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

Sponsors and Collaborators:	Park Nicollet Institute Abbott Diabetes Care
Information provided by:	Park Nicollet Institute
ClinicalTrials.gov Identifier:	NCT00465881

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 I

MedlinePlus related topics: Diabetes

Drug Information available for: Dextrose

U.S. FDA Resources

Study Type:	Observational
Study Design:	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

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

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

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

Keywords provided by Park Nicollet Institute:

Diabetes
CGM

Study placed in the following topic categories:

Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases

Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on January 16, 2009