Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01007266
First received: November 3, 2009
Last updated: June 12, 2014
Last verified: April 2014

November 3, 2009
June 12, 2014
October 2009
Not Provided
To evaluate the effect of a minimally invasive intervention (the buddy system) on hemoglobin A1c levels in adolescents with T2DM. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01007266 on ClinicalTrials.gov Archive Site
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. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Obesity
  • Diabetes Mellitus, Type 2
  • Abnormal Glucose Metabolism
  • Type 2 Diabetes
Behavioral: Assignment of a Lay Patient Partner
N/A
  • Group A
    Buddy Group - Individuals with type 2 diabetes receive conventional diabetes treatment and are assigned a patient partner (Buddy)
    Intervention: Behavioral: Assignment of a Lay Patient Partner
  • Active Comparator: Group B
    Individuals receive conventional treatment for type 2 diabetes
    Intervention: Behavioral: Assignment of a Lay Patient Partner

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1
January 2013
Not Provided
  • 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
Both
12 Years to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01007266
100002, 10-DK-0002
Not Provided
Not Provided
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Principal Investigator: Kristina I Rother, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
National Institutes of Health Clinical Center (CC)
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP