AN OPEN, MULTI-CENTER, RANDOMIZED, CONTROLLED PILOT TRIAL EVALUATING THE METRONOM CONTINUOUS GLUCOSE MONITORING SYSTEM IN SUBJECTS WITH TYPE 1 DIABETES MELLITUS

• Register: German Clinical Trials Register
• Last refreshed on: 8 April 2024
• Main ID: DRKS00013295
• Date of registration: 28/11/2017
• Prospective Registration: Yes
• Primary sponsor: Metronom HealthVP Clinical & RA, Metronom Health
• Public title: AN OPEN, MULTI-CENTER, RANDOMIZED, CONTROLLED PILOT TRIAL EVALUATING THE METRONOM CONTINUOUS GLUCOSE MONITORING SYSTEM IN SUBJECTS WITH TYPE 1 DIABETES MELLITUS
• Scientific title: AN OPEN, MULTI-CENTER, RANDOMIZED, CONTROLLED PILOT TRIAL EVALUATING THE METRONOM CONTINUOUS GLUCOSE MONITORING SYSTEM IN SUBJECTS WITH TYPE 1 DIABETES MELLITUS - ELITE_02
• Date of first enrolment: 18/12/2017
• Target sample size: 20
• Recruitment status: Recruiting withdrawn before recruiting started
• URL: http://drks.de/search/en/trial/DRKS00013295
• Study type: interventional
• Study design: Allocation: Randomized controlled study; Masking: Open (masking not used); Control: Other; Assignment: other; Study design purpose: treatment
• Phase: 1

Countries of recruitment

Austria, Canada, Denmark

Contacts

• Name: Daniela Schwarzenbacher
• Affiliation: Clinical Research Center, Medizinische Universität Graz

• Name: Julia Mader
• Affiliation: Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Abteilung für Endokrinologie und Stoffwechsel

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: None
Gender: All

Health Condition(s) or Problem(s) studied

E10

Type 1 diabetes mellitus

Intervention(s)

Group 1: Visit schedule:
Visit 0 (Screening) --> Visit 1 (D1) --> Visit A (D4) --> Visit 2 (D7) --> Visit 3 (D14) --> Visit 4 (Follow-up)

Procedures:
At Visits 1, 2, 3, and A/B a meal/insulin test with frequent plasma glucose monitoring (15 minute intervals for up to 8 hours)
Group 2: Visit schedule:
Visit 0 (Screening) --> Visit 1 (D1) --> Visit 2 (D7) --> Visit B (D10) --> Visit 3 (D14) --> Visit 4 (Follow-up)

Procedures see arm 1

Primary Outcome(s)

Overall percentage of sensor values(Metronom sensor) which fall within ± 20 mg/dl of the mean reference values at glucose (Super GL2/YSI).

Measurements are performed at every in-house visit(D1, D7, D14, D4/10 of wear time) in 15 minute intervals for up to 8 hours.

Secondary Outcome(s)

- 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
- Percentage of sensor values which fall within ± 15 mg/dl of the mean reference values at glucose concentrations <100 mg/dl and within ± 15% at glucose concentrations =100 mg/dl (cf. ISO 15197: 2013, Chapter 6.3.3) (overall, on different days of wear-time)
- 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)
- 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)
- Overall percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) =15%.
- Percentage of test-to-reference measurement pairs with an Absolute Relative Difference (ARD) =15% (overall, on different days of wear-time)
- Mean (MARD) and Median Absolute Relative Difference (MedARD) (overall, on different days of wear-time)
- 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 wear-time)
- Bland–Altman analysis comparing sensor values with reference measurements (overall, on different days of wear-time)
- Distribution of data points in the Point and Rate Error Grid (overall, on different days of wear-time)

Source(s) of Monetary Support

Metronom HealthVP Clinical & RA, Metronom Health

Ethics review

Status: Approved
Approval date: 10/11/2017
Contact:

[e-mail]

Ethikkommission der Medizinischen Universität Graz

[phone]

[e-mail]

Results

• URL: http://drks.de/search/en/trial/DRKS00013295#studyResults