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Completed

NCT Number: NCT00961974

Intensive Care Program for Youth With Diabetes

The purpose of this study was to determine the ability of a family-focused, office-based intervention to improve medical and behavioral outcomes for children and adolescents with type 1 diabetes.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Margins of Excision Metabolic Diseases Morphological and Microscopic Findings Nutritional and Metabolic Diseases Pathological Conditions, Signs and Symptoms

Age range

8 year–16 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

  • Age 8-16 years
  • Type 1 diabetes diagnosed by standard American Diabetes Association criteria
  • Type 1 diabetes duration of at least 6 months
  • Residence in northeastern U.S.
  • Established clinic patient
  • Fluency in English or Spanish

Exclusion criteria

  • Major psychiatric disorder (e.g., major depression, severe eating disorder, mental retardation)
  • Unstable living environment (e.g., Department of Social Services or Department of Youth Services involvement)

Treatment and study plan

Care Ambassador Intervention

Behavioral

Care Ambassador provides additional monthly outreach (by phone or e-mail) to families between clinic visits.

Psychoeducational intervention

Behavioral

A psychoeducational intervention module is reviewed with the family by the Care Ambassador at each clinic visit. The intervention focuses on incorporating intensive therapy into the daily routine of the child through positive family support for blood glucose monitoring and healthy eating. The intervention modules review positive family communication, realistic expectations, ways to avoid perfectionism and maintain family involvement, prevention of hypoglycemia, avoidance of diabetes-specific family conflict, and approaches to reducing "diabetes burnout".

Primary outcomes

  1. Glycemic control, assessed by hemoglobin A1c

    Time frame: Every 3 months

Secondary outcomes

  1. Psychosocial factors (diabetes-specific family conflict, responsibility-sharing for diabetes management tasks, quality of life, affect regarding blood glucose monitoring, disordered eating behaviors)

    Time frame: Annually

  2. Weight, assessed by z-BMI (age- and gender-adjusted body mass index)

    Time frame: Every 3 months

  3. Frequency of hospitalizations, emergency department visits, and episodes of severe hypoglycemia

    Time frame: Every 3 months

Sponsors and collaborators

Lead sponsor

Joslin Diabetes Center

Other

Collaborators

  • Charles H. Hood Foundation
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2002
Primary completion
2005
Study completion
2005
First posted
Aug 19, 2009
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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