protocolSection identificationModule nctId: NCT06330194, orgStudyIdInfo id: AID-study, briefTitle: Next Generation Advanced Insulin Delivery System in Adults With Diabetes and Advanced Renal Disease, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-18, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Steno Diabetes Center Copenhagen, class: OTHER, collaborators name: Rigshospitalet, Denmark, descriptionModule briefSummary: The goal of this this randomized, clinical trial is to test an automated insulin delivery system (AID) in people with type 1 or type 2 diabetes who are on hemodialysis, peritoneal dialysis, or have advanced chronic kidney disease (CKD).The main objective is:• To test if the AID is superior in regulating blood sugar levels compared with usual care in patients with advanced renal diseaseSecondary objectives are:• To evaluate the impact on life quality, incidence of low blood sugar, and if the treatment is feasible in this populationParticipants will be randomized to receive either eight weeks with the AID System (780G from Medtronic) or eight weeks of Control (usual care) with cross over at the end of the first eight weeks.Researchers will compare blood sugar levels between the AID group and the Control group to determine if the AID system is superior in regulating blood sugar levels., conditionsModule conditions: Dialysis, conditions: Chronic Kidney Disease, conditions: Diabetes Mellitus, Type 2, conditions: Diabetes Mellitus, Type 1, conditions: Hemodialysis, conditions: Peritoneal Dialysis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Design: Prospective, open-label, two-stage randomised-crossover study.Population: Patients with type 1 or type 2 diabetes undergoing hemodialysis (n=5), peritoneal dialysis (n=5) or chronic kidney disease stage 3b to stage 5 (n=5).Methods: Participants entering the study will have a four-to-six-week run-in phase with diabetes education. During the run-in phase three weeks of unblinded continous glucose monitoring (CGM) will be performed to assess baseline glucose levels.All participants will be randomized to receive either eight weeks with an advanced insulin delivery (AID) System or eight weeks of control (usual care) with cross over at the end of the first eight weeks.CGM study outcome data will be collected by identical methods, using unblinded-CGM devices, for participants in both intervention and control study arms., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 15, type: ESTIMATED, armsInterventionsModule interventions name: 2nd Generation Automated Insulin Delivery (AID) system, outcomesModule primaryOutcomes measure: Percent time in sensor glucose target range (3.9-10.0 mmol/L), secondaryOutcomes measure: Proportion of time spent <2.8 mmol/L, secondaryOutcomes measure: Proportion of time spent <3.0 mmol/L, secondaryOutcomes measure: Proportion of time spent <3.3 mmol/L, secondaryOutcomes measure: Proportion of time spent <3.9 mmol/L, secondaryOutcomes measure: Proportion of time spent 3.9-7.8, secondaryOutcomes measure: Proportion of time spent >10.0 mmol/L, secondaryOutcomes measure: Proportion of time spent >13.9 mmol/L, secondaryOutcomes measure: Proportion of time spent >16.7 mmol/L, secondaryOutcomes measure: Glucose variability (SD and coefficient of variation), secondaryOutcomes measure: Mean glucose, secondaryOutcomes measure: HbA1c, secondaryOutcomes measure: Episodes of CGM time in < 3.0 mmol/L range lasting >15 minutes, secondaryOutcomes measure: Diabetic ketoacidosis og Hyperosmolar non-ketotic hyperglycemia, secondaryOutcomes measure: eGFR (estimated glomerular filtration rate), secondaryOutcomes measure: Potassium pre-dialysis, secondaryOutcomes measure: Urine albumine-to-creatinine ratio, secondaryOutcomes measure: Actigraph Metrics for sleep architecture, secondaryOutcomes measure: Sleep diary, secondaryOutcomes measure: Proportion of time Automode is active, secondaryOutcomes measure: Diabetic ketoacidosis, secondaryOutcomes measure: Severe hypoglycemia, secondaryOutcomes measure: Serious Adverse Event, secondaryOutcomes measure: Unanticipated Serious Adverse Device Event, secondaryOutcomes measure: Satisfaction with diabetes treatment, secondaryOutcomes measure: Satisfaction with diabetes treatment, secondaryOutcomes measure: Fear of hypoglycaemia, secondaryOutcomes measure: Hypoglycaemia awareness, secondaryOutcomes measure: Diabetes distress, secondaryOutcomes measure: Sleep Quality, secondaryOutcomes measure: Cognitive function, secondaryOutcomes measure: Sarcopenia, secondaryOutcomes measure: Semi-structured interview, secondaryOutcomes measure: Health-related quality of life, secondaryOutcomes measure: Frailty, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tobias Bomholt, status: RECRUITING, city: Copenhagen, zip: 2100, country: Denmark, contacts name: Tobias Bomholt, MD, PhD, role: CONTACT, phone: +4535457952, email: Tobias.bomholt@regionh.dk, contacts name: Christine Meyer Olesen, MD, role: CONTACT, phone: 21495144, email: clmolesen@gmail.com, geoPoint lat: 55.67594, lon: 12.56553, hasResults: False