NOT_YET_RECRUITING
Closed Loop and Education for Hypoglycemia Awareness Restoration
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.
Conditions:
🦠 Diabetes Mellitus, Type 1
🗓️ Study Start (Actual) 1 November 2024
🗓️ Primary Completion (Estimated) 30 June 2027
✅ Study Completion (Estimated) 31 December 2027
👥 Enrollment (Estimated) 324
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 La Jolla, California, United States
📍 Orlando, Florida, United States
📍 Lexington, Kentucky, United States
📍 Minneapolis, Minnesota, United States
📍 Philadelphia, Pennsylvania, United States
📍 Fitzroy, Victoria, Australia
📍 Leicester, United Kingdom
📍 Sheffield, United Kingdom

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 18 Years to 75 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ 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

  • First Submitted 5 March 2024
  • First Submitted that Met QC Criteria 15 March 2024
  • First Posted 22 March 2024

Study Record Updates

  • Last Update Submitted that Met QC Criteria 19 July 2024
  • Last Update Posted 22 July 2024
  • Last Verified July 2024