Early Phase 1 Type 1 Diabetes Trial, Recruiting NCT05317455 Sponsor: Yale University Condition: Type 1 Diabetes
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Early Phase 1 Type 1 Diabetes Trial, Recruiting

NCT05317455
Recruiting Early Phase 1

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:

  • People who have been diagnosed with Type 1 diabetes and have a history of severe low blood sugar episodes and/or are unable to feel or notice when their blood sugar drops dangerously low
  • People who have had a severe low blood sugar episode where their blood sugar dropped below 54 mg/dL and needed help from another person to recover (for example, by taking sugar by mouth, receiving glucose through a drip, or being given glucagon)
  • People whose continuous glucose monitor (a device that tracks blood sugar levels) recorded at least 2 readings below 54 mg/dL during a 2-week monitoring period done in the week before the study begins

Who may not be able to join:

  • People younger than 18 years old or older than 55 years old
  • People who weigh more than 85 kilograms at the initial screening visit
  • People with a BMI (a measure of body weight relative to height) above 30
  • People who have an untreated advanced eye condition related to diabetes (called proliferative retinopathy)
  • People who carry a specific genetic variation in a gene called GSTZ-1, which may cause a buildup of a substance called DCA that can be harmful

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 12 July 2026
Early Phase 1 studies are small, early exploratory studies that come before the main Phase 1 to 3 testing, so a standard phase success rate does not apply.

Contact this trial

Principal Investigator: Raimund Herzog, MD, Yale University

Phone: 4753210504

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
Early Phase 1
Sponsor
Registry
ClinicalTrials.gov
Start date
13 May 2025
Est. completion
1 May 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Cognitive Function

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: 12 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