Effect of Intensive Nutrition Training, Education, and Support in Gestational Diabetes - The INTENSE-GDM TRIAL

Launched by STENO DIABETES CENTER COPENHAGEN · Nov 8, 2023

Keywords

ClinConnect Summary

The INTENSE-GDM Trial is a research study that aims to understand how different levels of dietary support can affect women with gestational diabetes (GDM). GDM is a condition that can occur during pregnancy, where blood sugar levels become too high. This trial will compare two groups of women: one group will receive intensive nutrition training and support from a dietitian, while the other will receive standard dietary care. The main goal is to see if women who get more help with their diet can avoid needing insulin treatment, which can have various personal and healthcare costs.

To participate in this study, women must be newly diagnosed with GDM and referred to a specific hospital. They should have certain blood sugar measurements that indicate GDM and be less than 34 weeks pregnant at the time of diagnosis. Women with certain health issues or those who have had weight-loss surgery will not be included. Participants can expect to receive personalized dietary advice and support during their pregnancy, and their progress will be monitored throughout the trial. This study is currently recruiting eligible women to help improve understanding and treatment of GDM.

Gender

FEMALE

Eligibility 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