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OpenTrials
Completed

NCT Number: NCT00401622

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

Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oshawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OneTouch® Ultra®2 System

Behavioral

Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program

Standard Care

Behavioral

Standard education and self-monitoring of blood glucose performed with traditional meter systems

Primary outcomes

  1. Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS.

    Time frame: From baseline to 52 wks

Secondary outcomes

  1. Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS.

    Time frame: 52 wks

Sponsors and collaborators

Lead sponsor

LifeScan

Industry

Collaborators

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

Registry information

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Nov 20, 2006
Registry last updated
May 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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