Closed Loop and Education for Hypoglycemia Awareness Restoration (CLEAR), Conducted by the Impaired Awareness of Hypoglycemia Consortium (IAHC)
Status: Recruiting
Location: See all (8) locations...
Intervention Type: Behavioral, Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:
• Clinical diagnosis of type 1 diabetes
• Gold Score or Clarke Score ≥ 4 (highly associated with IAH)
• Random non-fasting C-peptide \< 200 pmol/L
• Diabetes duration ≥ 10 years
• HbA1c \< 10.5%
• Total Daily Insulin Dose of \< 1 unit/kg
• Ability to read and speak English (because validated non-English versions of the cognitive tests and the educational interventions are not available)
Locations
United States
California
University of California, San Diego
RECRUITING
La Jolla
Florida
AdventHealth
RECRUITING
Orlando
Kentucky
University of Kentucky
RECRUITING
Lexington
Minnesota
University of Minnesota
RECRUITING
Minneapolis
Pennsylvania
University of Pennsylvania
RECRUITING
Philadelphia
Other Locations
Australia
University of Melbourne
RECRUITING
Fitzroy
United Kingdom
University of Leicester
RECRUITING
Leicester
University of Sheffield
RECRUITING
Sheffield
Contact Information
Primary
Abid Kazi, PhD
akazi@pennstatehealth.psu.edu
717-531-0003
Backup
Venus Grella, MPH
vgrella@pennstatehealth.psu.edu
717-531-0003
Time Frame
Start Date: 2025-09-17
Estimated Completion Date: 2028-07-31
Participants
Target number of participants: 324
Treatments
Experimental: current HCL non-user: HCL x 24 months
Hybrid closed loop device over a 24-month period for individuals currently not using a hybrid closed loop device
Experimental: current HCL non-user: HCL x 12 months, then HCL x an additional 12 months
Hybrid closed loop device over a 12-month period for individuals currently not using a hybrid closed loop device, and then a hybrid closed loop device for an additional 12 months
Experimental: current HCL non-user: HCL x 12 months, then HCL + HARPdoc x 12 months
Hybrid closed loop device over a 12-month period for individuals currently not using a hybrid closed loop device, then a hybrid closed loop device plus HARPdoc education for an additional 12 months
Active_comparator: current HCL non-user: Usual Care and My HypoCOMPaSS x 12 months, then HCL x 12 months
Usual Care and My HypoCOMPaSS education over 12 months for individuals currently not using a hybrid closed loop device, then hybrid closed loop device for 12 months
Active_comparator: current HCL non-user: Usual Care and My HypoCOMPaSS x 24 months
Usual Care and My HypoCOMPaSS education over 24 months for individuals currently not using a hybrid closed loop device
Experimental: current HCL user: HCL x 24 months
Hybrid closed loop device over a 24-month period for individuals currently using a hybrid closed loop device
Experimental: current HCL user: HCL x 12 months, then HCL x an additional 12 months
Hybrid closed loop device over a 12-month period for individuals currently using a hybrid closed loop device, and then a hybrid closed loop device for an additional 12 months
Experimental: current HCL user: HCL x 12 months, then HCL + HARPdoc x 12 months
Hybrid closed loop device over a 12-month period for individuals currently using a hybrid closed loop device, then a hybrid closed loop device plus HARPdoc education for an additional 12 months
Active_comparator: current HCL user: HCL and My HypoCOMPaSS x 12 months, then HCL x 12 months
Hybrid closed loop device and My HypoCOMPaSS education over 12 months for individuals currently using a hybrid closed loop device, then hybrid closed loop device for 12 months
Active_comparator: current HCL user: HCL + My HypoCOMPaSS x 12 months, then HCL + My HypoCOMPaSS + HARPDOC x 12 months
Hybrid closed loop device and My HypoCOMPaSS education over 12 months for individuals currently using a hybrid closed loop device, then hybrid closed loop device plus My HypoCOMPaSS eduction + HARPdoc education for 12 months
Experimental: current HCL user: HCL + My HypoCOMPaSS x 24 months
Hybrid closed loop device plus My HypoCOMPaSS education over a 24-month period for individuals currently using a hybrid closed loop device
Related Therapeutic Areas
Sponsors
Collaborators: University of Melbourne, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of California, San Diego, AdventHealth, University of Leicester, University of Kentucky, Jaeb Center for Health Research, University of Sheffield, University of Minnesota, University of Pennsylvania
Leads: Milton S. Hershey Medical Center