Intensive nutrition support for women with gestational diabetes
Effect of Intensive Nutrition Training, Education, and Support Versus Standard Care in Reducing the Need for Insulin Therapy in Gestational Diabetes (INTENSE-GDM): A Randomised Controlled Trial
This study tests whether extra help with diet can improve health for pregnant women with gestational diabetes and their babies compared to standard diet advice.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 214 (estimated) |
| Sex | Female |
| Sponsor | Steno Diabetes Center Copenhagen Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT06127823 on ClinicalTrials.gov |
What this trial studies
This trial investigates the effects of intensive dietary therapy compared to standard dietary care for women diagnosed with gestational diabetes (GDM). It aims to determine how varying levels of support and guidance from dietitians impact clinical, cost-related, and patient-reported outcomes for both mothers and their children. Participants will be newly diagnosed women with GDM who are at risk of requiring insulin treatment during pregnancy. The study will assess the effectiveness of dietary interventions in managing blood glucose levels and improving overall health outcomes during pregnancy.
Who should consider this trial
Good fit: Ideal candidates are newly diagnosed women with gestational diabetes who are at risk of requiring insulin treatment.
Not a fit: Patients who are not newly diagnosed with gestational diabetes or those who do not meet the specific eligibility criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of gestational diabetes, reducing the need for insulin and improving health outcomes for mothers and their babies.
How similar studies have performed: Other studies have shown promising results with dietary interventions in managing gestational diabetes, suggesting that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newly diagnosed women with GDM referred to Department of Obstetrics Herlev Hospital * Women diagnosed with GDM based on 2-hour OGTT plasma glucose value ≥ 9.0 mmol/l * Women diagnosed with GDM based on at least 2 plasma glucose measurements above targets (either pre-prandial ≥6.0 mmol/l, or 2-hours postprandial ≥8.0 mmol/l) * GA at GDM diagnosis ≤ 34 * Women with an estimated probability of ≥20% for initiating insulin treatment during pregnancy. The estimated probability is based on a logistic regression model developed at SDCC and includes the following variables: prepregnancy BMI, GA at GDM diagnosis, and HbA1c at GDM diagnosis. In cases where HbA1c has not been measured during the initial visit with the dietitian (screening visit), prepregnancy BMI, GA at the time of diagnosis and 2H OGTT will be used to estimate the probability of initiating insulin therapy. * Provided voluntary written informed parental consent in Danish or English or after translation by an interpreter for non-Danish and non-English speaking parents Exclusion Criteria: * Bariatric surgery * Other intercurrent illness (e.g., cancer, ulcerative colitis) as judged by medical experts * Uncontrolled medical issues, as judged by medical experts * Concomitant participation in other clinical trials that could interfere with the INTENSE- GDM Trial as evaluated by the principle investigator * Unable to understand the informed consent/procedures regardless of spoked language
Where this trial is running
Herlev
- Steno Diabetes Center Copenhagen — Herlev, Denmark (Recruiting)
Study contacts
- Principal investigator: Bettina Ewers, PhD — Steno Diabetes Center Copenhagen
- Study coordinator: Bettina Ewers, PhD
- Email: bettina.ewers@regionh.dk
- Phone: +4530912997
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.