Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study

Study Overview
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Brief Summary
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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.

Official Title
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Ease of Use of New Blood Glucose Meter With In-built Insulin Calculator at Home Study

Conditions
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Diabetes Mellitus

Intervention / Treatment
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* Device: ADC blood glucose meter
* Device: Comparator blood glucose meter
* Device: ADC blood glucose meter with insulin calculator active


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADC, Then Comparator, Then ADC With Calculator<br>Subject 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. | Device: ADC blood glucose meter<br>* Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter.<br>* Other names: Abbott Freestyle InsuLinx;Device: Comparator blood glucose meter<br>* Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter.<br>* Other names: Bayer Contour USB;Device: ADC blood glucose meter with insulin calculator active<br>* Subjects used the FreeStyle InsuLinx with the insulin calculator activated.<br>* Other names: Abbott FreeStyle InsuLinx;|
| Experimental: Comparator, Then ADC, Then ADC With Calculator<br>Subject 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. | Device: ADC blood glucose meter<br>* Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter.<br>* Other names: Abbott Freestyle InsuLinx;Device: Comparator blood glucose meter<br>* Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter.<br>* Other names: Bayer Contour USB;Device: ADC blood glucose meter with insulin calculator active<br>* Subjects used the FreeStyle InsuLinx with the insulin calculator activated.<br>* Other names: Abbott FreeStyle InsuLinx;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference Questionnaire (Insulin Calculator Not Activated) | Result for the question: The meter the subject would change to | 25 days (results recorded after the two 7 day periods) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes, SMBG, Insulin calculator