Partners for Better Health in Adolescent Type 2 Diabetes: The Buddy Study

Summary

Background:

* Type 2 diabetes mellitus (T2DM) is becoming more common among youth, particularly in minority populations. Few drug treatments are approved for T2DM in adolescents, and behavioral and lifestyle factors may contribute to their difficulties in following strict treatment regimens.
* It is unknown whether a minimally invasive patient partner ( buddy ) program, which has been developed to help improve diabetes control and quality of life, will be successful in a population of pediatric patients with T2DM.

Objectives:

* To evaluate the effect of a minimally invasive intervention (being assigned a patient partner, or buddy ) on blood sugar levels in adolescents with T2DM.
* To assess changes between groups in body weight, number of home glucose monitor checks, compliance with medications, adherence to visit schedule, and psychological well-being.

Eligibility:

\- Adolescents and young adults between 12 and 20 years of age who have been diagnosed with type 2 diabetes and whose blood glucose control needs improvement.

Design:

* Participants will be divided by chance into two groups: in one group, participants will have a buddy and receive standard care; while in the other group, participants will receive standard care alone.
* The buddy is not a health care professional and is not authorized to provide any medical advice.
* Participants will be followed in the study for a total of 6 months. All study participants will receive standard treatment for T2DM.
* All patients will be asked to fill out a screening questionnaire (on paper or online) at the beginning of the study and a quality of life and eating behaviors questionnaire at the beginning and at the end of the study. These forms will include questions on medical history, emotions, well-being, and eating habits.
* Participants in both groups will have one diabetes clinic visit at the NIH Clinical Center or at Children s National Medical Center (CNMC) at the beginning of the study and two follow-up visits at the NIH or CNMC approximately 3 months apart. All visits include a physical examination, detailed medical history, and laboratory testing which is part of routine care for diabetes.
* Participants assigned to the buddy group will receive phone or online messages from the buddy once a week and will meet with the buddy once a month for less than 1 hour. The purpose of the in-person visit is to get to know each other better outside the usual hospital or clinic environment. The visits should take place at home, but may also take place elsewhere, for example, at schools, cafes, or libraries chosen by both the participant and the buddy. These face-to-face meetings may also take place at NIH or at CNMC if this is more convenient.

Conditions

• Obesity
• Diabetes Mellitus, Type 2
• Abnormal Glucose Metabolism
• Type 2 Diabetes

Interventions

BEHAVIORAL

Assignment of a Lay Patient Partner

Sponsors & Collaborators

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

  lead NIH

Principal Investigators

• Kristina I Rother, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

20 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-10-09

Completion

2013-01-24

Countries

• United States

Study Locations