Diabetes mellitus Nutritional, Metabolic, Endocrine Diabetes mellitus
Conditions
Interventions
Participants will wear two masked sensors for a period of up to 14 days. They will be requested to obtain at least four fingerstick readings per day whilst wearing the sensors (using the built-in test
each in-clinic visit will consist of eight hours of reference sampling at 15 minute intervals, from an IV port.
Sponsors
Abbott Diabetes Care Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 18 years or over 2. Type 1 or type 2 diabetes requiring insulin therapy for at least 6 months prior to enrolment 3. Participant reports self-testing their blood glucose levels at least twice per day 4. Suitable venous access for study participation
Exclusion criteria
Exclusion criteria: 1. Have a known allergy to medical grade adhesive 2. Be pregnant or planning to become pregnant within the study duration 3. Have skin abnormality at the application sites 4. Have a pacemaker or any other neurostimulators 5. 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 6. Have anaemia 7. Currently participating in another clinical study 8. Participant is unsuitable for participation due to any other cause as determined by the Investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The point accuracy of the FreeStyle Libre Flash Glucose Monitoring System, measured using percentage of readings that are within ±20% of the YSI reference value for glucose levels = 80 mg/dL (4.4 mmol/L) and within ±20 mg/dL (1.1 mmol/L) for YSI glucose levels <80 mg/dL(4.4 mmol/L), with and without a potential In-Reader correction. Measured on days 1, 2, 5, 7, 11 and 14 of sensor wear. | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcome measures | — |
Countries
England, United Kingdom
Contacts
Public ContactPamela Reid
Outcome results
None listed