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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Diabete Mellitus
• Intervention / Treatment: Other: Metronom CGM device; Other: Metronom CGM device

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Austria
  • Graz, Austria
    • Medical University of Graz
• Denmark
  • Copenhagen, Denmark
    • Steno Diabetes Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reliability	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 on different days of wear-time	14 days
Reliability	Percentage of sensor values which fall within ± 15 mg/dl of the mean reference values ≥100 mg/dl (cf. ISO 15197: 2013, Chapter 6.3.3) (overall, on different days of wear-time)	14 days
Reliability	Percentage of sensor values which fall within ± 30 mg/dl of the mean reference values at glucose concentrations <100 mg/dl and within ± 30% at glucose concentrations ≥100 mg/dl (overall, on different days of wear-time)	14 days
Reliability	Percentage of sensor values which fall within ± 40 mg/dl of the mean reference values at glucose concentrations <100 mg/dl and within ± 40% at glucose concentrations ≥100 mg/dl (overall, on different days of wear-time)	14 days
Accuracy	Overall percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15%.	14 days
Reliability	Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15% (overall, on different days of wear-time)	14 days
Reliability	Mean (MARD) and Median Absolute Relative Difference (MedARD) (overall, on different days of wear-time)	14 days
Reliability	Mean (MARD) and Median Absolute Relative Difference (MedARD) with regard to reference measurements in the hypoglycaemic (≤70mg/dl), euglycaemic (70- 180mg/dl), and hyperglycaemic (≥180mg/dl) area (overall, on different days of weartime)	14 days
Reliability	Bland-Altman analysis comparing sensor values with reference measurements (overall, on different days of wear-time)	14 days
Reliability	Distribution of data points in the Point and Rate Error Grid (overall, on different days of wear-time)	14 days

Collaborators and Investigators

• Sponsor: Metronom Health
• Collaborators: Medical University of Graz
• Investigators: Principal Investigator: Julia Mader, Ass Prof, Medical University of Graz

Study record dates

Study Major Dates

• Study Start (Anticipated): June 1, 2020
• Primary Completion (Anticipated): August 1, 2020
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 8, 2017
• First Posted (Actual): November 14, 2017

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 14, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: ELITE02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No