Diabetic Mellitus Patients Glucose Range Awareness After Experiencing a New Blood Glucose Meter Feature

September 12, 2016 updated by: LifeScan
A single visit & single arm study in 80 subjects with diabetes to determine if a short educational experience with a new blood glucose meter feature improves the ability of each subject to better classify glucose results into acceptable glucose ranges.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosed with Type 1 diabetes Mellitus (T1DM) or Type 2 diabetes Mellitus (T2DM) for ≥ 3 months
  • Currently performing self monitoring of blood glucose (SMBG) at home
  • Aged ≥16 years

Exclusion Criteria:

  • Previous use of any blood glucose meter with the colour range indicator feature to be evaluated in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education with new meter feature.
Subjects experience a computer stimulation of a new meter feature ( colour range indicator) to help subjects interpret whether blood glucose results are low, in-range or high based on accepted guidance.
Behavioral: Education with new meter feature.
The blood glucose meter has default settings for the colour range indicator which can be customized by the subjects and/or their healthcare professional. This colour range indicator will be presented to the subjects as a computer simulation to show subjects a range of typical blood glucose values and how this new feature would classify these results as being low (blue), in-range (green) or high (red).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Success rate to categorize blood glucose values into accepted ranges.
Time Frame: On average within 30 mins post intervention.
On average within 30 mins post intervention.

Secondary Outcome Measures

Outcome Measure
Time Frame
Actual time taken to categorize blood glucose values into accepted ranges on the questionnaire provided.
Time Frame: On average within 30 mins post intervention.
On average within 30 mins post intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeScan

Investigators

  • Study Director: Mike Grady, Phd, LifeScan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2015

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

August 1, 2015

Study Registration Dates

First Submitted

July 9, 2015

First Submitted That Met QC Criteria

July 14, 2015

First Posted (Estimate)

July 15, 2015

Study Record Updates

Last Update Posted (Estimate)

September 14, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 3135718

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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