search
Back to results

The Diabetes TeleCare Study (DTC)

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Intervention
Usual Care
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, self-management, telemedicine, retinal, screening

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: Exclusion criteria applies to individuals with limitations that could limit safe participation in the study, 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. Additional exclusions may include inability to complete baseline tasks to the satisfaction of the lead interventionist or other more subjective assessment suggesting inability or unwillingness to adhere reasonably to the intervention based on interventionist review.

Sites / Locations

  • CareSouth Bennettsville

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Usual Care

Intervention

Arm Description

Outcomes

Primary Outcome Measures

Hemoglobin A1c

Secondary Outcome Measures

Blood pressure
LDL Cholesterol
Cost effectiveness and cost utility
Retinal examination rates
Weight
Waist Circumference

Full Information

First Posted
February 6, 2006
Last Updated
February 28, 2018
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of North Carolina, Chapel Hill
search

1. Study Identification

Unique Protocol Identification Number
NCT00288132
Brief Title
The Diabetes TeleCare Study
Acronym
DTC
Official Title
Bridging Barriers to Diabetes Care With Telemedicine: The Diabetes TeleCare Study (DTC)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
September 2005 (Actual)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators
University of North Carolina, Chapel Hill

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
According to recent 2002 estimates, the yearly cost of diabetes was approximately $132 billion. The burden of diabetes is considerable, particularly for ethnically diverse populations. Disease management programs that focus on self-management education have been effective in improving metabolic control. Accordingly, the American Diabetes Association clinical care guidelines stress the importance of metabolic control to prevent complications and improve quality of life for persons with this disease. Unfortunately, these advances have not resulted in 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. Our aims are to 1) develop and implement a 12-month intervention, Diabetes TeleCare to improve adherence to diabetes clinical care guidelines and improve diabetes control in two community health centers located in ethnically diverse, rural and medically underserved communities, 2) conduct a one-year randomized clinical trial (RCT) of 200 patients to formally evaluate the effectiveness of Diabetes TeleCare compared to Usual Care in a sample with >60% African-Americans, and 3) determine the cost-effectiveness and satisfaction of Diabetes TeleCare compared to Usual Care. Participants are recruited from two community health centers in rural South Carolina and randomized according to a patient randomization schedule. Diabetes TeleCare (a structured curriculum) is delivered by a team consisting of a registered nurse/certified diabetes educator (RN-CDE) and an experienced registered dietitian, with support by other health professionals who are linked by interactive video conferencing to participants (single and group) in rural health centers at distant locations. The primary outcomes are measures of metabolic control (A1c, lipids), blood pressure, and use of the telemedicine-facilitated retinal screening capacity. Secondary outcomes include satisfaction, quality of life, health beliefs, and knowledge. The economic analysis will include an assessment of resource utilization, cost, and health utilities. In addition, incremental reductions in costs per A1c and the estimated lifetime cost-utility of Diabetes TeleCare compared to usual care will be determined. Telemedicine may be an effective alternative to traditional health care delivery systems resulting in improved diabetes education and control. The intervention goal was to achieve an A1c <7%, with secondary goals of 10% weight loss and increasing exercise to at least 30 minutes a day, 5 days a week. Participants attend 13 sessions, 2 in the first month (1 group, 1 individual), monthly thereafter (9 group, 2 individual). Three group sessions were conducted in-person, all others were conducted via telemedicine. The self-management education team consisted of an RN/CDE and an RD. Sessions were conducted remotely, with a trained facilitator (LPN) at the clinic site. Participants were given a notebook and new material was added at each session. Completion of self-monitoring logs, including blood sugar, diet and physical activity, was assigned daily followed by less frequently based on progress towards intervention goals.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Diabetes, self-management, telemedicine, retinal, screening

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
165 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Title
Intervention
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Intervention
Intervention Description
A 12-month diabetes self-management intervention delivered via telemedicine, with opportunity to receive telemedicine-based screening eye exam, was conducted.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Hemoglobin A1c
Time Frame
6 mths, 12 mths, 24 mths
Secondary Outcome Measure Information:
Title
Blood pressure
Time Frame
6 mths, 12 mths, 24 mths
Title
LDL Cholesterol
Time Frame
6 mths, 12 mths, 24 mths
Title
Cost effectiveness and cost utility
Time Frame
6 mths, 12 mths
Title
Retinal examination rates
Time Frame
12 months
Title
Weight
Time Frame
6 mths, 12 mths, 24 mths
Title
Waist Circumference
Time Frame
6 mths, 12 mths, 24 mths

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: Exclusion criteria applies to individuals with limitations that could limit safe participation in the study, 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. Additional exclusions may include inability to complete baseline tasks to the satisfaction of the lead interventionist or other more subjective assessment suggesting inability or unwillingness to adhere reasonably to the intervention based on interventionist review.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard M Davis, MD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
CareSouth Bennettsville
City
Bennettsville
State/Province
South Carolina
ZIP/Postal Code
29512
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20484125
Citation
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.
Results Reference
result

Learn more about this trial

The Diabetes TeleCare Study

We'll reach out to this number within 24 hrs