Actively Recruiting
Closed Loop and Education for Hypoglycemia Awareness Restoration
Led by Milton S. Hershey Medical Center · Updated on 2026-03-03
324
Participants Needed
8
Research Sites
199 weeks
Total Duration
On this page
Sponsors
M
Milton S. Hershey Medical Center
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Closed Loop and Education for Hypoglycemia Awareness Restoration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of type 1 diabetes
- Gold Score or Clarke Score 2 4, indicating impaired awareness of hypoglycemia
- Random non-fasting C-peptide less than 200 pmol/L
- Duration of diabetes at least 10 years
- HbA1c below 10.5%
- Total daily insulin dose less than 1 unit per kg body weight
- Ability to read and speak English, as educational materials are in English
You will not qualify if you...
- Medical conditions limiting participation, including cognitive dysfunction, reduced hearing or vision, active cancer treatment, untreated angina, or organ failure
- Active alcohol or drug abuse as defined by recurrent use causing failure to meet major responsibilities, hazardous use, or legal problems
- Social factors limiting participation, such as homelessness, food insecurity, or lack of social support
- Seizure disorder unrelated to hypoglycemia unless seizure-free for more than 12 months on stable treatment
- Skin conditions preventing use of continuous glucose monitoring
- Use of steroids above physiological doses within one month before enrollment
- Kidney function with eGFR below 45 mL/min/1.73 m2
- History of bariatric surgery that changes gut nerves and structure
- Abnormal potassium levels (serum potassium above 5.5 or below 3.5 mmol/L)
- Hemoglobin below 10 g/dL
- Medical need for high-dose glucocorticoids
- Pregnancy, planning pregnancy, or breastfeeding
- Significant abnormal thyroid function
- Liver enzyme levels more than three times the normal upper limit
- Hospitalization for mental illness within the past year
- History of adrenal gland removal
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 8 locations
1
University of California, San Diego
La Jolla, California, United States, 92037
Actively Recruiting
2
AdventHealth
Orlando, Florida, United States, 32804
Actively Recruiting
3
University of Kentucky
Lexington, Kentucky, United States, 40508
Actively Recruiting
4
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
5
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
University of Melbourne
Fitzroy, Victoria, Australia, 3065
Actively Recruiting
7
University of Leicester
Leicester, United Kingdom, LE5 4PW
Actively Recruiting
8
University of Sheffield
Sheffield, United Kingdom, S10 2RX
Actively Recruiting
Research Team
A
Abid Kazi, PhD
CONTACT
V
Venus Grella, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
11
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