Smart Insoles + Diabetes Education for Diabetes

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

72 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Novel approaches to promote adherence to diabetic footwear and prevent high incidence of diabetes foot ulcers are urgently needed. Investigators propose to translate an innovative and practical technology to supplement clinical and risk evaluation for patients with diabetes through wearable insoles and smart watch, along with foot self-care education, to improve adherence to prescribed footwear and reduce incidence of foot ulcers in those with diabetes and at risk for foot ulcers.

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.

Is the combination of smart insoles and diabetes education safe for humans?

The research indicates that smart insoles and diabetes education are generally safe for humans, though some users reported discomfort and device malfunctions. Improvements in understanding and foot care practices were noted, but further refinements of the device are needed to enhance comfort and usability. ^{1 2 3 4 5}

How does the Smart Insoles + Diabetes Education treatment differ from other treatments for diabetes?

This treatment is unique because it combines smart insoles, which help monitor foot health, with personalized diabetes education and regular follow-up discussions. This approach not only focuses on physical monitoring but also enhances patients' understanding and self-care practices, which is not typically emphasized in standard diabetes treatments. ^{3 6 7 8 9}

What data supports the effectiveness of this treatment?

Research shows that foot care education can significantly improve knowledge and behavior in people with diabetes, which is a key part of the treatment. Additionally, using smart insoles with health coaching has been shown to improve understanding and foot care practices in people with diabetes-related neuropathy. ^{3 10 11 12 13}

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

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]

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]

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]

Citations

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

The Effect of Foot Care Education for Patients with Diabetes on Knowledge, Self-Efficacy and Behavior: Systematic Review and Meta-Analysis. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Podiatrist-Delivered Health Coaching to Facilitate the Use of a Smart Insole to Support Foot Health Monitoring in People with Diabetes-Related Peripheral Neuropathy. [2022]

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

A self-efficacy education programme on foot self-care behaviour among older patients with diabetes in a public long-term care institution, Malaysia: a Quasi-experimental Pilot Study. [2022]

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

The effectiveness of motivational interviewing on adherence to wearing orthopedic shoes in people with diabetes at low-to-high risk of foot ulceration: A multicenter cluster-randomized controlled trial. [2023]

5. Ireland pubmed.ncbi.nlm.nih.gov

Effectiveness of a theory-based foot care education program (3STEPFUN) in improving foot self-care behaviours and foot risk factors for ulceration in people with type 2 diabetes. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Educational Interventions on Diabetic Foot Self-Care: A Study Protocol for a Pragmatic Randomized Controlled Trial. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Patient and Provider Perspective of Smart Wearable Technology in Diabetic Foot Ulcer Prevention: A Systematic Review. [2021]

8. England pubmed.ncbi.nlm.nih.gov

A comparison of two methods of foot health education: the Fremantle Diabetes Study Phase II. [2022]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Self-Monitoring Diabetes-Related Foot Ulcers with the MyFootCare App: A Mixed Methods Study. [2023]

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

Effectiveness of different types of footwear insoles for the diabetic neuropathic foot: a follow-up study. [2022]

11. England pubmed.ncbi.nlm.nih.gov

Innovative intelligent insole system reduces diabetic foot ulcer recurrence at plantar sites: a prospective, randomised, proof-of-concept study. [2021]

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

Self-care habits and disease-state understanding of diabetic patients. [2011]

13. England 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. [2022]