Optimizing Adherence and Glycemia in Youth With New Insulin-dependent Diabetes Mellitus (IDDM)

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: Family Teamwork Intervention

• Registration Number: NCT00745342
• Lead Sponsor: Joslin Diabetes Center

Brief Summary

This 2-year randomized, controlled trial examined the impact of a clinic-based, family teamwork intervention on glycemic control in youth with recently diagnosed type 1 diabetes.

Detailed Description

Not available

Study Timeline

• Study Start: 1999-03
• Primary Completion: 2002-10
• Study Completion: 2002-10
• Study First Submitted: 2008-08-29
• Study First Submitted QC: 2008-09-02
• Study First Posted: 2008-09-03
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-03
• Last Update Posted: 2021-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 105

Inclusion Criteria

• 8 to 17 years old
• Duration of type 1 diabetes between 2 months and 6 years
• Residence in New England or New York
• At least 1 outpatient visit in the past year

Exclusion Criteria

• Major co-morbid psychiatric or medical illness in youth
• Diagnosis of an active major psychiatric disorder in either parent
• Diagnosis of a life-threatening medical illness in either parent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Teamwork Group	Family Teamwork Intervention	Families randomized to the Teamwork Group received the behavioral family teamwork intervention.

Primary Outcome Measures

Name	Time	Method
Glycemic control, assessed by hemoglobin A1c	2 years	Change in A1c from baseline to 2 years, measured every 3 months

Secondary Outcome Measures

Name	Time	Method
Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey	2 years	Measured at baseline, 1 year, and 2 years
Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions)	2 years	Measured at baseline, 1 year, and 2 years
Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions)	2 years	Measured at baseline, 1 year, and 2 years

Trial Locations

Locations (1)

Joslin Diabetes Center; 🇺🇸 Boston, Massachusetts, United States