Diabetes mellitus (type 1 or type 2) Nutritional, Metabolic, Endocrine Diabetes mellitus (type 1 or type 2)
Conditions
Interventions
Participants will wear a Masked FreeStyle Libre Glucose Monitoring Sensor for 14 days and perform four fingerprick readings per day for each day of sensor wear using the built-in test strip port. Ther
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 3. Requiring insulin therapy 4. Willing and able to test their blood glucose levels via fingerprick at least four times a day using the FreeStyle Libre System 5. In the investigator’s opinion, technically capable of using the study device 6. On stable haemodialysis (i.e. treatment using dialysis has been in progress for a minimum of 90 days)
Exclusion criteria
Exclusion criteria: 1. Concomitant disease or condition that may compromise patient safety including and not limited to cystic fibrosis, severe mental illness, known or suspected eating disorder or any uncontrolled long term medical condition 2. Currently prescribed oral steroid therapy for any acute or chronic condition 3. Female participant known to be pregnant 4. Have a pacemaker or any other neurostimulators 5. Known (or suspected) allergy to medical grade adhesives 6. In the investigator’s opinion, is unsuitable to participate due to any other reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The accuracy of the system will be measured for the duration the subject is wearing the device (up to 14 days). Each blood glucose result recorded on the reader will be paired with the nearest Sensor glucose result. 2. The safety of the device in the diabetic population sub-group will be measured using the number and percentage of participants experiencing adverse events during the study from the point of consent until the end of the study. | — |
Countries
England, United Kingdom
Contacts
Public ContactPamela Reid
Outcome results
None listed