Very Low Carbohydrate Diet for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
Despite major technological advances, management of type one diabetes mellitus (T1D) remains suboptimal, putting millions of people at risk for immediate and long-term complications. After meals, a mismatch between carbohydrate absorption rate and insulin action typically leads to alternating periods of hyper- and hypoglycemia. A conceptually promising approach to control both problems is dietary carbohydrate restriction to reduce postprandial blood glucose changes and insulin needs. In a prior survey study, the investigators documented exceptional glycemic control (HbA1c 5.67%) and low acute complication rates among 316 children and adults with T1D consuming a very-low-carbohydrate diet.To test the feasibility of this approach, the investigators will conduct a randomized-controlled feeding study involving 32 adults and adolescents with T1D. Participants will be randomized to receive a very low carbohydrate vs. standard carbohydrate diet. Participants will be in the study for 12 weeks and receive all their meals by meal delivery.They will share continuous glucose monitoring data with the study team and be in close communication to adjust insulin doses as needed. All participants will have a screening visit, an individual or group education session, and 3 study visits to evaluate diabetes control and metabolic health. Some of these visits will have a fasting blood draw. Two of the visits will also comprise additional metabolic studies to assess glucagon response and brain function during hypoglycemia by magnetic resonance imaging (MRI). Participants will have IV catheters placed and receive IV insulin to drop blood glucose levels to 50 mg/dl for up to 30 minutes. The primary outcome will be HbA1c change from baseline. Secondary outcomes include detailed measures of glycemic variability, metabolic health, and quality of life.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it mentions that you cannot use medications other than insulin and metformin that could affect metabolic or glycemic variables. If you are on other medications, you might need to discuss this with the study team.
Is a very low carbohydrate diet safe for people with diabetes?
Research indicates that low-carbohydrate diets, including very low carbohydrate ketogenic diets, are generally safe for people with diabetes and can improve overall health, though concerns about safety remain. These diets have been shown to help with weight loss and may reduce the need for medication in some cases.12345
How does the Very Low Carbohydrate Diet treatment differ from other treatments for Type 1 diabetes?
The Very Low Carbohydrate Diet (VLCD) is unique because it focuses on significantly reducing carbohydrate intake, which can help manage blood sugar levels more effectively and potentially reduce the need for insulin. Unlike standard treatments that involve matching carbohydrate intake with insulin, this diet restricts carbs to about 75 grams per day, which may improve overall health and diabetes management.12456
What data supports the effectiveness of a very low carbohydrate diet as a treatment for Type 1 diabetes?
Are You a Good Fit for This Trial?
Adults and adolescents aged 18-40 with Type 1 Diabetes, using an insulin pump and CGM, who have attended a diabetes care visit in the past year. They should not be on any restrictive diets or have conditions like celiac disease that affect diet.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Education
Participants attend an individual or group education session
Treatment
Participants receive a very low carbohydrate or standard carbohydrate diet for 12 weeks with continuous glucose monitoring and insulin dose adjustments
Metabolic Studies
Participants undergo metabolic studies including glucagon response and brain function assessment during hypoglycemia
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Standard Carbohydrate Diet
- Very Low Carbohydrate Diet
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Children's Hospital
Lead Sponsor