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

Mathematical Modeling of Type 2 Diabetes Mellitus

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Wearing a device, Blood draws

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will also use continuous glucose monitoring and wearable physical activity tracking devices during free-living conditions."
  • "Eligible participants will receive a continuous glucose monitor (CGM) and wearable activity tracker and will complete dietary recall assessments during the outpatient monitoring period."
  • "Participants will undergo approximately 8 days of outpatient monitoring using continuous glucose monitoring and wearable physical activity tracking devices during free-living conditions."
  • "Blood samples will be collected before and over a 4-hour period after consumption of a standardized liquid meal consisting of vanilla-flavored Ensure®."
  • "The information collected from continuous glucose monitoring, wearable activity tracking, dietary assessments, and repeated blood sampling will be used to develop mathematical models capable of simulating physiologic and metabolic responses in individuals with insulin-dependent type 2 diabetes mellitus."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at blood sugar and hormone changes after a liquid meal in adults ages 18–65 with type 2 diabetes who use insulin. It includes blood tests over 4 hours and devices that track blood sugar and activity during daily life. Researchers will use the data to build computer models, called “digital twins,” to better understand how people respond to meals, activity, and diabetes treatments.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18–65.
  • Have type 2 diabetes that needs insulin, with an HbA1c of at least 6.5% at screening. HbA1c measures average blood sugar.
  • Have used insulin for at least 6 months before screening.
  • Do not smoke. Past smokers must have quit at least 12 months ago.
  • Are judged to be in good health based on medical history, with no signs of heart, lung, kidney, digestive, liver, or metabolic disease (problems with how the body uses food for energy).
  • Can understand and agree to take part.
  • Can follow study rules, including diet limits, study foods, a food diary, sample collection, and study visits.

Who can't join

  • Have a known or suspected allergy or other bad reaction to study foods.
  • Have hemoglobin below 9.5 g/dL at screening, a sign of anemia (too little of the protein in red blood cells that carries oxygen).
  • Have blood pressure above 160/100 at screening.
  • Are pregnant or plan to become pregnant during the study.
  • Had a major injury or surgery within 2 months. A longer wait may be needed after review by the lead researcher.
  • Follow a vegan or other very strict diet, such as Atkins, as judged by the researcher; or have an eating disorder diagnosed by a health professional.
  • Donated blood in the last 3 months, or gained or lost 11 pounds (5 kg) in the last 2 months.
  • Work unusual hours, such as overnight shifts.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

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 sites (1)

IL