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Clinical trial Recruiting at 8 sites Interventional Ages 18 to 75

Restoring low-blood-sugar awareness with closed-loop pumps or targeted education

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

Run by Milton S. Hershey Medical Center · NCT06325202 · Data updated 2026-11-12

This study will test whether using hybrid closed-loop insulin systems or focused education can help adults with type 1 diabetes who no longer notice low blood sugar regain their awareness.

Quick facts

Study typeInterventional
Ages18 Years to 75 Years
SexAll
Enrollment324 (estimated)
SponsorMilton S. Hershey Medical Center
Academic / other
Locations8 sites (La Jolla, California and 7 other locations)
StatusRecruiting
StartedOctober 3, 2025
Main results expectedDecember 31, 2029
Study endsDecember 31, 2029
Registry record updatedOctober 30, 2026
Trial IDNCT06325202 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Adults with type 1 diabetes of at least 10 years' duration who have impaired awareness of hypoglycemia (Gold or Clarke score ≥4), low C‑peptide (<200 pmol/L), HbA1c <10.5%, and total daily insulin dose <1 unit/kg who can read and speak English are ideal candidates.

Probably not a fit

People without impaired hypoglycemia awareness, with significant medical or cognitive conditions that limit participation, active substance abuse, or who do not meet the biochemical/insulin criteria (for example C‑peptide ≥200 pmol/L or insulin ≥1 unit/kg) are unlikely to benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults with long-duration type 1 diabetes and impaired awareness of hypoglycemia are assigned to use an advanced hybrid closed-loop system (Omnipod 5 or Medtronic 780G) or to participate in one of two structured education programs (My HypoCOMPaSS or HARPdoc). The primary outcome is change in counterregulatory hormonal and symptomatic responses to low blood sugar measured using experimental hypoglycemia clamp testing. The trial is conducted at multiple U.S. centers and includes behavioral and technology-based approaches to reduce hypoglycemia exposure. The study will also examine whether participant characteristics influence which intervention works best.

Why it matters

Potential benefit: If successful, the interventions could help people regain warning symptoms of low blood sugar and reduce episodes of severe hypoglycemia.

How similar studies have gone: Previous work shows CGM and hybrid closed-loop systems reduce severe hypoglycemia and behavioral education can lower hypoglycemia rates, but it remains unclear from prior studies whether these approaches reverse counterregulatory deficits, and direct comparisons are limited.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • University of California, San Diego
    La Jolla, California, United States     Recruiting
  • AdventHealth
    Orlando, Florida, United States     Recruiting
  • University of Kentucky
    Lexington, Kentucky, United States     Recruiting
  • University of Minnesota
    Minneapolis, Minnesota, United States     Recruiting
  • University of Pennsylvania
    Philadelphia, Pennsylvania, United States     Recruiting
  • University of Melbourne
    Fitzroy, Victoria, Australia     Recruiting
Show 2 more locations
  • University of Leicester
    Leicester, United Kingdom     Recruiting
  • University of Sheffield
    Sheffield, United Kingdom     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Diabetes Mellitus, Type 1 68Milton S. Hershey Medical Center 42
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.