Metronom Continuous Glucose Monitoring System

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabete Mellitus

Intervention / Treatment
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* Other: Metronom CGM device
* Other: Metronom CGM device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Induction day 1, 4, 7, 14<br>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<br>* 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.<br>|
| Other: Induction day 1, 7, 10, 14<br>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<br>* 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.<br>|

What is the study measuring?
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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 |