RecruitingNot Applicable

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

France8 participantsStarted 2022-05-05

Plain-language 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

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Adult men or women (age ≥ 18 years);
✓. Diagnosis of Type 1 Diabetes (T1D) for more than 2 years at the start of screening;
✓. Body mass index (BMI) \> 16 kg/m2 and \< 35 kg/m2;
✓. Well managed intensive SubCutaneous (SC) insulin therapy, i.e. patient using for at least 3 months:
✓. 7.0% \< Serum HbA1c \< 12.0%;
✓. Patient characterized by one of the following conditions:

Exclusion criteria

✕. Renal glomerular filtration rate \<30 mL/min/1.73m2 as per Chronic Kidney Disease - Epidemiology Collaboration (CDK-EPI) calculation;
✕. Immunocompromised patient;
✕. Local or systemic acute or chronic inflammation (rheumatoid arthritis, sclerodermia);
✕. Active infection or inflammation;
✕. Known history of skin affliction that could impact ExOlin® tolerance;
✕. Ongoing active anticoagulant therapy;
✕. Severe wound healing issues;
✕. Parietal reinforcement prostheses;

What they're measuring

Safety: Percentage of patients who will experience at least one relevant adverse event (AE) judged by the investigator as probably or highly probably related to ExOlin® for the duration of mandatory phases of the study

Timeframe: From implantation of the device (4 weeks after screening visit) till end of post-explantation safety follow-up (week 36), meaning a duration of 32 weeks.

Safety: Percentage of patients who will experience at least one relevant adverse event (AE) judged by the investigator as probably or highly probably related to ExOlin® for the whole duration of the study (extension phase included)

Timeframe: From implantation of the device (4 weeks after screening visit) till end of post-explantation safety follow-up, meaning a duration up to of 168 weeks maximum for patients completing extension phase.

Trial details

NCT IDNCT05221359

SponsorDefymed

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-12

View on ClinicalTrials.gov More Type 1 Diabetes trials