๐ŸŒ EnglishEN

AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

Carbohydrate Beta Cell Function and Glucose Control in Children With Diabetes

RecruitingNAAges 5 Years - 12 YearsAllBoston Children's Hospital
NCT05899166 on ClinicalTrials.gov โ†—
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

The goal of this clinical trial is to test the effects of a ketogenic diet on the progression and control of type 1 diabetes in children with newly diagnosed diabetes. The main questions to answer are: * Does a ketogenic diet prolong the honeymoon period of type 1 diabetes? * Does a ketogenic diet improve diabetes control? * Is a ketogenic diet safe, acceptable and sustainable in children with newly diagnosed diabetes? * What are the microbiome, inflammatory and metabolic changes linking diet to ฮฒ-cell function? Participants will receive a combination of free meals, groceries, micronutrient supplements, and intensive diet and diabetes education for 9 months. * Diabetes care devices will be connected for cloud-based data collection. * Bi-weekly data downloads and remote check-ins will assess dietary intake, satisfaction with diet and study procedures, and possible safety concerns. * Du

Sign in to get the eligibility rules as simple questions to take to your doctor.

Sign in
๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Children aged 5 to 12 years. * Within 3 month of diabetes diagnosis. * Insulin adjusted HbA1c โ‰ค9 if enrolled โ‰ฅ 2 months pat diagnosis. * Type 1 diabetes confirmed by immediate insulin requirement and any 2 of the following criteria: autoimmunity marker \[glutamate decarboxylase-65, islet-antigen-2, zinc transporter-8, insulin \[prior to first insulin dose\]; age under 10 years, BMI \<95th percentile. * Family committed and able to participate in study education and implement dietary intervention. Exclusion Criteria: * Dietary needs or habits incompatible with the study meal plans, (e.g., vegan, major food intolerances/allergies, ketogenic). * Eating disorders as assessed by Chede-Q8. * Major medical illness or use of medications other than insulin that could interfere with metabolic or glycemic variables. * Major psychiatric illness.
๐Ÿ’Š

What it tests

  • Ketogenic diet, food delivery and education
  • Standard diet, food delivery and education
๐Ÿ“

Where

1 site
Boston Children's Hospital
Boston, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy