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

 Type 2 diabetes mellitus (T2DM) is becoming increasingly prevalent among youth, particularly
 in minority populations. Few pharmacologic agents are approved for the treatment of T2DM in
 adolescents, and behavioral and lifestyle factors may contribute to adolescents difficulty
 adhering to treatment regimens. A minimally-invasive buddy-intervention (to help improve
 diabetes control and to foster improvement in quality of life) has not been systematically
 evaluated in a population of pediatric patients with T2DM.

 Objectives

 1. To evaluate the effect of a minimally invasive intervention the buddy on hemoglobin A1c
 (HbA1c) levels in adolescents with T2DM.

 2. 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.

 Methods

 Patients will be randomized to conventional treatment versus interventional group (buddy
 arm), and will be followed for 6 months. During this period, all patients should undergo two
 visits including laboratory testing (HbA1c) approximately 3 months apart. Those in the buddy
 arm will have weekly phone or online contact and once-monthly home visits from the buddy (a
 volunteer patient partner), with the use of systematic questionnaires and a secure database
 for data collection and maintenance.
-  INCLUSION CRITERIA:

 Any patient with type 2 diabetes mellitus as documented by his or her primary physician

 1. Age 12-20 years at enrollment

 2. Most recent HbA1c greater than or equal to 7%

 EXCLUSION CRITERIA:

 1. Significant comorbidity that, in the opinion of the investigators, may limit adequate
 study participation

 2. Significant psychiatric or cognitive disorder, or communication difficulty that will,
 in the opinion of the investigators, limit the subject's ability to interact with the
 patient assistant or may present a danger to the patient assistant; patients with
 current suicidal or homicidal ideation, history of arrest for violent behavior, or
 history of school suspension/expulsion for violent behavior will be excluded.

 3. Pregnancy or intention to become pregnant within 6 months