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RecruitingNot applicable

Advancing Precision Nutrition: Wearable Technology for Noninvasive Insulin Monitoring

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 90 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device, Blood draws, X-rays, Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The goal of the proposed research is to develop a wearable device that can directly stimulate sweat secretion and rapidly quantify the concentration of insulin in sweat."
  • "In stark contrast to a blood draw and subsequent insulin quantification in a clinical lab, the envisioned wearable sweat sensor can noninvasively and rapidly quantify insulin at any desired time at home."
  • "This study will validate the performance of the wearable devices for in situ quantification of insulin in sweat and determine the concentration correlation between sweat, dermal interstitial fluid, and blood."
  • "On the screening day, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured."
  • "Questionnaires about overall health and well-being will also be completed."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at wearable technology to measure insulin without needles. Insulin is a hormone that helps control blood sugar. The study is for adults ages 18–30 or 50–90.

Noninvasively monitoring insulin is crucial for advancing precision nutrition and promoting healthy living by enabling a deeper understanding of individual metabolic responses to dietary intake. Insulin is a key regulator of blood sugar and energy metabolism, and its dysregulation is linked to conditions such as diabetes, obesity, and metabolic syndrome. By noninvasively tracking insulin levels, individuals can gain real-time insights into how their body processes different foods, allowing for the personalization of diets to optimize metabolic health, manage weight, and reduce disease risk. This approach also empowers proactive lifestyle adjustments to maintain insulin sensitivity, improve glycemic control, and enhance overall well-being. Decentralized insulin quantification in biofluids, including saliva and serum, based on lateral flow assay or electrochemical sensor has been reported. However, these approaches have poor sensitivity and fail to quantify insulin with a high temporal resolution.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Are ages 18–30 or 50–90.
  • Have a BMI between 18 and 35. BMI is a measure of weight compared with height.
  • Can walk, sit down, and stand up, on your own or with a walking aid.
  • Are willing to lie on your back in bed for up to 9 hours.
  • Are willing and able to follow the study instructions.

Who can't join

  • Have an allergy to meal ingredients or substances used to apply the devices, including sunflower oil, maltodextrin, whey protein, or pilocarpine solutions.
  • Have a diagnosed disease being actively treated: diabetes needing insulin, active cancer, heart failure, kidney or liver disease, HIV/AIDS, moderate to severe asthma, or hepatitis A, B, or C.
  • Have a history of an untreated disease affecting how your body uses food and energy, including liver or kidney problems; have a current illness or an unstable long-term illness.
  • Have an active dependence on alcohol or drugs.
  • Took a short course of steroid medicine by mouth in the past 4 weeks, or take it long term.
  • Had a fever in the past 3 days, or plan to have non-emergency surgery requiring at least 2 days in the hospital during the study.
  • Are pregnant or may be pregnant. Women ages 18–30 will have a urine pregnancy test.
  • Cannot give informed consent, meaning agreement after learning about the study; the study doctor doubts your willingness or ability to take part; or the doctor or nurse finds a condition that could affect the study or your safety.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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

Study sites (1)

TX