Technology-Enhanced Diabetes Education for Type 2 Diabetes

(TIDES Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: State University of New York at Buffalo

Disqualifiers: Dementia, Alcohol abuse, Psychosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 17

Duration: 12 weeks

200 Participants Needed

What You Need to Know Before You Apply

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is Technology-Enhanced Diabetes Education for Type 2 Diabetes safe for humans?

The safety information available mainly discusses insulin pumps, which are used for diabetes management. These devices can have issues like pump failure or user error, leading to potential risks such as high or low blood sugar. However, specific safety data for Technology-Enhanced Diabetes Education itself is not provided. ^{1 2 3 4 5}

How is the Technology Intensified treatment for Type 2 Diabetes different from other treatments?

Technology Intensified treatment for Type 2 Diabetes is unique because it uses digital health tools like apps and virtual learning to enhance diabetes education and self-management, making it more accessible and engaging compared to traditional in-person programs. ^{6 7 8 9 10}

What data supports the effectiveness of the treatment Technology Intensified for Type 2 Diabetes?

Research shows that computer-aided diabetes education, which is part of technology-enhanced treatments, can significantly improve health outcomes for people with diabetes. In a review of 19 trials, 84.2% reported positive outcomes, suggesting that using technology to support diabetes education and self-management can be effective. ^{11 12 13 14 15}

Who Is on the Research Team?

Leonard E Egede, MD, MS

Principal Investigator

Medical College of Wisconsin

Are You a Good Fit for This Trial?

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

Subjects must have access to a telephone (landline for data uploads) for the study period

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.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive weekly telephone-delivered diabetes education and skills training for 12 weeks

12 weeks

12 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with blood specimens collected and blood pressure measured at multiple intervals

12 months

4 visits (in-person) at 3, 6, 9, and 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Technology Intensified

Trial Overview 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.

How Is the Trial Designed?

Group I: Techonology Intensified Experimental Treatment 1 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 Care Active Control 1 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.

Who Is Running the Clinical Trial?

State University of New York at Buffalo

Lead Sponsor

Trials

279

Recruited

52,600+

Medical College of Wisconsin

Lead Sponsor

Trials

645

Recruited

1,180,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Medical University of South Carolina

Collaborator

Trials

994

Recruited

7,408,000+

Published Research Related to This Trial

Information technology significantly enhances diabetes management by providing patients with tailored, just-in-time support, allowing for better self-management of their condition through online tools and resources.

The integration of technology in diabetes care enables clinicians to efficiently support a larger number of patients, facilitating continuous communication and personalized guidance without the constraints of traditional office hours.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Internet and information technology use in treatment of diabetes. Kaufman, N.[2022]

A randomized clinical trial involving 48 insulin-dependent diabetes patients showed that a 12-week electronic education program significantly reduced hemoglobin A1C levels (p < 0.001) and low-density lipoprotein cholesterol (p < 0.002) in the intervention group.

The study suggests that electronic education can effectively improve metabolic control in diabetes patients, enhancing health outcomes and patient satisfaction while reducing the need for additional training personnel.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of electronic education on metabolic control indicators in patients with diabetes who need insulin: a randomised clinical control trial. Moattari, M., Hashemi, M., Dabbaghmanesh, MH.[2022]

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but it carries risks of serious complications like hyperglycemia and hypoglycemia due to various factors including pump failures and user errors.

There is a lack of transparency and sufficient data on the safety and long-term efficacy of insulin pumps, highlighting the need for better regulatory practices and more public funding for research to improve user education and prevent adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2022]

A study involving 549 participants from the TuDiabetes.org online community found that 75 reported device-related adverse events, with nearly half requiring intervention, highlighting the potential for online networks to capture real-world device issues.

Only 4% of these adverse events were reported to the FDA, suggesting that online participatory surveillance can provide more comprehensive outcome data compared to traditional reporting methods, which often lack detailed information.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting. Mandl, KD., McNabb, M., Marks, N., et al.[2021]

A total of 7076 individual case safety reports (ICSRs) were analyzed, revealing that 63.6% came from the Middle East, with most reports being nonserious (91.5%) and primarily reported by consumers (70.7%).

Patients in the Middle East were younger (average age 34.2 years) and often used insulin for gestational diabetes, while those in Africa were older (average age 48.1 years) and more likely to have type 2 diabetes, indicating significant regional differences in insulin use and associated adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Individual Case Safety Reports Analysis for Patients with Diabetes Mellitus on Insulin in Africa and the Middle East. Mlotshwa, CRN., Burger, JR., Vorster, M., et al.[2022]

Insulin pump therapy (CSII) is crucial for managing type 1 diabetes, but users face significant risks from potential errors in insulin delivery, which can lead to serious health issues like hyperglycemia or hypoglycemia.

Current safety evaluations of insulin pumps are inadequate, with limited transparency in reporting adverse events and insufficient long-term data on real-world usage, highlighting the need for improved regulatory practices and more comprehensive research on pump therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Heinemann, L., Fleming, GA., Petrie, JR., et al.[2018]

A study involving 31 diabetes educators in Australia revealed that they found the use of technology in managing type 1 diabetes to be burdensome, indicating a need for better support and training in technology use.

Despite the potential benefits of diabetes-related technologies, care delivery was often fragmented and inconsistent, suggesting that improvements in policy and service structure are necessary to enhance the effectiveness of these tools in patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diabetes Educators: Perceived Experiences, Supports and Barriers to Use of Common Diabetes-Related Technologies. James, S., Perry, L., Gallagher, R., et al.[2018]

The myDiabetes app, a digital health intervention, successfully activated nearly 50% of users referred by healthcare teams, indicating its potential to enhance diabetes education delivery.

Post-COVID-19, there was a significant increase in app usage, suggesting that digital health tools can effectively support diabetes self-management and may improve education rates when combined with traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can digital health apps provide patients with support to promote structured diabetes education and ongoing self-management? A real-world evaluation of myDiabetes usage. Blythin, AM., Elkes, J., van Lindholm, T., et al.[2023]

Citations

1. Ireland pubmed.ncbi.nlm.nih.gov

Outcomes of educational interventions in type 2 diabetes: WEKA data-mining analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Computer-aided diabetes education: a synthesis of randomized controlled trials. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Internet and information technology use in treatment of diabetes. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Diabetes patient education: a meta-analysis and meta-regression. [2022]

5. England pubmed.ncbi.nlm.nih.gov

The impact of electronic education on metabolic control indicators in patients with diabetes who need insulin: a randomised clinical control trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting, and research needs: a joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Participatory surveillance of diabetes device safety: a social media-based complement to traditional FDA reporting. [2021]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Individual Case Safety Reports Analysis for Patients with Diabetes Mellitus on Insulin in Africa and the Middle East. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

More Focus is Needed to Reduce Adverse Events for Diabetes Devices. [2022]

10. Germany pubmed.ncbi.nlm.nih.gov

Insulin pump risks and benefits: a clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. [2018]

11. United States pubmed.ncbi.nlm.nih.gov

Diabetes Educators: Perceived Experiences, Supports and Barriers to Use of Common Diabetes-Related Technologies. [2018]

12. United States pubmed.ncbi.nlm.nih.gov

Computer-aided learning in insulin pump training. [2021]

13. United States pubmed.ncbi.nlm.nih.gov

Can digital health apps provide patients with support to promote structured diabetes education and ongoing self-management? A real-world evaluation of myDiabetes usage. [2023]

14. United States pubmed.ncbi.nlm.nih.gov

Diabetes Educators' Intended and Reported Use of Common Diabetes-Related Technologies: Discrepancies and Dissonance. [2018]

15. United States pubmed.ncbi.nlm.nih.gov

Technology Integration: The Role of the Diabetes Care and Education Specialist in Practice. [2021]