NCT07650682 · Clinical Nutrition Research Center, Illinois Institute of Technology
Mathematical Modeling of Blood Sugar and Hormone Responses in Insulin-Dependent Type 2 Diabetes
(MT2D)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Change in Plasma Glucose Concentration (mg/dL)
Time frame: -10 to 240 minutes relative to meal consumption
Plasma glucose concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a clinical chemistry analyzer (Randox). Unit of Measure: mg/dL
Change in Plasma Insulin Concentration (µIU/mL)
Time frame: -10 to 240 minutes relative to meal consumption
Plasma insulin concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a clinical chemistry analyzer (Randox). Unit of Measure: (µIU/mL)
Change in Plasma Glucagon Concentration (pg/mL)
Time frame: -10 to 240 minutes relative to meal consumption
Plasma glucagon concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a multiplex immunoassay platform (Luminex). Unit of Measure: pg/mL
Change in Plasma C-Peptide Concentration (ng/mL)
Time frame: -10 to 240 minutes relative to meal consumption
Plasma C-peptide concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a multiplex immunoassay platform (Luminex). Unit of Measure: ng/mL
Change in Plasma Triglyceride Concentration (mg/dL)
Time frame: -10 to 240 minutes relative to meal consumption
Plasma triglyceride concentrations will be measured from venous blood samples collected at baseline and multiple postprandial time points using a clinical chemistry analyzer (Randox). Unit of Measure: mg/dL
Continuous Glucose Monitoring Metrics During Free-Living Conditions
Time frame: Approximately 8 days during outpatient monitoring
Interstitial Glucose Concentration during Free-Living Conditions via Continuous Glucose Monitor Description: Interstitial glucose concentration measured continuously during outpatient free-living conditions using the Dexcom G7 continuous glucose monitoring device. Unit of Measure: mg/dL
Average Daily Step Count (steps/day)
Time frame: Approximately 8 days during outpatient monitoring.
Average daily step count, reported in steps per day, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.
Average Daily Active Minutes (minutes/day)
Time frame: Approximately 8 days during outpatient monitoring.
Average daily active minutes, reported in minutes per day, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.
Average Daily Sleep Duration (hours/night)
Time frame: Approximately 8 days during outpatient monitoring.
Average sleep duration, reported in hours per night, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.
Average Resting Heart Rate (beats/minute)
Time frame: Approximately 8 days during outpatient monitoring.
Average resting heart rate, reported in beats per minute (bpm), measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 3 months
- Unstable weight: gained or lost weight +/- 5 kg (11 lbs) in previous 2 months
- Unusual working hours i.e., working overnight (e.g. 3rd shift)
Where
- Chicago, Illinois
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 16, 2026 · Source of record for eligibility and locations