Ignite Creation Date:
2024-05-06 @ 1:39 PM
Last Modification Date:
2024-10-26 @ 1:17 PM
Study NCT ID:
NCT04081883
Status:
COMPLETED
Last Update Posted:
2024-03-15
First Post:
2019-09-04
Brief Title:
Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Decoding Islet Algorithms in Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump Coupled to Sensors
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DIABLO
Brief Summary:
In T1D the destruction of beta-pancreatic cells causes insulin deficiency and requires insulin therapy whose control remains complex even with recent technologies of continuous measurement and monitoring of blood glucose CGM current systems are electrochemical insulin therapy algorithms do not are not optimal and cannot completely eliminate vital risks such as hypoglycemia A new biosensor connected to the patient by microdialysis will be tested in a clinical trial in CHU-Bdx on 10 T1D patients with an internal or external insulin pump In various daily scenarios meals physical exercise the biosensor DIABLO responses will be compared to the measurements of standard CGM systems
Detailed Description:
Continuous monitoring and linked drug delivery is a novel approach to the treatment of chronic diseases that provides powerful means to improve therapeutic outcomes and quality of patients life Type 1 diabetes T1D concerns 5 to 10 of the estimated 415 million cases of diabetes worldwide in 2016 expected to rise to 642 million by 20401 Continuous glucose monitoring systems CGMS linked to insulin delivery has provided a major advance2 T1D is a serious currently chronic and costly disease in children or young adults Indeed the destruction of pancreatic beta-cells leads to absolute insulin deficiency in T1D
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None