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

This study has been completed.
Sponsor:
Collaborator:
Abbott Diabetes Care
Information provided by:
Park Nicollet Institute
ClinicalTrials.gov Identifier:
NCT00465881
First received: April 24, 2007
Last updated: December 5, 2007
Last verified: September 2007
  Purpose

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.


Condition Intervention Phase
Diabetes
Glucose Variability
CGM
Device: CGM System for Type 1 and Type 2 Diabetes Mellitus
Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official 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

Resource links provided by NLM:


Further study details as provided by Park Nicollet Institute:

Estimated Enrollment: 30
Study Start Date: January 2006
Study Completion Date: April 2006
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00465881

Locations
United States, Minnesota
International Diabetes Center - Park Nicollet Health Services
Minneapolis, Minnesota, United States, 55416
Sponsors and Collaborators
Park Nicollet Institute
Abbott Diabetes Care
Investigators
Principal Investigator: Roger S. Mazze, PhD International Diabetes Center - Park Nicollet Institute
Principal Investigator: Richard M. Bergenstal, MD International Diabetes Center - Park Nicollet Institute
Principal Investigator: Ellie S. Strock, RN BC-ANP International Diabetes Center - Park Nicollet Institute
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00465881     History of Changes
Other Study ID Numbers: 01929-05-C
Study First Received: April 24, 2007
Last Updated: December 5, 2007
Health Authority: United States: Food and Drug Administration

Keywords provided by Park Nicollet Institute:
Diabetes
CGM

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on October 19, 2014