protocolSection identificationModule nctId: NCT06325202, orgStudyIdInfo id: STUDY00020946, secondaryIdInfos id: 1U01DK135126, type: NIH, link: https://reporter.nih.gov/quickSearch/1U01DK135126, briefTitle: Closed Loop and Education for Hypoglycemia Awareness Restoration, acronym: CLEAR, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-07-01, primaryCompletionDateStruct date: 2027-06-30, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-22, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Milton S. Hershey Medical Center, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), collaborators name: University of Minnesota, collaborators name: University of Kentucky, collaborators name: University of Pennsylvania, collaborators name: University of California, San Diego, collaborators name: AdventHealth, collaborators name: University of Leicester, collaborators name: University of Sheffield, collaborators name: University of Melbourne, collaborators name: Jaeb Center for Health Research, descriptionModule briefSummary: 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., conditionsModule conditions: Diabetes Mellitus, Type 1, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Sequential Multiple Assignment Randomized Trial (SMART) design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 324, type: ESTIMATED, armsInterventionsModule interventions name: Omnipod 5 or Medtronic 780G, interventions name: My HypoCOMPaSS Education, interventions name: HARPdoc Education, outcomesModule primaryOutcomes measure: epinephrine (pg/ml), primaryOutcomes measure: Towler questionnaire, secondaryOutcomes measure: geometric mean of plasma glucagon, secondaryOutcomes measure: geometric mean of plasma pancreatic polypeptide, secondaryOutcomes measure: geometric mean of plasma free fatty acids, secondaryOutcomes measure: glucose infusion rate, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: % of time with sensor hypoglycemia <70 mg/dL, secondaryOutcomes measure: % of time with sensor hypoglycemia <54 mg/dL, secondaryOutcomes measure: number of hypoglycemia events, secondaryOutcomes measure: % time with sensor glucose in range, secondaryOutcomes measure: sensor glucose coefficient of variation, secondaryOutcomes measure: sensor use as the average numbers of days per week, secondaryOutcomes measure: glycemia risk index, secondaryOutcomes measure: Trail Making Test - Part B, secondaryOutcomes measure: Four Choice Reaction Time, secondaryOutcomes measure: sleep duration, secondaryOutcomes measure: sleep quality, secondaryOutcomes measure: 24-hour step count, secondaryOutcomes measure: exercise bouts, secondaryOutcomes measure: resting heart rate, secondaryOutcomes measure: heart rate during exercise, secondaryOutcomes measure: heart rate variability, secondaryOutcomes measure: Hypo-METRICS questionnaire, secondaryOutcomes measure: Hypoglycemic Confidence Scale, secondaryOutcomes measure: Hypoglycemia Fear Survey-II, secondaryOutcomes measure: Attitudes to Awareness of Hypoglycaemia, secondaryOutcomes measure: Type 1 Diabetes Distress Scale, secondaryOutcomes measure: Diabetes Self-Management Questionnaire, secondaryOutcomes measure: Diabetes Management Experiences Questionnaire, secondaryOutcomes measure: PROMIS Sleep Disturbance - Short Form 8a, secondaryOutcomes measure: Hospital Anxiety and Depression Scale, secondaryOutcomes measure: 12-Item Hypoglycemia Impact Profile, secondaryOutcomes measure: EQ-5D-5L, secondaryOutcomes measure: device-related adverse events, secondaryOutcomes measure: severe hypoglycemic events, self-reported on a CLEAR data collection form, secondaryOutcomes measure: diabetic ketoacidosis (DKA) events, secondaryOutcomes measure: number of participants with hospitalizations, secondaryOutcomes measure: number of participants with emergency room (ER) visits, secondaryOutcomes measure: major adverse cardiovascular events (MACE), secondaryOutcomes measure: all-cause mortality, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of California, San Diego, city: La Jolla, state: California, zip: 92037, country: United States, contacts name: Jeremy H Pettus, MD, role: CONTACT, phone: 858-246-2160, email: jpettus@ucsd.edu, contacts name: Jeremy H Pettus, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.84727, lon: -117.2742, locations facility: AdventHealth, city: Orlando, state: Florida, zip: 32804, country: United States, contacts name: Keri Whitaker, role: CONTACT, phone: 407-303-2519, email: keri.whitaker@adventhealth.com, contacts name: Richard E Pratley, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Anna Casu, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.53834, lon: -81.37924, locations facility: University of Kentucky, city: Lexington, state: Kentucky, zip: 40508, country: United States, contacts name: Simon Fisher, MD, PhD, role: CONTACT, phone: 859-562-0473, email: simon.fisher@uky.edu, contacts name: Simon Fisher, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.98869, lon: -84.47772, locations facility: University of Minnesota, city: Minneapolis, state: Minnesota, zip: 55455, country: United States, geoPoint lat: 44.97997, lon: -93.26384, locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, contacts name: Cornelia (Ginger) Dalton-Bakes, role: CONTACT, phone: 215-746-2085, email: corneliv@pennmedicine.upenn.edu, contacts name: Michael R Rickels, MD, MS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: University of Melbourne, city: Fitzroy, state: Victoria, zip: 3065, country: Australia, contacts name: Katrin Brown, role: CONTACT, phone: 61 3 9231 2574, email: katie.brown@unimelb.edu.au, contacts name: Catriona Sims, role: CONTACT, phone: 61 3 9231 2574, email: catriona.sims@unimelb.edu.au, contacts name: David O'Neal, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -37.79839, lon: 144.97833, locations facility: University of Leicester, city: Leicester, zip: LE5 4PW, country: United Kingdom, contacts name: Andrew Kingsnorth, role: CONTACT, phone: 44 116-258-4874, email: a.kingsnorth@leicester.ac.uk, contacts name: Pratik Choudhary, MBBS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 52.6386, lon: -1.13169, locations facility: University of Sheffield, city: Sheffield, zip: S10 2RX, country: United Kingdom, contacts name: Simon Heller, MD, role: CONTACT, phone: 44 114-215-9009, email: s.heller@sheffield.ac.uk, contacts name: Simon Heller, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.38297, lon: -1.4659, hasResults: False