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Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes

NCT05221359 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-07-27

No results posted yet for this study

Summary

First in Human, pilot investigation An Open Label, Monocentric, Pilot Study Evaluating Safety of ExOlin® in Patients with Poorly Controlled Type 1 Diabetes with High Glucose Fluctuations, Prone to Severe Hypoglycemia

Conditions

Interventions

DEVICE

ExOlin®

Implantation of ExOlin® device, safety follow-up followed by a treatment period in which device is used to administer insulin. Device explanted with a safety follow-up.

DRUG

Insulin aspart

Use of NovoRapid insulin during all periods of the clinical investigations

Sponsors & Collaborators

  • Defymed

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-05
Primary Completion
2026-12-31
Completion
2027-04-30

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT05221359 on ClinicalTrials.gov