Trial record 2 of 4580 for:    "Diabetes Mellitus, Type 2"

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
  Purpose

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.

Condition Intervention Phase
Obesity
Diabetes Mellitus, Type 2
Abnormal Glucose Metabolism
Type 2 Diabetes
Behavioral: Assignment of a Lay Patient Partner
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Partners for Better Health in Adolescent Type 2 Diabetes: The Buddy Study

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 1
Study Start Date: October 2009
Study Completion Date: January 2013
Arms Assigned Interventions
Group A
Buddy Group - Individuals with type 2 diabetes receive conventional diabetes treatment and are assigned a patient partner (Buddy)
Behavioral: Assignment of a Lay Patient Partner
N/A
Active Comparator: Group B
Individuals receive conventional treatment for type 2 diabetes
Behavioral: Assignment of a Lay Patient Partner
N/A

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.

  Eligibility

Ages Eligible for Study:   12 Years to 20 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007266

Locations
United States, District of Columbia
Childrens National Medical Center
Washington, District of Columbia, United States
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
Investigators
Principal Investigator: Kristina I Rother, M.D. National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT01007266     History of Changes
Other Study ID Numbers: 100002, 10-DK-0002
Study First Received: November 3, 2009
Last Updated: June 12, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Type 2 Diabetes Mellitus
Adolescents
Pediatric
Patient Partner
Buddy
Obesity
Type 2 Diabetes

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on August 20, 2014