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Metronom Continuous Glucose Monitoring System

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Metronom CGM device
Metronom CGM device
Sponsored by
Metronom Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 1

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Medical University of Graz
  • Steno diabetes center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Induction day 1, 4, 7, 14

Induction day 1, 7, 10, 14

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 30, 2017
Last Updated
August 14, 2019
Sponsor
Metronom Health
Collaborators
Medical University of Graz
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1. Study Identification

Unique Protocol Identification Number
NCT03341026
Brief Title
Metronom Continuous Glucose Monitoring System
Official Title
An Open, Multicenter, Randomized, Controlled Pilot Trial Evaluating the Metronom Continuous Glucose Monitoring System in Subjects With Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
June 2020 (Anticipated)
Primary Completion Date
August 2020 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Metronom Health
Collaborators
Medical University of Graz

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabete Mellitus

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Induction day 1, 4, 7, 14
Arm Type
Other
Arm Description
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.
Arm Title
Induction day 1, 7, 10, 14
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Metronom CGM device
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Metronom CGM device
Intervention Description
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.
Primary Outcome Measure Information:
Title
Accuracy
Description
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
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Reliability
Description
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
Time Frame
14 days
Title
Reliability
Description
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)
Time Frame
14 days
Title
Reliability
Description
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)
Time Frame
14 days
Title
Reliability
Description
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)
Time Frame
14 days
Title
Accuracy
Description
Overall percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15%.
Time Frame
14 days
Title
Reliability
Description
Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15% (overall, on different days of wear-time)
Time Frame
14 days
Title
Reliability
Description
Mean (MARD) and Median Absolute Relative Difference (MedARD) (overall, on different days of wear-time)
Time Frame
14 days
Title
Reliability
Description
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)
Time Frame
14 days
Title
Reliability
Description
Bland-Altman analysis comparing sensor values with reference measurements (overall, on different days of wear-time)
Time Frame
14 days
Title
Reliability
Description
Distribution of data points in the Point and Rate Error Grid (overall, on different days of wear-time)
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ursula Morjaria, MSc
Phone
0032(0)10 23 38 80
Email
umorjaria@metronomhealth.com
First Name & Middle Initial & Last Name or Official Title & Degree
Joris Coteur, MSc
Phone
0032(0)10 23 38 80
Email
jcoteur@metronomhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julia Mader, Ass Prof
Organizational Affiliation
Medical University of Graz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Graz
City
Graz
Country
Austria
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julia Mader, Ass. Prof.
Facility Name
Steno diabetes center
City
Copenhagen
Country
Denmark
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kirsten Norgaard, Ass. Prof.

12. IPD Sharing Statement

Plan to Share IPD
No

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