Type 1 DiabetesPilot'ExNCT05221359
Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes
A study testing ExOlin® and Insulin aspart in people with Type 1 Diabetes and Type 1 Diabetes Mellitus With Hypoglycemia, run by Defymed at 1 site in France.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Type 1 Diabetes Mellitus With Hypoglycemia
- What is being tested?
- ExOlin® and Insulin aspart
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteFrance
- Study dates
- 5 May 2022to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- CSII, whatever the insulin pump used, and
- Continuous Glucose Monitoring (CGM), by using Dexcom G6;
Show all 15Show fewer
- 7.0% < Serum HbA1c < 12.0%;
- Patient characterized by one of the following conditions:
- Unstable diabetes/poor glycemic control, meaning patient presenting:
- at least one episode of severe hypoglycemia during the 12 months prior to study screening. Severe hypoglycemia is defined by American Diabetes Association (ADA) standards as "severe cognitive impairment requiring assistance from another person for recovery" (as per ADA's definition in "standards of care in diabetes");
- or glycemic excursions (post-prandial hyperglycemic or nocturnal hypoglycemic episodes) considered as too frequent and of high amplitude by the investigator, during the previous month;
- Presence of adverse side effects of SC insulin-therapy:
- SC insulin resistance;
- or severe acquired lipodystrophy resistant to pump treatment;
- or genetic skin atrophy or lipodystrophy.
Who cannot join
- 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;
Show all 25Show fewer
- Severe wound healing issues;
- Parietal reinforcement prostheses;
- Known allergy to one of the devices' components, including known allergy to fixation systems (e.g. patch, plaster) for SC administration devices such as external pumps and CGM, or chronic allergy related to prolonged wearing of such systems;
- Known allergy to insulin NovoRapid®;
- Known allergy to anesthetics, or products containing iodine and its derivates, or antibiotics used during surgery (cefazolin, and combination of clindamycin and gentamycin);
- Activity contraindicated as per external pump and CGM use recommendations;
- Patient willing to practice activities with risks of trauma or major change in the environment pressure such as combat sport or scuba diving;
- Cardiac condition incompatible with surgery requirements as per anesthesiologist's opinion;
- Unstable diabetic retinopathy (as per ophthalmologist's review within 6 months before screening);
- Current or history of unresolved malignancy within 5 years before screening (with exceptions for squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast carcinoma without lymph node metastases, well-differentiated thyroid carcinoma or other non-invasive lesion that, in the opinion of the investigator, is considered as cured with minimal risk of recurrence within 5 years);
- Other surgical or medical condition that, in the judgment of the investigator, might warrant exclusion or be contraindicated, like for instance visual or hand-use symptoms;
- Mental handicap or psychiatric condition incompatible with appropriate handling of devices or compliance to treatment or investigation-related tasks;
- Known active alcohol or drug abuse;
- Having received corticoid treatment within 4 weeks prior to enrollment;
- Having received an investigational product within 12 weeks prior to enrollment, or currently participating in another clinical trial, with the exception of observational / non-interventional; registries, for which written prior approval of Defymed is needed;
- Women planning for pregnancy, being pregnant or breastfeeding or unwilling to use adequate contraceptive methods for the duration of the study (oral hormonal contraceptives, implants, injectables, hormonal or copper intrauterine device, or vasectomized partner);
- Person under guardianship, trusteeship or deprived of liberty;
- Person not affiliated to one of the French social security systems;
- Unwilling to give written informed consent to participation in the study, or unable to do so for psychiatric, cognitive or linguistic reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Hôpitaux Universitaires de Strasbourg
Strasbourg, 67000
Nathalie Jeandidier, MD, +33 3 88 11 66 03, Nathalie.jeandidier@chru-strasbourg.fr
Nathalie Jeandidier, MD
About this study
Official title: 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
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
- Being tested
- ExOlin®, Insulin aspart
- Keywords
- Safety, Pilot, Type 1 Diabetes, High glucose fluctuations, Severe Hypoglycemia, Hypoglycemia unawareness, Extraperitoneal, Insulin
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExOlin®Device
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.
Insulin aspartDrug
Use of NovoRapid insulin during all periods of the clinical investigations
| Study group | Role | What they receive |
|---|---|---|
| test arm | Experimental | 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. Receives: Device: ExOlin®; Drug: Insulin aspart |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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 (7)
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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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.
Measured: at the end of the Treatment phase (3rd month of treatment) versus data at the end of the Screening phase (1 month duration)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start5 May 2022
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All patients enrolled will undergo period with subcutaneous delivery of insulin, as a baseline data collection. Then, patients will receive the ExOlin device, undergo post-implantation FU, and then get insulin therapy via ExOlin. Explantation of the device, when required, will be accompanied by a safety FU. During all study phases, NovoRapid insulin will be used.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Defymed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221359
- Sponsor's protocol ID
- DEXN-T1D-2017-01
- Other IDs
- 2020-A01763-36, 2020-003020-17
- Acronym
- Pilot'Ex
- Status last verified
- Jul 2022
- First submitted
- 3 Dec 2021
- Last updated
- 27 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05221359
- Acronym / sponsor ID
- Pilot'Ex / DEXN-T1D-2017-01
- Keywords
- Safety, Pilot, Type 1 Diabetes, High glucose fluctuations, Severe Hypoglycemia, Hypoglycemia unawareness, Extraperitoneal, Insulin
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- DefymedIndustry (pharma, biotech, devices)
- Study start
- 5 May 2022 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All patients enrolled will undergo period with subcutaneous delivery of insulin, as a baseline data collection. Then, patients will receive the ExOlin device, undergo post-implantation FU, and then get insulin therapy via ExOlin. Explantation of the device, when required, will be accompanied by a safety FU. During all study phases, NovoRapid insulin will be used.
| Arm | Type | Receives |
|---|---|---|
| test arm | Experimental | Device: ExOlin®, Drug: Insulin aspartAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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%;
Key exclusion criteria (25 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExOlin®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. | Device | test arm |
| Insulin aspartUse of NovoRapid insulin during all periods of the clinical investigations | Drug | test arm |
Primary outcome
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
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.
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.
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)
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.
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.
7 secondary outcomes
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.
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.
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
Time frame: 2nd month of treatment (meaning week 20) vs end of screening (week 4)
Early Performance: Glycemic control
Time frame: 3rd month of treatment (meaning week 24) vs end of screening (week 4)
Early Performance: Glycemic control
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
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
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2022.
Related trials for Type 1 Diabetes
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
RecruitingPhase 1
Pharmacokinetics, Safety, and Immunogenicity Comparison of Bmab1700 and Opdivo® as Adjuvant Monotherapy in Participants With Melanoma
Melanoma
Active, not recruitingPhase 2
A Study of Botensilimab and Balstilimab for the Treatment of Colorectal Cancer
Metastatic Colorectal Cancer
Not yet recruiting
Inter-Arm Differences in Continuous Glucose Monitor Readings in Adults With Diabetes
Continuous Glucose Monitoring, Type 1 Diabetes
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hôpitaux Universitaires de Strasbourg
Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ExOlin® and Insulin aspart in people with Type 1 Diabetes and Type 1 Diabetes Mellitus With Hypoglycemia, run by Defymed at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 25 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2022.