Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet

Launched by BOSTON CHILDREN'S HOSPITAL · Oct 17, 2018

Keywords

ClinConnect Summary

This clinical trial is studying how a very low carbohydrate diet compares to a standard carbohydrate diet for managing type 1 diabetes (T1D). The goal is to see if eating fewer carbohydrates can help keep blood sugar levels more stable and reduce the need for insulin. The trial will involve 32 adults and adolescents with T1D who will eat meals provided by the study for 12 weeks. Participants will track their blood sugar levels continuously and work closely with the study team to adjust their insulin as needed.

To be eligible for the study, participants must be between 18 and 40 years old, have had T1D for at least a year, use a continuous glucose monitor and an insulin pump, and have stable blood sugar control. Throughout the trial, participants will have several visits to evaluate their diabetes management and may undergo additional tests, including MRI scans. Importantly, this study aims to improve diabetes control and overall well-being, so if you or someone you know fits the eligibility criteria, it could be a great opportunity to contribute to this important research.

Gender

ALL

Eligibility criteria

• 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)