Diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Have type 1 or type 2 diabetes 3. Be self-testing their blood glucose levels at least twice per day 4. Be able to follow the instructions provided to him/her by the study site and perform all study tasks as specified by the protocol, in the investigator’s opinion 5. Be available for all study visits 6. Be willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Participated in the same study event 2. Be a member of the study staff 3. Have a known allergy to medical grade adhesive 4. Be pregnant or planning to become pregnant within the study event duration 5. Have skin abnormality at the application sites 6. Have a pacemaker or any other neuro stimulators 7. Have concomitant medical condition which in the investigator’s opinion could interfere with the study or present a risk to the safety or welfare of the participant or study staff
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy performance of the Abbott FreeStyle Libre Flash Glucose Monitoring System compared to capillary fingerstick blood glucose values (FreeStyle Optium blood glucose test strips) using the consensus error grid. | — |
Secondary
| Measure | Time frame |
|---|---|
| Precision within Sensor lot. | — |
Countries
England, United Kingdom