NCT00327210

Brief Summary

BGATHome is an interactive, web-based training program designed to improve the ability of adults with Type 1 Diabetes to recognize, predict, treat, and avoid extreme blood glucose (BG) events. It was developed at the University of Virginia over the past 20 years with funding from the National Institutes of Health and the American Diabetes Association. BGATHome provides important knowledge about personal insulin use, food, and activity regimens that influence BG levels. Users of this program will learn to monitor and recognize the cues that signal hyper and hypoglycemic events, and enhance their ability to control these fluctuations.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2005

Longer than P75 for not_applicable

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

May 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 16, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 18, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
Last Updated

November 8, 2017

Status Verified

November 1, 2017

Enrollment Period

4.2 years

First QC Date

May 16, 2006

Last Update Submit

November 6, 2017

Conditions

Keywords

BGATBlood Glucose Awareness TrainingDiabetesT1DMInternetWebInterventionTreatmentBehaviorEducationAwareness

Outcome Measures

Primary Outcomes (1)

  • Feasibility

    Internet Evaluation

    12 weeks

Secondary Outcomes (4)

  • Improved blood glucose awareness

    12 weeks

  • Reduced adverse events

    12 weeks

  • Improved psychological functioning

    12 weeks

  • Improved knowledge

    12 weeks

Study Arms (2)

BGATHome

EXPERIMENTAL

Blood Glucose Awareness Training at Home Internet Intervention

Behavioral: Blood Glucose Awareness Training

Control

NO INTERVENTION

No intervention

Interventions

Eligibility Criteria

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

You may qualify if:

  • Type 1 diabetes for at least one year.
  • Access to the Internet.
  • Routinely perform Self Monitoring of Blood Glucose at least three times a day.
  • ≥ 21 years of age

You may not qualify if:

  • \- Not able to complete the Internet program in 12 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Viginia Health System

Charlottesville, Virginia, 22907, United States

Location

Related Publications (1)

  • Cox D, Ritterband L, Magee J, Clarke W, Gonder-Frederick L. Blood glucose awareness training delivered over the internet. Diabetes Care. 2008 Aug;31(8):1527-8. doi: 10.2337/dc07-1956. Epub 2008 May 13.

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusBehavior

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Daniel J Cox, Ph.D

    University of Virginia Health System

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 16, 2006

First Posted

May 18, 2006

Study Start

May 1, 2005

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

November 8, 2017

Record last verified: 2017-11

Locations