Accu Chek DiaPort PMCF study

• Research type

  Research Study

• Full title

  Accu-Chek® DiaPort observational study: Continuous Intraperitoneal Insulin Infusion study with long term surveillance of subjects after implantation of the Accu-Chek® DiaPort system, a percutaneous port system. Post Market Clinical Follow-Up Plan

• IRAS ID

  219026

• Contact name

  Nicholas Oliver

• Contact email

  Nick.oliver@imperial.ac.uk

• Sponsor organisation

  Roche Diabetes Care GmbH

• Duration of Study in the UK

  2 years, 0 months, 31 days

• Research summary

  Study Title:
  Accu-Chek® DiaPort observational study: Continuous Intraperitoneal Insulin Infusion study with long term surveillance of subjects after implantation of the Accu-Chek® DiaPort system, a percutaneous port system

  Medical Device:
  Accu-Chek® DiaPort, Class IIb
  The Accu-Chek® DiaPort system is a percutaneous port system for continuous intraperitoneal insulin infusion in patients with diabetes.

  Study Objectives:
  The study objectives are to assess the following aspects under real life settings:
  o Safety of the Accu-Chek® DiaPort system
  o Usability around the Accu-Chek® DiaPort system
  o Evolution of diabetes therapy
  o Quality of Life

  Study Sites:
  Multicenter, Accu-Chek® DiaPort center of excellence clinics

  Study Design:
  Post-marketing, Long term non-interventional, observational, multicenter, multinational, prospective, uncontrolled cohort clinical follow-up study of diabetic subjects implanted with an Accu-Chek® DiaPort system.

  Diagnosis and Indication:
  Type 1 or Type 2 diabetes requiring insulin when therapeutic goals are not reached with other modes of insulin therapy, or when subcutaneous insulin is not effective or not tolerated.

  Number of Patients:
  Because of the very limited number of patients fulfilling the inclusion criteria, the concrete number of patients is not determined.

  Duration of the Study:
  The study will be continued until the cumulative experience with the Accu-Chek® DiaPort system of all subjects enrolled will have reached at least 50 patient years.

  Selection Criteria:
  To be eligible for this PMCF study, subjects must meet
  ALL of the following criteria:
  o Written informed consent
  o Male and female subjects aged at least 6 years
  o Insulin-dependent type 1 or type 2 diabetes
  o Status of implantation with Accu-Chek® DiaPort system:
  - Patients planned for implantation shortly or
  - Patients with recent implantation or
  - Accu-Chek® DiaPort system Clinical Study subjects already implanted since Oct
  2011 or
  - Compassionate Use Patients already implanted since Oct 2011
  o Legal competence of subjects, parents, and legally authorized representatives
  o No concurrent participation in a clinical trial at time of Accu-Chek® DiaPort
  system implantation
  o Not being pregnant at the time of implantation

• REC name

  London - Dulwich Research Ethics Committee

• REC reference

  17/LO/0170

• Date of REC Opinion

  22 Feb 2017

• REC opinion

  Further Information Favourable Opinion