Impact of a built-in Insulin Calculator Feature on Diabetes Control

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2012-10-31

Brief Summary

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The purpose of this study is to investigate the effect of using FreeStyle InsuLinx (a blood glucose meter with a built-in insulin calculator) on glucose control in people with type 1 diabetes.

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Detailed Description

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Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Intervention

Subjects will use a FreeStyle InsuLinx blood glucose meter during the study

Group Type OTHER

FreeStyle InsuLinx

Intervention Type DEVICE

FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.

Control

Subjects will use a FreeStyle Freedom Lite blood glucose meter during the study.

Group Type OTHER

FreeStyle Freedom Lite

Intervention Type DEVICE

FreeStyle Freedom Lite is a blood glucose meter

Interventions

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FreeStyle InsuLinx

FreeStyle InsuLinx is a blood glucose meter with a built-in insulin calculator feature.

Intervention Type DEVICE

FreeStyle Freedom Lite

FreeStyle Freedom Lite is a blood glucose meter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Subject with Type 1 diabetes on MDI (3 or more insulin injections per day (U100 insulin)) for at least 1 year and insulin adjusting
* HbA1c between 7.0% and 9.5% (53 to 80 mmol/mol) inclusive
* Age 18 and over
* In the investigator's opinion, thought technically capable of using masked CGM
* Subject self reporting a minimum of 21 SMBG tests per week prior to study enrolment
* Willing to perform a minimum of 4 SMBG tests per day during study

Exclusion Criteria

* Subject has any concomitant disease or condition that, in the investigator's opinion, may compromise patient safety
* Subject is participating in another study of a glucose monitoring device / drug that could affect glucose measurements / management
* Subject is pregnant / planning to become pregnant within the planned study timeline
* Subject is known to require a dose of more than 50 units of U100 insulin in any one bolus injection
* Subject is currently on an insulin pump
* Subject is currently using the FreeStyle InsuLinx
* Subject is currently using the FreeStyle Freedom Lite
* Subject is currently using CGM
* Subject has an allergy to medical grade adhesives

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No