Status:
COMPLETED
Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study
Lead Sponsor:
Abbott Diabetes Care
Conditions:
Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2012
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT01432275
Start Date
September 1 2011
End Date
April 1 2012
Last Update
August 4 2017
Active Locations (7)
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1
Tameside Hospital NHS Foundation Trust
Ashton-under-Lyne, United Kingdom, OL6 9RW
2
Ayr Hospital
Ayr, United Kingdom, KA6 6DX
3
Royal United Hospital
Bath, United Kingdom, BA1 3NG
4
Royal Blackburn Hospital
Blackburn, United Kingdom, BB2 7PL