RecruitingNot ApplicableNCT06325202

Closed Loop and Education for Hypoglycemia Awareness Restoration

Closed Loop and Education for Hypoglycemia Awareness Restoration (CLEAR), Conducted by the Impaired Awareness of Hypoglycemia Consortium (IAHC)


Sponsor

Milton S. Hershey Medical Center

Enrollment

324 participants

Start Date

Oct 3, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of the CLEAR study is to determine the effect on counterregulatory responses (CRR) of intervening (by attempting to strictly avoid hypoglycemia) to improve awareness of hypoglycemic symptoms among adults with type 1 diabetes (T1D) who have impaired awareness of hypoglycemia (IAH). IAH affects 20-25% of adults with T1D, and rises with increasing duration of T1D.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether using a closed-loop insulin delivery system (also called an "artificial pancreas") combined with special education can help people with type 1 diabetes who no longer feel the warning signs of low blood sugar (a condition called impaired awareness of hypoglycemia, or IAH). When you stop feeling low blood sugars coming on, it becomes dangerous — this trial aims to restore that awareness. **You may be eligible if...** - You have type 1 diabetes - You score 4 or higher on a standard hypoglycemia awareness questionnaire (Gold or Clarke score) - You have had type 1 diabetes for 10 or more years - Your HbA1c is below 10.5% - You can read and speak English - Your daily insulin dose is less than 1 unit per kilogram of body weight **You may NOT be eligible if...** - You have a medical condition that limits your ability to participate (e.g., cognitive issues, active cancer, organ failure) - You have active problems with alcohol or drug misuse - You have significant social challenges (homelessness, food insecurity) - You have a seizure disorder unrelated to low blood sugar - You have a skin condition that prevents wearing a continuous glucose monitor (CGM) - You have recently used high-dose steroids - You have significantly reduced kidney function Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEOmnipod 5 or Medtronic 780G

Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.

BEHAVIORALMy HypoCOMPaSS Education

My HypoCOMPaSS is a brief, standardized psycho-educational program delivered in small groups. Facilitated discussions focus on advocating rigorous avoidance of hypoglycemia while maintaining time in target glycemic range.

BEHAVIORALHARPdoc Education

The HARPdoc program targets cognitions around hypoglycemia that act as barriers to hypoglycemia avoidance and recovery of awareness using motivational and cognitive approaches, delivered by diabetes educators, trained and supported by a clinical psychologist, in small group format.


Locations(8)

University of California, San Diego

La Jolla, California, United States

AdventHealth

Orlando, Florida, United States

University of Kentucky

Lexington, Kentucky, United States

University of Minnesota

Minneapolis, Minnesota, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

University of Melbourne

Fitzroy, Victoria, Australia

University of Leicester

Leicester, United Kingdom

University of Sheffield

Sheffield, United Kingdom

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06325202


Related Trials