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Glucose Control Through a Bihormonal Artificial Pancreas in Patients After Total Pancreatectomy

NCT06346366 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2024-04-04

No results posted yet for this study

Summary

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

  • Pancreatic Neoplasms
  • Type 3c Diabetes
  • Total Pancreatectomy

Interventions

DEVICE

Bihormonal artificial pancreas (BIHAP) / closed loop

The investigational device is a dual-hormonal fully closed loop system (BIHAP; industrial name AP® 5, Inreda Diabetic B.V.) which aims at optimally controlling plasma glucose levels. This BIHAP contains of two pumps for subcutaneous infusion of either insulin (Humalog, 3 ml pre-fill cartridge, Eli Lilly) or glucagon (GlucaGen, Novo Nordisk; 3.15 ml cartridge Accu-Chek Spirit, Roche) via an infusion set (Accu-Chek Insight Flex or AccuChek Flex Link, Roche), two subcutaneously placed glucose-sensors (Guardian, Medtronic) and an algorithm driving pump infusion rates based on the sensor input. Daily self-measurements of blood glucose (SMBGs; Accu-Chek Instant, Roche) are needed for calibration of the glucose sensors. The BIHAP-system has to be worn continuously, except while showering.

Sponsors & Collaborators

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-04-25
Primary Completion
2024-04-01
Completion
2024-04-01

Countries

  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06346366 on ClinicalTrials.gov