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

NCT05207020 | Completed

• 1 other identifier: RC31/21/0305
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2

Keywords

Type 2 diabetes mellitus; self monitoring of blood glucose,; breath glucose monitoring system

Outcome Measures

Primary Outcomes (4)

• Collect glucose values

  Collect successive fasting blood glucose values in patients with type 2 diabetes

  1 day

• Collect glucose values

  Collect successive blood glucose values after taking a test meal, in patients with type 2 diabetes

  1day

• Collect glucose values (fasting)

  Measurement of blood glucose by the exhaled air analyzer from volatile compounds in exhaled air (fasting)

  1 day

• 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

Study Arms (1)

Blood sugar levels estimated by analysis of exhaled air

EXPERIMENTAL

Device: Glycemia estimated by exhaled air analyzer; Behavioral: Questionnaire; Biological: Veinous glycemia; Biological: Capillary glycemia; Biological: constitution biological collection; Biological: Blood sample; Other: Test meal

Interventions

Glycemia estimated by exhaled air analyzer 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

Blood sugar levels estimated by analysis of exhaled air

Questionnaire 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

Blood sugar levels estimated by analysis of exhaled air

Veinous glycemia BIOLOGICAL

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

Blood sugar levels estimated by analysis of exhaled air

Capillary glycemia BIOLOGICAL

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

Blood sugar levels estimated by analysis of exhaled air

constitution biological collection BIOLOGICAL

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

Blood sugar levels estimated by analysis of exhaled air

Blood sample BIOLOGICAL

Single blood sample before mealtimes for HbA1C molecular analysis

Blood sugar levels estimated by analysis of exhaled air

Test meal OTHER

taking a test meal before the various blood sugar measurements

Blood sugar levels estimated by analysis of exhaled air

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Patient under guardianship, curatorship or legal protection.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (1)

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

Toulouse, 31059, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Surveys and Questionnaires; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative

Study Officials

• Pierre GOURDY, MD, PhD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single group with a device

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: January 26, 2022
• Study Start: December 1, 2021
• Primary Completion: February 9, 2023
• Study Completion: February 9, 2023
• Last Updated: February 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)