Clinical trial NCT00465881: Develop Novel Methods to Display, Report and Analyze CGM Data for Clinical Decision-Making in People With Diabetes
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Glucose Variability
CGM
Keywords: Diabetes
CGM
Lead sponsor: HealthPartners Institute
Sponsor class: OTHER
Collaborators: name: Abbott Diabetes Care
First posted: 2007-04-25
Enrollment: 30
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE

Brief summary: 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.

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 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: International Diabetes Center - Park Nicollet Health Services
state: Minnesota
Study officials:
affiliation: International Diabetes Center - Park Nicollet Institute
name: Roger S. Mazze, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center - Park Nicollet Institute
name: Richard M. Bergenstal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: International Diabetes Center - Park Nicollet Institute
name: Ellie S. Strock, RN BC-ANP
role: PRINCIPAL_INVESTIGATOR
References: