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Completed

NCT Number: NCT00745342

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

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Family Teamwork Intervention

Behavioral

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.

Primary outcomes

  1. Glycemic control, assessed by hemoglobin A1c

    Time frame: 2 years

    Change in A1c from baseline to 2 years, measured every 3 months

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

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

Registry information

Official study title

Optimizing Adherence and Glycemia in Youth With New IDDM

Important dates

Study start
1999
Primary completion
2002
Study completion
2002
First posted
Sep 3, 2008
Registry last updated
Aug 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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