An interventional study of ExOlin® and Insulin aspart in Type 1 Diabetes and Type 1 Diabetes Mellitus With Hypoglycemia, sponsored by Defymed. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-07-27.
Sponsored by Defymed · Not applicable, Interventional, and Treatment
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
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 8 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →This is the only study on the registry with Defymed as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Well managed intensive SubCutaneous (SC) insulin therapy, i.e. patient using for at least 3 months:
Patient characterized by one of the following conditions:
Unstable diabetes/poor glycemic control, meaning patient presenting:
Presence of adverse side effects of SC insulin-therapy:
Exclusion Criteria:
All patients will be enrolled in same arm which contains the two interventions (device + drug) and follow mandatory phases of trial: screening, implantation, treatment with ExOlin, explantation.
Device: ExOlin® · Drug: Insulin aspart
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.
Use of NovoRapid insulin during all periods of the clinical investigations
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.
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.
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 phase
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 phase
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)
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)
Early Performance: Glycemic control
Glycemic control during the global Follow-Up (FU) of the patient across all study (monthly values, by use of Continuous Glucose Monitor Dexcom G6) by comparison of data collected when ExOlin® is used versus data collected during CSII
Time frame: Every 4 weeks starting from 2nd month of treatment (meaning week 20) and till end of use of ExOlin (up to week 160) vs end of screening (week 4)
Early Performance
Glycemic control as per HbA1c
Time frame: Baseline, then every 12 weeks up to end of use of ExOlin (up to week 160)
Quality of Life: Overall score and subscores of the Diabetes Quality of Life (DQOL) questionnaire
Overall score and subscores of the Diabetes Quality of Life (DQOL) questionnaire: scale from 0 to 100. The higher patient rates, the better the outcome is.
Time frame: at the end of the Treatment phase (3rd month of treatment) versus data at the end of the Screening phase (1 month duration)
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