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New treatment option for Diabetes Mellitus, Type 1
Official title Closed Loop and Education for Hypoglycemia Awareness Restoration
ClinicalTrials.gov ID: NCT06325202
What this study is testing
- What it's testing
- 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.
- Time commitment: about 24 months
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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%
You likely can't join if
- Medical conditions that limit participation in study activities, as determined by the PI (including but not limited to cognitive dysfunction, reduced...
- 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...
- Social determinants of health that limit participation in study activities, as determined by the PI (including but not limited to homelessness, food...
- Seizure disorder unrelated to hypoglycemia associated seizures, unless documented seizure-free for \>12 months and on a stable regimen of...
- Skin conditions that would preclude the use of a CGM
- Super-physiologic exposure to steroids within one month of enrollment
See the full eligibility 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)
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- 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
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 24 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include La Jolla, California, United States; Orlando, Florida, United States; Lexington, Kentucky, United States; Minneapolis, Minnesota, United States; Philadelphia, Pennsylvania, United States; Fitzroy, Victoria, Australia and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.