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Tests treatment safety and results for Type 1 Diabetes
Official title Pilot Study Evaluating Safety of ExOlin® in Patients With Poorly Controlled Type 1 Diabetes
ClinicalTrials.gov ID: NCT05221359
What this study is testing
What is Insulin aspart?
Insulin aspart is an investigational medicine, being studied as a potential treatment for type 1 diabetes.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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;
See the full eligibility 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:
- CSII, whatever the insulin pump used, and
- Continuous Glucose Monitoring (CGM), by using Dexcom G6;
- 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...
- 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.
- 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;
- 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...
- 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...
- 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-treatment; registries, for which written...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Strasbourg, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Strasbourg, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.