Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes
Trial Parameters
Brief Summary
Despite strong evidence that tight control of blood sugar reduces the risk of diabetes complications, most people with type 1 diabetes do not achieve recommended blood sugar targets. This randomized controlled trial will test whether a very-low- carbohydrate ketogenic diet can effectively and safely improve blood sugar control in adults with type 1 diabetes.
Eligibility Criteria
Inclusion Criteria: * Age ≥18 and ≤65 years * T1D diagnosed \>1 year prior to screening * HbA1c 7.0%-9.0% * Stable insulin delivery method for the past 30 days * Ability to read all device instructions and insulin pump settings * eGFR ≥60 mL/min/1.73 m2 * Use of an insulin pump or insulin delivery by multiple daily injections * Use of personal CGM for at least 12 weeks and willing to change to Dexcom CGM for the duration of the study, if using a different sensor, to reduce variability in glucose values associated with different CGM products * Use of cellular phone with data capability for wireless connectivity to the CGM system. Exclusion Criteria: * Body mass index \<20.0 or \>34.9 kg/m2 * Severe gastroparesis or history of bariatric surgery * Diabetes-related hospitalization (including for diabetic ketoacidosis or severe hypoglycemia) within 12 months of screening * Poorly controlled hypertension (SBP ≥160 mmHg or DBP ≥100 mmHg) * Taking diabetes medications, other than insulin (part