N/A
N=50
Postpartum Continuous Glucose Monitoring (CGM) Study
Gestational Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT05714761 ↗Enrolled (actual)
50
Serious AEs
0.0%
Results posted
Mar 2025
Primary outcome: Primary: Number of Participants With at Least 72 Hours of CGM Data Downloaded. — 43 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dexcom glucose sensor (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With at Least 72 Hours of CGM Data Downloaded. |
43 | — |
| SECONDARY Specificity |
78; 83.33 | — |
| SECONDARY Sensitivity |
100; 66.67 | — |
| SECONDARY Positive Predictive Value (PPV) |
53.49; 50 | — |
| SECONDARY Positive Likelihood Ratio (PLR) |
4.5; 3.83 | — |
| SECONDARY Negative Predictive Value (NPV) |
100; 90 | — |
| SECONDARY Negative Likelihood Ratio (NLR) |
0; 0.4 | — |
Summary
This research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. This study will use a glucose sensor worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test. This is a single site study at the Icahn School of Medicine at Mount Sinai. The research team plans to enroll 50 participants aged 18years or older into the study. Participation in the study is expected to last up to 20 weeks and involves 4-5 visits depending on if enrollment is in the 3rd trimester of pregnancy or immediate postpartum. Study procedures include 1. Consent & screening. 2.Sensor placement and download after 10 days of wear. 3. a second sensor placement 2-5 days before oral glucose tolerance test (OGTT).
Eligibility Criteria
Inclusion criteria
- include diagnosis of gestational diabetes during a current or recent pregnancy
- age 18 or older.
Exclusion criteria
- include known pregestational diabetes,
- known skin adhesive allergy which would prevent subject from wearing a CGM,
- chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.
Data sourced from ClinicalTrials.gov (NCT05714761). 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.