N/A
Completed N=32
Use of the FreeStyle Navigator Continuous Glucose Monitoring System to Enhance Education and Glycaemic Control
Source: ClinicalTrials.gov NCT01214824 ↗Enrolled (actual)
32
Serious AEs
9.4%
Results posted
Jun 2013
Primary outcomePrimary: Change in HbA1C From Baseline to 6 Months — 9.3; 9.1 HbA1c % — p=0.014
Summary
To demonstrate that in patients with persistent poorly controlled diabetes, short/intermittent use of continuous glucose monitoring can driver better longer-term glycaemic control and HbA1c.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in HbA1C From Baseline to 6 Months |
9.3; 9.1 | 0.014 sig |
| SECONDARY Number of Subjects Who Had Reduction in HbA1c of > or = 0.5% |
14 | — |
| SECONDARY Proportion of Time in Hypoglycaemia (<3.9 mmol/L)- Masked |
0.93; 1.06 | 0.5304 |
| SECONDARY Proportion of Time in Hypoglycaemia (<3.9mmol/L)-Unmasked |
0.60; 0.49 | — |
Eligibility Criteria
Inclusion Criteria
- Subject with Type 1 or Type 2 diabetes requiring Multiple Daily Injections (MDI) (for >1yr)
- Age 18-65 years
- HbA1c above 8.0% for previous 2 HbA1c tests; the last HbA1c result being obtained within 3 months prior to enrolment
- Completed a structured education programme meeting NICE criteria between 6 to 24 months prior to enrolment.
- Testing Blood Glucose ≥ 4 times a day for previous 12 months
Exclusion Criteria
- Subject is currently on an insulin pump.
- Subject has known allergy to medical grade adhesives
- Subject has concomitant disease that influences metabolic control
- Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
- Subject is currently using another continuous glucose monitoring device or has previously used real-time continuous glucose monitoring.
- Subject is receiving peritoneal dialysis solutions containing icodextrin
- Subject is pregnant / planning to become pregnant during study
Data sourced from ClinicalTrials.gov (NCT01214824). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.