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Completed

NCT Number: NCT00465881

Develop Novel Methods to Display, Report and Analyze CGM Data for Clinical Decision-Making in People With Diabetes

The purpose of this study is to obtain sufficient continuous glucose monitoring (CGM) data in a manner that provides clinical information that is not available using conventional self-monitored blood glucose. Currently, a formal method does not exist for evaluating CGM data except for looking at each glucose reading across the days a CGM system has been worn and evaluating it based on clinical practice experience. The hope is that a mathematical model can be developed that will enable health care providers to quickly and easily determine what changes in diabetes treatment need to be made after CGM data is obtained.

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Key information

Conditions

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

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

International Diabetes Center - Park Nicollet Health Services

Minneapolis, Minnesota, 55416, United States

About this study

There are two purposes to the study. First, to use an investigational device, the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System (Abbott Diabetes Care) to obtain sufficient longitudinal data in order to develop a method for reporting CGM data in a manner that provides clinical information that is not available using conventional SMBG. The long-term goad is to determine the manner and degree to which CGM contributes to clinical decision-making. Because of the evidence that glucose regulation may be indirectly related to blood pressure levels, a second purpose of the study is to monitor variation in BP control by means of self-monitored BP.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Male or female
  • Diagnosed with type 1 or type 2 diabetes
  • Treated with insulin therapy
  • Can also be taking other diabetes medication treatment
  • Age 21 and older
  • Willing to give informed consent
  • Capable of following the protocol and instructions of study staff
  • Available for scheduled visits
  • Access to telephone communications

Exclusion criteria

  • Under 21 years of age
  • Unable to follow protocol
  • Unable to read and write in English
  • Skin abnormalities at insertion sites
  • Allergy to adhesives
  • Any concomitant medication thay would likely affect evaluation of device

Treatment and study plan

CGM System for Type 1 and Type 2 Diabetes Mellitus

Device

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Collaborators

  • Abbott Diabetes Care

Registry information

Official study title

Observational Study of Interstitial Glucose Monitoring With the FreeStyle Navigator Continuous Glucose Monitoring (CGM) System to Develop Novel Methods for Displaying, Reporting and Analyzing CGM Data for Clinical Decision-Making

Important dates

Study start
2006
Study completion
2006
First posted
Apr 25, 2007
Registry last updated
Dec 3, 2015

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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