Identification and Treatment of Diabetes In Solid Organ Transplant Recipients

Emory University

Status: Completed

Conditions: Complications of Transplanted Organs and Tissue

Treatments: Behavioral: Psychologist Support; Behavioral: Pediatric Certified Diabetes Educators (CDEs) Support

Study type: Interventional

Funder types: Other

Identifiers

NCT02605200

IRB00081257

Details and patient eligibility

About

The purpose of this study is to determine the influence of post-transplant diabetes on medical and psychosocial outcomes in individuals who receive solid-organ transplant prior to 18 years of age and their families.

Full description

This study seeks to understand how organ transplant patients are affected by the development of diabetes, and to test whether early diagnosis of diabetes and comprehensive professional support will:

1. facilitate the adjustment of children and their families to the rigors of diabetes care
2. improve adherence to medication regimens
3. reduce acute complications of diabetes and organ rejection.

Enrollment: 65 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients of Children's Healthcare of Atlanta who have received a kidney, liver, or heart transplant

Exclusion criteria

• Received a transplant after 18 years of age
• Cognitively unable to participant as determined by the study team psychologist
• Not receiving a solid organ transplant for kidney, liver, or heart
• Declines participation invitation

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Participants

Other group

Description:

Participants will complete tests of glucose tolerance and psychosocial assessments, and will undergo medical history screening. Those children identified with diabetes and/or abnormal glucose tolerance will receive both diabetes self-management education and psychosocial support from a pediatric Certified Diabetes Educator (CDE) and a psychologist, respectively.

Treatment:

Behavioral: Pediatric Certified Diabetes Educators (CDEs) Support

Behavioral: Psychologist Support