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OpenTrials
Completed

NCT Number: NCT00782496

Glucose Meter Study

The purpose of this study is to evaluate if the meal marker and reminder feature of the Contour meter along with education maintains or increases frequency of testing blood sugar after meals and enables behavioral changes that may lead to improvement in glycemic control.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Atlanta Diabetes Associates, Atlanta, Georgia, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Persons with type 1 or type 2 diabetes
  • Persons who are on a pump or are taking at least 1 mealtime injection of insulin a day
  • Persons at least 21 years of age
  • Persons willing to complete all study visits and study procedures including:
  • Using the meal-marker + reminder feature regularly (Group 2 subjects only)
  • Using the paper logbook provided (both Groups)
  • Testing their BG at least 3 times a day during the entire study.
  • Persons who are able to speak, read and understand English
  • Persons who are currently performing self-testing of blood glucose at home routinely (at least 3 times per day) for 4 weeks or more

Exclusion criteria

  • Persons who have been using a CONTOUR, BREEZE or BREEZE 2 meter regularly during the previous 6 months
  • Persons who test over 6 times/day regularly
  • Persons who wear a BG sensor 2 weeks or more during each month.
  • Persons with home heath aides who assist with their BG testing.
  • Persons with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:
  • Significant visual impairment
  • Significant hearing impairment
  • Cognitive disorder
  • Significant unstable co-morbidity (with notable change within the past 3 months)
  • Any other condition as per investigator's discretion

Treatment and study plan

Education + new meter

Device

Diabetes education and a new meter with basic features

Education + new meter + feature activation

Device

Diabetes education and a new meter with advanced features

Primary outcomes

  1. Average Number of Weekly Post-Prandial Blood Glucose Tests Performed by Subjects Using Either Basic or Advanced Meter Features

    Time frame: 6 months

Secondary outcomes

  1. Percent of Level 2 Participants Who Rated Helpfulness of Advanced Meter Features as 1 or 2

    Time frame: Over six month period

    Level 2 participants, who used advanced meter features, responded to questionnaires. They rated helpfulness of the meal marker reminder feature on a 5 point scale, 1 being strongly agree and 5 being strongly disagree.

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study title

A New Contour Blood Glucose Monitoring System With High Frequency Testing Patients

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 31, 2008
Registry last updated
Feb 29, 2016

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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