Pancreatic Islet Quality ControlISLET CHIPNCT03067324
Quality Control of Pancreatic Islet Intended to Islet Graft Cells Intended to Stabilot Islet Graft Protocol
An observational study of Pancreatic Islet Quality Control, run by University Hospital, Grenoble at 8 sites in 2 countries.
Trial summary
Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pancreatic Islet Quality Control
- How many people
- 40 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 11 Jan 2017to 1 Jul 2021
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 65 years
- All sexes
- Adult, Older adult
Study population: Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP
Who may be able to join
- Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP
Who cannot join
- Patients not enrolled in STABILOT Pancreatic Islet cell graft or patients that signed the form expressing their refuse to participate to ISLET CHIP.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
France7 sites, 7 recruiting
- Recruiting
Besançon University Hospital
Besançon
Sophie BOROT, MD, PhD, +33 3 81 66 82 29, sophie.borot@univ-fcomte.fr
Sophie BOROT, MD, PhD
- Not yet recruiting
Clermont Ferrand University hospital
Clermont-Ferrand
Igor TAUVERON, MD, PhD, +33 4 73 75 15 29, itauveron@chu-clermontferrand.fr
Igor TAUVERON, MD, PhD
- Recruiting
Grenoble University Hospital
Grenoble, 38000
Sandrine LABLANCHE, +33476769349, slablanche@chu-grenoble.fr
Myriam HADDOUCHE, +33476766983, mhaddouche@chu-grenoble.fr
- Recruiting
Lyon University Hospital
Lyon, 69000
Charles THIVOLET, MD, PhD, +33 4 78 86 14 87, charles.thivolet@chu-lyon.fr
Charles THIVOLET, MD, PhD
- Recruiting
Montpellier University Hospital
Montpellier, 34000
Anne WOJTUSCISZYN, MD, PhD, +33 4 67 33 83 86, a-wojtusciszyn@chu-montpellier.fr
Anne WOJTUSCISZYN, MD, PhD
- Not yet recruiting
Nancy University hospital
Nancy, 54511
Sophie GIRERD, MD, PhD, +33 3.83.15.31.69, s.girerd@chu-nancy.fr
Luc FRIMAT, MD, PhD
- Recruiting
University hospital of Strasbourg
Strasbourg, 67000
Laurence KESSLER, MD, PhD, +33 3 88 11 62 67, laurence.kessler@chru-strasbourg.fr
Laurence KESSLER, MD, PhD
Switzerland1 site
- Active, not recruiting
Geneva University Hospital
Geneva, CH-1211
About this study
Official title: Quality Control of Pancreatic Islet Intended to Islet Graft
Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.
Read the detailed description
Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.
The project aims to :
- develop the bio-sensor necessary to measure islet membrane electric potential
- develop interface between bio-sensor and user
- correlate analysis data collected by bio-sensor with metabolic results of islet graft
- Conditions
- Pancreatic Islet Quality Control
- Keywords
- Islet Transplantation
What is being measured
The primary outcome is the main question the study is designed to answer.
Beta-score
Beta-score in continuous variable, using the last Beta-score known before the second islet graft. Beta-score is a composite score that reflects pancreatic islet graft function after transplantation and measured from the following criteria: severe hypoglycemia, HbA1c, stimulated C-peptide, fasting glucose, insulin dose or oral diabetes, glycemic variability.
Measured: 6 months in average before second islet graft
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2017
- Study start11 Jan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pancreatic Islet Quality ControlStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe 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
- 40 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Bordeaux
- Responsible party
- Sponsor
- Investigators
- Sandrine LABLANCHE, MD, PhD, Principal investigator, University Hospital, GrenobleBogdan CATARGI, MD, PhD, Study director, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03067324
- Sponsor's protocol ID
- 38RC14.041
- Acronym
- ISLET CHIP
- Status last verified
- Oct 2020
- First submitted
- 21 Feb 2017
- Last updated
- 26 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kusnik-Joinville O, Weill A, Salanave B, Ricordeau P, Allemand H. Prevalence and treatment of diabetes in France: trends between 2000 and 2005. Diabetes Metab. 2008 Jun;34(3):266-72. doi: 10.1016/j.diabet.2008.01.005. Epub 2008 Jun 3.
PubMed 18524662Gruessner RW, Gruessner AC. The current state of pancreas transplantation. Nat Rev Endocrinol. 2013 Sep;9(9):555-62. doi: 10.1038/nrendo.2013.138. Epub 2013 Jul 30.
PubMed 23897173Ricordi C, Lacy PE, Finke EH, Olack BJ, Scharp DW. Automated method for isolation of human pancreatic islets. Diabetes. 1988 Apr;37(4):413-20. doi: 10.2337/diab.37.4.413.
PubMed 3288530Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tetaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.
PubMed 26068866Lebreton F, Pirog A, Belouah I, Bosco D, Berney T, Meda P, Bornat Y, Catargi B, Renaud S, Raoux M, Lang J. Slow potentials encode intercellular coupling and insulin demand in pancreatic beta cells. Diabetologia. 2015 Jun;58(6):1291-9. doi: 10.1007/s00125-015-3558-z. Epub 2015 Mar 19.
PubMed 25788295Renaud S, Catargi B, Lang J. Biosensors in diabetes : how to get the most out of evolution and transpose it into a signal. IEEE Pulse. 2014 May-Jun;5(3):30-4. doi: 10.1109/MPUL.2014.2309577.
PubMed 24838208
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Control of Pancreatic Islet Intended to Islet Graft
- ClinicalTrials.gov ID
- NCT03067324
- Acronym / sponsor ID
- ISLET CHIP / 38RC14.041
- Conditions
- Pancreatic Islet Quality Control
- Keywords
- Islet Transplantation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Collaborators
- University Hospital, Bordeaux
- Study start
- 11 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 1 Mar 2017 (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 quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.
Detailed description
Islet quality control after pancreatic islets isolation process is insufficient. The Islet Chip study proposes to develop a bio-sensor that will allow a multi-parametric analysis of islet graft based on measurement of islet membrane electric potential.
The project aims to :
- develop the bio-sensor necessary to measure islet membrane electric potential
- develop interface between bio-sensor and user
- correlate analysis data collected by bio-sensor with metabolic results of islet graft
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP
Key inclusion criteria (1 listed)
- Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP
Key exclusion criteria (1 listed)
- Patients not enrolled in STABILOT Pancreatic Islet cell graft or patients that signed the form expressing their refuse to participate to ISLET CHIP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Beta-score
Time frame: 6 months in average before second islet graft
Beta-score in continuous variable, using the last Beta-score known before the second islet graft. Beta-score is a composite score that reflects pancreatic islet graft function after transplantation and measured from the following criteria: severe hypoglycemia, HbA1c, stimulated C-peptide, fasting glucose, insulin dose or oral diabetes, glycemic variability.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Background: PubMed 18524662Kusnik-Joinville O, Weill A, Salanave B, Ricordeau P, Allemand H. Prevalence and treatment of diabetes in France: trends between 2000 and 2005. Diabetes Metab. 2008 Jun;34(3):266-72. doi: 10.1016/j.diabet.2008.01.005. Epub 2008 Jun 3.
- Background: PubMed 23897173Gruessner RW, Gruessner AC. The current state of pancreas transplantation. Nat Rev Endocrinol. 2013 Sep;9(9):555-62. doi: 10.1038/nrendo.2013.138. Epub 2013 Jul 30.
- Background: PubMed 3288530Ricordi C, Lacy PE, Finke EH, Olack BJ, Scharp DW. Automated method for isolation of human pancreatic islets. Diabetes. 1988 Apr;37(4):413-20. doi: 10.2337/diab.37.4.413.
- Background: PubMed 26068866Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tetaz R, Badet L, Thivolet C, Morelon E, Frimat L, Penfornis A, Kessler L, Brault C, Colin C, Tauveron I, Bosco D, Berney T, Benhamou PY; GRAGIL Network. Five-Year Metabolic, Functional, and Safety Results of Patients With Type 1 Diabetes Transplanted With Allogenic Islets Within the Swiss-French GRAGIL Network. Diabetes Care. 2015 Sep;38(9):1714-22. doi: 10.2337/dc15-0094. Epub 2015 Jun 11.
- Background: PubMed 25788295Lebreton F, Pirog A, Belouah I, Bosco D, Berney T, Meda P, Bornat Y, Catargi B, Renaud S, Raoux M, Lang J. Slow potentials encode intercellular coupling and insulin demand in pancreatic beta cells. Diabetologia. 2015 Jun;58(6):1291-9. doi: 10.1007/s00125-015-3558-z. Epub 2015 Mar 19.
- Background: PubMed 24838208Renaud S, Catargi B, Lang J. Biosensors in diabetes : how to get the most out of evolution and transpose it into a signal. IEEE Pulse. 2014 May-Jun;5(3):30-4. doi: 10.1109/MPUL.2014.2309577.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
Sandrine LABLANCHE, MD, PhD principal investigator
University Hospital, Grenoble
Bogdan CATARGI, MD, PhD study director
University Hospital, Bordeaux
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreatic Islet Quality Control, run by University Hospital, Grenoble at 8 sites in 2 countries.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in France, Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sandrine LABLANCHE, MD, PhD (+33 4 76 63 54 26, SLablanche@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beta-score (time frame: 6 months in average before second islet graft). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03067324, which also lists 6 linked publications.
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 26 Oct 2020.