Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
20 participants
INTERVENTIONAL
2020-06-30
2020-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Adhesive Materials for Continuous Glucose Monitoring Systems
NCT03340467
Accuracy of Continuous Glucose Monitoring in Patients With Diabetes. A Prospective Observational Study
NCT06297850
Diabetes Self-management With Continuous Glucose Monitoring
NCT06453434
Evaluation of Updated Continuous Glucose Monitoring (CGM) Form Factor in Adults, Adolescents and Pediatrics
NCT04436822
Continuous Glucose Monitoring (CGM) in Subjects With Type 2 Diabetes
NCT01341067
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Induction day 1, 4, 7, 14
Patient will come to the hospital on day 1, 4, 7 and 14. A hypo- or hyperglycaemic experiment will start according to allocation by randomizer.
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.
Induction day 1, 7, 10, 14
Patient will come to the hospital on day 1, 7, 10 and 14. A hypo- or hyperglycaemic experiment will start according to allocation by randomizer.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Medical University of Graz
OTHER
Metronom Health
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Julia Mader, Ass Prof
Role: PRINCIPAL_INVESTIGATOR
Medical University of Graz
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medical University of Graz
Graz, , Austria
Steno diabetes center
Copenhagen, , Denmark
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Julia Mader, Ass. Prof.
Role: primary
Kirsten Norgaard, Ass. Prof.
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
ELITE02
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.