Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes

May 3, 2019 updated by: LifeScan
Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

320

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

  • Canada
    • Ontario
      • Oshawa, Ontario, Canada, L1H1017
      • Windsor, Ontario, Canada, N8W3P6
  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG2 7AG
    • Cardiff
      • Llanishen, Cardiff, United Kingdom, CF145GJ
    • Chorley
      • Buckshaw Village, Chorley, United Kingdom, PR7 7NA
    • Manchester
      • Lloyd Street North, Manchester, United Kingdom, M15 6SX
    • Scotland
      • Glasgow, Scotland, United Kingdom, G20 0XA
    • Surrey
      • Claygate, Surrey, United Kingdom, KT10 OSA
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85018
    • California
      • San Diego, California, United States, 92161
    • Delaware
      • Wilmington, Delaware, United States, 19805
    • Florida
      • Hollywood, Florida, United States, 33023
    • Georgia
      • Dawsonville, Georgia, United States, 30534
    • New Jersey
      • Whitehouse Station, New Jersey, United States, 08889
    • New York
      • East Syracuse, New York, United States, 13057
      • Endwell, New York, United States, 13760
      • Syracuse, New York, United States, 13210
    • Texas
      • San Antonio, Texas, United States, 78229

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:·

  • Current diagnosis of type 2 diabetes
  • Diagnosed at least 3 months prior to the start of the study but not more than 15 years from the start of the study
  • Stable regimen (i.e., no changes in therapeutic regimen) for the past three months
  • Baseline HbA1c of 7.0 to 8.9%, inclusive

Exclusion Criteria:

  • Using insulin
  • Using oral agents that target post-prandial hyperglycemia (Note: These medications may be added during the study)
  • Known history of anemia or disorders associated with anemia
  • Has previously used the devices being tested in the 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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OneTouch® Ultra®2 system
Test care group assigned to OneTouch® Ultra®2 system
Behavioral: OneTouch® Ultra®2 System
Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program
Active Comparator: Standard care
Control group receiving standard care with a traditional blood glucose monitoring system
Behavioral: Standard care
Standard education and self-monitoring of blood glucose performed with traditional meter systems

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.
Time Frame: From baseline to 52 wks
From baseline to 52 wks

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.
Time Frame: 52 wks
52 wks

Collaborators and Investigators

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

Sponsor

LifeScan

Collaborators

Synexus(UK)
CPS(UK)
Battelle CRO(US)
RPS CRO(US)
Robertson Centre For Biostatistics (UK)

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 (Actual)

October 1, 2006

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

January 1, 2009

Study Registration Dates

First Submitted

November 16, 2006

First Submitted That Met QC Criteria

November 17, 2006

First Posted (Estimate)

November 20, 2006

Study Record Updates

Last Update Posted (Actual)

May 15, 2019

Last Update Submitted That Met QC Criteria

May 3, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR-1039797

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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