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

Not Applicable

Completed

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Other: Biosensor algorithm

• Registration Number: NCT04081883
• Lead Sponsor: University Hospital, Bordeaux

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 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.

Study Timeline

• Study First Submitted: 2019-09-04
• Study First Submitted QC: 2019-09-06
• Study First Posted: 2019-09-09
• Study Start: 2023-01-27
• Primary Completion: 2024-01-27
• Study Completion: 2024-01-27
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-13
• Last Update Posted: 2024-03-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Patient over 18 years of age
• Patient with type 1 diabetes (T1D)
• Patient being equipped and trained with an external or internan insulin pump linked to a CGM
• Affiliated person or beneficiary of a social security scheme
• Free, informed and written consent

Exclusion Criteria

• Patient under 18 years
• Patient not having T2D
• Pregnant or lactating patient
• No consent signed by the patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Biosensor algorithm	Biosensor algorithm	The biosensor DIABLO algorithm is compared to Continuous Glucose Monitoring Systems (CGMS) utilisation.

Primary Outcome Measures

Name	Time	Method
Comparison between biosensor to CGMS responses	2 days after inclusion	Measure blood glucose every 10 minutes by taking interstitial fluid from DT1 patients with an internal or external insulin pump to compare the biosensor responses to measurements of standard CGM systems.

Trial Locations

Locations (1)

Hôpital Saint-André; 🇫🇷 Bordeaux, France