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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 Medical College of Wisconsin
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
Subject must be willing to use the FORA monitoring system for 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months post randomization
Awards & highlights
TIDES Trial 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.Check my eligibility
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.See study design
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.
TIDES Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have type 2 diabetes with an HbA1c level of 8% or higher.
Select...
I am willing to use the FORA monitoring system for a year.
Select...
I am 21 years old or older.
TIDES Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 months post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months post randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Hemoglobin A1c
Secondary outcome measures
Blood Pressure
Resource Utilization & Cost
TIDES 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.
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Who is running the clinical trial?
Medical College of WisconsinLead Sponsor
604 Previous Clinical Trials
1,162,056 Total Patients Enrolled
3 Trials studying Diabetes
166 Patients Enrolled for Diabetes
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,338 Previous Clinical Trials
4,313,999 Total Patients Enrolled
107 Trials studying Diabetes
138,663 Patients Enrolled for Diabetes
Medical University of South CarolinaOTHER
929 Previous Clinical Trials
7,393,617 Total Patients Enrolled
8 Trials studying Diabetes
4,710 Patients Enrolled for Diabetes
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot be taking part in any other research studies for diabetes.You have a problem with drinking alcohol or using drugs.You are currently experiencing severe mental health problems.I am willing to use the FORA monitoring system for a year.I have type 2 diabetes with an HbA1c level of 8% or higher.I am 21 years old or older.You have trouble remembering things or seem very confused during the interview, which could mean you have a serious memory problem.You are not expected to live for more than 12 months.You identify yourself as African American.
Research Study Groups:
This trial has the following groups:- Group 1: Techonology Intensified
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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