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Smart Insoles + Diabetes Education for Diabetes

N/A
Waitlist Available
Led By Ngozi Mbue
Research Sponsored by Texas Woman's University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Ambulatory
Diagnosis of Diabetes Mellitus
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 months, 4 months and 6 months
Awards & highlights

Study Summary

This trial is testing a new way to help people with diabetes remember to wear their diabetic footwear and to reduce their risk of developing foot ulcers.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Since the intervention involves educational components and non-invasive technology rather than medication, there are no direct side effects like you'd expect from drugs. However, participants may experience discomfort adjusting to new routines or technologies.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can walk on my own without help.
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I have been diagnosed with diabetes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 months, 4 months and 6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 months, 4 months and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
A Change in Adherence to prescribed footwear is being assessed
Secondary outcome measures
A change in Foot Self-Care knowledge is being assessed
A change in Perception of Benefits is being assessed
A change in Response Rate to Alert and Unreported Alert Duration is being assessed
Other outcome measures
A change in Acceptability and Ease of Use is being assessed
A change in Adherence to device wear is being assessed
A change in Foot Ulcers is being assessed
+1 more

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Smart insoles + EducationExperimental Treatment1 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 InsolesActive Control1 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 CareActive Control1 Intervention
Participants will not receive foot self-care education or the use of insoles and smart watch.

Find a Location

Who is running the clinical trial?

Texas Woman's UniversityLead Sponsor
86 Previous Clinical Trials
5,808 Total Patients Enrolled
Ngozi MbuePrincipal InvestigatorTexas Woman's University

Media Library

A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion Clinical Trial Eligibility Overview. Trial Name: NCT05074849 — N/A
Diabetes Research Study Groups: Smart insoles + Education, Smart Insoles, Usual Care
Diabetes Clinical Trial 2023: A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion Highlights & Side Effects. Trial Name: NCT05074849 — N/A
A 90-minute self-care education + bi-weekly 30-minute one-on-one follow-up phone discussion 2023 Treatment Timeline for Medical Study. Trial Name: NCT05074849 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment still available for individuals in this trial?

"As per the records on clinicaltrials.gov, patient recruitment for this medical trial is now complete. The entry was initially posted July 20th of 2021 and last edited October 21st 2022 - however 24 other studies are currently seeking participants."

Answered by AI

Who else is applying?

What state do they live in?
Texas
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Benefits of Insoles With Real-Time Alert and Foot Self-Care Education
2024. "Benefits of Insoles With Real-Time Alert and Foot Self-Care Education". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05074849.
~48 spots leftby Nov 2025
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