Comparing a ketogenic diet and a standard diet for diabetes control in children newly diagnosed with type 1 diabetes

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 β-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.
• During four study visits held at at baseline, 1, 5, and 9 months, an intravenous catheter (IV) will be placed for collection of 5 blood samples before and up to 2 hours after a liquid test meal (protein shake) to assess insulin response. A stool sample will also be collected to assess microbiome changes.
• Children and their caregivers may be invited to participate in a semi-structured interview, and online questionnaires to assess their experience with the diet and diabetes care, general well-being and quality of life.
• Children and their caregivers may be invited to participate in a follow-up visit to evaluate long-term effects after 24 months.

Comparison will be made between a ketogenic vs standard diet.