Type 1 Diabetes (T1D)ISLET-TITRNCT07470593
Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.
An observational study of Type 1 Diabetes (T1D), run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
Islet transplantation is associated with drastically improvement glucose control in people with type 1 diabetes. This treatment resulted in the disappearance of severe hypoglycemic events. However, its long-term effectiveness is limited by progressive loss of graft function. 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?
- Continuous glucose monitoring (CGM) with TITR measurement
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2025to 15 Dec 2029
- How long will I take part?
- 1 Year
- 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: Insulin-dependent diabetes (type 1 diabetes, secondary to chronic pancreatitis, MODY, cystic fibrosis).
Who may be able to join
- ≥18 years old
- Insulin-dependent diabetes (type 1 diabetes, secondary to chronic pancreatitis, MODY, cystic fibrosis)
- Patient who has completed a full cycle of pancreatic islet transplantation, either:
- Islet Transplantation Alone (ITA), or
- Islet After Kidney (IAK), or
- Simultaneous Islet Kidney (SIK), with >10,000 IEQ/kg of recipient body weight, or <10,000 IEQ/kg but having achieved insulin independence
- Patient who has provided consent for reuse of their data for this research
Who cannot join
- Patient refusal to wear continuous glucose monitoring device
- Pancreatic islet autotransplantation
- Inability to provide informed consent (e.g., difficulties understanding study information)
- Patient under judicial protection (safeguard of justice)
- Patient under guardianship or curatorship
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
Hopitaux Universitaires de Strasbourg
Strasbourg, 67200
Luc RAKOTOARISOA, 033 3 88 12 75 76, luc.rakotoarisoa@unistra.fr
Luc RAKOTOARISOA, Dr
About this study
Official title: Prospective Longitudinal Observational Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.
Islet transplantation is associated with drastically improvement glucose control in people with type 1 diabetes. This treatment resulted in the disappearance of severe hypoglycemic events. However, its long-term effectiveness is limited by progressive loss of graft function. Currently, there is no standardized method to detect early dysfunction of the transplanted islets.
This study aims to determine whether a parameter derived from continuous glucose monitoring (CGM), Time in Tight Range (70-140 mg/dL), is associated with pancreatic islet grafts function.
The study hypothesis is that a decrease in Time in Tight Range reflects early loss of islet graft function.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Continuous glucose monitoring (CGM) with TITR measurement
- 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.
Continuous glucose monitoring (CGM) with TITR measurementOther
Continuous glucose monitoring (CGM) with TITR measurement
| Study group | Role | What they receive |
|---|---|---|
| Insulin-dependent diabetes patients with full cycle of pancreatic islet transplantation | Continuous glucose monitoring (CGM) with TITR measurement Receives: Other: Continuous glucose monitoring (CGM) with TITR measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in Tight Range (70-140 mg/dL) >70% without severe hypoglycemia over 1 year.
Measured: 1 year post-transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start15 Dec 2025
- Primary completion15 Dec 2029 (estimated)
- Study completion15 Dec 2029 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luc RAKOTOARISOA, Dr, Principal investigator, HOPITAUX UNIVERSITAIRES DE STRASBOURG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07470593
- Sponsor's protocol ID
- RC25-0034
- Acronym
- ISLET-TITR
- Status last verified
- Mar 2026
- First submitted
- 9 Mar 2026
- Last updated
- 17 Mar 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 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Longitudinal Observational Study of Glucose Tolerance Abnormalities Using Continuous Glucose Monitoring for the Identification of Early Loss of Pancreatic Islet Graft Function.
- ClinicalTrials.gov ID
- NCT07470593
- Acronym / sponsor ID
- ISLET-TITR / RC25-0034
- Conditions
- Type 1 Diabetes (T1D)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 15 Dec 2025 (actual)
- Primary completion
- 15 Dec 2029 (estimated)
- Study completion
- 15 Dec 2029 (estimated)
- First posted
- 13 Mar 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 is associated with drastically improvement glucose control in people with type 1 diabetes. This treatment resulted in the disappearance of severe hypoglycemic events. However, its long-term effectiveness is limited by progressive loss of graft function. Currently, there is no standardized method to detect early dysfunction of the transplanted islets.
This study aims to determine whether a parameter derived from continuous glucose monitoring (CGM), Time in Tight Range (70-140 mg/dL), is associated with pancreatic islet grafts function.
The study hypothesis is that a decrease in Time in Tight Range reflects early loss of islet graft function.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Insulin-dependent diabetes patients with full cycle of pancreatic islet transplantation | – | Other: Continuous glucose monitoring (CGM) with TITR measurementContinuous glucose monitoring (CGM) with TITR measurement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Insulin-dependent diabetes (type 1 diabetes, secondary to chronic pancreatitis, MODY, cystic fibrosis).
Key inclusion criteria (7 listed)
- ≥18 years old
- Insulin-dependent diabetes (type 1 diabetes, secondary to chronic pancreatitis, MODY, cystic fibrosis)
- Patient who has completed a full cycle of pancreatic islet transplantation, either:
- Patient who has provided consent for reuse of their data for this research
Key exclusion criteria (5 listed)
- Patient refusal to wear continuous glucose monitoring device
- Pancreatic islet autotransplantation
- Inability to provide informed consent (e.g., difficulties understanding study information)
- Patient under judicial protection (safeguard of justice)
- Patient under guardianship or curatorship
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 |
|---|---|---|
| Continuous glucose monitoring (CGM) with TITR measurementContinuous glucose monitoring (CGM) with TITR measurement | Other | Insulin-dependent diabetes patients with full cycle of pancreatic islet transplantation |
Primary outcome
Time in Tight Range (70-140 mg/dL) >70% without severe hypoglycemia over 1 year.
Time frame: 1 year post-transplant
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 17 Mar 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.
Luc RAKOTOARISOA, Dr principal investigator
HOPITAUX 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 7 inclusion and 5 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 17 Mar 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 Pargol ZANDYAZDI (0033 3 88 11 54 30, pargol.zandyazdi@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in Tight Range (70-140 mg/dL) >70% without severe hypoglycemia over 1 year. (time frame: 1 year post-transplant). 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 17 Mar 2026.