Closed Loop and Education for Hypoglycemia Awareness Restoration
ConditionDiabetes Mellitus, Type 1
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorMilton S. Hershey Medical Center
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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)
Active alcohol or drug abuse (as defined by DSM criteria of either 1) recurrent use of alcohol/drugs resulting in a failure to fulfill major role obligations at work, school, or home, 2) recurrent alcohol/drug use in situations in which it is physically hazardous, or 3) recurrent alcohol or drug-related legal problems)
Social determinants of health that limit participation in study activities, as determined by the PI (including but not limited to homelessness, food insecurity, inadequate social support)
Seizure disorder unrelated to hypoglycemia associated seizures, unless documented seizure-free for >12 months and on a stable regimen of anti-convulsant therapy
Trial design
Design model
Sequential
Treatments tested in this trial
Omnipod 5 or Medtronic 780G
DeviceOmnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
My HypoCOMPaSS Education
BehavioralMy 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.
HARPdoc Education
BehavioralThe 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.
Treatment groups
324 Participants
are divided into 11 treatment groups11
Treatment groupsSee each treatment group below.
Group A: current HCL non-user: HCL x 24 monthsExperimental treatment 1 intervention
Group B: current HCL non-user: HCL x 12 months, then HCL x an additional 12 monthsExperimental treatment 1 intervention
Group C: current HCL non-user: HCL x 12 months, then HCL + HARPdoc x 12 monthsExperimental treatment 2 interventions
Group D: current HCL non-user: Usual Care and My HypoCOMPaSS x 12 months, then HCL x 12 monthsActive comparator 2 interventions
Group E: current HCL non-user: Usual Care and My HypoCOMPaSS x 24 monthsActive comparator 1 intervention
Group F: current HCL user: HCL x 24 monthsExperimental treatment 1 intervention
Group G: current HCL user: HCL x 12 months, then HCL x an additional 12 monthsExperimental treatment 1 intervention
Group H: current HCL user: HCL x 12 months, then HCL + HARPdoc x 12 monthsExperimental treatment 2 interventions
Group I: current HCL user: HCL and My HypoCOMPaSS x 12 months, then HCL x 12 monthsActive comparator 2 interventions
Group J: current HCL user: HCL + My HypoCOMPaSS x 12 months, then HCL + My HypoCOMPaSS + HARPDOC x 12 monthsActive comparator 3 interventions
Group K: current HCL user: HCL + My HypoCOMPaSS x 24 monthsExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
epinephrine (pg/ml)
a change in epinephrine (pg/ml) that exceeds 125 pg/ml between (1) 12 months and baseline, and (2) 24 months and baseline
Time frame
measured during the clamp studies at 0 (baseline), 12, and 24 months2
Towler questionnaire
the Towler questionnaire consists of 12 questions each on a 0-6 Likert scale; a change in the questionnaire that exceeds 20% between (1) 12 months and baseline, and (2) 24 months and baseline
Time frame
measured during the clamp studies at 0 (baseline), 12, and 24 monthsSecondary outcomes
1
geometric mean of plasma glucagon
geometric mean of plasma glucagon
Time frame
measured during the clamp studies at 0 (baseline), 12, and 24 months2
geometric mean of plasma pancreatic polypeptide
geometric mean of plasma pancreatic polypeptide
Time frame
measured during the clamp studies at 0 (baseline), 12, and 24 months3
geometric mean of plasma free fatty acids
geometric mean of plasma free fatty acids
Time frame
measured during the clamp studies at 0 (baseline), 12, and 24 months4
glucose infusion rate
glucose infusion rate
Time frame
measured during the clamp studies at 0 (baseline), 12, and 24 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Milton S. Hershey Medical Center
Lead sponsor
Penn State Health Milton S Hershey Medical Center
Sponsor institution
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
University of Minnesota
Collaborator
University of Kentucky
Collaborator
University of Pennsylvania
Collaborator
AdventHealth
Collaborator
University of Leicester
Collaborator
University of Sheffield
Collaborator
University of Melbourne
Collaborator
Jaeb Center for Health Research
Collaborator
University of California, San Diego
Collaborator
Source ClinicalTrials.gov