Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study
IHUT
1 other identifier
interventional
179
1 country
7
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 be comparing the ease of use of the FreeStyle InsuLinx system with comparator meters.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes-mellitus
Started Sep 2011
Shorter than P25 for not_applicable diabetes-mellitus
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 9, 2011
CompletedFirst Posted
Study publicly available on registry
September 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedResults Posted
Study results publicly available
August 4, 2017
CompletedAugust 4, 2017
April 1, 2017
7 months
September 9, 2011
July 10, 2013
April 27, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall User Preference for the FreeStyle InsuLinx System Compared to Current Method.
Overall user preference of the FreeStyle InsuLinx system as a diabetes management tool when compared against their usual method.
25 days
Secondary Outcomes (1)
Preference Questionnaire (Insulin Calculator Not Activated)
25 days (results recorded after the two 7 day periods)
Study Arms (2)
ADC, Then Comparator, Then ADC With Calculator
EXPERIMENTALSubject used the ADC blood glucose meter for 7 days with the insulin calculator not activated, followed by a comparator blood glucose meter for 7 days. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
Comparator, Then ADC, Then ADC With Calculator
EXPERIMENTALSubject used a comparator blood glucose meter for 7 days, followed by the ADC blood glucose meter for 7 days, with the insulin calculator not activated. For the last 10 days the subject used the ADC blood glucose meter with insulin calculator active.
Interventions
Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter.
Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter.
Subjects used the FreeStyle InsuLinx with the insulin calculator activated.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Tameside Hospital NHS Foundation Trust
Ashton-under-Lyne, OL6 9RW, United Kingdom
Ayr Hospital
Ayr, KA6 6DX, United Kingdom
Royal United Hospital
Bath, BA1 3NG, United Kingdom
Royal Blackburn Hospital
Blackburn, BB2 7PL, United Kingdom
North Manchester Diabetes Centre
Crumpsall, M8 5RB, United Kingdom
Ipswich Hospital NHS Trust
Ipswich, IP4 5PD, United Kingdom
Greenwood & Sneinton Family Medical Centre
Nottingham, NG3 7DQ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Snr Director, Clinical Development & Regulatory Affairs
- Organization
- Abbott Diabetes Care
Study Officials
- PRINCIPAL INVESTIGATOR
Shenaz Ramtoola
Royal Blackburn Hospital
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2011
First Posted
September 12, 2011
Study Start
September 1, 2011
Primary Completion
April 1, 2012
Study Completion
April 1, 2012
Last Updated
August 4, 2017
Results First Posted
August 4, 2017
Record last verified: 2017-04