Clinical trial NCT03341026: Metronom Continuous Glucose Monitoring System
Official title: An Open, Multicenter, Randomized, Controlled Pilot Trial Evaluating the Metronom Continuous Glucose Monitoring System in Subjects With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Diabetes Mellitus, Type 2
Diabete Mellitus
Lead sponsor: Metronom Health
Sponsor class: INDUSTRY
Collaborators: name: Medical University of Graz
First posted: 2017-11-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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 tested in an inpatient setting (meal/insulin test with frequent plasma glucose monitoring) at different days of wear-time. Sensor data will be compared to gold standard reference (Super GL2 analyser or YSI) and stability of sensor performance will be assessed over time. Additionally, safety and tolerability of the sensor will be investigated by regular assessment of the insertion site.


Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Accuracy
timeFrame: 14 days
Secondary outcomes:
measure: Reliability
timeFrame: 14 days
measure: Reliability
timeFrame: 14 days
measure: Reliability
timeFrame: 14 days
measure: Reliability
timeFrame: 14 days
measure: Accuracy
timeFrame: 14 days
measure: Reliability
timeFrame: 14 days
measure: Reliability
timeFrame: 14 days
measure: Reliability
timeFrame: 14 days
measure: Reliability
timeFrame: 14 days
measure: Reliability
timeFrame: 14 days
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Copenhagen
country: Denmark
facility: Steno diabetes center
Study officials:
affiliation: Medical University of Graz
name: Julia Mader, Ass Prof
role: PRINCIPAL_INVESTIGATOR
References: