NCT00465881

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2006

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 24, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2007

Completed
Last Updated

December 3, 2015

Status Verified

September 1, 2007

First QC Date

April 24, 2007

Last Update Submit

December 2, 2015

Conditions

DiabetesGlucose VariabilityCGM

Keywords

DiabetesCGM

Interventions

CGM System for Type 1 and Type 2 Diabetes MellitusDEVICE

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Diabetes Center - Park Nicollet Health Services

Minneapolis, Minnesota, 55416, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 24, 2007

First Posted

April 25, 2007

Study Start

January 1, 2006

Study Completion

April 1, 2006

Last Updated

December 3, 2015

Record last verified: 2007-09

Locations

US(1)