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CAPO: Continuous Glucose Monitoring in A2 Gestational Diabetes and Pregnancy Outcomes

NCT04219085 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2025-08-28

Study results available
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Summary

This study will utilize continuous glucose monitoring in women with A2 gestational diabetes. Women will be randomized to continuous glucose monitoring or routine care with fingersticks to check their blood glucose four times daily. It is hypothesized that women in the continuous glucose monitoring arm will have a lower incidence of the composite primary outcome, which includes the following variables: perinatal death, shoulder dystocia, birth weight greater than 4,000 grams, NICU admission for treatment of hypoglycemia (blood glucose level \<40mg/dL) and birth trauma, including fracture or nerve palsy.

Conditions

  • Gestational Diabetes
  • Maternal Complication of Pregnancy

Interventions

DEVICE

Continuous Glucose Monitor

Wearing of a continuous glucose monitor to monitor blood glucose levels in women with gestational diabetes

OTHER

Routine Care

Use of a glucometer to monitor blood glucose levels in women with gestational diabetes

Sponsors & Collaborators

  • Yale University

    lead OTHER

Principal Investigators

  • Audrey Merriam, MD, MS · Assistant Professor; Assistant Professor, Department of Obstetrics, Gynecology and Reproductive Sciences

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2024-08-30
Completion
2024-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04219085 on ClinicalTrials.gov