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