Closed Loop and Education for Hypoglycemia Awareness Restoration

NARecruitingINTERVENTIONAL
Enrollment

324

Participants

Timeline

Start Date

September 17, 2025

Primary Completion Date

July 31, 2028

Study Completion Date

July 31, 2028

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.

Trial Locations (8)

3065

RECRUITING

University of Melbourne, Fitzroy

19104

RECRUITING

University of Pennsylvania, Philadelphia

32804

RECRUITING

AdventHealth, Orlando

40508

RECRUITING

University of Kentucky, Lexington

55455

RECRUITING

University of Minnesota, Minneapolis

92037

RECRUITING

University of California, San Diego, La Jolla

LE5 4PW

RECRUITING

University of Leicester, Leicester

S10 2RX

RECRUITING

University of Sheffield, Sheffield

All Listed Sponsors
collaborator

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

NIH

collaborator

University of Minnesota

OTHER

collaborator

University of Kentucky

OTHER

collaborator

University of Pennsylvania

OTHER

collaborator

AdventHealth

OTHER

collaborator

University of Leicester

OTHER

collaborator

University of Sheffield

OTHER

collaborator

University of Melbourne

OTHER

collaborator

Jaeb Center for Health Research

OTHER

collaborator

University of California, San Diego

OTHER

lead

Milton S. Hershey Medical Center

OTHER