NCT00805506

Brief Summary

Evaluate the usefulness of continuous glucose monitoring devices in terms of their ability to identify periods throughout the day when glucose varies significantly.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2006

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

February 1, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

December 5, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 9, 2008

Completed
Last Updated

November 26, 2015

Status Verified

December 1, 2008

Enrollment Period

1.2 years

First QC Date

December 5, 2008

Last Update Submit

November 25, 2015

Conditions

Diabetes

Keywords

continuous glucose monitoring accuracy

Outcome Measures

Primary Outcomes (1)

  • To collect sufficient glucose data by means of continuous glucose monitoring for the purpose of detecting clinically relevant alterations in blood glucose throughout a typical or modal day.

    9 days

Study Arms (1)

Diabetes Insulin Treated

People with type 1 or type 2 diabetes on insulin.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adults with diabetes who are treated with insulin

You may qualify if:

  • adult
  • A1c \>7.4 within last 4 months
  • type 1 or 2 diabetes treated with basal/bolus insulin

You may not qualify if:

  • under 18 years of age
  • unable to read/write english
  • allergy to adhesives
  • employee of CGM company

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Diabetes Center

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 at Park Nicollet

    PRINCIPAL INVESTIGATOR

  • Elinor (Ellie) S Strock, APRN BC

    International Diabetes Center at Park Nicollet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 5, 2008

First Posted

December 9, 2008

Study Start

February 1, 2006

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

November 26, 2015

Record last verified: 2008-12

Locations

US(1)