Diabetes Mellitus, Type 1NCT03341026
Metronom Continuous Glucose Monitoring System
A study testing Metronom CGM device in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Metronom Health at 2 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabete Mellitus
- What is being tested?
- Metronom CGM device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2020to Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: 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.
- Being tested
- Metronom CGM device
- Medical subject headings
- Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Metronom CGM deviceOther
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 deviceOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Induction day 1, 4, 7, 14 | Other | 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. Receives: Other: Metronom CGM device |
| Induction day 1, 7, 10, 14 | Other | 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. Receives: Other: Metronom CGM device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 14 days
Secondary outcomes (10)
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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 14 days
Accuracy
Overall percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15%.
Measured: 14 days
Reliability
Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15% (overall, on different days of wear-time)
Measured: 14 days
Reliability
Mean (MARD) and Median Absolute Relative Difference (MedARD) (overall, on different days of wear-time)
Measured: 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)
Measured: 14 days
Reliability
Bland-Altman analysis comparing sensor values with reference measurements (overall, on different days of wear-time)
Measured: 14 days
Reliability
Distribution of data points in the Point and Rate Error Grid (overall, on different days of wear-time)
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2017
- Study startJun 2020 (estimated)
- Primary completionAug 2020 (estimated)
- Study completionAug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Metronom Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medical University of Graz
- Responsible party
- Sponsor
- Investigators
- Julia Mader, Ass Prof, Principal investigator, Medical University of Graz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03341026
- Sponsor's protocol ID
- ELITE02
- Status last verified
- Aug 2019
- First submitted
- 30 Oct 2017
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Multicenter, Randomized, Controlled Pilot Trial Evaluating the Metronom Continuous Glucose Monitoring System in Subjects With Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT03341026
- Acronym / sponsor ID
- ELITE02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Metronom HealthIndustry (pharma, biotech, devices)
- Collaborators
- Medical University of Graz
- Study start
- Jun 2020 (estimated)
- Primary completion
- Aug 2020 (estimated)
- Study completion
- Aug 2020 (estimated)
- First posted
- 14 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Induction day 1, 4, 7, 14 | Other | Other: Metronom CGM devicePatient will come to the hospital 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 | Other | Other: Metronom CGM devicePatient will come to the hospital on day 1, 7, 10 and 14. A hypo- or hyperglycaemic experiment will start according to allocation by randomizer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metronom CGM devicePatient 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 | Induction day 1, 4, 7, 14 |
| Metronom CGM devicePatient 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 |
Primary outcome
Accuracy
Time frame: 14 days
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
10 secondary outcomes
Reliability
Time frame: 14 days
Reliability
Time frame: 14 days
Reliability
Time frame: 14 days
Reliability
Time frame: 14 days
Accuracy
Time frame: 14 days
Reliability
Time frame: 14 days
Reliability
Time frame: 14 days
Reliability
Time frame: 14 days
Reliability
Time frame: 14 days
Reliability
Time frame: 14 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia Mader, Ass Prof principal investigator
Medical University of Graz
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Metronom CGM device in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by Metronom Health at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Austria, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ursula Morjaria, MSc (0032(0)10 23 38 80, umorjaria@metronomhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy (time frame: 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2019.