What side effects are associated with this type of intervention?

The most common treatments for diabetes include insulin, metformin, SGLT2 inhibitors, and GLP-1 receptor agonists. Insulin can cause hypoglycemia and weight gain. Metformin is generally well-tolerated but can cause gastrointestinal issues such as diarrhea and nausea. SGLT2 inhibitors, like canagliflozin, may increase the risk of urinary tract infections and, in some cases, lower limb amputations. GLP-1 receptor agonists, such as liraglutide, can cause gastrointestinal side effects and have been associated with an increased risk of pancreatitis. These treatments are essential for managing blood glucose levels but come with potential side effects that should be monitored by healthcare providers.

What prior FDA approvals exist?

FDA-approved treatments for diabetes include a variety of pharmacological options such as insulin therapy, DPP-4 inhibitors, GLP-1 receptor agonists, and SGLT2 inhibitors. These treatments aim to manage blood glucose levels and reduce complications associated with diabetes. In addition to these pharmacological treatments, innovative approaches like the use of wearable insoles and smart watches are being studied to improve adherence to prescribed footwear and prevent foot ulcers in diabetes patients. This novel technology supplements traditional clinical care by providing real-time alerts and promoting foot self-care education.

What other types of research exist?

Promising alternatives to wearable insoles and smart watches for diabetes patients include: 1) Continuous Glucose Monitoring (CGM) systems integrated with mobile apps for real-time feedback and alerts, 2) Telehealth platforms offering remote monitoring and personalized coaching, 3) Smart socks with embedded sensors to detect pressure points and temperature changes, and 4) Advanced wound care technologies such as bioengineered skin substitutes and smart bandages that monitor healing progress.

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Smart Insoles + Diabetes Education for Diabetes

Q: What is the mechanism of action of this treatment?

Common treatments for diabetes include insulin therapy, oral hypoglycemic agents, and lifestyle interventions. Insulin therapy helps regulate blood glucose levels by facilitating the uptake of glucose into cells. Oral hypoglycemic agents, such as metformin, improve insulin sensitivity and reduce glucose production in the liver. Lifestyle interventions, including diet and exercise, help manage weight and improve overall metabolic health. For diabetes patients, especially those at risk for foot ulcers, adherence to prescribed treatments is crucial. Technologies like wearable insoles and smart watches can monitor and encourage adherence to prescribed footwear, reducing the risk of foot ulcers and improving overall diabetes management.

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

Must not have

Wide spread malignancy or systemically immunocompromising disease

Cardiopulmonary disease (e.g. recent MI, Stroke)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 months, 4 months and 6 months

Awards & highlights

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have had a recent heart attack or stroke.

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I have gangrene.

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I have active Charcot foot or a major foot deformity.

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I currently have an infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 months, 4 months and 6 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

A Change in Adherence to prescribed footwear is being assessed

Secondary study objectives

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 study objectives

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 7Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for diabetes include insulin therapy, oral hypoglycemic agents, and lifestyle interventions. Insulin therapy helps regulate blood glucose levels by facilitating the uptake of glucose into cells. Oral hypoglycemic agents, such as metformin, improve insulin sensitivity and reduce glucose production in the liver. Lifestyle interventions, including diet and exercise, help manage weight and improve overall metabolic health. For diabetes patients, especially those at risk for foot ulcers, adherence to prescribed treatments is crucial. Technologies like wearable insoles and smart watches can monitor and encourage adherence to prescribed footwear, reducing the risk of foot ulcers and improving overall diabetes management.

Filling gaps in type 1 diabetes and exercise research: a scoping review and priority-setting project.Examining the Relationship Between Delay Discounting, Delay Aversion, Diabetes Self-care Behaviors, and Diabetes Outcomes in U.S. Adults With Type 2 Diabetes.Diabetes Technology: Review of the 2019 American Diabetes Association Standards of Medical Care in Diabetes.