Tests devices and education to restore low blood sugar awareness in type 1 diabetes
Tests whether avoiding low blood sugar helps adults with type 1 diabetes notice symptoms.
Plain-language title generated from the registry record
Registry title: Closed Loop and Education for Hypoglycemia Awareness Restoration
Key facts
- Where
- Leicester and Sheffield, United KingdomSee the 2 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT06325202, who can take part
Where in United Kingdom
- University of LeicesterLeicester, United KingdomTaking people
- University of SheffieldSheffield, United KingdomTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Milton S. Hershey Medical Center
- Trial code
- NCT06325202
- Record updated
- 30 October 2026
- Original description
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.Read full original descriptionShow less
Closed Loop and Education for Hypoglycemia Awareness Restoration (CLEAR), Conducted by the Impaired Awareness of Hypoglycemia Consortium (IAHC)
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.
Inclusion: 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: Super-physiologic exposure to steroids within one month of enrollment; 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; 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; 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*.