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RECRUITING
NCT06325202
NA

Closed Loop and Education for Hypoglycemia Awareness Restoration

Sponsor: Milton S. Hershey Medical Center

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

324

Start Date

2025-10-03

Completion Date

2029-07-31

Last Updated

2026-03-03

Healthy Volunteers

No

Interventions

DEVICE

Omnipod 5 or Medtronic 780G

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

BEHAVIORAL

My 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.

BEHAVIORAL

HARPdoc 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