NCT03341026

Metronom Continuous Glucose Monitoring System

An Open, Multicenter, Randomized, Controlled Pilot Trial Evaluating the Metronom Continuous Glucose Monitoring System in Subjects With Type 1 Diabetes Mellitus

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Metronom Health · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2
• Diabete Mellitus

Interventions

Type	Name	Description
OTHER	Metronom CGM device	Patient receives three Metronom CGM devices on day 1. On day 1, 4, 7 and 14, a hypo- or hyperglycaemic experiment will start according to allocation by randomizer.
OTHER	Metronom CGM device	Patient receives three Metronom CGM devices on day 1. On day 1, 7, 10 and 14, a hypo- or hyperglycaemic experiment will start according to allocation by randomizer.

Timeline

• Start date: 2020-06-01
• Primary completion: 2020-08-01
• Completion: 2020-08-01
• First posted: 2017-11-14
• Last updated: 2019-08-15

Locations

2 sites across 2 countries: Austria, Denmark