Closed Loop and Education for Hypoglycemia Awareness Restoration
Recruiting now · Not applicable
Conditions studied: Diabetes Mellitus, Type 1
In brief
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.
Key facts
- Study ID
- NCT06325202
- Run by
- Milton S. Hershey Medical Center
- People needed
- 324
- Starts
- 2025-10-03
- Expected to finish
- 2029-07-31
- Last updated by the study team
- 2026-03-03
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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.
Where it is running
- University of California, San Diego — La Jolla, California, United States (enrolling)
- AdventHealth — Orlando, Florida, United States (enrolling)
- University of Kentucky — Lexington, Kentucky, United States (enrolling)
- University of Minnesota — Minneapolis, Minnesota, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- University of Melbourne — Fitzroy, Victoria, Australia (enrolling)
- University of Leicester — Leicester, United Kingdom (enrolling)
- University of Sheffield — Sheffield, United Kingdom (enrolling)
Full record on ClinicalTrials.gov
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