N/A
Completed N=65
CAPO: Continuous Glucose Monitoring in A2 Gestational Diabetes and Pregnancy Outcomes
Diabetes · Maternal Complication of Pregnancy
Source: ClinicalTrials.gov NCT04219085 ↗
Enrolled (actual)
65
Serious AEs
0.0%
Results posted
Aug 2025
Primary outcomePrimary: Composite Primary Outcome — 0; 0; 0; 0 Participants — p=1.0
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Primary Outcome |
0; 0; 0; 0; 4; 6 | 1.0 |
| SECONDARY Cesarean Delivery for an Arrest of Labor Disorder |
1; 4 | 0.03 sig |
| SECONDARY Hypertensive Disorders of Pregnancy. |
5; 7 | 0.85 |
Eligibility Criteria
Inclusion 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
Exclusion Criteria
- pregestational diabetes
- diagnosis with gestational diabetes 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
Data sourced from ClinicalTrials.gov (NCT04219085). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.