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

N/A

Waitlist Available

Led By Leonard E Egede, MD, MS

Research Sponsored by State University of New York at Buffalo

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of T2DM and HbA1c ≥8% at the screening visit

Age ≥21 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months post randomization

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing whether a combination of technology and diabetes education can help African Americans with uncontrolled type 2 diabetes.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this study focuses on education and technology rather than medication, traditional side effects are not applicable. However, participants may experience discomfort or inconvenience from frequent health monitoring.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am 21 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months post randomization

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months post randomization

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months post randomization for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Hemoglobin A1c

Secondary study objectives

Blood Pressure

Resource Utilization & Cost

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met