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

• Sponsor: University Hospital, Grenoble (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03067324
• Collaborator: University Hospital, Bordeaux (Other)
• Enrollment: 40
• Locations: 8
• Anticipated Duration (Months): 53.6
• Patients Per Site: 5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 40 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Quality Control of Pancreatic Islet Intended to Islet Graft
• Actual Study Start Date: Jan 11, 2017
• Anticipated Primary Completion Date: Dec 31, 2020
• Anticipated Study Completion Date: Jul 1, 2021

Outcome Measures

Primary Outcome Measures

1. Beta-score [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Besançon University Hospital	Besancon		France
2	Clermont Ferrand University hospital	Clermont-Ferrand		France
3	Grenoble University Hospital	Grenoble		France	38000
4	Lyon University Hospital	Lyon		France	69000
5	Montpellier University Hospital	Montpellier		France	34000
6	Nancy University hospital	Nancy		France	54511
7	University hospital of Strasbourg	Strasbourg		France	67000
8	Geneva University Hospital	Geneva		Switzerland	CH-1211

Sponsors and Collaborators

• University Hospital, Grenoble
• University Hospital, Bordeaux

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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. Review.
• 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.
• Lablanche S, Borot S, Wojtusciszyn A, Bayle F, Tétaz 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.
• 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. Review.
• 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.

• Responsible Party: University Hospital, Grenoble
• ClinicalTrials.gov Identifier: NCT03067324
• Other Study ID Numbers: 38RC14.041
• First Posted: Mar 1, 2017
• Last Update Posted: Oct 26, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Grenoble: Islet Transplantation

Study Results

No Results Posted as of Oct 26, 2020