Development and Validation of the Blood Glucose Measurement Device by Air Analysis Expired
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

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.
    

Intervention name(s): Glycemia estimated by exhaled air analyzer; Questionnaire; Veinous glycemia; Capillary glycemia; constitution biological collection; Blood sample; Test meal
Intervention type(s): Device; Behavioral; Biological; Biological; Biological; Biological; Other
Intervention description(s): 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; 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; Measurement of the veinous glycemia at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal; 7-step capillary glycemia measurement: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal; Sampling for storage of serum at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal; Single blood sample before mealtimes for HbA1C molecular analysis; taking a test meal before the various blood sugar measurements
Intervention model: Single Group Assignment
Intervention model description: Single group with a device
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Type 2 diabetes mellitus; self monitoring of blood glucose,; breath glucose monitoring system