Diabetes Mellitus
Conditions
Brief summary
Study to determine the performance of the LifeScan BGMS when conducted at MAC clinical site.
Detailed description
This study will evaluate the performance of the MAC clinical site to evaluate accuracy performance of LifeScan blood glucose monitoring systems as it is conducted at other LifeScan UK affiliated clinic sites. Multiple LifeScan Blood Glucose Monitoring System (BGMS) will be tested with production lots which have passed release testing.
Interventions
DEVICEOneTouch Verio
OneTouch Verio Blood Glucose Monitoring System.
DEVICEOneTouch Select Plus
OneTouch Select Plus Blood Glucose Monitoring System.
DEVICEOneTouch Ultra
OneTouch Ultra Blood Glucose Monitoring System.
Sponsors
MAC Clinical Research
LifeScan Scotland Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants must be enrolled in LifeScan Patient Registry. * Participants must have read the Information sheet and signed an informedconsent form \>prior to study participation. * Participants must be 16 years or older. * Participants must be diagnosed with Diabetes
Exclusion criteria
\> Participants not enrolled in the LifeScan Patient Registry
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Evaluation of Blood Glucose result (mg/dl) from LifeScan Blood Glucose Monitoring Systems by comparison of a blood glucose result (mg/dl) obtained from a reference instrument (YSI2900) to demonstrate accuracy (%). | Less than 30 minutes | Clinical Evaluation of Blood Glucose result (mg/dl) from LifeScan Blood Glucose Monitoring Systems by comparison of a blood glucose result (mg/dl) obtained from a reference instrument (YSI2900) to demonstrate accuracy (%). |
Countries
United Kingdom
Outcome results
None listed