RecruitingNot Applicable

Mathematical Modeling of Blood Sugar and Hormone Responses in Insulin-Dependent Type 2 Diabetes

United States25 participantsStarted 2026-05-20

Plain-language summary

This observational study aims to collect detailed metabolic and physiologic data from adults with insulin-dependent type 2 diabetes mellitus following consumption of a mixed meal tolerance test. Participants will undergo frequent blood sampling over a 4-hour period after consuming a standardized liquid mixed meal to measure glucose, insulin, glucagon, C-peptide, and triglyceride responses. Participants will also use continuous glucose monitoring and wearable physical activity tracking devices during free-living conditions. The purpose of this study is to develop mathematical models and digital representations ("digital twins") of people with type 2 diabetes mellitus. These models may help researchers better understand metabolic responses to meals, physical activity, and diabetes treatments, and may support future development of personalized diabetes technologies and therapies.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Men or women, 18-65 years of age * Diagnosed with insulin-dependent type 2 diabetes mellitus HbA1c ≥ 6.5% at screening * Current insulin therapy for ≥ 6 months prior to screening * Nonsmokers (past smokers can be allowed if they have abstained for a minimum of 12 months) * Judged to be in good health based on medical history (i.e., no clinical evidence of cardiovascular, metabolic, respiratory, renal, gastrointestinal, or hepatic disease) * Able to provide informed consent * Able to comply with and perform the procedures requested by the protocol (including dietary restrictions, consumption of study foods, records of food diary, sample collection procedures, and study visit schedule) Exclusion Criteria: * Men and women with known or suspected intolerance, allergies, or hypersensitivity to study foods * Men and women with low hemoglobin (Hgb) levels below 9.5 g/dL at the screening visit, indicating anemia * Men and women with blood pressure \>160 mmHg (systolic) / 100 mmHg (diastolic) at the screening visit * Women who are pregnant or planning to become pregnant during the study * Major trauma or a surgical event within 2 months (or longer depending on trauma or event) and after consultation with PI. * Vegan or other extreme dietary regimens (e.g., Atkins diet, etc.) as judged by the investigator * History of an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or binge eating) diagnosed by a health professional * Donated blood within the last …

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study seems focused on mathematical modeling and measuring things like glucose, insulin, and glucagon rather than testing a new treatment — does that mean I wouldn't receive any experimental drug or therapy, and what would actually happen to me during the study?
2The trial is tracking my daily activity, sleep, and heart rate alongside blood sugar hormones — how much of my daily routine would I need to change or report on, and is that level of monitoring realistic given my current schedule?
3Since this is a Phase N/A observational-style study measuring hormone responses rather than a treatment trial, would participating in this help my own care in any way, or is it primarily contributing to future research?
4This study measures C-peptide levels, which can show how much insulin my pancreas is still making — could the data collected here give my doctor any useful new information about my specific type of insulin-dependent Type 2 diabetes?
5Given that this study appears to be about building mathematical models rather than testing a therapy, would my doctor recommend I look into other trials that are actually testing new treatments for insulin-dependent Type 2 diabetes instead of, or alongside, this one?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Plasma Glucose Concentration (mg/dL)

Timeframe: -10 to 240 minutes relative to meal consumption

Change in Plasma Insulin Concentration (µIU/mL)

Timeframe: -10 to 240 minutes relative to meal consumption

Change in Plasma Glucagon Concentration (pg/mL)

Timeframe: -10 to 240 minutes relative to meal consumption

Change in Plasma C-Peptide Concentration (ng/mL)

Timeframe: -10 to 240 minutes relative to meal consumption

Change in Plasma Triglyceride Concentration (mg/dL)

Timeframe: -10 to 240 minutes relative to meal consumption

Continuous Glucose Monitoring Metrics During Free-Living Conditions

Timeframe: Approximately 8 days during outpatient monitoring

Average Daily Step Count (steps/day)

Timeframe: Approximately 8 days during outpatient monitoring.

Trial details

NCT IDNCT07650682

SponsorClinical Nutrition Research Center, Illinois Institute of Technology

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2026-10-20

Contact for this trial

Chelsea Preiss, Clinical Research Manager, MS

312-567-5300 cpreiss@illinoistech.edu

View on ClinicalTrials.gov More Type 2 Diabetes trials

Plain-language summary

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Plasma Glucose Concentration (mg/dL)

Timeframe: -10 to 240 minutes relative to meal consumption

Change in Plasma Insulin Concentration (µIU/mL)

Timeframe: -10 to 240 minutes relative to meal consumption

Change in Plasma Glucagon Concentration (pg/mL)

Timeframe: -10 to 240 minutes relative to meal consumption

Change in Plasma C-Peptide Concentration (ng/mL)

Timeframe: -10 to 240 minutes relative to meal consumption

Change in Plasma Triglyceride Concentration (mg/dL)

Timeframe: -10 to 240 minutes relative to meal consumption

Continuous Glucose Monitoring Metrics During Free-Living Conditions

Timeframe: Approximately 8 days during outpatient monitoring

Average Daily Step Count (steps/day)

Timeframe: Approximately 8 days during outpatient monitoring.