Wearable sweat sensor to noninvasively measure insulin

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

Inclusion criteria:

* Age
* ● 18-30 years old
* ● 50-90 years old
* BMI between 18 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 it's running

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

Study contacts

• Study coordinator: Nicolaas Deutz
• Email: nep.deutz@ctral.org
• Phone: 979-458-1484

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.