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.
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.
United States1 site, 1 recruiting
- Recruiting
Texas A&M University
College Station, Texas, 77843
Nicolaas Deutz
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.
- Conditions
- Insulin Response, Type 1 Diabetes
- 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 group | Role | What they receive |
|---|---|---|
| Standardized liquid meal drink | Experimental | The 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.
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.
- First posted28 Nov 2025
- Study start11 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marielle PKJ Engelen, PhD, Texas A&M University
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
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advancing Precision Nutrition: Wearable Technology for Noninvasive Insulin Monitoring
- ClinicalTrials.gov ID
- NCT07254364
- Acronym / sponsor ID
- 105-Sweat
- Conditions
- Insulin Response, Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- 11 Sep 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 28 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Individual response to a standardized liquid nutrition meal.
| Arm | Type | Receives |
|---|---|---|
| Standardized liquid meal drink | Experimental | Other: Standardized meal 1The researchers will provide a standardized drink consisting of whey, maltodextrin and sunflower oil, flavored using vanilla sugar-free instant pudding. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (16 listed)
- Known allergy to any of the components of the meal or agents used for the application of the devices
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standardized meal 1Meal 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. | Other | Standardized liquid meal drink |
Primary outcome
Quantification of protein biomarkers
Time frame: up to 9 hours, 1 day
Time-varying plasma insulin concentrations and correlation between sweat and dermal interstitial fluid.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
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.