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

This study has been completed.
Information provided by (Responsible Party):
Lori Laffel, Joslin Diabetes Center
ClinicalTrials.gov Identifier:
First received: August 29, 2008
Last updated: August 6, 2015
Last verified: August 2015

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.

Condition Intervention
Type 1 Diabetes Mellitus
Behavioral: Family Teamwork Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Optimizing Adherence and Glycemia in Youth With New IDDM

Resource links provided by NLM:

Further study details as provided by Joslin Diabetes Center:

Primary Outcome Measures:
  • Glycemic control, assessed by hemoglobin A1c [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change in A1c from baseline to 2 years, measured every 3 months

Secondary Outcome Measures:
  • Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measured at baseline, 1 year, and 2 years

  • Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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) [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Measured at baseline, 1 year, and 2 years

Enrollment: 105
Study Start Date: March 1999
Study Completion Date: October 2002
Primary Completion Date: October 2002 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Teamwork Group
Families randomized to the Teamwork Group received the behavioral family teamwork intervention.
Behavioral: Family 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.
No Intervention: Standard Care
Families in the Standard Care group received standard diabetes care and equal attention from study staff between visits to schedule appointments and encourage regular diabetes follow-up care.


Ages Eligible for Study:   8 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00745342

United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
Principal Investigator: Lori MB Laffel, MD, MPH Joslin Diabetes Center
  More Information

Responsible Party: Lori Laffel, Chief, Pediatric, Adolescent, & Young Adult Section; Investigator, Genetics & Epidemiology Section, Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT00745342     History of Changes
Other Study ID Numbers: 92-23, R01DK046887
Study First Received: August 29, 2008
Last Updated: August 6, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by Joslin Diabetes Center:
type 1 diabetes
glycemic control
family conflict
quality of life
parental involvement

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases

ClinicalTrials.gov processed this record on September 03, 2015