Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05221359

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

Led by Defymed · Updated on 2022-07-27

8

Participants Needed

1

Research Sites

256 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult men or women aged 18 years or older
  • Diagnosis of Type 1 Diabetes for more than 2 years before screening
  • Body mass index (BMI) greater than 16 kg/m2 and less than 35 kg/m2
  • Using intensive subcutaneous insulin therapy with an insulin pump for at least 3 months
  • Using Dexcom G6 continuous glucose monitoring for at least 3 months
  • Serum HbA1c level between 7.0% and 12.0%
  • History of at least one severe hypoglycemia episode in the past 12 months or frequent high blood sugar fluctuations
  • Presence of side effects from subcutaneous insulin therapy such as insulin resistance or lipodystrophy
Not Eligible

You will not qualify if you...

  • Renal glomerular filtration rate less than 30 mL/min/1.73m2
  • Immunocompromised status
  • Acute or chronic inflammation including rheumatoid arthritis or sclerodermia
  • Active infection or inflammation
  • Known skin conditions affecting device tolerance
  • Current anticoagulant therapy
  • Severe wound healing problems
  • Parietal reinforcement prostheses
  • Allergy to device components, insulin NovoRapid, anesthetics, iodine products, or surgery antibiotics
  • Contraindications to insulin pump or continuous glucose monitoring use
  • Participation in high-risk activities like combat sports or scuba diving
  • Cardiac conditions incompatible with surgery
  • Unstable diabetic retinopathy
  • History of unresolved cancer within 5 years except certain skin and thyroid cancers
  • Medical or surgical conditions preventing study participation
  • Mental or psychiatric conditions affecting compliance
  • Active alcohol or drug abuse
  • Recent corticosteroid use within 4 weeks
  • Recent participation in other clinical trials within 12 weeks
  • Women who are pregnant, breastfeeding, planning pregnancy, or unwilling to use contraception
  • Persons under legal guardianship or deprived of liberty
  • Not affiliated with French social security
  • Unable or unwilling to give informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Hôpitaux Universitaires de Strasbourg

Strasbourg, France, 67000

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here