Closed Loop and Education for Hypoglycemia Awareness Restoration
NCT ID: NCT06325202
Last Updated: 2026-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
324 participants
INTERVENTIONAL
2025-10-03
2029-07-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Closing the Loop in Adults With Type 1 Diabetes (CLEAR)
NCT04977908
Efficacy of Closed-loop Insulin Therapy in Adults Prone to Hypoglycemia
NCT04266379
Closing the Loop in Adults With Type 1 Diabetes
NCT00910767
Diabetes Closed-Loop Project 6 (DCLP6): Fully Automated Closed-Loop Control in Type 1 Diabetes Using Meal Anticipation
NCT04877730
24/7 Closed-loop in Older Subjects With Type 1 Diabetes
NCT04025762
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* the CRR (tested via an experimental hypoglycemia clamp procedure)
* hypoglycemia awareness (self-reported via the Towler Questionnaire during the experimental hypoglycemia clamp procedure)
The study will use a Sequential Multiple Assignment Randomized Trial (SMART) design. At baseline, all participants who are HCL naïve will be randomized to HCL or Usual Care (UC) plus brief education (My HypoCOMPaSS) with a follow-up of two years. UC will consist of real-time continuous glucose monitoring (CGM) and insulin delivery via pump or multiple daily injections. Participants who fail to increase their CRR at 12 months will be randomized, or assigned, to a second intervention consisting of a small-group educational program focusing on motivations and unhelpful cognitions acting as barriers to hypoglycemia avoidance (HARPdoc). At baseline, all participants who are HCL non-naïve will be randomized to optimized HCL or HCL plus My HypoCOMPaSS; those with non-responsive CRR at 12 months will be randomized to either continue HCL (on the basis they need a longer period to reverse impaired CRR and total symptomatic responses) or to the HARPdoc intervention. Participants randomized to an HCL device are expected to wear the device continually, as well as a CGM. The My HypoCOMPaSS education requires 4-5 hours of training, whereas, the HARPdoc education requires four training sessions of seven hours each during weeks 1,2,3, and 6.
The specific aims and hypotheses are as follows:
Aim 1: To determine the effect on CRR (epinephrine increase ≥ 125 pg/ml over baseline) and total symptom responses (Towler Questionnaire increase ≥ 20% over baseline) during a hyperinsulinemic-hypoglycemic clamp procedure (glucose \< 50 mg/dl) after 12 months of HCL versus Usual Care plus My HypoCOMPaSS Educational Intervention among adults with T1D and IAH who have never used HCL therapy previously.
Hypothesis 1: At 12 months, those allocated to Usual Care plus My HypoCOMPaSS will be more likely to have improved CRR and total symptomatic responses than those allocated to HCL.
Aim 2: To determine the effect on CRR and total symptom responses at 12 months of HCL plus My HypoCOMPaSS versus HCL alone among adults with T1D and IAH who are currently using HCL therapy prior to entering the study.
Hypothesis 2: At 12 months, those allocated to HCL plus My HypoCOMPaSS will be more likely to have improved hypoglycemic awareness and improved CRR than those using HCL alone.
Aim 3: To determine the durability of effect over 24 months of the intervention that improves CRR at 12 months among adults with type 1 diabetes and IAH at baseline.
Hypothesis 3: At 24 months, CRR will improve further among those who had restored CRR at 12 months.
Aim 4. To determine the effect on hypoglycemic awareness (Towler Questionnaire increase ≥ 20% over baseline) and CRR (epinephrine increase ≥ 125 pg/ml over baseline) during a hyperinsulinemic hypoglycemic clamp procedure at 24 months of an in-depth educational program (HARPdoc), initiated throughout months 12-24, among adults with T1D and IAH at baseline, for whom the intervention allocated at baseline did not restore CRR at 12 months.
Hypothesis 4: At 24 months, those allocated to HARPdoc for months 12-24 months will be more likely to have improved hypoglycemic awareness and CRR than those who continue with the therapy allocated at baseline.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
current HCL non-user: HCL x 24 months
Hybrid closed loop device over a 24-month period for individuals currently not using a hybrid closed loop device
Omnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
current HCL non-user: HCL x 12 months, then HCL x an additional 12 months
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
Omnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
current HCL non-user: HCL x 12 months, then HCL + HARPdoc x 12 months
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
Omnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
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.
current HCL non-user: Usual Care and My HypoCOMPaSS x 12 months, then HCL x 12 months
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
Omnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
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.
current HCL non-user: Usual Care and My HypoCOMPaSS x 24 months
Usual Care and My HypoCOMPaSS education over 24 months for individuals currently not using a hybrid closed loop device
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.
current HCL user: HCL x 24 months
Hybrid closed loop device over a 24-month period for individuals currently using a hybrid closed loop device
Omnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
current HCL user: HCL x 12 months, then HCL x an additional 12 months
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
Omnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
current HCL user: HCL x 12 months, then HCL + HARPdoc x 12 months
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
Omnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
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.
current HCL user: HCL and My HypoCOMPaSS x 12 months, then HCL x 12 months
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
Omnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
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.
current HCL user: HCL + My HypoCOMPaSS x 12 months, then HCL + My HypoCOMPaSS + HARPDOC x 12 months
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
Omnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
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.
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.
current HCL user: HCL + My HypoCOMPaSS x 24 months
Hybrid closed loop device plus My HypoCOMPaSS education over a 24-month period for individuals currently using a hybrid closed loop device
Omnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Omnipod 5 or Medtronic 780G
Omnipod 5 and Medtronic 780G are hybrid closed loop devices that provide automated insulin delivery.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
* Skin conditions that would preclude the use of a CGM
* Super-physiologic exposure to steroids within one month of enrollment
* eGFR \< 45 mL/min/1.73 m2
* History of bariatric surgery that irreversibly alters gut innervation and structure
* Hyper- or hypokalemia (serum potassium \>5.5 or \<3.5 mmol/L)\*
* Hemoglobin \< 10 g/dL\*
* Medical condition that requires intermittent or continuous use of glucocorticoids at greater than physiological replacement doses
* Pregnancy, plan for pregnancy, or breast feeding
* Abnormal thyroid function tests of clinical significance, as determined by PI\*
* Liver transaminases \> 3 times the upper limit of normal\*
* Hospitalization for mental illness in last year
* History of adrenalectomy
* At discretion of the PI, laboratory tests may be repeated once. If the participant is not eligible after the second attempt, then the participant. The participant may be screened again.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Minnesota
OTHER
University of Kentucky
OTHER
University of Pennsylvania
OTHER
AdventHealth
OTHER
University of Leicester
OTHER
University of Sheffield
OTHER
University of Melbourne
OTHER
Jaeb Center for Health Research
OTHER
University of California, San Diego
OTHER
Milton S. Hershey Medical Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Vernon Michael Chinchilli
Distinguished Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Vernon M Chinchilli, PhD
Role: PRINCIPAL_INVESTIGATOR
Penn State College of Medicine
Elizabeth R Seaquist, MD
Role: STUDY_CHAIR
University of Minnesota
Simon Heller, MD
Role: STUDY_CHAIR
University of Sheffield
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of California, San Diego
La Jolla, California, United States
AdventHealth
Orlando, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
University of Minnesota
Minneapolis, Minnesota, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
University of Melbourne
Fitzroy, Victoria, Australia
University of Leicester
Leicester, , United Kingdom
University of Sheffield
Sheffield, , United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
STUDY00020946
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.