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

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2015

Interventions

  • 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).

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LifeScan
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mike Grady, Phd, Study Director, LifeScan

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