Status:
UNKNOWN
Metronom Continuous Glucose Monitoring System
Lead Sponsor:
Metronom Health
Collaborating Sponsors:
Medical University of Graz
Conditions:
Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The aim of the present study is to investigate the clinical performance of the Metronom CGM system in patients with type 1 diabetes over a period of 14 days. In this study, the CGM sensor will be test...
Eligibility Criteria
Inclusion
- Informed consent obtained after being advised of the nature of the study
- Male or female aged ≥18 years
- Type 1 diabetes for at least 6 months according to the WHO definition treated with multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII) for at least 3 months (for T1D only)
- Body Mass Index (BMI) \<35 kg/m²
- Flash or continuous glucose monitoring (FGM, CGM) user
- Willing and able to wear the Metronom CGM System for the duration of the study and undergo all study procedures
- HbA1c ≤86 mmol/mol
Exclusion
- Any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
- Female of childbearing potential who is pregnant, breast-feeding or intend to become pregnant or is not using adequate contraceptive methods
- Any mental condition rendering the subject incapable of giving his consent
- Subject is using any medication that significantly impacts glucose metabolism (oral steroids) except if stable for at least the last three months and expected to remain stable for the study duration
- Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the subject's safety or successful participation in the study
- Subject is actively enrolled in another clinical trial
- Known adrenal gland problem, pancreatic tumour, or insulinoma
- Known bleeding disorder
- Known hypersensitivity to adhesive or skin lesions that hinder sensor insertion
- Inability of the subject to comply with all study procedures
- Inability of the subject to understand the subject information
- Subject donated blood in the last 3 months
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03341026
Start Date
June 1 2020
End Date
August 1 2020
Last Update
August 15 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Graz
Graz, Austria
2
Steno diabetes center
Copenhagen, Denmark