, and 6 months after delivery).

Treatment:

Diagnostic Test: 2-hour 75-g oral glucose tolerance test and Dexcom G6 Pro continuous glucose monitor