E10.9
Conditions
Interventions
Group 1: All participants receive a subcutaneous sensor (CGM) for a 14 days wearing period, which has to be calibrated with blood from finger pricks. Furthermore all participates receive a diary and,
Sponsors
A. Menarini Diagnostics S.r.l.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Clinical diagnosis of diabetes 2. MDI or CSII therapy 3. Experience with CGM or FGM systems (at least three months in the last year) 4. Age 18-80 years 5. An understanding of and willingness to follow the protocol and sign the informed consent
Exclusion criteria
Exclusion criteria: 1. Inability to adhere to the protocol or to attend the required follow-up visits and tests 2. Diseases or conditions of the abdominal wall skin which, in the opinion of Clinician might contraindicate the insertion of the needle-type sensor into the subcutaneous tissue 3. Legal incapacity and/or other circumstances rendering the subject unable to understand the nature, scope and possible consequences of the study 4. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of the study. 5. Subjects currently participating in an investigational clinical study 6. Pregnancy or breastfeeding 7. Alcoholism 8. Persons on dialysis 9. Known severe skin tape reactions or allergies 10. History of frequent catheter abscesses associated with pump therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| * Mean Absolute Relative Difference (MARD), calculated as the mean of the absolute percentage bias between all CGM values and matched reference (YSI) blood glucose concentration. * CEG (Consensus Error Grid) obtained by plotting paired CGM/ (YSI) reference values on an x-y grid divided in 5 risk zones (A, B, C, D, and E). | — |
Secondary
| Measure | Time frame |
|---|---|
| * Mean Absolute Relative Difference (MARD), calculated as the mean of the absolute percentage bias between all CGM values and matched SMBG blood glucose concentration * Mean Percentage Difference between sensors on the same subject * Total useful monitoring session duration * Scores evaluation of questionnaires compiled by subjects | — |
Countries
Austria
Contacts
Public ContactJulia Mader
LKH Universitätsklinikum Graz Abteilung für Endokrinologie & Diabetologie
Outcome results
None listed