Type 1 Diabetes (T1D)EVIFITNCT07812974
Extracellular Vesicle-based Strategy to Stratify Islets and Improve Their FItness Before Transplantation
An observational study of Type 1 Diabetes (T1D), run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Islet transplantation restores glucose tolerance in people living with diabetes characterised by high glycaemic variability: 90 per cent of patients were free from severe hypoglycaemia at 5 years, compared with 26 per cent prior to transplantation, and 50 per cent of patients were insulin-independent at 1 year. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- beta2score
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2026to Jan 2032
- Phase
- Observational
- 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
Study population: Patients with type 1 diabetes
Who may be able to join
- Adult patients with no upper age limit
- Men or women
- Patients with type 1 diabetes
- Patients on the waiting list for a pancreatic islet transplant (Agence de Biomédecine)
- Patients who have given their consent for their data to be reused for the purposes of this research
Who cannot join
- Pregnant women
- Patients under guardianship or administration
- Individuals subject to judicial protection measures
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
Hôpitaux universitaires de Strasbourg
Strasbourg, 67200
Laurent MEYER, MD, laurent.meyer@chru-strasbourg.fr
Laurence KESSLER, MD, kesslerl@unistra.fr
About this study
Islet transplantation restores glucose tolerance in people living with diabetes characterised by high glycaemic variability: 90 per cent of patients were free from severe hypoglycaemia at 5 years, compared with 26 per cent prior to transplantation, and 50 per cent of patients were insulin-independent at 1 year. However, follow-up of participants is characterised by a gradual loss of islet function, with only 30 per cent of patients remaining insulin-independent at 5 years.
The greatest limitation and challenge of islet transplantation lies in the substantial loss of islet mass infused via the portal vein at the start of the post-transplant period. Up to 50 per cent of the graft may be lost in the days following transplantation. This early loss is due to a combination of stress and non-specific inflammatory and immune mechanisms, as well as blood-mediated inflammatory reactions, which compromise the survival, engraftment, revascularisation and early function of the transplanted islets. Consequently, multiple islet infusions are often required to achieve satisfactory metabolic outcomes in recipients. However, due to the scarcity of available donors, the widespread application of islet transplantation remains limited as a result. During the culture period, cells in the islet preparation release extracellular vesicles (EVs) - either secreted by the plasma membrane (microvesicles, MVs) or of intracellular endosomal origin (exosomes) - which play a major role in intercellular communication. Microvesicles carry various markers and effectors that can render them either harmful (pro-coagulant, pro-apoptotic, pro-inflammatory and pro-senescent) or protective. We therefore hypothesise that (1) EVs released during the preparation of islets prior to transplantation (hereinafter referred to as Graft-EVs) reflect the quality of the pancreatic islets, (2) certain EVs have a protective or deleterious effect on the pancreatic islet, and (3) reconditioning the islets by enriching them with protective EVs improved graft quality under the pro-inflammatory conditions of IBMIR.
We therefore propose to develop an EV-based islet preconditioning strategy to improve graft survival and function.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- beta2score
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beta2scoreOther
The BETA-2 score enables the detection of insulin independence following islet transplantation (BETA-2 score < 20) with a specificity and sensitivity of over 82 per cent.
| Study group | Role | What they receive |
|---|---|---|
| Patient with type 1 diabetes on the waiting list for a pancreatic islet transplant | Not described Receives: Other: beta2score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary function of the graft measured one month after the last islet injection (beta2score)
Measured: 1 month after the last islet injection
Using the criteria for graft success (IGLS score)
Measured: one and two years post-transplant in recipients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionJan 2032 (estimated)
- Study completionJan 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent MEYER, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812974
- Sponsor's protocol ID
- 9904
- Acronym
- EVIFIT
- Status last verified
- Sep 2026
- First submitted
- 31 Aug 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Extracellular Vesicle-based Strategy to Stratify Islets and Improve Their FItness Before Transplantation
- ClinicalTrials.gov ID
- NCT07812974
- Acronym / sponsor ID
- EVIFIT / 9904
- Conditions
- Type 1 Diabetes (T1D)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Jan 2032 (estimated)
- Study completion
- Jan 2032 (estimated)
- First posted
- 10 Sep 2026 (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.
Islet transplantation restores glucose tolerance in people living with diabetes characterised by high glycaemic variability: 90 per cent of patients were free from severe hypoglycaemia at 5 years, compared with 26 per cent prior to transplantation, and 50 per cent of patients were insulin-independent at 1 year. However, follow-up of participants is characterised by a gradual loss of islet function, with only 30 per cent of patients remaining insulin-independent at 5 years.
The greatest limitation and challenge of islet transplantation lies in the substantial loss of islet mass infused via the portal vein at the start of the post-transplant period. Up to 50 per cent of the graft may be lost in the days following transplantation. This early loss is due to a combination of stress and non-specific inflammatory and immune mechanisms, as well as blood-mediated inflammatory reactions, which compromise the survival, engraftment, revascularisation and early function of the transplanted islets. Consequently, multiple islet infusions are often required to achieve satisfactory metabolic outcomes in recipients. However, due to the scarcity of available donors, the widespread application of islet transplantation remains limited as a result. During the culture period, cells in the islet preparation release extracellular vesicles (EVs) - either secreted by the plasma membrane (microvesicles, MVs) or of intracellular endosomal origin (exosomes) - which play a major role in intercellular communication. Microvesicles carry various markers and effectors that can render them either harmful (pro-coagulant, pro-apoptotic, pro-inflammatory and pro-senescent) or protective. We therefore hypothesise that (1) EVs released during the preparation of islets prior to transplantation (hereinafter referred to as Graft-EVs) reflect the quality of the pancreatic islets, (2) certain EVs have a protective or deleterious effect on the pancreatic islet, and (3) reconditioning the islets by enriching them with protective EVs improved graft quality under the pro-inflammatory conditions of IBMIR.
We therefore propose to develop an EV-based islet preconditioning strategy to improve graft survival and function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with type 1 diabetes on the waiting list for a pancreatic islet transplant | – | Other: beta2score |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with type 1 diabetes
Key inclusion criteria (5 listed)
- Adult patients with no upper age limit
- Men or women
- Patients with type 1 diabetes
- Patients on the waiting list for a pancreatic islet transplant (Agence de Biomédecine)
- Patients who have given their consent for their data to be reused for the purposes of this research
Key exclusion criteria (3 listed)
- Pregnant women
- Patients under guardianship or administration
- Individuals subject to judicial protection measures
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 |
|---|---|---|
| beta2scoreThe BETA-2 score enables the detection of insulin independence following islet transplantation (BETA-2 score < 20) with a specificity and sensitivity of over 82 per cent. | Other | Patient with type 1 diabetes on the waiting list for a pancreatic islet transplant |
Primary outcome
Primary function of the graft measured one month after the last islet injection (beta2score)
Time frame: 1 month after the last islet injection
Using the criteria for graft success (IGLS score)
Time frame: one and two years post-transplant in recipients
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 10 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Laurent MEYER principal investigator
Hôpitaux Universitaires de Strasbourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes (T1D), run by University Hospital, Strasbourg, France 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 10 Sep 2026. 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?
Contact Cécile Arnold (0033 3 88 11 51 48, cecile.arnold@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary function of the graft measured one month after the last islet injection (beta2score) (time frame: 1 month after the last islet injection). 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 10 Sep 2026.