Development and Validation of the Blood Glucose Measurement Device by Air Analysis Expired

Diabetes Mellitus, Type 2 Clinical Trial

— BOYDSENSE  

Official title:

Study Allowing the Collection of Clinical and Biological Data Necessary for Development and Validation of the Blood Glucose Measurement Device by Air Analysis Expired Developed by the Company BOYDSense

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05207020
• Other study ID #: RC31/21/0305
• Status: Completed
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: February 9, 2023

Study information

• Verified date: February 2023
• Source: University Hospital, Toulouse
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: February 9, 2023
• Est. primary completion date: February 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Device:
• Glycemia 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

Behavioral:
• Questionnaire
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

Biological:
• Veinous glycemia
Measurement of the veinous glycemia at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal
• Capillary glycemia
7-step capillary glycemia measurement: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal
• constitution biological collection
Sampling for storage of serum at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal
• Blood sample
Single blood sample before mealtimes for HbA1C molecular analysis

Other:
• Test meal
taking a test meal before the various blood sugar measurements

Locations

Country	Name	City	State
France	Service de Diabétologie, maladies métaboliques et nutrition, CHU Toulouse, 1 avenue Jean Pouilhes, TSA 50032	Toulouse Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Toulouse

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collect glucose values	Collect successive fasting blood glucose values in patients with type 2 diabetes	1 day
Primary	Collect glucose values	Collect successive blood glucose values after taking a test meal, in patients with type 2 diabetes	1day
Primary	Collect glucose values (fasting)	Measurement of blood glucose by the exhaled air analyzer from volatile compounds in exhaled air (fasting)	1 day
Primary	Collect glucose values (after a test meal)	Measurement of blood glucose by the exhaled air analyzer from volatile compounds in exhaled air (after taking a test meal))	1 day