Comparing treatment thresholds for gestational diabetes
Gestational Diabetes and Pharmacotherapy (GAP) - a Randomized Controlled Trial Investigating Timing of Pharmacotherapy Initiation for Patients with Gestational Diabetes
This study is testing if starting treatment for gestational diabetes when blood sugar is only slightly high (20% above the target) leads to better outcomes for pregnant women than starting treatment when it's more elevated (40% above the target).
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 416 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Medical College of Wisconsin Academic / other |
| Locations | 1 site (Milwaukee, Wisconsin) |
| Trial ID | NCT03527537 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate two different thresholds for initiating medical treatment in pregnant women diagnosed with gestational diabetes mellitus (GDM). Participants will be randomized to start pharmacotherapy when their capillary blood glucose (CBG) values exceed either 20% or 40% above the target goal. The hypothesis is that starting treatment at the lower threshold of 20% will result in fewer obstetric and medical complications compared to the higher threshold. The study will involve 416 women and seeks to establish clearer guidelines for pharmacotherapy initiation in GDM management.
Who should consider this trial
Good fit: Ideal candidates are pregnant women aged 18 and older diagnosed with gestational diabetes who can communicate in English.
Not a fit: Patients with pre-gestational diabetes or those who have already started pharmacotherapy prior to referral will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of gestational diabetes, reducing complications for both mothers and their babies.
How similar studies have performed: While there is limited consensus on treatment thresholds for GDM, this study's approach is novel and has not been extensively tested in randomized trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Viable singleton pregnancy * Age \>= 18 years old * Diagnosed with gestational diabetes mellitus * Able to communicate in English Exclusion Criteria: * Pre-gestational diabetes * Significantly abnormal GDM testing, suggestive of the presence of pre-gestational diabetes, either with fasting values \>=126 mg/dL or 2-hour post-prandial levels \>=200 mg/dL * Patients who check blood sugars on average less than 2 times per day after appropriate counseling * Already started pharmacotherapy prior to referral to the study
Where this trial is running
Milwaukee, Wisconsin
- Medical College of Wisconsin — Milwaukee, Wisconsin, United States (Recruiting)
Study contacts
- Study coordinator: Anna Palatnik, MD
- Email: apalatnik@mcw.edu
- Phone: 414-805-6627
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.