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Closed Loop and Education for Hypoglycemia Awareness Restoration
Sponsor: Milton S. Hershey Medical Center
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
Conditions
Interventions
Omnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
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.
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