ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00745342
Recruitment Status : Completed
First Posted : September 3, 2008
Last Update Posted : April 23, 2018
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Lori Laffel, 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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Behavioral: Family Teamwork Intervention Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 105 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Optimizing Adherence and Glycemia in Youth With New IDDM
Study Start Date : March 1999
Actual Primary Completion Date : October 2002
Actual Study Completion Date : October 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Glycemic control, assessed by hemoglobin A1c [ Time Frame: 2 years ]
    Change in A1c from baseline to 2 years, measured every 3 months


Secondary Outcome Measures :
  1. Youth quality of life, measured using the youth PedsQL survey and the parent-proxy PedsQL survey [ Time Frame: 2 years ]
    Measured at baseline, 1 year, and 2 years

  2. Diabetes-specific family conflict, measured using the Diabetes Family Conflict survey (youth and parent versions) [ Time Frame: 2 years ]
    Measured at baseline, 1 year, and 2 years

  3. Parent involvement in diabetes management tasks, measured using the Diabetes Family Responsibility Questionnaire (youth and parent versions) [ Time Frame: 2 years ]
    Measured at baseline, 1 year, and 2 years



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   8 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00745342


Locations
United States, Massachusetts
Joslin Diabetes Center
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Joslin Diabetes Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Lori MB Laffel, MD, MPH Joslin Diabetes Center

Publications of Results:
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 ( U.S. NIH Grant/Contract )
First Posted: September 3, 2008    Key Record Dates
Last Update Posted: April 23, 2018
Last Verified: April 2018

Keywords provided by Lori Laffel, 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
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases