RecruitingNot ApplicableNCT05221359

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


Sponsor

Defymed

Enrollment

8 participants

Start Date

May 5, 2022

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing the safety of a new wearable insulin delivery device called ExOlin in adults with Type 1 diabetes whose blood sugar is difficult to control with standard insulin pumps. **You may be eligible if...** - You are 18 or older and have had Type 1 diabetes for more than 2 years - Your HbA1c (a measure of blood sugar control over 3 months) is between 7% and 12% - You currently use an insulin pump and a continuous glucose monitor (specifically the Dexcom G6) - You have poorly controlled blood sugar, severe low blood sugar episodes, or problems with insulin under the skin (such as scar tissue or insulin resistance) **You may NOT be eligible if...** - You have severe kidney disease - You have an active infection or inflammatory condition (such as rheumatoid arthritis) - You are on blood thinners - You have serious wound healing problems - You are immunocompromised Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEExOlin®

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.

DRUGInsulin aspart

Use of NovoRapid insulin during all periods of the clinical investigations


Locations(1)

Hôpitaux Universitaires de Strasbourg

Strasbourg, France

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NCT05221359


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