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Closed Loop and Education for Hypoglycemia Awareness Restoration

Recruiting

Closed Loop and Education for Hypoglycemia Awareness Restoration (CLEAR), Conducted by the Impaired Awareness of Hypoglycemia Consortium (IAHC)

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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)

Exclusion Criteria:

* 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
* Skin conditions that would preclude the use of a CGM
* Super-physiologic exposure to steroids within one month of enrollment
* eGFR \< 45 mL/min/1.73 m2
* History of bariatric surgery that irreversibly alters gut innervation and structure
* Hyper- or hypokalemia (serum potassium \>5.5 or \<3.5 mmol/L)\*
* Hemoglobin \< 10 g/dL\*
* Medical condition that requires intermittent or continuous use of glucocorticoids at greater than physiological replacement doses
* Pregnancy, plan for pregnancy, or breast feeding
* Abnormal thyroid function tests of clinical significance, as determined by PI\*
* Liver transaminases \> 3 times the upper limit of normal\*
* Hospitalization for mental illness in last year
* History of adrenalectomy

  * 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.

About the study

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.

What is being tested

Sponsor: Milton S. Hershey Medical Center · Participants: 324 · Started: Oct 3, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06325202

Locations in the U.S.

CaliforniaUniversity of California, San Diego, La Jolla
FloridaAdventHealth, Orlando
KentuckyUniversity of Kentucky, Lexington
MinnesotaUniversity of Minnesota, Minneapolis
PennsylvaniaUniversity of Pennsylvania, Philadelphia

Conditions

From ClinicalTrials.gov, data retrieved Sep 29, 2026. Each study sets its own eligibility; the study team decides who can join.