Recruiting

Observational Study

Sponsor:

Clinical Nutrition Research Center, Illinois Institute of Technology

Code:

NCT07650682

Conditions

Type 2 Diabetes

Insulin Dependent Diabetes

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT07650682

Start date

May 20, 2026

Status verified date

Jun, 2026

Completion date

Mar 20, 2027

Anticipated

Primary completion date

Oct 20, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Change in Plasma Glucose Concentration (mg/dL) [ Time Frame: -10 to 240 minutes relative to meal consumption ]
  • Change in Plasma Insulin Concentration (µIU/mL) [ Time Frame: -10 to 240 minutes relative to meal consumption ]
  • Change in Plasma Glucagon Concentration (pg/mL) [ Time Frame: -10 to 240 minutes relative to meal consumption ]
  • Change in Plasma C-Peptide Concentration (ng/mL) [ Time Frame: -10 to 240 minutes relative to meal consumption ]
  • Change in Plasma Triglyceride Concentration (mg/dL) [ Time Frame: -10 to 240 minutes relative to meal consumption ]
  • Continuous Glucose Monitoring Metrics During Free-Living Conditions [ Time Frame: Approximately 8 days during outpatient monitoring ]
  • Average Daily Step Count (steps/day) [ Time Frame: Approximately 8 days during outpatient monitoring. ]
  • Average Daily Active Minutes (minutes/day) [ Time Frame: Approximately 8 days during outpatient monitoring. ]
  • Average Daily Sleep Duration (hours/night) [ Time Frame: Approximately 8 days during outpatient monitoring. ]
  • Average Resting Heart Rate (beats/minute) [ Time Frame: Approximately 8 days during outpatient monitoring. ]

Central Contacts and Locations

Central contacts

Chelsea Preiss, Clinical Research Manager, MS

312-567-5300cpreiss@illinoistech.edu

Locations

Illinois Institute of Technology

Recruiting

Chicago, Illinois, United States, 60616

Contacts

Chelsea Preiss, MS

312-567-5300cpreiss@illinoistech.edu

Principal Investigator:

Indika Edirisinghe, PhD

More Information

Sponsor

Clinical Nutrition Research Center, Illinois Institute of Technology

Last update posted

Jun 16, 2026

Last verified

Jun, 2026

Keywords

  • Liquid Meal Test
  • Digital Twin
  • Continuous Glucose Monitoring

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Clinical Nutrition Research Center, Illinois Institute of Technology on 2026-06-16.