Closed Loop and Education for Hypoglycemia Awareness Restoration (CLEAR), Conducted by the Impaired Awareness of Hypoglycemia Consortium (IAHC)
Milton S. Hershey Medical Center
Summary
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.
Description
Individuals with IAH exhibit blunted symptomatic and CR hormonal responses to hypoglycemia and, as such, have an impaired ability to respond to hypoglycemia. Thus, rates of severe hypoglycemia are up to 6-fold greater in those affected. Intensive management of T1D is necessary in preventing long-term complications, but can be complicated by recurrent episodes of hypoglycemia which lead to and sustain the CRR deficits of IAH. Technologies such as continuous glucose monitoring (CGM) and hybrid closed-loop (HCL) systems can reduce severe hypoglycemia (and also may reduce IAH) but the ability of t…
Eligibility
- Age range
- 18–75 years
- Sex
- All
- Healthy volunteers
- No
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, reduce…
Interventions
- DeviceOmnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
- BehavioralMy HypoCOMPaSS Education
My HypoCOMPaSS is a brief, standardized psycho-educational program delivered in small groups. Facilitated discussions focus on advocating rigorous avoidance of hypoglycemia while maintaining time in target glycemic range.
- BehavioralHARPdoc Education
The HARPdoc program targets cognitions around hypoglycemia that act as barriers to hypoglycemia avoidance and recovery of awareness using motivational and cognitive approaches, delivered by diabetes educators, trained and supported by a clinical psychologist, in small group format.
Locations (8)
- University of California, San DiegoLa Jolla, California
- AdventHealthOrlando, Florida
- University of KentuckyLexington, Kentucky
- University of MinnesotaMinneapolis, Minnesota
- University of PennsylvaniaPhiladelphia, Pennsylvania
- University of MelbourneFitzroy, Victoria