N/A
N=105
A Study on the Use of Real -Time Continuous Glucose Monitoring (RT-CGM) in Gestational Diabetes
Gestational Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT04803357 ↗Enrolled (actual)
105
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Mean Glucose — 103.0; 106.2 mg/dl
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Continuous glucose monitor (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- University of Washington
- Primary completion
- Oct 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Glucose |
103.0; 106.2 | — |
| PRIMARY TIR CGM |
92.1; 92.4 | — |
| SECONDARY Fetal Birthweight |
3309.5; 3198.2 | — |
| SECONDARY TBR CGM GDM |
1.5; 0.4 | — |
| SECONDARY TAB CGM GDM |
6.4; 7.1 | — |
| SECONDARY MAGE CGM |
33.9; 34.0 | — |
| SECONDARY SD CGM |
18.6; 18.8 | — |
| SECONDARY CV CGM |
18.1; 17.6 | — |
| SECONDARY Neonatal Hypoglycemia |
0; 4 | — |
| SECONDARY Gestational Age at Delivery |
39.0; 38.5 | — |
| SECONDARY Mode of Delivery |
9; 15; 12; 29; 0; 0 | — |
| SECONDARY Type of Labor |
11; 21; 2; 9; 8; 14 | — |
| SECONDARY Shoulder Dystocia |
0; 0 | — |
| SECONDARY Preeclampsia or HTN |
2; 7 | — |
| SECONDARY Maternal Weight Gain |
21.1; 18.9 | — |
| SECONDARY Diabetes Medication Use |
2; 10 | — |
| SECONDARY 5 Minute Apgar |
9; 9 | — |
| SECONDARY Live Birth or Stillbirth |
21; 48; 0; 0 | — |
| SECONDARY Birthweight Ratio |
1.015; 0.99 | — |
| SECONDARY NICU Admission |
1; 3 | — |
| SECONDARY Neonatal Complications |
1; 1; 0; 0; 0; 0 | — |
| SECONDARY Glucose Meter Fingerstick Per Day |
3.4; 0.9 | — |
| SECONDARY Mean Days of RT-CGM Use |
64.4 | — |
| SECONDARY A1c |
5.4; 5.4 | — |
| SECONDARY Fructosamine |
191.9; 194.7 | — |
| SECONDARY Short Food Questionnaire |
3.8; 5.7 | — |
| SECONDARY WHO QOL Scale |
16.2; 15.3 | — |
| SECONDARY Diabetes Distress(PAID) Survey |
7.0; 8.9 | — |
| SECONDARY Walking Time Physcial Active Questionnaire |
95; 100 | — |
| SECONDARY Metformin Only Use |
4; 8 | — |
| SECONDARY Insulin Use Only |
1; 14 | — |
| SECONDARY Insulin Use Only |
1; 14 | — |
| SECONDARY Diabetes Medication Use Delivery |
2; 11 | — |
| SECONDARY Metformin Use Only at Delivery |
3; 7 | — |
Summary
The purpose of this study is to examine whether RT-CGM (real time continuous glucose monitoring) use improves glucose control, maternal outcomes, and fetal outcomes in patients diagnosed with gestational diabetes. Currently, there is very limited data on whether RT-CGM use helps patients diagnosed with gestational diabetes. By conducting this study, the investigator hopes to develop a deeper understanding of how use of a RT-CGM may affect glucose control in the gestational diabetes population.
Eligibility Criteria
Inclusion Criteria
- Pregnancy and Gestation < 30 weeks
- Singleton pregnancy
- Confirmed gestational diabetes (by 75g or 100g oral glucose tolerance test or HbA1c)
- Able to read English and completed 6th grade
- Is able to read, understand, and sign the Informed Consent Form (ICF) and if applicable, an Authorization to Use and Disclose Protected Health Information form (consistent with Health Insurance Portability and Accountability Act of 1996 [HIPAA] legislation), communicate with the investigator, and understand and comply with protocol requirements
Exclusion Criteria
- Pre-gestational Type 1 or Type 2 diabetes.
- Newly diagnosed overt-diabetes in pregnancy [HbA1c ≥ 48 mmol/mol (6.5%), fasting glucose ≥ 7.0 mmol/l, random glucose ≥ 11.1 mmol/l].
- Pregnancies with established fetal anomalies (aside from echogenic intracardiac foci and/or renal pyelectasis) or possible preterm delivery secondary to maternal disease besides GDM
- Known endogenous/exogenous Cushing's syndrome
- Known chronic infections
- Current use of any oral form of steroid medication
- Already receiving continuous glucose monitoring (CGM)
- History of bariatric surgery
- Gestational Age less than 14 weeks -
Data sourced from ClinicalTrials.gov (NCT04803357). 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.