Smart Insoles + Diabetes Education for Diabetes

Not yet recruiting at 1 trial location

Overseen By Ngozi Mbue, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas Woman's University

Disqualifiers: Charcot arthropathy, Cardiopulmonary disease, Gangrene, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new method to help people with diabetes prevent foot ulcers, a common and serious issue. It tests smart insoles paired with a smartwatch to monitor foot care, along with education on proper foot hygiene and shoe use. The goal is to determine if these tools can encourage consistent use of diabetic footwear and reduce the risk of foot ulcers. Individuals with diabetes who regularly use prescribed diabetic footwear and are willing to participate in scheduled follow-ups may be suitable for this study. As an unphased trial, this study provides a unique opportunity to contribute to innovative diabetes care solutions.

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 focuses on using smart insoles and diabetes education to prevent foot ulcers.

What prior data suggests that these wearable insoles and smart watch are safe for diabetes patients?

Research has shown that smart insoles are generally safe for people with diabetes. Studies indicate that regular use of these insoles can lower the chance of foot ulcers by up to 86%. They effectively monitor foot health by tracking changes in pressure, temperature, and moisture.

Regarding diabetes education, research has proven it greatly improves lifestyle choices and self-care for people with diabetes. These programs help individuals manage their condition better and lower the risk of foot ulcers.

In summary, both smart insoles and diabetes education are safe and helpful for people with diabetes, aiding in the prevention of complications like foot ulcers. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to improve foot care in people with diabetes. Unlike standard treatments that primarily focus on medication management and routine check-ups, this trial combines smart insoles with personalized education sessions. The smart insoles provide real-time feedback on foot pressure, helping prevent ulcers, while the education sessions empower patients with self-care strategies. By integrating technology with education, this approach aims to enhance patient involvement and potentially reduce complications associated with diabetes, which is an exciting development in diabetes care.

What evidence suggests that this trial's treatments could be effective for diabetes foot ulcers?

Research has shown that smart insoles, one of the treatments in this trial, can help prevent foot problems in people with diabetes. These insoles monitor foot pressure and other important factors, potentially lowering the risk of developing ulcers. One study found that people with diabetes wore smart insoles for more than 5 hours a day on average.

Studies also indicate that learning about foot care, another treatment option in this trial, is beneficial. This education improves foot care practices, reducing the chance of developing foot ulcers. Specifically, those who received foot care education demonstrated better knowledge and habits for maintaining foot health.

This trial will evaluate the combined use of smart insoles and foot care education, which might help reduce the risk of foot ulcers in people with diabetes. ^{6 7 8 9 10}

Who Is on the Research Team?

Ngozi Mbue

Principal Investigator

Texas Woman's University

Are You a Good Fit for This Trial?

This trial is for adults over 18 with diabetes who can walk, use prescribed diabetic footwear, and are willing to attend follow-up visits. It's not for those with severe foot deformities, active infections or gangrene, cognitive impairment (MOCA<20), widespread cancer, or recent serious heart/lung disease.

Inclusion Criteria

I can travel to follow-up visits, even if it's more than 30 miles away.

I can walk on my own without help.

I have been diagnosed with diabetes.

Exclusion Criteria

Your Montreal Cognitive Assessment (MOCA) score is less than 20.

My cancer has spread widely or I have a disease that weakens my immune system.

I have had a recent heart attack or stroke.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive smart insoles with real-time alerts and foot self-care education to improve adherence to prescribed footwear

6 months

Monthly check-ins (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including incidence of foot ulcers and adherence to footwear

6 months

What Are the Treatments Tested in This Trial?

Interventions

• A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion
• Wearable Insoles and Smart Watch

Trial Overview The study tests a combination of wearable insoles that alert users in real-time via a smartwatch and a comprehensive foot self-care education program. The goal is to see if this technology plus education improves adherence to using diabetic footwear and reduces the risk of foot ulcers.

How Is the Trial Designed?

Group I: Smart insoles + Education Experimental Treatment 1 Intervention

Participants in this group will receive a 90-minute group session education on foot self-care strategies (daily foot hygiene and cleanliness, foot protection, use of insoles and smart watch)

Group II: Smart Insoles Active Control 1 Intervention

Participants in this group will not receive a 90-minute group session education on foot self-care, but will receive foot care supplies, insoles and smart watch

Group III: Usual Care Active Control 1 Intervention

Participants will not receive foot self-care education or the use of insoles and smart watch.

Who Is Running the Clinical Trial?

Texas Woman's University

Lead Sponsor

Trials

90

Recruited

5,900+

Published Research Related to This Trial

In a study of 31 participants with diabetes at high risk for foot ulcers, providing custom-made indoor footwear significantly improved adherence to wearing appropriate footwear, especially among those with initially low adherence, increasing from 65% at baseline to 87% at 12 months.

Despite the increase in footwear adherence, the one-year ulcer recurrence rate was 26%, indicating that while adherence improved, further research is needed to understand its impact on preventing foot ulcers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Custom-made footwear designed for indoor use increases short-term and long-term adherence in people with diabetes at high ulcer risk. Keukenkamp, R., van Netten, JJ., Busch-Westbroek, TE., et al.[2022]

The innovative intelligent insole system significantly reduced the incidence of diabetic foot ulcers by 71% over 18 months in high-risk patients compared to a control group, demonstrating its efficacy in preventing ulcer recurrence.

In patients who complied well with the system, the reduction in ulcer incidence was even greater at 86%, highlighting the potential of continuous plantar pressure monitoring and dynamic offloading guidance in managing diabetic foot health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. Abbott, CA., Chatwin, KE., Foden, P., et al.[2021]

Smart wearable devices, particularly insole systems and smart socks, are generally perceived as comfortable and useful for preventing diabetic foot ulcers (DFUs), but their acceptance is hindered by design issues and malfunctions reported by users.

Both patients and podiatrists expressed a need for improvements in device design before they would consider adopting these technologies, highlighting that user experience significantly influences the willingness to use and recommend these devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Provider Perspective of Smart Wearable Technology in Diabetic Foot Ulcer Prevention: A Systematic Review. Orlando, G., Prior, Y., Reeves, ND., et al.[2021]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10850605/

Evaluation of diabetic foot care knowledge, determinants ... We identified educational attainment, diabetes duration, regular follow‐up, and blood sugar control as critical factors influencing knowledge about foot care.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0965206X23000669

The effectiveness of foot care educational interventions for ... The aim of this review is to derive evidence from existing systematic reviews and meta-analysis on the effectiveness of foot care educational interventions.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06538168

Effectiveness of a Digital Health Education on Self-Foot ... About 15% to 25% of diabetic patients develop foot ulcers at some point. Foot problems like ulcers, infections, and amputations are among the most significant ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32660807/

A Systematic Review of the Impact of Foot Care Education ... Eight of 11 studies identified significantly better foot self care behaviour scores in individuals randomised to education compared with ...

5. nature.com nature.com/articles/s41598-025-08246-1

impact of health education on diabetic foot Self-Care in a ... This study aimed to assess the effectiveness of a health education intervention on awareness and practice of foot self-care among diabetic patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8129774/

Effectiveness of diabetes self-management education (DSME ... Based on 15 articles, diabetes self-management education intervention provides significant effectiveness to lifestyle changes and the self-care of T2DM patients ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1471595325003178

Nurses' learning about foot care for patients with diabetes Practical and interactive learning methods are crucial for nurses' knowledge in foot care for patients with diabetes.

8. bmchealthservres.biomedcentral.com bmchealthservres.biomedcentral.com/articles/10.1186/s12913-025-13244-0

Impact of the Interprofessional Collaborative Education ... Individuals with diabetes are at high risk of foot complications such as ulcers and amputations, leading to morbidity and economic burden.

9. diabetesjournals.org diabetesjournals.org/care/article/43/7/1636/35565/Diabetes-Self-management-Education-and-Support-in

Diabetes Self-management Education and Support in Adults ... Diabetes is a complex and challenging disease that requires daily self-management decisions made by the person with diabetes.

10. journals.lww.com journals.lww.com/jaanp/fulltext/2024/06000/enhancing_foot_care_education_and_support.6.aspx

Enhancing foot care education and support strategies in... We explored the perspectives of adults with diabetes on their foot care practices to identify and enhance foot care education and support strategies.