NCT00315991

Brief Summary

The purpose of this study is to test a training program for parents of children with T1DM.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2006

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

April 1, 2006

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

April 18, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 19, 2006

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

January 16, 2013

Status Verified

January 1, 2013

Enrollment Period

2.7 years

First QC Date

April 18, 2006

Last Update Submit

January 14, 2013

Conditions

Diabetes Mellitus, Type 1

Keywords

BG perceptionhypoglycemic awarenesspediatric T1DM

Outcome Measures

Primary Outcomes (1)

  • Accuracy of blood glucose level estimation

    Parents and children asked to report symptoms and give an estimated bg level. Later compared to actual bg levels to give an accuracy rating.

    70 trials over a one month period

Study Arms (2)

BGAT Intervention

EXPERIMENTAL

Blood Glucose Awareness Training for Parents

Behavioral: Blood Glucose Awareness Training for Parents

Control

NO INTERVENTION

Enter PDA data and complete questionnaires only. No intervention received.

Interventions

Blood Glucose Awareness Training for ParentsBEHAVIORAL
BGAT Intervention

Eligibility Criteria

Age6 Years - 11 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Parent/Guardian with primary responsibility for a child's diabetes management
  • Child with T1DM between the ages 6 - 11 years.
  • Duration of child's diabetes \> 1 year
  • Routine self-testing of child's BG \> 2x day
  • Intention to remain in the study's geographical region for the next 5 months
  • Have a computer at home

You may not qualify if:

  • Significant comorbidity in the child that could interfere with BG awareness or psychosocial status
  • Medications taken by the child that interfere with symptom perception
  • Psychiatric disorder in a parent or child
  • Cognitive deficits/learning disabilities in the child that might preclude ability to complete the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Joslin Diabetes Center

Boston, Massachusetts, United States

Location

University of Virginia

Charlottesville, Virginia, 22908, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Linda Gonder-Frederick, Ph.D.

    University of Virginia, Department of Psychiatric Medicine, Behavioral Medicine Research

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

April 18, 2006

First Posted

April 19, 2006

Study Start

April 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

January 16, 2013

Record last verified: 2013-01

Locations

US(2)