Clinical trial · Interventional
Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy
Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy (PANORAMA): Randomized Controlled Crossover Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Neoplasms | Pancreatic Neoplasm | ONTOLOGY_EXACT | 0.98 |
| Total Pancreatectomy | — | UNRESOLVED | — |
| Type 3c Diabetes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bihormonal artificial pancreas (BIHAP) / closed loop | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Open loop
- description
- The control arm (open loop) consists of standard treatment for diabetes with continuous subcutaneous insulin infusion or insulin injections for 3 months.
- interventionNames
- Device: Bihormonal artificial pancreas (BIHAP) / closed loop
- type
- EXPERIMENTAL
- label
- Closed loop
- description
- The intervention arm is 3 months closed loop control of blood glucose with the BIHAP. The BIHAP contains a self-learning algorithm which automatically maintains the glucose levels within target limits via subcutaneous administration of insulin (Humalog®) and glucagon. Patients complete a training period before the intervention period will start.
- interventionNames
- Device: Bihormonal artificial pancreas (BIHAP) / closed loop
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Informed consent * Age ≥18 years * Insulin dependent diabetes after total pancreatectomy (patients who previously participated in APPEL 5+ are allowed to be included) * At least three months after total pancreatectomy * Patients using flash or continuous glucose sensor (Free Style Libre, Guardian or Medtronic) ,willing to scan this sensor at least three times per day during the control period and to remove this sensor during BIHAP treatment * Undergoing treatment with CSII or subcutaneous insulin injections. Exclusion Criteria: * Known or suspected allergy to trial product(s) or related products; * Suboptimal clinical condition, for instance due to active postoperative surgical complications, including skin condition prohibiting needle insertion; * Actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or device in the last 2 weeks before enrolment into this study, as per investigator judgment; * Donation of blood or plasma in the past month, or in excess of 500 mL within 12 weeks prior to screening for other clinical trial related purposes; * Current treatment with chemotherapy or when used less than 3 months prior to screening; * BMI \> 35 kg/m2; * HbA1c \> 97 mmol/ml (=11.0 %); * Use of oral glucose-lowering medication; * Limited ability to see, and to hear or feel alarms signals of the BIHAP; * Use of acetaminophen (paracetamol) during the use of the BIHAP, as this may influence the sensor glucose measurements. * Current pregnancy, breast feeding or planning to become pregnant during the trial or using ineffective birth control methods; * Patients with a concomitant disease affecting metabolic control; * Presence of a medical or psychiatric condition, longstanding serious adherence problems, anticipated problems in handing over diabetes control to a device or use of a medication that, in the judgment of the investigator, clinical protocol chair, or medical monitor, could compromise the results of the study or the safety of the participant.
References
Publications (0)
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