Post Authorisation Safety Study (PASS): an European observational cohort of patients with type 1 diabetes treated via intraperitoneal route with Insuman Implantable 400 IU/mL in Medtronic MiniMed implantable pump (IIMOS)

Study identification

• EU PAS number:
  EUPAS10872
• Study ID:
  49593
• Official title and acronym:
  Post Authorisation Safety Study (PASS): an European observational cohort of patients with type 1 diabetes treated via intraperitoneal route with Insuman Implantable 400 IU/mL in Medtronic MiniMed implantable pump (IIMOS)
• DARWIN EU® study:
  No
• Study countries:
  Belgium

  France
• Study description:
  This is a multinational, multicenter, observational, prospective cohort study for patients with type I diabetes who are treated with Insuman Implantable 400 IU/mL. The duration of the study is ten years from entry of first patient. The objective of the study is to increase knowledge on the safety profile of Insuman Implantable 400IU/ml delivered by an implantable pump into the intraperitoneal cavity and to monitor the safe use in real life setting. No visits or examinations, laboratory tests or procedures are mandated as part of this study. Visits will occur according to routine clinical practice for use of an implantable pump which is at refill visits (approximately every 40 to 45 days) and at ad hoc visits related to complications of the insulin treatment regimen or pump. Data will be collected by site and entered in an electronic case report form (e-CRF) (on an ongoing basis for adverse events, at three, and six months after study entry and then every six months for other study related information). Discontinuation of the Medtronic MIP led to reduced availability of pumps and implementation of a pump phase out process, which compromised the feasibility of completing the originally planned study. The total projected sample was reduced to 260 patients. It was therefore agreed with the PRAC to terminate the study early, with a maximum observed follow-up of 5.9 years instead of the originally planned 10-years.
• Study status:
  Finalised

Research institutions and networks

Institutions

IQVIA

United Kingdom

Study timelines

Date when funding contract was signed

Planned:24/07/2014

Actual:24/07/2014

Study start date

Planned:27/04/2016

Actual:27/04/2016

Data analysis start date

Planned:19/09/2016

Actual:19/09/2016

Date of interim report, if expected

Planned:15/02/2021

Actual:15/02/2021

Date of final study report

Planned:30/10/2026

Actual:21/09/2022

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Sanofi-Aventis

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)