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Clinical Trials in Australia / NCT06325202
Recruiting Not applicable

Closed Loop and Education for Hypoglycemia Awareness Restoration

NCT06325202 · tracked via the Priya Life Science Australia tracker
Phase
Not applicable
Started
2025-10-03
Last updated
2026-03-03

Condition(s) studied

Diabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

Omnipod 5 or Medtronic 780GMy HypoCOMPaSS EducationHARPdoc Education

Omnipod 5 or Medtronic 780G: Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.

My HypoCOMPaSS Education: My HypoCOMPaSS is a brief, standardized psycho-educational program delivered in small groups. Facilitated discussions focus on advocating rigorous avoidance of hypoglycemia while maintaining time in target glycemic range.

HARPdoc Education: The HARPdoc program targets cognitions around hypoglycemia that act as barriers to hypoglycemia avoidance and recovery of awareness using motivational and cognitive approaches, delivered by diabetes educators, trained and supported by a clinical psychologist, in small group format.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (8)

FacilityCityRegionStatus
University of California, San Diego La Jolla California Recruiting
AdventHealth Orlando Florida Recruiting
University of Kentucky Lexington Kentucky Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
University of Melbourne Fitzroy Victoria Recruiting
University of Leicester Leicester United Kingdom Recruiting
University of Sheffield Sheffield United Kingdom Recruiting

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06325202 on ClinicalTrials.gov ↗ ← All trials in Australia