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
1 other identifier
interventional
20
2 countries
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2020
Shorter than P25 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2017
CompletedFirst Posted
Study publicly available on registry
November 14, 2017
CompletedStudy Start
First participant enrolled
June 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2020
CompletedAugust 15, 2019
August 1, 2019
2 months
October 30, 2017
August 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy
Overall percentage of sensor values which fall within ± 20 mg/dl of the mean reference values at glucose concentrations \<100 mg/dl and within ± 20% at glucose concentrations ≥100 mg/dl
14 days
Secondary Outcomes (10)
Reliability
14 days
Reliability
14 days
Reliability
14 days
Reliability
14 days
Accuracy
14 days
- +5 more secondary outcomes
Study Arms (2)
Induction day 1, 4, 7, 14
OTHERPatient will come to the hospital on day 1, 4, 7 and 14. A hypo- or hyperglycaemic experiment will start according to allocation by randomizer.
Induction day 1, 7, 10, 14
OTHERPatient will come to the hospital on day 1, 7, 10 and 14. A hypo- or hyperglycaemic experiment will start according to allocation by randomizer.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Metronom Healthlead
- Medical University of Grazcollaborator
Study Sites (2)
Medical University of Graz
Graz, Austria
Steno diabetes center
Copenhagen, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julia Mader, Ass Prof
Medical University of Graz
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2017
First Posted
November 14, 2017
Study Start
June 1, 2020
Primary Completion
August 1, 2020
Study Completion
August 1, 2020
Last Updated
August 15, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share