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

Optimizing Adherence and Glycemia in Youth With New IDDM

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00745342

Enrollment

105

Registered

2008-09-03

Start date

1999-03-31

Completion date

2002-10-31

Last updated

2021-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus

Keywords

type 1 diabetes, glycemic control, family conflict, quality of life, parental involvement

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.

Interventions

BEHAVIORALFamily Teamwork Intervention

Families in the teamwork group received quarterly psychoeducational interventions at regular clinic visits, focusing on promoting family teamwork and reducing diabetes-specific family conflict and diabetes burnout.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

8 Years to 17 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Glycemic control, assessed by hemoglobin A1c	2 years	Change in A1c from baseline to 2 years, measured every 3 months

Secondary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026