Metronom Continuous Glucose Monitoring System

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03341026
• Other study ID #: ELITE02
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2020
• Est. completion date: August 2020

Study information

• Verified date: August 2019
• Source: Metronom Health
• Contact: Ursula Morjaria, MSc
• Phone: 0032(0)10 23 38 80
• Email: umorjaria[@]metronomhealth.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: August 2020
• Est. primary completion date: August 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabete Mellitus
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Diabetes Mellitus, Type 2

Intervention

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.
• 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.

Locations

Country	Name	City	State
Austria	Medical University of Graz	Graz
Denmark	Steno diabetes center	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Metronom Health	Medical University of Graz

Countries where clinical trial is conducted

Austria,  Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Accuracy	Overall percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) =15%.	14 days
Secondary	Reliability	Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) =15% (overall, on different days of wear-time)	14 days
Secondary	Reliability	Mean (MARD) and Median Absolute Relative Difference (MedARD) (overall, on different days of wear-time)	14 days
Secondary	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
Secondary	Reliability	Bland-Altman analysis comparing sensor values with reference measurements (overall, on different days of wear-time)	14 days
Secondary	Reliability	Distribution of data points in the Point and Rate Error Grid (overall, on different days of wear-time)	14 days