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

NCT ID: NCT05207020

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2023-02-09

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.

Conditions

Diabetes Mellitus, Type 2

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Blood sugar levels estimated by analysis of exhaled air

Group Type: EXPERIMENTAL

Glycemia estimated by exhaled air analyzer

Intervention Type: DEVICE

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

Questionnaire

Intervention Type: BEHAVIORAL

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

Veinous glycemia

Intervention Type: BIOLOGICAL

Measurement of the veinous glycemia at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal

Capillary glycemia

Intervention Type: BIOLOGICAL

7-step capillary glycemia measurement: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal

constitution biological collection

Intervention Type: BIOLOGICAL

Sampling for storage of serum at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal

Blood sample

Intervention Type: BIOLOGICAL

Single blood sample before mealtimes for HbA1C molecular analysis

Test meal

Intervention Type: OTHER

taking a test meal before the various blood sugar measurements

Interventions

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

Intervention Type: DEVICE

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

Intervention Type: BEHAVIORAL

Veinous glycemia

Measurement of the veinous glycemia at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal

Intervention Type: BIOLOGICAL

Capillary glycemia

7-step capillary glycemia measurement: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal

Intervention Type: BIOLOGICAL

constitution biological collection

Sampling for storage of serum at 7 times: T0, 30min, 1H, 1H30, 2H, 2H30, 3H after test meal

Intervention Type: BIOLOGICAL

Blood sample

Single blood sample before mealtimes for HbA1C molecular analysis

Intervention Type: BIOLOGICAL

Test meal

taking a test meal before the various blood sugar measurements

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Toulouse

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pierre GOURDY, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Toulouse

Locations

Service de Diabétologie, maladies métaboliques et nutrition, CHU Toulouse, 1 avenue Jean Pouilhes, TSA 50032

Toulouse, , France

Countries

France

Other Identifiers

RC31/21/0305

Identifier Type: -

Identifier Source: org_study_id