Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

{ "Ketogenic Diet for Type 1 Diabetes", "This study is looking at whether a very-low-carbohydrate ketogenic diet can help adults with type 1 diabetes better manage their blood sugar. You would either follow a ketogenic diet or a standard diet recommended by the American Diabetes Association for 12 weeks. Researchers will measure how much time your blood sugar stays in a healthy range and your muscle's sensitivity to insulin. To join, you need to be between 18 and 65 years old, have had type 1 diabetes for over a year, and have an HbA1c (a measure of average blood sugar) between 7.0% and 9.0%. Your kidney function (eGFR) also needs to be at least 60 mL/min/1.73 m2. The study is currently unclear on its recruitment status and plans to enroll 58 participants.", "design": "This is an interventional study comparing two different diets. It aims to enroll 58 participants.", "commitments": "Participants will follow either a ketogenic diet or a standard diet for 12 weeks.", "compensation": "Not stated in the trial record.", "follow_up": "Blood sugar control and insulin sensitivity will be measured immediately after the 12-week dietary intervention.", }

Study design: Not specified.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

Recruiting

NAAges 18–65InterventionalTreatment

Washington University School of Medicine

~58 participants

Updated 2026-03-19 on ClinicalTrials.gov

What's tested:Ketogenic DietStandard Diet

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Change in continuous glucose monitor (CGM) time-in-range

Measured over Before and immediately after the dietary intervention

+1 more outcome measured

Conditions

Diabetes Mellitus, Type 1

Where it's being run

1 sites across 1 states

Missouri1

Study leadership

Samuel Klein, MD · PRINCIPAL_INVESTIGATOR · Washington University School of Medicine

Who to contact

Tara Wilmot, RDN

[email protected]

314-399-8576

Email the study team

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Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Change in continuous glucose monitor (CGM) time-in-rangeBefore and immediately after the dietary intervention
Interstitial glucose percent time in range assessed by using a continuous glucose monitor
Change in skeletal muscle insulin sensitivityBefore and immediately after the dietary intervention
Insulin sensitivity will be determined by the hyperinsulinemic-euglycemic clamp procedure

Trialytics