Observational Study on Blood Sugar and Hormone Responses in Insulin-Dependent Type 2 Diabetes

This study is looking for adults aged 18 to 65 who have type 2 diabetes and use insulin. The goal is to understand how your body's blood sugar (glucose) and hormones like insulin and glucagon respond after eating a meal. You'll have blood samples taken frequently over a 4-hour period after a standardized liquid meal. You'll also wear continuous glucose monitors and activity trackers at home for about 8 days. The information collected will help researchers create computer models, or "digital twins," to better understand type 2 diabetes. We're hoping to learn more about how these responses change over time.

Study design
This is an observational study, meaning there are no interventions or treatments being tested. It plans to enroll 25 participants.
What's involved
You will have a screening visit, followed by about 8 days of wearing a continuous glucose monitor and activity tracker at home. Then, you'll have an in-clinic visit for a liquid meal test, which involves frequent blood draws over 4 hours.
Compensation
Not stated in the trial record.
Follow-up
Blood sugar and hormone levels will be measured for up to 240 minutes (4 hours) after meal consumption during the in-clinic visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07650682

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

Recruiting
Not specifiedAges 18–65Observational
Clinical Nutrition Research Center, Illinois Institute of Technology
~25 participants
Updated 2026-06-16 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Plasma Glucose Concentration (mg/dL)
Measured over -10 to 240 minutes relative to meal consumption
+9 more outcomes measured
Type 2 Diabetes
Insulin Dependent Diabetes
1 sites across 1 states
Illinois1
  • Indika Edirisinghe, Ph.D · PRINCIPAL_INVESTIGATOR · Illinois Institute of Technology
Chelsea Preiss, Clinical Research Manager, MS
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Eligibility criteria

Inclusion

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

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)
  • Change in Plasma Glucose Concentration (mg/dL)-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)-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)-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)-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)-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 ConditionsApproximately 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)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)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)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)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.