Trial Summary
What is the purpose of 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.
Research Team
SH
Simon Heller, MD
Principal Investigator
University of Sheffield
VM
Vernon M Chinchilli, PhD
Principal Investigator
Penn State College of Medicine
ER
Elizabeth R Seaquist, MD
Principal Investigator
University of Minnesota
Eligibility Criteria
Adults with type 1 diabetes who often don't notice when their blood sugar gets too low can join this study. They should be interested in using new tech like the Omnipod 5 or Medtronic 780G insulin pumps and willing to learn through educational programs designed to help recognize low blood sugar symptoms.Inclusion Criteria
HbA1c < 10.5%
Random non-fasting C-peptide < 200 pmol/L
Gold Score or Clarke Score ≥ 4 (highly associated with IAH)
See 4 more
Exclusion Criteria
Hemoglobin < 10 g/dL
Medical conditions that limit participation in study activities, as determined by the PI (including but not limited to cognitive dysfunction, reduced hearing, reduced vision, cancer under active treatment, untreated angina, organ failure)
I do not have skin conditions that prevent wearing a CGM.
See 13 more
Treatment Details
Interventions
- HARPdoc Education (Behavioral Intervention)
- My HypoCOMPaSS Education (Behavioral Intervention)
- Omnipod 5 or Medtronic 780G (Device)
Trial OverviewThe CLEAR study is testing whether special education programs (HARPdoc and My HypoCOMPaSS) combined with advanced insulin pumps (Omnipod 5 or Medtronic 780G) can help people better sense when their blood sugar drops, which is a common problem in long-term type 1 diabetes.
Participant Groups
11Treatment groups
Experimental Treatment
Active Control
Group I: current HCL user: HCL x 24 monthsExperimental Treatment1 Intervention
Hybrid closed loop device over a 24-month period for individuals currently using a hybrid closed loop device
Group II: current HCL user: HCL x 12 months, then HCL x an additional 12 monthsExperimental Treatment1 Intervention
Hybrid closed loop device over a 12-month period for individuals currently using a hybrid closed loop device, and then a hybrid closed loop device for an additional 12 months
Group III: current HCL user: HCL x 12 months, then HCL + HARPdoc x 12 monthsExperimental Treatment2 Interventions
Hybrid closed loop device over a 12-month period for individuals currently using a hybrid closed loop device, then a hybrid closed loop device plus HARPdoc education for an additional 12 months
Group IV: current HCL user: HCL + My HypoCOMPaSS x 24 monthsExperimental Treatment2 Interventions
Hybrid closed loop device plus My HypoCOMPaSS education over a 24-month period for individuals currently using a hybrid closed loop device
Group V: current HCL non-user: HCL x 24 monthsExperimental Treatment1 Intervention
Hybrid closed loop device over a 24-month period for individuals currently not using a hybrid closed loop device
Group VI: current HCL non-user: HCL x 12 months, then HCL x an additional 12 monthsExperimental Treatment1 Intervention
Hybrid closed loop device over a 12-month period for individuals currently not using a hybrid closed loop device, and then a hybrid closed loop device for an additional 12 months
Group VII: current HCL non-user: HCL x 12 months, then HCL + HARPdoc x 12 monthsExperimental Treatment2 Interventions
Hybrid closed loop device over a 12-month period for individuals currently not using a hybrid closed loop device, then a hybrid closed loop device plus HARPdoc education for an additional 12 months
Group VIII: current HCL user: HCL and My HypoCOMPaSS x 12 months, then HCL x 12 monthsActive Control2 Interventions
Hybrid closed loop device and My HypoCOMPaSS education over 12 months for individuals currently using a hybrid closed loop device, then hybrid closed loop device for 12 months
Group IX: current HCL user: HCL + My HypoCOMPaSS x 12 months, then HCL + My HypoCOMPaSS + HARPDOC x 12 monthsActive Control3 Interventions
Hybrid closed loop device and My HypoCOMPaSS education over 12 months for individuals currently using a hybrid closed loop device, then hybrid closed loop device plus My HypoCOMPaSS eduction + HARPdoc education for 12 months
Group X: current HCL non-user: Usual Care and My HypoCOMPaSS x 24 monthsActive Control1 Intervention
Usual Care and My HypoCOMPaSS education over 24 months for individuals currently not using a hybrid closed loop device
Group XI: current HCL non-user: Usual Care and My HypoCOMPaSS x 12 months, then HCL x 12 monthsActive Control2 Interventions
Usual Care and My HypoCOMPaSS education over 12 months for individuals currently not using a hybrid closed loop device, then hybrid closed loop device for 12 months
Find a Clinic Near You
Who Is Running the Clinical Trial?
Milton S. Hershey Medical Center
Lead Sponsor
Trials
515
Recruited
2,873,000+
AdventHealth
Collaborator
Trials
118
Recruited
31,800+
University of Leicester
Collaborator
Trials
218
Recruited
17,750,000+
University of Melbourne
Collaborator
Trials
193
Recruited
1,287,000+
University of California, San Diego
Collaborator
Trials
1,215
Recruited
1,593,000+
Jaeb Center for Health Research
Collaborator
Trials
162
Recruited
36,200+
University of Sheffield
Collaborator
Trials
200
Recruited
7,756,000+
University of Pennsylvania
Collaborator
Trials
2,118
Recruited
45,270,000+
University of Minnesota
Collaborator
Trials
1,459
Recruited
1,623,000+
University of Kentucky
Collaborator
Trials
198
Recruited
224,000+