Closed Loop and Education for Hypoglycemia Awareness Restoration

Recruiting N/A Interventional Study
Diabetes Mellitus, Type 1
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 – 75
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
324 (estimated)
Sponsor
Milton S. Hershey Medical Center · Other
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About This Trial

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.

Trial Locations
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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 (beca…
Contacts

Abid Kazi, PhD

717-531-0003

akazi@pennstatehealth.psu.edu

CONTACT

Venus Grella, MPH

717-531-0003

vgrella@pennstatehealth.psu.edu

CONTACT