Wearable Technology for Insulin Monitoring in Diabetes

Overseen By Nicolaas Deutz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Texas A&M University

Must not be taking: Oral corticosteroids

Disqualifiers: Insulin-dependent diabetes, Heart failure, Kidney disease, Liver disease, others

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

Compensation: Varies

Number of Visits: 3

Duration: 5 hours

32 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new wearable device that tracks insulin levels without needles. By monitoring insulin, participants can understand how their bodies react to different foods and make informed choices to stay healthy. The trial involves wearing the device and consuming a special drink to evaluate the device's effectiveness. Ideal participants can walk and lie down comfortably, have a BMI between 22 and 35, and do not have certain chronic illnesses or allergies to drink ingredients such as sunflower oil or whey protein. As an unphased trial, this study offers a unique opportunity to contribute to innovative research in health monitoring technology.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications, but it excludes those on active treatment for certain chronic diseases and those using corticosteroids. It's best to discuss your specific medications with the trial team.

What prior data suggests that this wearable technology is safe for insulin monitoring?

Research has shown that wearable technology plays an important role in monitoring health conditions like diabetes. Devices such as continuous glucose monitors (CGMs) provide real-time information on blood sugar levels, helping to prevent low blood sugar episodes. These devices are generally safe and easy to use. However, not all wearable devices have FDA approval for this purpose. Some, like certain smartwatches or smart rings, might not provide accurate readings and could give incorrect information. Always verify if a device is FDA-approved for monitoring specific health conditions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the use of wearable technology for monitoring insulin in people with diabetes, which could transform how we manage this condition. Unlike traditional methods like fingerstick blood tests and continuous glucose monitors that can be cumbersome, wearable tech offers a more convenient and potentially more comfortable way to track insulin levels in real-time. This approach could lead to better glucose control and improve quality of life for individuals with diabetes by reducing the burden of constant monitoring. Additionally, the use of a standardized liquid meal drink in the trial aims to provide consistent and reliable data, which could enhance the accuracy and effectiveness of insulin monitoring with wearables.

What evidence suggests that this wearable technology is effective for insulin monitoring in diabetes?

Research shows that wearable technology can greatly aid in managing diabetes. Studies have found that devices using artificial intelligence (AI) can predict blood sugar levels, simplifying insulin management. Many individuals with diabetes find these wearable devices beneficial for daily condition management. However, more evidence is needed regarding their long-term effects. This trial will explore wearable technology for insulin monitoring. Continuous glucose monitoring, which tracks blood sugar levels over time, has been linked to better blood sugar control and fewer doctor visits. This suggests that wearable devices could also enhance insulin management and overall health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals with diabetes interested in monitoring their insulin levels noninvasively to understand how their body reacts to food. The goal is to help them personalize their diet and improve metabolic health.

Inclusion Criteria

BMI between 22 and 35 kg/m2

Willingness and ability to comply with the protocol

I am either 18-30 or 50-90 years old.

Exclusion Criteria

Active dependence on alcohol or drugs

Any condition found during the screening visit that would interfere with the study or safety of the patient according to the PI or nurse

I have never been treated for liver or kidney disorders.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Baseline Assessment

Baseline biological samples of sweat, dermal interstitial fluid, and blood are collected

2 hours

1 visit (in-person)

Treatment

Participants receive a standardized liquid meal and undergo biological sampling for insulin quantification

5 hours

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 day

What Are the Treatments Tested in This Trial?

Interventions

• Wearable Technology

Trial Overview The study tests a new wearable technology that monitors insulin levels without needles, using standardized meals to assess individual metabolic responses and optimize dietary plans for better health outcomes.

How Is the Trial Designed?

Group I: Standardized liquid meal drink Experimental Treatment 1 Intervention

We will provide a standardized drink consisting of whey, maltodextrin and sunflower oil, flavored using vanilla sugar-free instant pudding.

Who Is Running the Clinical Trial?

Texas A&M University

Lead Sponsor

Trials

156

Recruited

28,900+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10131991/

The Effectiveness of Wearable Devices Using Artificial ... The Effectiveness of Wearable Devices Using Artificial Intelligence for Blood Glucose Level Forecasting or Prediction: Systematic Review

2. nature.com nature.com/articles/s41746-025-02036-9

Integration of artificial intelligence and wearable ... AI models paired with wearable devices showed promise in glycemic monitoring, adaptive insulin management, and predicting diabetes-related ...

3. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2025.1563003/full

Perspectives of people with diabetes on AI-integrated ... Conclusion: The findings indicate that people with diabetes regard wearable devices as effective instruments for managing their condition, ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1530891X23000460

Effectiveness of Wearable Activity Monitors on Metabolic ... Wearable technology appeared to be an effective tool for the self-management of T2DM; however, there is insufficient evidence about its long-term effect.

5. jmcp.org jmcp.org/doi/10.18553/jmcp.2024.24255

Initiating continuous glucose monitoring is associated with ... This study showed that CGM use in patients with diabetes was associated with clinically meaningful improvements in A1c and reduced health care resource ...

6. fda.gov fda.gov/medical-devices/safety-communications/do-not-use-smartwatches-or-smart-rings-measure-blood-glucose-levels-fda-safety-communication

Do Not Use Smartwatches or Smart Rings to Measure ... Do not use smartwatches or smart rings to measure blood glucose. They are not authorized by the FDA. Using them could result in inaccurate ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5478039/

Privacy and Security Issues Surrounding the Protection of ... CGMs keep patients safe from harm from low blood sugars, known as hypoglycemia, by alerting them when their glucose has fallen below a threshold ...

8. diabetes.org diabetes.org/about-diabetes/devices-technology

Diabetes Devices & Technology | ADA From blood glucose meters and continuous glucose monitoring (CGM) to cutting-edge insulin pumps and more, devices are easier to use and less invasive.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8212630/

Mobile and Wearable Technology for the Monitoring of ... This study aims to review the literature on the use of modern mobile and wearable technology for monitoring parameters that condition the development or ...

10. adces.org adces.org/education/danatech/glucose-monitoring/continuous-glucose-monitors-(cgm)/cgm-101/pros-cons-of-cgm

CGM l Pros and Cons of Continuous Glucose Monitors ... CGM provides continuous, real-time glucose data, eliminating the need for frequent fingerstick checks. It enhances hypoglycemia prevention, improves glycemic ...