NCT00288132

Brief Summary

The American Diabetes Association clinical care guidelines stress the importance of metabolic control to prevent complications and improve quality of life for persons with diabetes. Unfortunately, these guidelines have not had widespread acceptance into clinical practice. Therefore, we propose translational research to evaluate telemedicine technology using interactive video conferencing (Diabetes TeleCare) as a novel means to increase the availability of health professionals in rural communities for the effective delivery of a diabetes self-management education program and as a means to provide retinal screenings in the primary care setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
165

participants targeted

Target at P50-P75 for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Sep 2005

Longer than P75 for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

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

September 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 7, 2006

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

3.2 years

First QC Date

February 6, 2006

Last Update Submit

February 28, 2018

Conditions

Diabetes Mellitus, Type 2

Keywords

Diabetesself-managementtelemedicineretinalscreening

Outcome Measures

Primary Outcomes (1)

  • Hemoglobin A1c

    6 mths, 12 mths, 24 mths

Secondary Outcomes (6)

  • Blood pressure

    6 mths, 12 mths, 24 mths

  • LDL Cholesterol

    6 mths, 12 mths, 24 mths

  • Cost effectiveness and cost utility

    6 mths, 12 mths

  • Retinal examination rates

    12 months

  • Weight

    6 mths, 12 mths, 24 mths

  • +1 more secondary outcomes

Study Arms (2)

Usual Care

ACTIVE COMPARATOR
Behavioral: Usual Care

Intervention

EXPERIMENTAL
Behavioral: Intervention

Interventions

InterventionBEHAVIORAL

A 12-month diabetes self-management intervention delivered via telemedicine, with opportunity to receive telemedicine-based screening eye exam, was conducted.

Intervention
Usual CareBEHAVIORAL

Upon randomization, received one 15-minute diabetes self-management individual session, using American Diabetes Association materials. Continued care, as usual, from their primary care provider throughout duration of active 12 month intervention period.

Usual Care

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All participants must have a confirmed physician diagnosis of type 2 diabetes supported by American Diabetes Association diagnostic criteria for blood glucose levels or
  • Current use of oral hypoglycemic agents or insulin as confirmed by brief medical record review.
  • All adults (\> 21 years of age) who have a A1c value \> 7.0 will be eligible.

You may not qualify if:

  • such as metastatic cancer,
  • multiple or recent (within six months) myocardial infarction (MI) or stroke,
  • dialysis for end stage renal disease,
  • severe psychiatric disease or dementia, or
  • inability to walk without an assistive device.
  • We will also exclude women who are pregnant at the time of study recruitment (based on self report only) because of the unique needs related to diabetes self-management during pregnancy.
  • We will, however, retain women in the study should they become pregnant during the course of the project.
  • Individuals will be excluded if they plan to move out of the area.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CareSouth Bennettsville

Bennettsville, South Carolina, 29512, United States

Location

Related Publications (1)

  • Davis RM, Hitch AD, Salaam MM, Herman WH, Zimmer-Galler IE, Mayer-Davis EJ. TeleHealth improves diabetes self-management in an underserved community: diabetes TeleCare. Diabetes Care. 2010 Aug;33(8):1712-7. doi: 10.2337/dc09-1919. Epub 2010 May 18.

    PMID: 20484125RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

Methods

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Richard M Davis, MD

    University of South Carolina

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2006

First Posted

February 7, 2006

Study Start

September 1, 2005

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

March 2, 2018

Record last verified: 2018-02

Locations

US(1)