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

August 3, 2021 updated by: Lori Laffel, Joslin Diabetes Center

Optimizing Adherence and Glycemia in Youth With New IDDM

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

105

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Joslin Diabetes Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 years
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
2 years
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
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Joslin Diabetes Center

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Lori MB Laffel, MD, MPH, Joslin Diabetes Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1999

Primary Completion (Actual)

October 1, 2002

Study Completion (Actual)

October 1, 2002

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria

September 2, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Actual)

August 4, 2021

Last Update Submitted That Met QC Criteria

August 3, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 92-23
  • R01DK046887 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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