Diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Current interventions as of 26/09/2022:
Participants wear the three Sensors according to labelling instructions. The data is transferred and stored in the Reader memory by regular scan
Sponsors
Abbott Diabetes Care Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 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 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. For all primary and secondary outcomes, the data is generated during the Sensor wear period (up to 14 days) during which the participant measures their blood glucose (BG) at least 4 times a day with corresponding Sensor scans. The data recorded in the Reader will be uploaded at visit 2 (day 15) and subsequently transferred to Abbott Diabetes Care (ADC) for analysis. The primary outcome will be measured by calculating the proportion of paired Sensor and BG values within each zone of the Consensus Error Grid. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Precision within Sensor lot estimated by calculating the coefficient of variation of Sensor slopes. Slopes will be calculated for each sensor by standard linear regression of Sensor Glucose vs. BG 2. Relationship between HbA1c levels and glycaemic variability, determined from Sensor glucose values For all primary and secondary outcomes, the data is generated during the Sensor wear period (up to 14 days) during which the participant measures their blood glucose (BG) at least 4 times a day with corresponding Sensor scans. The data recorded in the Reader will be uploaded at visit 2 (day 15) and subsequently transferred to Abbott Diabetes Care (ADC) for analysis | — |
Countries
England, United Kingdom
Contacts
Public ContactPamela Reid
Outcome results
None listed