Managing Type 1 Diabetes with Low Carbohydrate Diets
Type 1 Diabetes Management Using a Very Low Carbohydrate Versus Standard Diet
This study is testing if a very low carbohydrate diet can help people with type 1 diabetes manage their blood sugar better than a standard diet over 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 32 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | Boston Children's Hospital Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT03710928 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a very low carbohydrate diet compared to a standard carbohydrate diet in managing type 1 diabetes (T1D). It aims to address the challenges of glycemic control by reducing post-meal blood glucose fluctuations and insulin requirements. The study will involve 32 adults and adolescents with T1D who will be randomly assigned to either diet for a duration of 12 weeks. The researchers previously observed promising glycemic control in individuals following a very low carbohydrate diet, which will be further evaluated in this controlled setting.
Who should consider this trial
Good fit: Ideal candidates are males and females aged 18 to 40 with type 1 diabetes for at least one year and stable glycemic control.
Not a fit: Patients with recent severe hypoglycemia, dietary restrictions incompatible with the study, or significant psychiatric illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve glycemic control and reduce complications for patients with type 1 diabetes.
How similar studies have performed: Previous studies have shown promising results with low carbohydrate diets in managing type 1 diabetes, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Boston, Massachusetts
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Study coordinator: Belinda Lennerz, MD PhD
- Email: belinda.lennerz@childrens.harvard.edu
- Phone: 8572183896
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.