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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

179 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-04-30

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.

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Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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ADC, Then Comparator, Then ADC With Calculator

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.

Group Type EXPERIMENTAL

ADC blood glucose meter

Intervention Type DEVICE

Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter.

Comparator blood glucose meter

Intervention Type DEVICE

Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter.

ADC blood glucose meter with insulin calculator active

Intervention Type DEVICE

Subjects used the FreeStyle InsuLinx with the insulin calculator activated.

Comparator, Then ADC, Then ADC With Calculator

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.

Group Type EXPERIMENTAL

ADC blood glucose meter

Intervention Type DEVICE

Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter.

Comparator blood glucose meter

Intervention Type DEVICE

Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter.

ADC blood glucose meter with insulin calculator active

Intervention Type DEVICE

Subjects used the FreeStyle InsuLinx with the insulin calculator activated.

Interventions

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ADC blood glucose meter

Subjects used the FreeStyle InsuLinx with the insulin calculator not activated. Subjects had not previously used the FreeStyle InsuLinx meter.

Intervention Type DEVICE

Comparator blood glucose meter

Subjects were randomly assigned one of the comparator meters. Subjects had not previously used the assigned comparator meter.

Intervention Type DEVICE

ADC blood glucose meter with insulin calculator active

Subjects used the FreeStyle InsuLinx with the insulin calculator activated.

Intervention Type DEVICE

Other Intervention Names

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Abbott Freestyle InsuLinx Roche Accu-Chek Aviva Nano Lifescan Verio Pro or Bayer Contour USB Abbott FreeStyle InsuLinx

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No