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Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether a ketogenic diet, which is very low in carbohydrates, can safely improve blood sugar control. It is for adults ages 18–65 who have had type 1 diabetes for more than a year.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–65, with type 1 diabetes diagnosed more than 1 year before screening.
  • HbA1c, a measure of average blood sugar, between 7.0% and 9.0%.
  • Use an insulin pump or several insulin shots each day.
  • Have used the same insulin delivery method for at least 30 days.
  • Can read all device instructions and insulin pump settings.
  • Kidney filtering test result (eGFR) of at least 60.
  • Have used a personal continuous glucose monitor (CGM) for at least 12 weeks and will switch to Dexcom during the study if needed.
  • Have a cell phone with data service that can connect wirelessly to the glucose monitor.

Who can't join

  • Body mass index (BMI), a weight-to-height measure, below 20 or above 34.9; weight change over 4% in 2 months; or already eating less than 130 grams of carbohydrates a day.
  • Severe slow stomach emptying; past weight-loss surgery; or a diabetes-related hospital stay in the past 12 months, including for dangerous acid buildup or very low blood sugar.
  • Blood pressure with a top number of 160 or higher or a bottom number of 100 or higher; serious organ disease; anemia with hemoglobin below 10; or an inherited condition causing very high cholesterol.
  • Use diabetes drugs other than insulin, or take medicines that could affect study results or safety and cannot be stopped for the study.
  • Do more than 210 minutes of planned exercise a week; smoke more than 8 cigarettes a day; use illegal drugs; or drink more than 10 standard alcoholic drinks a week.
  • Pregnant, breastfeeding, planning pregnancy during the 6-month study, or not using effective birth control before menopause.
  • Major mental illness, an active eating disorder, or food restrictions that do not fit the study diet. These include vegan or vegetarian diets, severe lactose intolerance, strong dislike of or sensitivity to eggs, fish, nuts, wheat, or soy, or any food allergy causing a life-threatening reaction.
  • Cannot freely give informed consent, cannot or will not follow study rules, or are considered unsuitable by the study team.

Simplified for readability. The official criteria below are what the study team uses.

Official 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 (particularly SGLT2 inhibitors, which are associated with an increased risk of euglycemic DKA) * Structured exercise \>210 minutes per week * Pregnant, lactating, not using effective birth control if premenopausal, or planning to become pregnant within the 6-month study period * Unstable weight (\>4% change in the last 2 months) * Significant organ system dysfunction (e.g., severe pulmonary, renal, hepatic, or cardiovascular disease) * Anemia (Hgb \<10 g/dL) * Major psychiatric illness * Active tobacco use (\>8 cigarettes/day) or illegal drug use * Regular alcohol consumption (\>10 standard drinks per week) * Use of medications known to affect the study outcome measures or increase the risk of study procedures that cannot be temporarily discontinued for this study * Familial hypercholesterolemia * Active eating disorder * Dietary restrictions incompatible with a very-low-carbohydrate KD, vegan diet, vegetarian diet, severe lactose intolerance, severe aversion/sensitivity to eggs, fish, nuts, wheat, or soy, and any anaphylactic food allergy * Already consuming a low-carbohydrate (\<130 g/day) diet * Persons who are not able to grant voluntary informed consent * Persons who are unable or unwilling to follow the study protocol or who, for any reason, the research team considers an inappropriate candidate for the study.

Study sites (1)

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