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Medical Device Post-Marketing Clinical Follow-Up

Case study
Medical Device Post-Marketing Clinical Follow-Up: An Automated Insulin Delivery System

A global medical device manufacturer operating in the home healthcare and diabetes management space conducted a prospective, multicentre post-marketing clinical follow-up (PMCF) study to evaluate the real-world performance of a CE-marked automated insulin delivery system used in routine clinical practice.
The investigated device was a commercially available AID system, integrating:

 

  • Continuous glucose monitoring (CGM)
  • An insulin pump embedding an automated control algorithm
  • A closed-loop solution designed to support glycaemic management in people with diabetes

The Challenge

Following CE marking, the manufacturer was required to generate robust post-market clinical evidence to confirm device performance and safety in real-world use, in line with European regulatory expectations. It was also crucial to ensure the regulatory-compliant clinical operations outside a traditional interventional trial framework. The study was conducted as a post-CE-mark clinical investigation (Category 4.2).

Prospective PMCF study design in routine clinical settings

Multicentre execution with consistent data capture

Extended recruitment and follow-up timelines

Prospective PMCF study design in routine clinical settings

Multicentre execution with consistent data capture

Extended recruitment and follow-up timelines

The APICES Approach

APICES France (formerly Kappa Santé) supported the sponsor in the design, operational execution, and clinical oversight of the PMCF study, ensuring methodological rigor and regulatory alignment.

Key elements of the approach included:

  • Design and execution of a prospective, multicentre PMCF study in France
  • Operational support of PMCF (Cat. 4.2) under applicable regulatory frameworks
  • Coordination of participating clinical sites and study activities
  • Management of patient recruitment (60 patients) and longitudinal follow-up
  • Oversight of study execution across two phases, incl. a 12-month follow-up period

This approach enabled reliable real-world evidence generation while minimizing disruption to routine clinical practice.

Patients’ prospective real-world clinical data collected

Months of longitudinal follow-up, aligned with PMCF objectives

Multicentre study execution completed in France

Patients’ prospective real-world clinical data collected

Months of longitudinal follow-up, aligned with PMCF objectives

Multicentre study execution completed in France

This case study highlights APICES France (formely Kappa Santé) capability to deliver regulatory-compliant PMCF studies for connected medical devices, supporting post-market surveillance, scientific communication, evidence generation.