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

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.

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Key information

Conditions

Diabetes Mellitus, Type 1 Autoimmune Diseases Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Saint-André

Bordeaux, 33000, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biosensor algorithm

Other

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.

Primary outcomes

Comparison between biosensor to CGMS responses

Time frame: 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.

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: DIABLO

Important dates

Study start: 2023
Primary completion: 2024
Study completion: 2024
First posted: Sep 9, 2019
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed