Phase 3 Type 1 Diabetes Trial, Recruiting NCT05819138 Sponsor: University of Colorado, Denver Condition: Type 1 Diabetes
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Phase 3 Type 1 Diabetes Trial, Recruiting

NCT05819138
Recruiting Phase 3

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 49 years old
  • You have been diagnosed with Type 1 diabetes, either confirmed by a blood antibody test or by a doctor's diagnosis along with needing insulin since you were diagnosed
  • You use an insulin pump or an automated insulin delivery system (sometimes called a "closed-loop" or "artificial pancreas" system)
  • Your kidneys are working at a reasonably healthy level (confirm with trial site)
  • Any medications you take for your heart or kidneys (such as blood pressure medicines or cholesterol medicines) have been at a stable dose for a period of time
  • Your body mass index (BMI) falls between 20 and 45
  • If you are female and able to become pregnant, you are using a reliable form of contraception

Who may not be able to join:

  • Your recent blood sugar control test (HbA1c) result is above 9%, or you have recently had a serious diabetes emergency (diabetic ketoacidosis) or been hospitalised
  • You have a major heart condition present from birth, anaemia, or a significant eye condition related to diabetes
  • You or a close family member have a history of a specific type of thyroid cancer, a hormonal condition called MEN2, or a history of pancreas inflammation
  • You are currently pregnant, planning to become pregnant, or breastfeeding
  • You have thyroid disease or high blood pressure that is not well controlled (blood pressure at or above 160/100 even with treatment)
  • You have taken non-insulin diabetes medicines, insulin-sensitising medicines, or steroid tablets in the past 3 months
  • You currently take a type of medication called atypical antipsychotics
  • You have a serious ongoing illness such as cancer
  • You have an allergy to shellfish or iodine (this may only affect one part of the study — confirm with trial site)
  • You have certain conditions that prevent you from having an MRI scan, or an allergy to a specific medication used in one part of the study (confirm with trial site)

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 5 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Petter M Bjornstad, MD, University of Washington

Phone: 720-777-9500

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
Phase 3
Registry
ClinicalTrials.gov
Start date
21 June 2023
Est. completion
1 October 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in Ascending Aortic Pulse Wave Velocity (AA PWV); Change in Carotid and Femoral Artery Pulse Wave Velocity (CF-PWV); Change in Carotid and Radial Artery Pulse Wave Velocity (CR-PWV)

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: 5 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