Wearable sweat sensor to noninvasively measure insulin

Advancing Precision Nutrition: Wearable Technology for Noninvasive Insulin Monitoring

This research tests a wearable that stimulates sweat and measures insulin to see if sweat insulin levels track blood insulin in adults aged 18–30 and 50–90 with BMI 22–35.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 90 Years
• Sex: All
• Sponsor: Texas A&M University (Academic / other)
• Locations: 1 site (College Station, Texas)
• Trial ID: NCT07254364 on ClinicalTrials.gov

What this trial studies

The study develops a wearable device that directly stimulates sweat secretion and rapidly quantifies insulin concentration using on-device sensing technology. Participants come fasted, receive a standardized meal, and provide matched samples of sweat, dermal interstitial fluid, and blood so device readings can be compared with laboratory measurements. Screening includes body composition by DXA, a six-minute walk test, and skeletal muscle function tests, with some procedures omitted if recent results exist. All data will be recorded in case report forms and stored in REDCap while device performance is validated in situ.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18–30 or 50–90 with BMI 22–35 who can walk and lie supine for study procedures and who do not have insulin-dependent diabetes or active chronic illness.

Not a fit: People with insulin-dependent diabetes, active chronic diseases (such as heart, liver, or kidney disease), allergies to the meal or device components, or those unable to comply with fasting and immobilization requirements are unlikely to receive benefit from participation.

Why it matters

Potential benefit: If successful, this could allow people to monitor insulin noninvasively at home to personalize diet, improve glycemic control, and reduce metabolic risk.

How similar studies have performed: Previous noninvasive insulin measurements in saliva or serum have been reported but showed poor sensitivity, so wearable sweat-based insulin quantification is a relatively novel and still unproven approach.

Eligibility criteria

Inclusion criteria:

* Age

  * 18-30 years old
  * 50-90 years old
* BMI between 22 and 35 kg/m2
* Ability to walk, sit down, and stand up (independently or with a walking assistance device)
* Willingness to lay supine in bed for up to 9 hours
* Willingness and ability to comply with the protocol

Exclusion criteria

* Known allergy to any of the components of the meal or agents used for the application of the devices

  * Sunflower oil
  * Maltodextrin
  * Whey protein
  * Pilocarpine solutions
* Established diagnosis and active treatment of chronic disease: insulin-dependent diabetes, active malignancy, heart failure, kidney disease, liver disease, HIV/AIDS, asthma (moderate to severe), Hep (A, B, or C)
* History of untreated metabolic disease including hepatic or renal disorder
* Presence of acute illness or metabolically unstable chronic illness
* Active dependence on alcohol or drugs
* Use of a short course of oral corticosteroids within 4 weeks preceding study day
* Current use of long-term oral corticosteroids
* Presence of fever within the last 3 days
* Planned elective surgery requiring 2 or more days of hospitalization during the entire study
* (Possible) pregnancy (confirmed via urine pregnancy test for females 18-30 years)
* Failure to give informed consent or Investigator's uncertainty about the willingness or ability of the subject
* Any condition according to the PI or nurse that was found during the screening visit, that would interfere with the study or safety of the patient

Where this trial is running

College Station, Texas

• Texas A&M University — College Station, Texas, United States (Recruiting)

Study contacts

• Study coordinator: Nicolaas Deutz

Conditions Insulin Response