Diabetes Nutritional, Metabolic, Endocrine Diabetes
Conditions
Interventions
Following a 20 day masked (baseline) period using the Freestyle Navigator subjects will be randomised into one of 3 groups for the next 80 days:
1. The first group will wear the FreeStyle Navigator fo
Sponsors
Abbott Diabetes Care Ltd (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria as of 13/03/2012: 1. Subject with type 1 or type 2 diabetes on multiple daily injections (MDI) (3 or more insulin injections per day) or continuous subcutaneous insulin infusion (CSII) for greater than 6 months prior to study enrolment 2. Aged 18 - 65 years, either sex and, in the Investigator's opinion, thought technically capable of using CGM 3. HbA1c between 7% and 11% (inclusive) for previous HbA1c test obtained within 3 months prior to enrolment 4. Subject reporting testing of blood glucose an average of 2 - 7 times per day Previous inclusion criteria 1. Subject with type 1 or type 2 diabetes on multiple daily injections (MDI) (3 or more insulin injections per day) or continuous subcutaneous insulin infusion (CSII) for greater than 1 year prior to study enrolment 2. Aged 18 - 65 years, either sex and, in the Investigator's opinion, thought technically capable of using CGM 3. HbA1c between 7.5% and 10% (inclusive) for previous HbA1c test obtained within 3 months prior to enrolment 4. Subject reporting testing of blood glucose an average of 2 - 7 times per day
Exclusion criteria
Exclusion criteria: 1. Subject has known allergy to medical grade adhesives 2. Subject has concomitant disease or condition that influences metabolic control or, in the investigator?s opinion, may compromise patient safety 3. Subject is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management 4. Subject is currently using another continuous glucose monitoring device or has used real-time continuous glucose monitoring in the last 6 months 5. Subject is pregnant/planning to become pregnant within the planned study duration
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time spent outside of glucose target: no alarms versus SMBG (days 80 - 100) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Time spent outside of glucose target: no alarms versus CGM (days 80 - 100) 2. Time spent outside of glucose target: CGM versus SMBG (days 80 - 100) 3. Time spent outside of glucose target (days 40 - 60) 4. HbA1c 5. Average glucose (days 40 - 60 and 80 - 100) 6. Glucose variability (days 40 - 60 and 80 - 100) 7. Quality of life measures 8. Adverse events | — |
Countries
Germany, United Kingdom
Outcome results
None listed