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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Gestational Diabetes
Intervention / Treatment

-

Contacts and Locations

New Haven

Yale University, New Haven, Connecticut, United States, 06511

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * women between 18-50 years old
  • * pregnant
  • * singleton gestation
  • * diagnosis of gestational diabetes requiring medication (A2) during the current pregnancy between 24-36 weeks' gestation
  • * pregestational diabetes
  • * diagnosis with gestational diabetes \< 24 weeks gestation or \> 36 weeks gestation
  • * known fetal anomalies
  • * fetal growth restriction diagnosed during the current pregnancy
  • * diagnosis of polyhydramnios at time of randomization
  • * abnormal diagnostic genetic testing or genetic screening for the fetus in the current pregnancy prior to randomization
  • * twin or higher order multiple gestation
  • * non-compliance with prenatal visits (missing ≥3 visits prior to enrollment) prior to diagnosis with A2 gestational diabetes
  • * maternal medical comorbidities including the following: lupus, chronic hypertension, cancer, ischemic cardiovascular disease

Ages Eligible for Study

18 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Yale University,

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

Study Record Dates

2026-06-30