Diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Whole blood obtained from the subject (venous whole blood from venepuncture or capillary whole blood from a fingerstick) will be tested on the blood glucose monitoring systems, the HemoCue analyser an
Sponsors
Abbott Diabetes Care Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosed with diabetes 2. =16 years of age
Exclusion criteria
Exclusion criteria: 1. Participated in the study event already 2. Member of the site study team
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The accuracy of the blood glucose monitoring system compared to the YSI analyser using fingerstick capillary or venous whole blood samples: 1.1. Capillary: Percentage of replicates within ISO15197 2003 or 2015 system accuracy criteria 1.2. Venous: Percentage of responses within each zone of the Consensus Error Grid Measured at the single study visit | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Precision: Mean paired replicate coefficient of variation (Capillary/Venous) 2. Error grid analysis: Percentage of replicates within each zone of the Consensus Error Grid (Capillary) Measured at the single study visit | — |
Countries
United Kingdom
Contacts
Public ContactPamela Reid
Outcome results
None listed