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

Diabetes Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465881
• Other study ID #: 01929-05-C
• Status: Completed
• Phase: Phase 1
• First received: April 24, 2007
• Last updated: December 2, 2015
• Start date: January 2006
• Est. completion date: April 2006

Study information

• Verified date: September 2007
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: April 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• CGM
• Diabetes
• Glucose Variability

Intervention

Device:
• CGM System for Type 1 and Type 2 Diabetes Mellitus

Locations

Country	Name	City	State
United States	International Diabetes Center - Park Nicollet Health Services	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
HealthPartners Institute	Abbott Diabetes Care

Country where clinical trial is conducted

United States,