Closed Loop and Education for Hypoglycemia Awareness Restoration

Prior treatment

• Super-physiologic exposure to steroids within one month of enrollment

Other illness

• 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)
• 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
• History of bariatric surgery that irreversibly alters gut innervation and structure
• Medical condition that requires intermittent or continuous use of glucocorticoids at greater than physiological replacement doses
• Hospitalization for mental illness in last year

Lab values

• eGFR \< 45 mL/min/1.73 m2
• Hyper- or hypokalemia (serum potassium \>5.5 or \<3.5 mmol/L)\*
• Hemoglobin \< 10 g/dL\*
• Liver transaminases \> 3 times the upper limit of normal\*
• 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.

Other

• 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)
• Pregnancy, plan for pregnancy, or breast feeding
• Abnormal thyroid function tests of clinical significance, as determined by PI\*

• 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)