About this trial
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 criteria
Qualifiers
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
Disqualifiers
Medical conditions that limit participation in study activities, as determined by the PI (including but not limited to cognitive dysfunction, reduced hearing, reduced vision, cancer under active treatment, untreated angina, organ failure)
Active alcohol or drug abuse (as defined by DSM criteria of either 1) recurrent use of alcohol/drugs resulting in a failure to fulfill major role obligations at work, school, or home, 2) recurrent alcohol/drug use in situations in which it is physically hazardous, or 3) recurrent alcohol or drug-related legal problems)
Social determinants of health that limit participation in study activities, as determined by the PI (including but not limited to homelessness, food insecurity, inadequate social support)
Seizure disorder unrelated to hypoglycemia associated seizures, unless documented seizure-free for >12 months and on a stable regimen of anti-convulsant therapy
Trial design
Treatments tested in this trial
- Omnipod 5 or Medtronic 780G
- My HypoCOMPaSS Education
- HARPdoc Education
Treatment groups
11
Treatment groupsSee each treatment group below.
Sponsors and collaborators
Milton S. Hershey Medical Center
Lead sponsor
Penn State Health Milton S Hershey Medical Center
Sponsor institution
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Minnesota
Collaborator
University of Kentucky
Collaborator
University of Pennsylvania
Collaborator
AdventHealth
Collaborator
University of Leicester
Collaborator
University of Sheffield
Collaborator
University of Melbourne
Collaborator
Jaeb Center for Health Research
Collaborator
University of California, San Diego
Collaborator