NCT05221359

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 8 (estimated)
• Sponsor: Defymed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

• Type 1 Diabetes
• Type 1 Diabetes Mellitus With Hypoglycemia

Interventions

Type	Name	Description
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

Timeline

• Start date: 2022-05-05
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2022-02-03
• Last updated: 2022-07-27

Locations

1 site across 1 country: France