Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDefymed
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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;
CSII, whatever the insulin pump used, and
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
ExOlin®
DeviceImplantation 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.
Insulin aspart
DrugUse of NovoRapid insulin during all periods of the clinical investigations
Treatment groups
8 Participants
are divided into 1 treatment groupGroup A: test armExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
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
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 the study : * Linked to implantation (any unexpected or severe signs of cutaneous or extraperitoneal intolerance s.a. redness, edema or delayed healing, as per clinical exam of the skin and palpation in regard of the scar and SC port, associated to systemic signs s.a. fever, chills, abnormal biologic values \[including: complete blood count, C-reactive protein\]); * linked to therapeutic use of ExOlin (i.e. to administrate insulin: ExOlin® device failure or local infection); * other unexpected related AEs. The primary endpoint will be achieved when the device has been retrieved from all enrolled patients and post-explantation observation time (3 months post explantation) has been completed.
Time frame
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.2
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)
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 the study : * Linked to implantation (any unexpected or severe signs of cutaneous or extraperitoneal intolerance s.a. redness, edema or delayed healing, as per clinical exam of the skin and palpation in regard of the scar and SC port, associated to systemic signs s.a. fever, chills, abnormal biologic values \[including: complete blood count, C-reactive protein\]); * linked to therapeutic use of ExOlin (i.e. to administrate insulin: ExOlin® device failure or local infection); * other unexpected related AEs. The primary endpoint will be achieved when the device has been retrieved from all enrolled patients and post-explantation observation time (3 months post explantation) has been completed.
Time frame
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.Secondary outcomes
1
Safety : Percentage of patients who will experience at least one AE, according to its severity, seriousness, relation with the device or the surgery or the treatment, outcome, by system-organ-class and preferred term.
Percentage of patients who will experience at least one AE, according to its severity, seriousness, relation with the device or the surgery or the treatment, outcome, by system-organ-class and preferred term.
Time frame
From implantation of the device through study completion, meaning from 1 month after screening, duration of 8 months for mandatory phases and up to 3 years and 3 months for patients reaching end of extension phase2
Safety: Percentage of participants with abnormal vital signs or physical findings.
Percentage of participants with abnormal vital signs (blood pressures, heart rate, body temperature) or physical findings (i.e. significant abnormal lab results s.a. WBC or observation of abnormal scar)
Time frame
From implantation of the device through study completion, meaning from 1 month after screening, duration of 8 months for mandatory phases and up to 3 years and 3 months for patients reaching end of extension phase3
Early Performance: Glycemic control
Glycemic control as measured by use of a Continuous Glucose Monitor (Dexcom G6): comparison of data collected when ExOlin® is used versus data collected during Continuous Subcutaneous Insulin Infusion (CSII)
Time frame
2nd month of treatment (meaning week 20) vs end of screening (week 4)4
Early Performance: Glycemic control
Glycemic control as measured by use of a Continuous Glucose Monitor (Dexcom G6): comparison of data collected when ExOlin® is used versus data collected during Continuous Subcutaneous Insulin Infusion (CSII)
Time frame
3rd month of treatment (meaning week 24) vs end of screening (week 4) Source ClinicalTrials.gov