Diabetes Mellitus, Type 1
Conditions
Keywords
Continuous Glucose Monitoring, Biosensor
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.
Interventions
OTHERBiosensor 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.
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
France
Contacts
PRINCIPAL_INVESTIGATORBogdan CATARGI, Pr
University Hospital, Bordeaux
Outcome results
None listed