NCT04081883

Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump

Decoding Islet Algorithms in Biosensors for Open and Closed-loop Glycemia Control in T1D Patients With Insulin Pump Coupled to Sensors.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 patient's 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 2040(1). Continuous glucose monitoring systems (CGMS) linked to insulin delivery has provided a major advance(2). 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.

Conditions

• Diabetes Mellitus, Type 1

Interventions

Type	Name	Description
OTHER	Biosensor algorithm	The biosensor DIABLO responses will be compared to the measurements of standard CGMS, using blood glucose measures every 10 minutes by taking interstitial fluid from Diabetes Type 1 (DT1) patients with an internal or external insulin pump.

Timeline

• Start date: 2023-01-27
• Primary completion: 2024-01-27
• Completion: 2024-01-27
• First posted: 2019-09-09
• Last updated: 2024-03-15

Locations

1 site across 1 country: France