Status:
COMPLETED
Development and Validation of the Blood Glucose Measurement Device by Air Analysis Expired
Lead Sponsor:
University Hospital, Toulouse
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-90 years
Phase:
NA
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 adju...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 9 2023
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT05207020
Start Date
December 1 2021
End Date
February 9 2023
Last Update
February 13 2023
Active Locations (1)
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1
Service de Diabétologie, maladies métaboliques et nutrition, CHU Toulouse, 1 avenue Jean Pouilhes, TSA 50032
Toulouse, France, 31059