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Quality Control of Pancreatic Islet Intended to Islet Graft Cells Intended to Stabilot Islet Graft Protocol

Quality Control of Pancreatic Islet Intended to Islet Graft

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03067324
Acronym
ISLET CHIP
Enrollment
40
Registered
2017-03-01
Start date
2017-01-11
Completion date
2021-07-01
Last updated
2020-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Islet Quality Control

Keywords

Islet Transplantation

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.

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

Interventions

None listed

Sponsors

University Hospital, Bordeaux
CollaboratorOTHER
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Beta-score6 months in average before second islet graftBeta-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.

Countries

France, Switzerland

Contacts

Primary ContactSandrine LABLANCHE, MD, PhD
SLablanche@chu-grenoble.fr+33 4 76 63 54 26
Backup ContactMyriam HADDOUCHE
MHaddouche@chu-grenoble.fr+33476766983

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026