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

Diabetes Mellitus, Type 1 Clinical Trial

— DIABLO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04081883
• Other study ID #: CHUBX 2018/48
• Status: Completed
• Phase: N/A
• Start date: January 27, 2023
• Est. completion date: January 27, 2024

Study information

• Verified date: March 2024
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: January 27, 2024
• Est. primary completion date: January 27, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

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.

Locations

Country	Name	City	State
France	Hôpital Saint-André	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison between biosensor to CGMS responses	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.	2 days after inclusion