Comparing glucose monitoring methods for diagnosing gestational diabetes
Insights Into Glucose Variability Using Continuous Glucose Monitoring in Mothers With Gestational Diabetes Compared to Mothers at High Risk of Gestational Diabetes Who Have a Negative Oral Glucose Tolerance Test.
This study is testing if continuous glucose monitoring can better diagnose gestational diabetes in pregnant women compared to the standard glucose tolerance test.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Portsmouth Hospitals NHS Trust Government |
| Locations | 1 site (Portsmouth) |
| Trial ID | NCT05981547 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare glucose variability in pregnant women diagnosed with gestational diabetes (GDM) against those at high risk but not diagnosed. Utilizing continuous glucose monitoring (CGM) sensors, the study will involve 400 participants around the time of their standard GDM testing. A subgroup of 60 participants will be monitored further to assess the progression of high blood glucose levels. The goal is to evaluate the reliability of CGM as a diagnostic tool compared to the traditional oral glucose tolerance test (OGTT).
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and above, between 12-26 weeks gestation, identified as having one or more risk factors for GDM.
Not a fit: Patients with pre-existing diabetes or those who have previously had GDM may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate diagnoses of gestational diabetes, potentially reducing complications for mothers and babies.
How similar studies have performed: While the use of CGM in managing diabetes is well-established, this approach for diagnosing GDM is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Female aged 18 years of above * Between 12-26 weeks gestation * Identified by NICE as having one or more independent risk factor for GDM * Suitable for the standard care pathway under the joint antenatal clinic for GDM * Willing and able to give informed consent. Exclusion Criteria: * Pre-existing diabetes * Previous GDM * Unsuitable for standard joint antenatal clinic pathway * Known allergy to freestyle libre adhesive pad * Planning to move geographical area during the study timeframe * Participating in a different study that could interfere with glucose levels or affect ability to participate.
Where this trial is running
Portsmouth
- Portsmouth Hospitals University NHS Trust — Portsmouth, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Michael Cummings, MBBS
- Email: michael.cummings@porthosp.nhs.uk
- Phone: 02392286044
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.