Assessment of Blood Glucose Monitoring Devices With New Insight Features

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

267 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-01

Study Completion Date

2017-06-22

Brief Summary

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To investigate whether novel insight features in new BGMs can improve glycemic control.

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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

FACTORIAL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control

Subject continue to use their own Blood Glucose Monitoring System ( BGMS) for 12 weeks.

Group Type ACTIVE_COMPARATOR

Subject's Own Blood Glucose Meter

Intervention Type DEVICE

Subject's Own Blood Glucose Meter

OneTouch Verio®

Subjects use LifeScan provided BGMS (OneTouch Verio®) for 12 weeks

Group Type EXPERIMENTAL

OneTouch Verio®

Intervention Type DEVICE

Colour Enhanced Blood Glucose Meter.

Intervention 02

Subjects use LifeScan provided BGMS (OneTouch Verio® Flex ) for 12 weeks.

Group Type EXPERIMENTAL

OneTouch Verio® Flex

Intervention Type DEVICE

Colour Enhanced Blood Glucose Meter.

Interventions

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OneTouch Verio®

Colour Enhanced Blood Glucose Meter.

Intervention Type DEVICE

OneTouch Verio® Flex

Colour Enhanced Blood Glucose Meter.

Intervention Type DEVICE

Subject's Own Blood Glucose Meter

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with T1DM or T2DM for ≥ 3 month prior to screening
* Currently performing SMBG at home for diabetes management decisions
* Willingness to notify the study staff if they become pregnant during the study
* Willing to sign an informed consent

Exclusion Criteria

* Is unlikely to be compliant with the diabetes regimen in the opinion of study staff
* Currently pregnant or planning pregnancy within duration of study or breast feeding; subjects who become pregnant during the study will be withdrawn
* Conflict of Interest

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No