Comparing a new tablet to a glucose drink for diagnosing gestational diabetes
Randomized Crossover Study Comparing the Standard Glucose Beverage and Dex4® Tablets for 2 Hour Oral Glucose Tolerance Testing in Pregnant Women With a Positive Screen on the 50g Glucose Tolerance Challenge for Gestational Diabetes
PHASE2 · Sunnybrook Health Sciences Centre · NCT05115188
This study is testing if a new tablet can be a better option than the usual glucose drink for diagnosing gestational diabetes in pregnant women.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 42 (estimated) |
| Sex | Female |
| Sponsor | Sunnybrook Health Sciences Centre (other) |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05115188 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the effectiveness and side effects of Dex4® tablets as an alternative to the standard glucose beverage for diagnosing gestational diabetes. It is a prospective randomized crossover study involving 42 pregnant women who have screened positive for gestational diabetes. Participants will undergo two tests within a week, one with the glucose beverage and the other with Dex4® tablets, while serving as their own control. Side effects and preferences will be assessed through questionnaires after each test, and serum glucose levels will be measured using standardized methods.
Who should consider this trial
Good fit: Ideal candidates are pregnant women between 24-32 weeks' gestation who have screened positive for gestational diabetes.
Not a fit: Patients with a previous diagnosis of diabetes or those who have used certain medications recently may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more tolerable and convenient method for diagnosing gestational diabetes.
How similar studies have performed: While this approach is innovative, similar studies have not been widely reported, making this a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Eligibility criteria must be met by 32 weeks' gestation to allow enrollment in the study. Inclusion Criteria: * Positive 50g GCT result between 7.8-11.0 mmol/L * Female * Singleton pregnancy * Informed consent obtained and signed Exclusion Criteria: * Use of steroids, terbutaline, or metformin within the last 4 weeks * Previous diagnosis of diabetes type 1 or 2 outside of pregnancy or diagnosis with any form of diabetes prior to 20 weeks of pregnancy * Allergy to any ingredients (including the non-medicinal ingredients) in Dex4® tablets or Glucodex solution
Where this trial is running
Toronto, Ontario
- Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)
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.
Conditions: Diabetes, Gestational