Diabetes Mellitus, Type 2
Conditions
Keywords
Type 2 diabetes mellitus, self monitoring of blood glucose,, breath glucose monitoring system
Brief summary
This clinical study aims to finalize the algorithm and assess the performance of the BOYDSense® breath glucose monitoring system prototype in patients living with type 2 diabetes.
Detailed description
Self-monitoring of blood glucose (SMBG) is prescribed to patients living with diabetes according to their type of diabetes, their clinical profile and their personalized needs such as therapeutic adjustments, detection of an asymptomatic hyperglycaemic drift, prevention of hypoglycaemia, or adaptation of the therapeutic strategy to the evolution of the pathology. Most of the people living with type2 diabetes mellitus (T2DM) use an invasive finger prick SMBG glucometer. A pilot study conducted by the BOYDSense mother company Alpha-MOS showed that the analysis of volatile organic compounds (VOC) in exhaled air could reliably predict blood glucose. The development of a breath glucose-monitoring device, by its non-invasive nature, should be an alternative to existing systems by making it possible to avoid capillary samples. Investigators could expect a better quality of life and a better compliance with SMBG in the majority of patients with T2DM. The objectives of our study are to improve the BOYDSense®glucose algorithm based on the VOC analysis of exhaled air; then to assess the performance of the BOYDSense® prototype with the finalized algorithm. This study aims to gather, in patients with T2DM, successive blood and capillary reference glucose values during a meal test, and to compare them to glucose levels estimated by the BOYDSense® prototype. All the enrolled patients will undergo a 3 hours standardized meal test with seven glucose measurement endpoints at T0, 30 min, 1hour 1H30, 2H, 2H30 and 3H post meal. Blood glucose will be measured with three different techniques: venous blood glucose measured with a COBAS 8000 automatic analyzer, SMBG measured with a commercial glucometer and blood glucose value estimated from exhaled air using the BOYDSense® prototype. The study duration will be 4H for each enrolled patient. After the meal test being completed, the end of study procedure includes a 30 min observational period dedicated to the completion of the patients'questionnaire.
Interventions
DEVICEGlycemia estimated by exhaled air analyzer
Measurement of volatile compounds in the air exhaled by the volunteer on 3 different MIBs (3 breaths in total) at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal
BEHAVIORALQuestionnaire
The questionnaire focuses on the methods and feelings of the blood glucose self-monitoring that he is currently carrying out, a first feedback on user experience on the operation of the prototype and the collection of his expectations for a future commercial device
BIOLOGICALVeinous glycemia
Measurement of the veinous glycemia at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal
BIOLOGICALCapillary glycemia
7-step capillary glycemia measurement: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal
BIOLOGICALconstitution biological collection
Sampling for storage of serum at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal
BIOLOGICALBlood sample
Single blood sample before mealtimes for HbA1C molecular analysis
OTHERTest meal
taking a test meal before the various blood sugar measurements
Sponsors
University Hospital, Toulouse
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Single group with a device
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Type 2 diabetes diagnosed for at least 3 months. * Acceptance of constraints related to participation in the study. * Acceptance to participate in the constitution of a plasma library. * Ability to sign informed consent. * Affiliation to a social security scheme.
Exclusion criteria
* Ongoing prandial insulin therapy * Treated bacterial or viral respiratory infection in the 2 weeks preceding the meal test. * Surgical intervention under general anesthesia in the last 12 weeks. * Asthmatic subjects with bronchospasm or under chronic inhaled therapy. * Ongoing COVID-19 (PCR +) or contact case in the isolation period. * Pregnancy or breast-feeding. * Participation in another clinical study or exclusion period from another research protocol. * Patient under guardianship, curatorship or legal protection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Collect glucose values | 1 day | Collect successive fasting blood glucose values in patients with type 2 diabetes |
| Collect glucose values (fasting) | 1 day | Measurement of blood glucose by the exhaled air analyzer from volatile compounds in exhaled air (fasting) |
| Collect glucose values (after a test meal) | 1 day | Measurement of blood glucose by the exhaled air analyzer from volatile compounds in exhaled air (after taking a test meal)) |
Countries
France
Outcome results
None listed