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

NCT07650682 | Recruiting

• 1 other identifier: IRB-2026-33
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes; Insulin Dependent Diabetes

Keywords

Liquid Meal Test; Digital Twin; Continuous Glucose Monitoring

Outcome Measures

Primary Outcomes (10)

• Change in Plasma Glucose Concentration (mg/dL)

  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

  -10 to 240 minutes relative to meal consumption

• Change in Plasma Insulin Concentration (µIU/mL)

  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)

  -10 to 240 minutes relative to meal consumption

• Change in Plasma Glucagon Concentration (pg/mL)

  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

  -10 to 240 minutes relative to meal consumption

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

  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

  -10 to 240 minutes relative to meal consumption

• Change in Plasma Triglyceride Concentration (mg/dL)

  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

  -10 to 240 minutes relative to meal consumption

• Continuous Glucose Monitoring Metrics During Free-Living Conditions

  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

  Approximately 8 days during outpatient monitoring

• Average Daily Step Count (steps/day)

  Average daily step count, reported in steps per day, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.

  Approximately 8 days during outpatient monitoring.

• Average Daily Active Minutes (minutes/day)

  Average daily active minutes, reported in minutes per day, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.

  Approximately 8 days during outpatient monitoring.

• Average Daily Sleep Duration (hours/night)

  Average sleep duration, reported in hours per night, measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.

  Approximately 8 days during outpatient monitoring.

• Average Resting Heart Rate (beats/minute)

  Average resting heart rate, reported in beats per minute (bpm), measured during outpatient free-living conditions using the Fitbit Sense 2 wearable activity tracker.

  Approximately 8 days during outpatient monitoring.

Secondary Outcomes (1)

• Dietary Intake Assessment Using ASA24 Dietary Recall

  Approximately 8 days during outpatient monitoring

Study Arms (1)

Adults With Insulin-Dependent Type 2 Diabetes Mellitus

Adults 18 to 65 years of age with insulin-dependent type 2 diabetes mellitus who will undergo a liquid meal tolerance test with frequent blood sampling over 4 hours following consumption of a standardized liquid meal. Participants will also undergo outpatient continuous glucose monitoring and wearable physical activity tracking during free-living conditions to support mathematical modeling of metabolic and physiologic responses.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults 18 to 65 years of age with insulin-dependent type 2 diabetes mellitus will be recruited from the Illinois Institute of Technology Clinical Nutrition Research Center proprietary database, online advertisements, social media, community outreach, and local flyers. Eligible participants must be willing to undergo continuous glucose monitoring, wearable activity tracking, dietary assessment, overnight fasting, repeated blood collection, and a liquid meal tolerance test.

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Clinical Nutrition Research Center, Illinois Institute of Technology: lead

Study Sites (1)

Illinois Institute of Technology

Chicago, Illinois, 60616, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples will be analyzed for glucose, insulin, glucagon, C-peptide, and triglycerides.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Indika Edirisinghe, Ph.D

  Illinois Institute of Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chelsea Preiss, Clinical Research Manager, MS

CONTACT

312-567-5300; cpreiss@illinoistech.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2026
• First Posted: June 16, 2026
• Study Start: May 20, 2026
• Primary Completion (Estimated): October 20, 2026
• Study Completion (Estimated): March 20, 2027
• Last Updated: June 16, 2026

Record last verified: 2026-06

Locations

US (1)