Technology Intensified Diabetes Education Study in African Americans

NCT02088658 | Completed Results DMC

• 2 other identifiers: Pro000150641R01DK098529
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test the usefulness of an intervention that combines technology with diabetes education and skills training. This study has been designed specifically for African Americans with poorly controlled type 2 diabetes.

Conditions

Diabetes Mellitus, Non-Insulin-Dependent; Diabetes Mellitus, Noninsulin Dependent; Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset; Diabetes Mellitus, Type II

Keywords

Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset; Diabetes Mellitus, Non-Insulin-Dependent; Diabetes Mellitus, Noninsulin Dependent; Diabetes Mellitus, Type II; African Americans; Blacks; non-Hispanic Blacks; Randomized Control Trial; Controlled Clinical Trial; Behavioral Research; Behavioral Medicine

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1c

  Hemoglobin A1c (HbA1c): blood specimens collected at the 12-months follow-up visit

  12 months post randomization

Study Arms (2)

Techonology Intensified

EXPERIMENTAL

Subjects randomized to this group will receive: 1) the FORA system for self-monitoring; 2) weekly telephone-delivered diabetes education/skills training; 3) patient activation (list of 5 questions to ask their provider at every visit and training on how to ask the questions); and 4) patient empowerment (diabetes responsibility contracts, personal goals, and flow charts for patients to record lab results/medications and training on how to use the empowerment tools). The intervention will be delivered by telephone once a week for 12 weeks with each session lasting \~30 minutes.

Behavioral: Technology Intensified

Usual Care

NO INTERVENTION

Apart from study visits, patients will be followed by their primary care providers. The provider will be responsible for determining treatment parameters, making changes in the treatment regimen, and determining the timing of follow up visits. Between scheduled office encounters, contact between patient and provider will be patient initiated. The provider may use clinic nurses to follow up on problematic patients or patients with abnormal results. In essence, this group will receive the current standard of care at the study clinics.

Interventions

Technology Intensified BEHAVIORAL

The intervention is based on the Information-Motivation-Behavioral Skills (IMB) model and provides information, motivation, and behavioral skills training (using motivational enhancement techniques). Patients will be assigned the FORA 2-in-1 Telehealth System and provided glucose test strips to allow testing at least once a day. They will be asked to perform glucose testing and blood pressure measurement using the FORA system once daily. They will be asked to upload the measurements daily as soon as possible after the test is performed. The nurse educators will have access to a secure server to which the uploaded measurements are stored in real time. The glucose and BP readings will be used to tailor and reinforce behavior change during weekly telephone-delivered diabetes education sessions.

Techonology Intensified

Eligibility Criteria

• Age: 21 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥21 years
• Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit
• Self-identified as AA
• Subject must be willing to use the FORA monitoring system for 12 months
• Subjects must be able to communicate in English
• Subjects must have access to a telephone (landline for data uploads) for the study period

You may not qualify if:

• Mental confusion on interview suggesting significant dementia
• Participation in other diabetes clinical trials
• Alcohol or drug abuse/dependency
• Active psychosis or acute mental disorder
• Life expectancy \<12 months

Sponsors & Collaborators

• State University of New York at Buffalo: lead
• Medical University of South Carolina: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Related Publications (2)

• Williams JS, Lynch CP, Knapp RG, Egede LE. Technology-Intensified Diabetes Education Study (TIDES) in African Americans with type 2 diabetes: study protocol for a randomized controlled trial. Trials. 2014 Nov 25;15:460. doi: 10.1186/1745-6215-15-460.

  PMID: 25425504 BACKGROUND

• Egede LE, Campbell JA, Walker RJ. Development and Psychometric Properties of the 5-Item Diabetes Fatalism Scale Short Form (DFS-SF). J Gen Intern Med. 2026 Feb 25. doi: 10.1007/s11606-026-10287-9. Online ahead of print.

  PMID: 41741866 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Principal Investigator
• Organization: SUNY at Buffalo

jstooks@buffalo.edu

716-829-2364

Study Officials

• Leonard E Egede, MD, MS

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor & Chair, Department of Medicine

Study Record Dates

• First Submitted: March 13, 2014
• First Posted: March 17, 2014
• Study Start: May 1, 2013
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2026
• Last Updated: March 6, 2026
• Results First Posted: March 6, 2026

Record last verified: 2026-02

Locations

US (1)