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

Trial ID: NCT06325202

Interventional - Phase Unknown - Recruiting

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

Interventions

• Omnipod 5 or Medtronic 780G
• My HypoCOMPaSS Education
• HARPdoc Education

Eligibility

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.

Sponsor

Milton S. Hershey Medical Center, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), University of Minnesota, University of Kentucky, University of Pennsylvania, AdventHealth, University of Leicester, University of Sheffield, University of Melbourne, Jaeb Center for Health Research, University of California, San Diego

Source: ClinicalTrials.gov

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