Advancing Precision Nutrition: Wearable Technology for Noninvasive Insulin Monitoring
Study Overview
Status
Conditions
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Nicolaas Deutz
- Phone Number: 979-458-1484
- Email: nep.deutz@ctral.org
Study Contact Backup
- Name: Laura Ruebush
- Phone Number: 979-458-1484
- Email: le.ruebush@ctral.org
Study Locations
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Texas
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College Station, Texas, United States, 77843
- Recruiting
- Texas A&M University
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Contact:
- Nicolaas Deutz
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion criteria:
- Age 18-90 years old
- Type 1 Diabetes (T1D) group only
- ● Recently diagnosed (≤ 5 years)
- ● Established diagnosis (> 5 years)
- 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
- Willingness and ability to comply with the protocol including wearing of a continuous glucose monitor
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: 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Standardized liquid meal drink
The researchers will provide a standardized drink consisting of whey, maltodextrin and sunflower oil, flavored using vanilla sugar-free instant pudding.
|
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.
Meal contains use Whey powder (30g) as protein, Maltodextrin (Polycose; 95g) as carbohydrate, and Sunflower Oil (0g) as the fat source.
The meal is mixed and flavored using vanilla sugar-free instant pudding.
Meal contains will use Whey powder (30g) as protein, Maltodextrin (Polycose; 95g) as carbohydrate, and Sunflower Oil (26g) as the fat source.
The meal is mixed and flavored using vanilla sugar-free instant pudding.
Meal contains Whey powder (30g) as protein, Maltodextrin (Polycose; 52g) as carbohydrate, and Sunflower Oil (26g) as the fat source.
The meal is mixed and flavored using vanilla sugar-free instant pudding.
Meal contains Whey powder (30g) as protein, Maltodextrin (Polycose; 52g) as carbohydrate, and Sunflower Oil (0g) as the fat source.
The meal is mixed and flavored using vanilla sugar-free instant pudding.
Meal contains Whey powder (15g) as protein, Maltodextrin (Polycose; 52g) as carbohydrate, and Sunflower Oil (6g) as the fat source.
The meal is mixed and flavored using vanilla sugar-free instant pudding.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Quantification of protein biomarkers
Time Frame: up to 9 hours, 1 day
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Time-varying plasma insulin concentrations and correlation between sweat and dermal interstitial fluid.
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up to 9 hours, 1 day
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 105-Sweat
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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