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Metronom Continuous Glucose Monitoring System

NCT03341026 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2019-08-15

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Medical University of Graz

    collaborator OTHER

  • Metronom Health

    lead INDUSTRY

Principal Investigators

  • Julia Mader, Ass Prof · Medical University of Graz

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-30
Primary Completion
2020-08-31
Completion
2020-08-31

Countries

  • Austria
  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03341026 on ClinicalTrials.gov