protocolSection identificationModule nctId: NCT06346366, orgStudyIdInfo id: NL.82557.018.22, briefTitle: Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy, acronym: PANORAMA, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-25, primaryCompletionDateStruct date: 2024-04-01, completionDateStruct date: 2024-04-01, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA), class: OTHER, descriptionModule briefSummary: In recent years total pancreatectomy is increasingly performed in selected patients due to the increasing use of preoperative chemotherapy, making more patients operable. After total pancreatectomy, all patients develop insulin dependent diabetes mellitus (IDDM). Glucose control in these patients is challenging due to the complete absence of both pancreatic insulin and glucagon secretion, and most patients report decreased quality of life due to fear of hypoglycemic events and the need for continuous glucose monitoring.The CE marked bihormonal artificial pancreas (BIHAP) provides continuous fully automatic glucose monitoring and administration of insulin and glucagon using a self-learning algorithm. In a recent pilot study (APPEL5+, NL.8871) the BIHAP was being compared to current diabetes treatment in 10 patients after total pancreatectomy. This trial demonstrated that treatment with BIHAP was safe and improved time spent in euglycemia significantly during one week treatment (78.30%, \[IQR 71.05%-82.61%\] vs. 57.38% \[IQR 52.38%-81.35%\], p=0.03).Now, larger randomized studies with a longer treatment period are necessary to confirm safety and efficacy of BIHAP for the treatment of diabetes in patients after total pancreatectomy, with sufficient attention for long-term glycemic control (HbA1c) and patient-reported outcomes.The PANORAMA trial will evaluate the efficacy of a 3-month treatment with BIHAP in 40 patients after total pancreatectomy as compared to a 3-month treatment period with current diabetes care in a randomized cross-over trial. Patients will be randomized to start with the BIHAP (after a training period) or current diabetes care (i.e. insulin pen or pump). Hereafter, all patients will cross over., conditionsModule conditions: Pancreatic Neoplasms, conditions: Type 3c Diabetes, conditions: Total Pancreatectomy, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: Patients are randomized to a 3-month treatment period with the bihormonal artificial pancreas (BIHAP) (preceded by a training period) or a 3-month treatment with their current diabetes care. Hereafter, all patients will cross over., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Bihormonal artificial pancreas (BIHAP) / closed loop, outcomesModule primaryOutcomes measure: Time in range, secondaryOutcomes measure: Efficacy of open and closed loop system, secondaryOutcomes measure: Efficacy of open and closed loop system, secondaryOutcomes measure: Efficacy of open and closed loop system, secondaryOutcomes measure: Efficacy of open and closed loop system, secondaryOutcomes measure: Efficacy of open and closed loop system, secondaryOutcomes measure: Adverse events and device issues associated with closed loop system with BIHAP, secondaryOutcomes measure: Patient reported outcomes on quality of life - WHO-5, secondaryOutcomes measure: Patient reported outcomes on quality of life - EQ-5D-5L, secondaryOutcomes measure: Patient reported outcomes on quality of life - DTSQc andDTSQs, secondaryOutcomes measure: Patient reported outcomes on quality of life - PAID-20, secondaryOutcomes measure: Patient reported outcomes on quality of life - HFS-II, secondaryOutcomes measure: Patient reported outcomes on quality of life - PSQI, secondaryOutcomes measure: Patient reported outcomes on quality of life - INSPIRE, secondaryOutcomes measure: Patient reported outcomes on quality of life - Hypoglycaemia unawareness, secondaryOutcomes measure: Patient reported outcomes on quality of life - benefits and disadvantages of BIHAP treatment, otherOutcomes measure: Other treatment endpoints - daily insulin and glucagon use, otherOutcomes measure: Other treatment endpoints - activity of BIHAP algorithm, otherOutcomes measure: Other treatment endpoints - daily insulin use, otherOutcomes measure: Other treatment endpoints - treatment related actions, otherOutcomes measure: Other treatment endpoints - demographics, otherOutcomes measure: Other treatment endpoints - demographics, otherOutcomes measure: Other treatment endpoints - concomitant medication, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Amsterdam UMC, city: Amsterdam, zip: 1081 HV, country: Netherlands, geoPoint lat: 52.37403, lon: 4.88969, hasResults: False