Closed Loop and Education for hypoglycemia Awareness Restoration

Recruiting

18 years - 75 years

All

Phase N/A

30 participants needed

1 Location

Brief description of study

Do you have Type 1 Diabetes for more than 10 years? The purpose of this study is to learn how to improve hypoglycemia unawareness - a condition where people with T1D may not be able to tell how low their blood sugar levels are. Hypoglycemia unawareness happens because their body’s response to low blood sugar has weakened. This study will use different types of education and devices to see if they can help you become more aware when your blood sugar is low. Learn more about our study on our website here! (https://theclearstudy.org/)

Approximately 324 people from 8 sites will take part in this research study worldwide.

You will be compensated for your time.

Fill out this interest form and we will get in touch with you! (https://redcap.med.upenn.edu/surveys/?s=MHFLWYFLHR499DNM)

Detailed description of study

If you are eligible and consent to participate in the research, you will be required to attend 19 study visits; some of these will be in-person visits (at least 7), and some will be remote visits (tele-health: Zoom or TEAMS).

The study will last a little over 2 to 2.5 years (about 27-30 months).

During the study, you will be asked to do the following:

Agree to be randomized (randomly placed into groups like flipping a coin, without anyone being able to guess or influence what study group you will be enrolled in) to a study treatment for type 1 diabetes
Wear a Garmin Smart watch as an activity monitor
Install and use study application(s) on your smartphone

At in-person study visits, you will:

Go over your medical history
Have a physical exam
Share your continuous glucose monitoring (CGM) data
Have an electrocardiogram (EKG)
Give blood for testing,
Undergo 3 clamp procedures,
Inform the study staff if you think you are pregnant at any time during the study.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions: Type 1 Diabetes, Hypoglycemia, Diabetes, T1D
Age: 18 years - 75 years
Gender: All

Inclusion

Ages 18-75 years
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
A1c < 10.5%
Total Daily Insulin Dose of < 1 unit/kg
Ability to read and speak English

Exclusion

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.
Social determinants of health that limit participation in study activities, as determined by the PI
Seizure disorder unrelated to hypoglycemia associated seizures, unless documented seizure-free for >12 months and on a stable regimen of anti-convulsant therapy
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)
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
Liver transaminases > 3 times the upper limit of normal
Hospitalization for mental illness in last year
History of adrenalectomy

Updated on 16 Jan 2026. Study ID: 24-2125

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