Models of Nutrition From Continuous Glucose Monitors

Completed

Conditions studied: Diabetes Mellitus, Type 2, Pre-diabetes, Diet Habit, Diet, Healthy

In brief

With this study, researchers want to conduct ambulatory studies in which people (healthy, with T2D, or at-risk of T2D) will consume a variety of pre-set and conventional meals in free-living conditions while wearing one or more continuous glucose monitors (CGMs) and, to assess physical activity, a smart watch. With data from these devices, researchers will develop algorithms that can predict the content of a meal.

Key facts

Study ID

NCT04991142

Run by

Texas A&M University

People needed

45

Starts

2021-09-17

Expected to finish

2024-08-01

Last updated by the study team

2024-08-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Adults ≥ 18 years of age at enrollment visit.
• Ability to walk, sit down and stand up independently.
• Exclusive and continuous use, for the up to 14 day participation period, of a study-compatible smart phone, as well as ability to use a smart phone with sufficient proficiency to engage in study activities.
• Based on the research staff's judgment, participant must have a good understanding, ability, and willingness to adhere to the protocol, including performance of self-monitored data collection during the free-living portion of the study.
• Live or work within range of the study's meal delivery service.
• Able to speak and read English sufficiently to engage in study activities.
• Ability to refrigerate provided meals.

You may not qualify if…

• Under 18 years of age.
• Type 1 diabetes or a history of diabetic ketoacidosis.
• Type 2 diabetes treated with oral medicines (other than Metformin) or any injectable GLP-1 receptor agonist or insulin.
• Life expectancy < 12 months.
• Any active clinically significant physical or mental disease or disorder that, in the investigator's opinion, could interfere with the participation in the study.
• History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).
• Renal impairment, defined as estimated glomerular filtration rate <60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula.
• Known or suspected abuse of alcohol, narcotics, or illicit drugs.
• Language and/or technology barriers precluding comprehension of study activities and informed consent.
• Any food allergies that, in the investigator's opinion, could interfere with participation in the study.
• Pregnant (self-reported).
• Current participation in other trials involving medications or devices.

Where it is running

• Sansum Diabetes Research Institute — Santa Barbara, California, United States
• Texas A&M University — College Station, Texas, United States

Full record on ClinicalTrials.gov

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