Exploring very low carbohydrate diets for managing Type 1 diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of a very low carbohydrate diet on glucagon response in individuals with Type 1 diabetes (T1D). It aims to address the challenges of glycemic control by potentially reducing post-meal blood glucose fluctuations and insulin requirements. Participants will be adults aged 18 to 40 with stable glycemic control who use continuous glucose monitors and insulin pumps. The study will assess the safety and efficacy of this dietary approach in managing T1D complications.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Males and females with T1D for at least 1 year
* Age 18 to 40 years
* Tanner stage ≥ IV
* BMI 18.5-35 kg/m2
* Stable glycemic control (HbA1c 6.5-9%)
* Use of a continuous glucose monitor (CGM)
* Use of an insulin pump
* Attendance of at least 1 diabetes care visit over the past 12 months (including virtual)

Exclusion Criteria:

* Ketoacidosis or severe hypoglycemia with seizure or coma in the past 6 months
* Dietary restrictions or intolerances that are incompatible with the planned food deliveries, e.g. celiac disease, gastroparesis, certain food allergies
* Following a weight-loss or otherwise restrictive diet
* Vigorous exercise \>2 hours on \>3 days a week
* History of an eating disorder or at risk for eating disorder, assessed by the Eating Disorders Diagnostic Scale (EDDS)
* Major medical illness or use of medications other than insulin and metformin that could interfere with metabolic or glycemic variables
* Significant psychiatric illness
* Smoking, use of recreational drugs, or excessive alcohol consumption
* Pregnancy or breastfeeding
* Anemia
* For participants who undergo MRI:

  1. Standard MRI exclusion criteria
  2. Irregular menses
  3. Use of psychotropic medication other than SSRIs or other mild antidepressant or anxiety medications (unless these medications are safe to be held for several days to allow for the acquisition of MRI data).

Where it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Belinda S Lennerz — Boston Children's Hospital
• Study coordinator: Belinda S Lennerz, MD, PhD
• Email: belinda.lennerz@childrens.harvard.edu
• Phone: 8572183896

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Continuous Glucose Monitor Accuracy and Safety in Adults with Type 1 Diabetes

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• Tirzepatide for obesity in people with type 1 diabetes

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• New real-time continuous glucose monitor accuracy and safety in adults with type 1 diabetes

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.