Partners for Better Health in Adolescent Type 2 Diabetes: The Buddy Study
Condition: Obesity; Diabetes Mellitus, Type 2; Abnormal Glucose Metabolism; Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      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.
    

Intervention name(s): Assignment of a Lay Patient Partner
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; Adolescents; Pediatric; Patient Partner; Buddy; Obesity; Type 2 Diabetes