Technology-Enhanced Diabetes Education for Type 2 Diabetes (TIDES Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByLeonard E Egede, MD, MS

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: State University of New York at Buffalo

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for African Americans aged 21 or older with poorly controlled type 2 diabetes (HbA1c ≥8%). Participants must be willing to use the FORA monitoring system, communicate in English, and have telephone access. Those with acute mental disorders, substance abuse issues, other clinical trial participation, significant dementia or a life expectancy under one year cannot join.

Inclusion Criteria

I have type 2 diabetes with an HbA1c level of 8% or higher.

I am 21 years old or older.

Participant Groups

The study tests an intervention that uses technology alongside diabetes education and skills training tailored for African Americans with type 2 diabetes to see if it can help manage their condition better.

2Treatment groups

Experimental Treatment

Active Control

Group I: Techonology IntensifiedExperimental Treatment1 Intervention

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.

Group II: Usual CareActive Control1 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.