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

NACompletedINTERVENTIONAL
Enrollment

130

Participants

Timeline

Start Date

December 1, 2021

Primary Completion Date

February 9, 2023

Study Completion Date

February 9, 2023

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

Trial Locations (1)

31059

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

All Listed Sponsors
lead

University Hospital, Toulouse

OTHER

NCT05207020 - Development and Validation of the Blood Glucose Measurement Device by Air Analysis Expired | Biotech Hunter | Biotech Hunter