Type 1 Diabetes Trial, Recruiting NCT06503809 Sponsor: Washington University School of Medicine Condition: Type 1 Diabetes
Back to Type 1 Diabetes

Type 1 Diabetes Trial, Recruiting

NCT06503809
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are between 18 and 65 years old
  • You have been diagnosed with Type 1 diabetes for more than 1 year before joining the study
  • Your HbA1c (a measure of average blood sugar over roughly 3 months) is between 7.0% and 9.0%
  • Your method of taking insulin has not changed in the past 30 days
  • You are able to read and understand device instructions and insulin pump settings
  • Your kidneys are working at a healthy enough level (eGFR of 60 or above — confirm with trial site if unsure)
  • You currently use an insulin pump or take multiple daily insulin injections
  • You have been using a continuous glucose monitor (CGM) for at least 12 weeks, and you are willing to switch to a Dexcom CGM for the length of the study if you currently use a different brand
  • You have a smartphone with mobile data that can connect wirelessly to the CGM device

Who may not be able to join:

  • Your body weight falls outside a certain healthy range (BMI below 20.0 or above 34.9 — confirm with trial site if unsure)
  • You have severe stomach-emptying problems (gastroparesis) or have had weight-loss (bariatric) surgery in the past
  • You were hospitalised for a diabetes-related reason — such as diabetic ketoacidosis or a serious low blood sugar episode — within the past 12 months
  • You have poorly controlled high blood pressure
  • You take any diabetes medications other than insulin (for example, SGLT2 inhibitors)
  • You do structured exercise for more than 210 minutes per week
  • You are pregnant, breastfeeding, planning to become pregnant within the 6-month study period, or not using effective birth control (if applicable)
  • Your weight has changed by more than 4% in the last 2 months
  • You have serious problems with major organs such as your lungs, liver, heart, or kidneys
  • You have anaemia (low red blood cell levels)
  • You have a major psychiatric (mental health) illness
  • You currently smoke more than 8 cigarettes a day or use illegal drugs
  • You regularly drink more than 10 standard alcoholic drinks per week
  • You take certain medications that could affect the study results and cannot be safely stopped during the study (confirm with trial site)
  • You have a hereditary cholesterol condition called familial hypercholesterolemia
  • You have an active eating disorder
  • Your diet has restrictions that would make it impossible to follow a very-low-carbohydrate diet — for example, a vegan or vegetarian diet, severe lactose intolerance, severe sensitivity to eggs, fish, nuts, wheat, or soy, or a serious food allergy
  • You are already eating a low-carbohydrate diet (fewer than 130 grams of carbs per day)
  • You are not able to give informed, voluntary consent to take part
  • You are unable or unwilling to follow the study plan, or the research team considers you an unsuitable candidate for any reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 21 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Samuel Klein, MD, Washington University School of Medicine

Phone: 314-399-8576

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
12 August 2024
Est. completion
28 February 2030

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in continuous glucose monitor (CGM) time-in-range; Change in skeletal muscle insulin sensitivity

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 21 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov