Recruiting

Insulin Monitoring

Sponsor:

Texas A&M University

Code:

NCT07254364

Conditions

Insulin Response

Type 1 Diabetes (T1D)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Standardized meal 1

Standardized meal 2

Standardized meal 3

Standardized meal 4

Standardized meal 5

Study Details

Brief 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. 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.

Conditions

Insulin Response

Type 1 Diabetes (T1D)

Study ID

NCT07254364

Start date

Sep 11, 2025

Status verified date

Aug, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

92 participants

Anticipated

Intervention Model

Crossover

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

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.

Interventions

Standardized meal 1

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.

Standardized meal 2

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.

Standardized meal 3

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.

Standardized meal 4

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.

Standardized meal 5

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.

Standardized meal 6

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.

Primary outcome measure

  • Quantification of protein biomarkers [ Time Frame: up to 9 hours, 1 day ]

Central Contacts and Locations

Central contacts

Nicolaas Deutz

979-458-1484nep.deutz@ctral.org

Laura Ruebush

979-458-1484le.ruebush@ctral.org

Locations

Texas A&M University

Recruiting

College Station, Texas, United States, 77843

More Information

Sponsor

Texas A&M University

Last update posted

Aug 28, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-29. This information was provided to ClinicalTrials.gov by Texas A&M University on 2026-08-28. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.