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Closed Loop and Education for Hypoglycemia Awareness Restoration

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Questionnaires, Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The investigators propose to study the effect of specific interventions aimed at restoring * the CRR (tested via an experimental hypoglycemia clamp procedure) * hypoglycemia awareness (self-reported via the Towler Questionnaire during the experimental hypoglycemia clamp procedure) The study will use a Sequential Multiple Assignment Randomized Trial (SMART) design."
  • "UC will consist of real-time continuous glucose monitoring (CGM) and insulin delivery via pump or multiple daily injections."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

The CLEAR study tests whether strictly avoiding low blood sugar helps adults with type 1 diabetes notice low blood sugar symptoms again. It also looks at the body's natural response to low blood sugar. It is for adults who have trouble noticing when their blood sugar is low.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have a diagnosis of type 1 diabetes.
  • Score 4 or higher on the Gold or Clarke test, which checks how well you notice low blood sugar.
  • Have a C-peptide level below 200 pmol/L on a blood test without fasting. This measures how much insulin your body makes.
  • Have had diabetes for at least 10 years.
  • Have an HbA1c below 10.5%. This blood test shows your average blood sugar over time.
  • Use less than 1 unit of insulin per kilogram of body weight each day.
  • Be able to read and speak English.

Who can't join

  • Have health or life problems that the study doctor says would limit participation. Examples include problems with thinking, hearing, or vision; cancer being treated; untreated heart-related chest pain; organ failure; or not enough housing, food, or support.
  • Have ongoing alcohol or drug misuse that causes problems with daily duties, safety, or the law; or have been hospitalized for mental illness in the past year.
  • Have seizures not caused by low blood sugar, unless you have been seizure-free for more than 12 months and on stable seizure medicine.
  • Have a skin condition that prevents use of a continuous glucose monitor, a device that tracks blood sugar.
  • Have used steroids above the body's normal hormone levels within one month of joining, or have a condition that requires these doses from time to time or regularly.
  • Have any of these test results: kidney filtering rate (eGFR) below 45; potassium above 5.5 or below 3.5 mmol/L; hemoglobin, which carries oxygen in blood, below 10 g/dL; liver enzymes above 3 times the normal limit; or thyroid results the study doctor considers a concern. Some tests may be repeated.
  • Have had weight-loss surgery that permanently changes the gut's nerves and structure, or surgery to remove an adrenal gland.
  • Are pregnant, planning pregnancy, or breastfeeding.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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.

Study sites (5)

CA

FL

KY

MN

PA