N/A
N=814
Continuous Glucose Monitoring for Screening for Diabetes in Pregnancy
Gestational Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05430204 ↗Enrolled (actual)
814
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Number of Neonates That Show Composite Adverse Neonatal Outcome — 130; 114 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Group 1: one-hour GCT (Device); Group 2: CGM placement (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The University of Texas Health Science Center, Houston
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Neonates That Show Composite Adverse Neonatal Outcome |
130; 114 | — |
| PRIMARY Number of Neonates That Show Adverse Neonatal Outcome of Large for Gestational Age(LGA) |
32; 29 | — |
| PRIMARY Number of Neonates That Show Adverse Neonatal Outcome of Shoulder Dystocia |
5; 3 | — |
| PRIMARY Number of Neonates That Show Adverse Neonatal Outcome of Birth Injury |
1; 0 | — |
| PRIMARY Number of Neonates That Show Adverse Neonatal Outcome of Neonatal Hypoglycemia |
87; 68 | — |
| PRIMARY Number of Neonates That Show Adverse Neonatal Outcome of Respiratory Distress |
45; 47 | — |
| PRIMARY Number of Fetal or Neonatal Deaths |
2; 2 | — |
| SECONDARY Feasibility as Assessed by the Number of Participants Who Complete the CGM Diagnostic Testing |
388 | — |
| SECONDARY Number of Women That Use Diabetic Medication During Pregnancy |
7; 9; 21; 8 | — |
| SECONDARY Number of Women That Show Polyhydramnios During Pregnancy Not Related to Known Fetal Anomaly |
63; 67 | — |
| SECONDARY Number of Women That Have Preterm Birth |
68; 65 | — |
| SECONDARY Number of Women That Undergo Induced Labor |
194; 207 | — |
| SECONDARY Number of Women That Experience Pregnancy Induced Hypertension |
63; 71 | — |
| SECONDARY Number of Women That Experience Eclampsia: Seizures |
0; 0 | — |
| SECONDARY Number of Women Admitted Due to Poor Glucose Control |
1; 0 | — |
| SECONDARY Number of Women With Primary Cesarean Section |
67; 73 | — |
| SECONDARY Number of Women With Postpartum Hemorrhage: Defined as Greater Then 1000ml |
17; 18 | — |
| SECONDARY Number of Women With Endometritis |
6; 4 | — |
| SECONDARY Number of Women With Wound Complications |
1; 1 | — |
| SECONDARY Number of Women With Diagnosis of Type 2 Diabetes During Postpartum |
2; 1 | — |
| SECONDARY Number of Neonates With Apgar Score Less Than 7 |
17; 18 | — |
| SECONDARY Number of Neonates That Are Admitted to the Neonatal Intensive Care Unit (NICU) |
69; 74 | — |
| SECONDARY NICU Length of Stay |
100; 123.5 | — |
| SECONDARY Number of Neonates With Hyperbilirubinemia Requiring Phototherapy |
32; 33 | — |
| SECONDARY Number of Neonates With Need for Intravenous or Oral Administration Glucose Therapy |
75; 60 | — |
| SECONDARY Number of Neonates That Are Small for Gestational Age |
41; 39 | — |
| SECONDARY Number of Participants Who Breastfed Their Babies |
121; 141 | — |
| SECONDARY Number of Participants Who Formula Fed Their Babies |
75; 74 | — |
| SECONDARY Maximum Bilirubin Level - Neonates |
— | — |
| SECONDARY Cord Arterial pH |
7.2; 7.2 | — |
| SECONDARY Number of Neonates With Polycythemia |
32; 33 | — |
| SECONDARY Number of Women That Experience Preeclampsia With Severe Features |
24; 26 | — |
| SECONDARY Number of Women That Experience Super Imposed Preeclampsia |
15; 17 | — |
| SECONDARY Number of Women With Need for Blood Transfusion |
22; 24 | — |
| SECONDARY Number of Participants With Ultrasound Diagnosis of Estimated Fetal Weight >90%Ile in the Third Trimester |
5; 4 | — |
| SECONDARY Number of Women That Experience HELLP Syndrome |
0; 0 | — |
| SECONDARY Cord Venous pH |
— | — |
| SECONDARY Total Health System Costs for Mothers and Infants |
— | — |
Summary
The purpose of this study is to evaluate whether Continuous glucose monitoring (CGM) for diagnosis of gestational diabetes mellitus (GDM) improves maternal and neonatal outcomes related to GDM and to evaluate whether CGM for GDM diagnosis reduces the health system costs for mother-infant dyads compared to usual care
Eligibility Criteria
Inclusion Criteria
- 24-30 weeks gestation undergoing GDM screening
Exclusion Criteria
- Known diagnosis of Type I and II DM
- History of bariatric surgery
- Major fetal anomalies
- Unwilling to use CGM for GDM screening
- Incarcerated subjects
- History of allergic reaction to any of CGM metals or adhesives in contact with the skin
Data sourced from ClinicalTrials.gov (NCT05430204). 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.