Closed Loop and Education for Hypoglycemia Awareness Restoration

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMilton S. Hershey Medical Center

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

324 Participants
are divided into 11 treatment groups

11

Treatment groups

See 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