RECRUITING

Closed Loop and Education for Hypoglycemia Awareness Restoration

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Conditions

Diabetes Mellitus, Type 1impaired awareness of hypoglycemiahybrid closed loop devicecontinuous glucose monitor

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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)

Quick Facts

Study Start:2025-09-17
Study Completion:2028-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06325202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinical diagnosis of type 1 diabetes
  2. * Gold Score or Clarke Score ≥ 4 (highly associated with IAH)
  3. * Random non-fasting C-peptide \< 200 pmol/L
  4. * Diabetes duration ≥ 10 years
  5. * HbA1c \< 10.5%
  6. * Total Daily Insulin Dose of \< 1 unit/kg
  7. * Ability to read and speak English (because validated non-English versions of the cognitive tests and the educational interventions are not available)
  1. * 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)
  2. * 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)
  3. * 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)
  4. * Seizure disorder unrelated to hypoglycemia associated seizures, unless documented seizure-free for \>12 months and on a stable regimen of anti-convulsant therapy
  5. * Skin conditions that would preclude the use of a CGM
  6. * Super-physiologic exposure to steroids within one month of enrollment
  7. * eGFR \< 45 mL/min/1.73 m2
  8. * History of bariatric surgery that irreversibly alters gut innervation and structure
  9. * Hyper- or hypokalemia (serum potassium \>5.5 or \<3.5 mmol/L)\*
  10. * Hemoglobin \< 10 g/dL\*
  11. * Medical condition that requires intermittent or continuous use of glucocorticoids at greater than physiological replacement doses
  12. * Pregnancy, plan for pregnancy, or breast feeding
  13. * Abnormal thyroid function tests of clinical significance, as determined by PI\*
  14. * Liver transaminases \> 3 times the upper limit of normal\*
  15. * Hospitalization for mental illness in last year
  16. * History of adrenalectomy
  17. * At discretion of the PI, laboratory tests may be repeated once. If the participant is not eligible after the second attempt, then the participant. The participant may be screened again.

Contacts and Locations

Study Contact

Abid Kazi, PhD
CONTACT
717-531-0003
akazi@pennstatehealth.psu.edu
Venus Grella, MPH
CONTACT
717-531-0003
vgrella@pennstatehealth.psu.edu

Principal Investigator

Vernon M Chinchilli, PhD
PRINCIPAL_INVESTIGATOR
Penn State College of Medicine
Elizabeth R Seaquist, MD
STUDY_CHAIR
University of Minnesota
Simon Heller, MD
STUDY_CHAIR
University of Sheffield

Study Locations (Sites)

University of California, San Diego
La Jolla, California, 92037
United States
AdventHealth
Orlando, Florida, 32804
United States
University of Kentucky
Lexington, Kentucky, 40508
United States
University of Minnesota
Minneapolis, Minnesota, 55455
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Vernon M Chinchilli, PhD, PRINCIPAL_INVESTIGATOR, Penn State College of Medicine
  • Elizabeth R Seaquist, MD, STUDY_CHAIR, University of Minnesota
  • Simon Heller, MD, STUDY_CHAIR, University of Sheffield

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-09-17
Study Completion Date2028-07-31

Study Record Updates

Study Start Date2025-09-17
Study Completion Date2028-07-31

Terms related to this study

Keywords Provided by Researchers

  • impaired awareness of hypoglycemia
  • hybrid closed loop device
  • continuous glucose monitor

Additional Relevant MeSH Terms

  • Diabetes Mellitus, Type 1