Actively Recruiting

Phase Not Applicable
Age: 18Years - 65Years
All Genders
NCT06503809

Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

Led by Washington University School of Medicine · Updated on 2026-03-19

58

Participants Needed

1

Research Sites

293 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Efficacy and Safety of a Ketogenic Diet in Type 1 Diabetes

Who Can Participate

Age: 18Years - 65Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 to 65 years
  • Diagnosis of type 1 diabetes for more than 1 year prior to screening
  • HbA1c between 7.0% and 9.0%
  • Stable insulin delivery method for the past 30 days
  • Able to read all device instructions and insulin pump settings
  • Estimated glomerular filtration rate (eGFR) 60 mL/min/1.73 m2 or higher
  • Use of an insulin pump or insulin delivery by multiple daily injections
  • Use of personal continuous glucose monitor (CGM) for at least 12 weeks and willing to switch to Dexcom CGM if using a different sensor
  • Use of cellular phone with data capability for wireless connectivity to the CGM system
Not Eligible

You will not qualify if you...

  • Body mass index less than 20.0 or greater than 34.9 kg/m2
  • Severe gastroparesis or history of bariatric surgery
  • Diabetes-related hospitalization, including diabetic ketoacidosis or severe hypoglycemia, within 12 months of screening
  • Poorly controlled hypertension (systolic blood pressure 160 mmHg or higher or diastolic blood pressure 100 mmHg or higher)
  • Use of diabetes medications other than insulin, especially SGLT2 inhibitors
  • Structured exercise more than 210 minutes per week
  • Pregnant, lactating, not using effective birth control if premenopausal, or planning pregnancy during the 6-month study
  • Unstable weight with more than 4% change in the last 2 months
  • Significant organ system dysfunction such as severe lung, kidney, liver, or heart disease
  • Anemia with hemoglobin less than 10 g/dL
  • Major psychiatric illness
  • Active tobacco use of more than 8 cigarettes per day or illegal drug use
  • Regular alcohol use exceeding 10 standard drinks per week
  • Use of medications that affect study outcomes or increase risks and cannot be stopped during the study
  • Familial hypercholesterolemia
  • Active eating disorder
  • Dietary restrictions incompatible with a very-low-carbohydrate ketogenic diet, vegan or vegetarian diets, severe lactose intolerance, severe aversion or sensitivity to eggs, fish, nuts, wheat, or soy, or any anaphylactic food allergy
  • Already consuming a low-carbohydrate diet with less than 130 grams per day
  • Unable to provide voluntary informed consent
  • Unable or unwilling to follow study protocol or considered inappropriate by the research team

AI-Screening

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Trial Site Locations

Total: 1 location

1

Washington University School of Medicine

St Louis, Missouri, United States, 63110

Actively Recruiting

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Research Team

T

Tara Wilmot, RDN

CONTACT

M

Max C Petersen, MD PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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