N/A
Completed N=177
Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study
Source: ClinicalTrials.gov NCT01432275 ↗Enrolled (actual)
177
Serious AEs
0.6%
Results posted
Aug 2017
Primary outcomePrimary: Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method. — 125 participants — p=<0.0001
Summary
The aim of this study is to evaluate user preference and ease of use of the FreeStyle InsuLinx system, compared to current methodology, when used at home by subjects with diabetes.
Subjects will also be comparing the ease of use of the FreeStyle InsuLinx system with comparator meters.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method. |
125 | <0.0001 sig |
| SECONDARY Preference Questionnaire (Insulin Calculator Not Activated) |
98; 32; 34 | — |
Eligibility Criteria
Inclusion Criteria
- Subject with Type 1 or 2 diabetes on a bolus regime (U100 insulin), one or more bolus injections per day for at least 6 months;
- Age 18 yrs and above;
- Regularly testing SMBG 3 or more times per day;
- Willingness to test at least 4 times per day.
Exclusion Criteria
- Know to require a bolus injection of more than 50U in a single dose;
- Has previously used either the InsuLinx or assigned comparison meter;
- Participated in structured diabetes management training in the last 6 months
- Is currently on an insulin pump;
- Has concomitant disease that, in the Investigator's opinion, may compromise patient safety;
- Is participating in another study of a glucose monitoring device or drug that could affect glucose measurements or glucose management;
- Female subject who is pregnant or planning to become pregnant during the course of the study.
Data sourced from ClinicalTrials.gov (NCT01432275). 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.