- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03341026
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
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ursula Morjaria, MSc
- Phone Number: 0032(0)10 23 38 80
- Email: umorjaria@metronomhealth.com
Study Contact Backup
- Name: Joris Coteur, MSc
- Phone Number: 0032(0)10 23 38 80
- Email: jcoteur@metronomhealth.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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)
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.
|
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.
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.
|
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.
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
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 |
14 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reliability
Time Frame: 14 days
|
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
Time Frame: 14 days
|
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
Time Frame: 14 days
|
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
Time Frame: 14 days
|
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
Time Frame: 14 days
|
Overall percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15%.
|
14 days
|
Reliability
Time Frame: 14 days
|
Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) ≤15% (overall, on different days of wear-time)
|
14 days
|
Reliability
Time Frame: 14 days
|
Mean (MARD) and Median Absolute Relative Difference (MedARD) (overall, on different days of wear-time)
|
14 days
|
Reliability
Time Frame: 14 days
|
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
Time Frame: 14 days
|
Bland-Altman analysis comparing sensor values with reference measurements (overall, on different days of wear-time)
|
14 days
|
Reliability
Time Frame: 14 days
|
Distribution of data points in the Point and Rate Error Grid (overall, on different days of wear-time)
|
14 days
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Julia Mader, Ass Prof, Medical University of Graz
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ELITE02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus, Type 2
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Mannkind CorporationTerminatedType 2 Diabetes Mellitus | Type 1 Diabetes MellitusUnited States
-
RWTH Aachen UniversityBoehringer IngelheimCompletedDiabetes Mellitus Type 2 (T2DM)Germany
-
University Hospital Inselspital, BerneCompletedType 2 Diabetes MellitusSwitzerland
-
India Diabetes Research Foundation & Dr. A. Ramachandran...CompletedTYpe 2 Diabetes MellitusIndia
-
Scripps Whittier Diabetes InstituteSan Diego State UniversityCompletedType 2 Diabetes Mellitus (T2DM)United States
-
Griffin HospitalCalifornia Walnut CommissionCompletedDIABETES MELLITUS TYPE 2United States
-
US Department of Veterans AffairsAmerican Diabetes AssociationCompletedType 2 Diabetes MellitusUnited States
-
Dexa Medica GroupCompletedType-2 Diabetes MellitusIndonesia
-
Diabetes Foundation, IndiaNational Diabetes Obesity and Cholesterol FoundationRecruitingType 2 Diabetes Mellitus With ComplicationIndia
Clinical Trials on Metronom CGM device
-
Ceragem Clinical Inc.Not yet recruitingKyphosis | Cervical Kyphosis | Cervical Lordosis
-
Baylor Research InstituteEnrolling by invitationDiabetes Mellitus | Diabetes | Glucose, Low Blood | Glucose, High BloodUnited States
-
Intermountain Health Care, Inc.AbbottActive, not recruitingDiabetes Mellitus, Type 2United States
-
Beijing Tsinghua Chang Gung HospitalThe First Affiliated Hospital of Anhui Medical University; Beijing Tiantan... and other collaboratorsRecruitingComprehensive Complication IndexChina
-
Signos IncRecruitingDiabetes Mellitus, Type 2 | Metabolic Syndrome | Insulin Resistance | Weight Loss | Glucose Intolerance | Central Obesity | Metabolic Glucose DisordersUnited States
-
Signos IncRecruitingMetabolic Syndrome | Weight Loss | Glucose Intolerance | Pre-diabetes | Central Obesity | Metabolic Glucose DisordersUnited States
-
Scripps Whittier Diabetes InstituteNot yet recruiting
-
University of the PacificRecruitingType 1 Diabetes | Type 2 DiabetesUnited States
-
Jaeb Center for Health ResearchDexCom, Inc.Completed
-
Tel-Aviv Sourasky Medical CenterDexCom, Inc.RecruitingDiabetes Mellitus | Pregnancy Complications | Hyperglycemic DisorderIsrael