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Insulin ResponseNCT07254364

Advancing Precision Nutrition: Wearable Technology for Noninvasive Insulin Monitoring

A study testing Standardized meal 1 in people with Insulin Response and Type 1 Diabetes, run by Texas A&M University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 90 yearsHealthy volunteers can take part
Conditions the study is for
Insulin Response, Type 1 Diabetes
What is being tested?
Standardized meal 1
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteUnited States
Study dates
11 Sep 2025to Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 90 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 16Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Nicolaas Deutz contact

979-458-1484

nep.deutz@ctral.org

United States1 site, 1 recruiting
  • Texas A&M University

    College Station, Texas, 77843

    Nicolaas Deutz

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

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.

The study will take place at the research facility of the Center for Translational Research on Aging and Longevity (CTRAL), Texas A\&M University located in the Human Clinical Research Building) affiliated with Texas A\&M University. Some study procedures (e.g., body composition) may be skipped if completed within the past 3 months at CTRAL. All data will be recorded in Case Report Form and stored in the Research Electronic Data Capturing (REDCap) System.

Subjects will be asked to arrive in the fasted state on all study days. Fasting prior to screening is not required. On the screening day, body weight, height, and body composition by Dual-energy X-ray absorptiometry (DXA) will be measured. In addition, The Six-Minute Walk Test (6MWT) and skeletal muscle function tests will be assessed at the end of each screening visit. Questionnaires about overall health and well-being will also be completed. The study visit will begin with vital signs. Before administration of the feeding or the tracer solution, baseline blood will be collected for measurement of the natural enrichment of metabolites. The research nurse will place a catheter (small, flexible, plastic tube) in a vein of the arm or hand. The hand will be placed in a warmed box to increase blood flow. There will be a device with electrodes used to generate and collect sweat on the forearm. Once sweat collection is started, we will also apply a microneedle patch to the forearm of the subject for 5-30 minutes duration. Microneedle patches (sensors) are small flexible sticker-like devices. They will be applied to the skin using a small spring loaded applicator to measure the chemical analytes in the dermal interstitial fluids. After 2 hours of baseline biological samples of sweat, dermal interstitial fluid, and blood have been collected, the researchers will provide a standardized meal as a liquid drink consisting of whey, maltodextrin and sunflower oil, flavored using vanilla sugar-free instant pudding. Biological sampling will continue to occur for the following 5 hours.

Being tested
Standardized meal 1
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Standardized meal 1Other

    Meal contains Whey powder (60g) as protein, Maltodextrin (Polycose; 170g) as carbohydrate, and Sunflower Oil (48g) as the fat source. The meal is mixed and flavored using vanilla sugar-free instant pudding.

Study groups in NCT07254364
Study groupRoleWhat they receive
Standardized liquid meal drinkExperimentalThe researchers will provide a standardized drink consisting of whey, maltodextrin and sunflower oil, flavored using vanilla sugar-free instant pudding.
Receives: Other: Standardized meal 1

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Quantification of protein biomarkers

    Time-varying plasma insulin concentrations and correlation between sweat and dermal interstitial fluid.

    Measured: up to 9 hours, 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2025
  2. Study start11 Sep 2025
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Model description
Individual response to a standardized liquid nutrition meal.
Masking
None (open label)
Enrolment
32 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07254364
Sponsor's protocol ID
105-Sweat
Status last verified
Sep 2026
First submitted
19 Nov 2025
Last updated
5 Oct 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Standardized meal 1 in people with Insulin Response and Type 1 Diabetes, run by Texas A&M University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicolaas Deutz (979-458-1484, nep.deutz@ctral.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Quantification of protein biomarkers (time frame: up to 9 hours, 1 day). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2026.

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