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

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, we 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, we 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 be be in close
communication with the study team to help adjust insulin doses as needed. All participants
will have a screening visit, a 2-hour group education session, and 7 study visits with
fasting blood draws to evaluate diabetes control and metabolic health. Participants will also
be required to continue their normal exercise routine, and share continuous glucose
monitoring data with the study team. The primary outcome will be HbA1C change from baseline.
Secondary outcomes include detailed measures of glycemic variability, metabolic health, and
quality of life.