Skip to content
type1.science
Phase 1RecruitingNCT05221359

Pilot'Ex: first-in-human pilot study of Defymed's ExOlin extraperitoneal insulin diffusion device

What this study tests

Open-label monocentric pilot trial at University Hospital Strasbourg evaluating the safety, local tissue tolerance, and portal insulin absorption pharmacokinetics of Defymed's ExOlin implantable semi-permeable membrane pouch in 8 adults with poorly controlled Type 1 Diabetes. Validates the extraperitoneal membrane hardware shared with Defymed's MailPan bioartificial pancreas.

Editorial review: .

Registry checked: 2026-10-26. Registry’s own update: 2022-07-27.

Most recent recorded citation date: 2022-07-27. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.

Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence

Full sources ↓Full discussion ↓Report an issue →

Evidence at a glance

Who can enter the study?
Adults aged 18–70 with poorly controlled Type 1 Diabetes despite subcutaneous insulin pump therapy. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
Reported benefit and results
No human outcomes have been posted to the registry or published in peer-reviewed literature yet.Read the result sources and their limitations →
Important harms
Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
Research access and approval
Study regions: European Union. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
What remains uncertain?
Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.

Research status alone does not establish approval, clinical benefit or local availability.

Primary endpoints

  • Incidence of device- and procedure-related serious adverse events and extraperitoneal insulin pharmacokinetic profile

The full picture

Study design

First-in-human open-label monocentric pilot trial (Pilot'Ex) at University Hospital Strasbourg evaluating the safety, local extraperitoneal tissue tolerance, and portal insulin absorption pharmacokinetics of Defymed's ExOlin implantable semi-permeable membrane pouch in 8 adults with poorly controlled Type 1 Diabetes. Serves as clinical hardware and membrane biocompatibility validation for Defymed's MailPan bioartificial pancreas platform.

Sources

  1. [1]