Diabetes Mellitus (Diabetes) Nutritional, Metabolic, Endocrine Diabetes Mellitus
Conditions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age at least 18 years 2. Type 2 diabetes, on oral glucose-lowering medication, or, oral glucose-lowering medication and biphasic insulin
Exclusion criteria
Exclusion criteria: 1. Currently prescribed basal insulin 2. Currently prescribed bolus insulin 3. Currently prescribed glucagon-like peptide 1 (GLP-1) without being prescribed biphasic insulin 4. Concomitant disease or condition that may compromise patient safety including and not limited to; cystic fibrosis, severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition 5. Has a pacemaker or any other neurostimulators 6. Currently receiving dialysis treatment or planning to receive dialysis during the study 7. Women who are pregnant, plan to become pregnant or become pregnant during the study 8. Participating in another study of a glucose monitoring device or drug that could affect glucose measurements or management 9. Known (or suspected) allergy to medical grade adhesives 10. In the investigator’s opinion the participant is unsuitable to participate due to any other cause/reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Responses to HCP questionnaire using HbA1c results alone Responses to a second questionnaire using HbA1c results and the reports generated from the FreeStyle Libre Pro system | — |
Secondary
| Measure | Time frame |
|---|---|
| Glycaemic measures, measured using sensor glucose data collected by the FreeStyle Libre Pro Flash Glucose Monitoring System during the two-week study duration. 1. Time in hypoglycaemia (10.0 mmol/L) 3. Time in range (3.9-10.0 mmol/L) 4. Mean glucose, SD glucose and CV glucose | — |
Countries
England, United Kingdom