NCT01007266

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_2 obesity

Timeline
Completed

Started Oct 2009

Typical duration for phase_2 obesity

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 9, 2009

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
3.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 24, 2013

Completed
Last Updated

December 17, 2019

Status Verified

April 14, 2016

First QC Date

November 3, 2009

Last Update Submit

December 14, 2019

Conditions

ObesityDiabetes Mellitus, Type 2Abnormal Glucose MetabolismType 2 Diabetes

Keywords

Type 2 Diabetes MellitusAdolescentsPediatricPatient PartnerBuddyObesityType 2 Diabetes

Outcome Measures

Primary Outcomes (1)

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

    6 months

Secondary Outcomes (1)

  • 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.

    6 months

Study Arms (2)

Group A

OTHER

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

Group B

ACTIVE COMPARATOR

Individuals receive conventional treatment for type 2 diabetes

Behavioral: Assignment of a Lay Patient Partner

Interventions

Assignment of a Lay Patient PartnerBEHAVIORAL
Group AGroup B

Eligibility Criteria

Age12 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Any patient with type 2 diabetes mellitus as documented by his or her primary physician
  • Age 12-20 years at enrollment
  • Most recent HbA1c greater than or equal to 7%

You may not qualify if:

  • Significant comorbidity that, in the opinion of the investigators, may limit adequate study participation
  • 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.
  • Pregnancy or intention to become pregnant within 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Childrens National Medical Center

Washington D.C., District of Columbia, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Yokoyama H, Okudaira M, Otani T, Takaike H, Miura J, Saeki A, Uchigata Y, Omori Y. Existence of early-onset NIDDM Japanese demonstrating severe diabetic complications. Diabetes Care. 1997 May;20(5):844-7. doi: 10.2337/diacare.20.5.844.

    PMID: 9135953BACKGROUND

  • Krieger J, Collier C, Song L, Martin D. Linking community-based blood pressure measurement to clinical care: a randomized controlled trial of outreach and tracking by community health workers. Am J Public Health. 1999 Jun;89(6):856-61. doi: 10.2105/ajph.89.6.856.

    PMID: 10358675BACKGROUND

  • Duncan GE. Prevalence of diabetes and impaired fasting glucose levels among US adolescents: National Health and Nutrition Examination Survey, 1999-2002. Arch Pediatr Adolesc Med. 2006 May;160(5):523-8. doi: 10.1001/archpedi.160.5.523.

    PMID: 16651496BACKGROUND

MeSH Terms

Conditions

ObesityDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesEndocrine System Diseases

Study Officials

  • Kristina I Rother, M.D.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
NIH

Study Record Dates

First Submitted

November 3, 2009

First Posted

November 4, 2009

Study Start

October 9, 2009

Study Completion

January 24, 2013

Last Updated

December 17, 2019

Record last verified: 2016-04-14

Locations

US(2)