Closed Loop and Education for Hypoglycemia Awareness Restoration

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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

DEVICE

Omnipod 5 or Medtronic 780G

Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.

BEHAVIORAL

My 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.

BEHAVIORAL

HARPdoc 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.

Sponsors & Collaborators

• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

  collaborator NIH

• University of Minnesota

  collaborator OTHER

• University of Kentucky

  collaborator OTHER

• University of Pennsylvania

  collaborator OTHER

• AdventHealth

  collaborator OTHER

• University of Leicester

  collaborator OTHER

• University of Sheffield

  collaborator OTHER

• University of Melbourne

  collaborator OTHER

• Jaeb Center for Health Research

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• Milton S. Hershey Medical Center

  lead OTHER

Principal Investigators

• Vernon M Chinchilli, PhD · Penn State College of Medicine

• Elizabeth R Seaquist, MD · University of Minnesota

• Simon Heller, MD · University of Sheffield

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-03

Primary Completion

2029-07-31

Completion

2029-07-31

FDA Device

Yes

Countries

• United States
• Australia
• United Kingdom

Study Locations