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

NCT05207020 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 130

Last updated 2023-02-13

No results posted yet for this study

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

Interventions

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

BIOLOGICAL

Capillary glycemia

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

BIOLOGICAL

constitution biological collection

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

BIOLOGICAL

Blood sample

Single blood sample before mealtimes for HbA1C molecular analysis

OTHER

Test meal

taking a test meal before the various blood sugar measurements

Sponsors & Collaborators

  • University Hospital, Toulouse

    lead OTHER

Principal Investigators

  • Pierre GOURDY, MD, PhD · University Hospital, Toulouse

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-12-01
Primary Completion
2023-02-09
Completion
2023-02-09

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05207020 on ClinicalTrials.gov