Quality Control of Pancreatic Islet Intended to Islet Graft Cells Intended to Stabilot Islet Graft Protocol (ISLET CHIP)

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatic Islet Quality Control

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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• France
  • Besancon, France
    • Recruiting
    • Besançon University Hospital
    • Contact: Sophie BOROT, MD, PhD; Phone Number: +33 3 81 66 82 29; Email: sophie.borot@univ-fcomte.fr
    • Principal Investigator: Sophie BOROT, MD, PhD
  • Clermont-Ferrand, France
    • Not yet recruiting
    • Clermont Ferrand University Hospital
    • Contact: Igor TAUVERON, MD, PhD; Phone Number: +33 4 73 75 15 29; Email: itauveron@chu-clermontferrand.fr
    • Principal Investigator: Igor TAUVERON, MD, PhD
  • Grenoble, France, 38000
    • Recruiting
    • Grenoble University Hospital
    • Contact: Myriam HADDOUCHE; Phone Number: +33476766983; Email: mhaddouche@chu-grenoble.fr
    • Contact: Sandrine LABLANCHE; Phone Number: +33476769349; Email: slablanche@chu-grenoble.fr
    • Principal Investigator: Sandrine LABLANCHE
    • Sub-Investigator: Pierre-Yves BENHAMOU
  • Lyon, France, 69000
    • Recruiting
    • Lyon University Hospital
    • Contact: Charles THIVOLET, MD, PhD; Phone Number: +33 4 78 86 14 87; Email: charles.thivolet@chu-lyon.fr
    • Principal Investigator: Charles THIVOLET, MD, PhD
    • Sub-Investigator: Emmanuel MORELON, MD, PhD
    • Sub-Investigator: Lionel BADET, MD, PhD
    • Sub-Investigator: Fanny BURON, MD
  • Montpellier, France, 34000
    • Recruiting
    • Montpellier University Hospital
    • Contact: Anne WOJTUSCISZYN, MD, PhD; Phone Number: +33 4 67 33 83 86; Email: a-wojtusciszyn@chu-montpellier.fr
    • Principal Investigator: Anne WOJTUSCISZYN, MD, PhD
    • Sub-Investigator: Eric RENARD, MD, PhD
  • Nancy, France, 54511
    • Not yet recruiting
    • Nancy University Hospital
    • Contact: Sophie GIRERD, MD, PhD; Phone Number: +33 3.83.15.31.69; Email: s.girerd@chu-nancy.fr
    • Principal Investigator: Luc FRIMAT, MD, PhD
    • Sub-Investigator: Sophie GIRERD, MD, PhD
    • Sub-Investigator: Bruno GUERCI, MD, PhD
  • Strasbourg, France, 67000
    • Recruiting
    • University Hospital of Strasbourg
    • Contact: Laurence KESSLER, MD, PhD; Phone Number: +33 3 88 11 62 67; Email: laurence.kessler@chru-strasbourg.fr
    • Principal Investigator: Laurence KESSLER, MD, PhD
• Switzerland
  • Geneva, Switzerland, CH-1211
    • Active, not recruiting
    • Geneva University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP

Description

Inclusion Criteria:

• Patients enrolled in STABILOT Pancreatic Islet cell graft protocol and willing to participate to ISLET CHIP

Exclusion Criteria:

• Patients not enrolled in STABILOT Pancreatic Islet cell graft or patients that signed the form expressing their refuse to participate to ISLET CHIP.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months in average before second islet graft

Collaborators and Investigators

• Sponsor: University Hospital, Grenoble
• Collaborators: University Hospital, Bordeaux
• Investigators: Principal Investigator: Sandrine LABLANCHE, MD, PhD, University Hospital, Grenoble; Study Director: Bogdan CATARGI, MD, PhD, University Hospital, Bordeaux

Publications and helpful links

General Publications

• Lablanche 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.
• 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.
• Gruessner 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.
• Ricordi 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.
• Lebreton 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.
• Renaud 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): July 1, 2021

Study Registration Dates

• First Submitted: February 21, 2017
• First Submitted That Met QC Criteria: February 24, 2017
• First Posted (Actual): March 1, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Islet Transplantation
• Other Study ID Numbers: 38RC14.041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No