Models of Nutrition From Continuous Glucose Monitors

Completed

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

• Registration Number: NCT04991142
• Lead Sponsor: Texas A&M University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-7-27
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Inclusion Criteria:<br><br> 1. Adults = 18 years of age at enrollment visit.<br><br> 2. Ability to walk, sit down and stand up independently.<br><br> 3. Exclusive and continuous use, for the up to 14 day participation period, of a<br> study-compatible smart phone, as well as ability to use a smart phone with<br> sufficient proficiency to engage in study activities.<br><br> 4. Based on the research staff's judgment, participant must have a good understanding,<br> ability, and willingness to adhere to the protocol, including performance of<br> self-monitored data collection during the free-living portion of the study.<br><br> 5. Live or work within range of the study's meal delivery service.<br><br> 6. Able to speak and read English sufficiently to engage in study activities.<br><br> 7. Ability to refrigerate provided meals.<br><br>Exclusion Criteria:<br><br> 1. Under 18 years of age.<br><br> 2. Type 1 diabetes or a history of diabetic ketoacidosis.<br><br> 3. Type 2 diabetes treated with oral medicines (other than Metformin) or any injectable<br> GLP-1 receptor agonist or insulin.<br><br> 4. Life expectancy < 12 months.<br><br> 5. Any active clinically significant physical or mental disease or disorder that, in<br> the investigator's opinion, could interfere with the participation in the study.<br><br> 6. History of major surgical procedures involving the stomach potentially affecting<br> absorption of trial product (e.g., subtotal and total gastrectomy, sleeve<br> gastrectomy, gastric bypass surgery).<br><br> 7. Renal impairment, defined as estimated glomerular filtration rate <60 mL/min/1.73 m2<br> as per Chronic Kidney Disease Epidemiology Collaboration formula.<br><br> 8. Known or suspected abuse of alcohol, narcotics, or illicit drugs.<br><br> 9. Language and/or technology barriers precluding comprehension of study activities and<br> informed consent.<br><br> 10. Any food allergies that, in the investigator's opinion, could interfere with<br> participation in the study.<br><br> 11. Pregnant (self-reported).<br><br> 12. Current participation in other trials involving medications or devices.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of measuring meal quantity and composition using CGMs

Secondary Outcome Measures

Name	Time	Method
Feasibility of measuring impact of physical activity on estimations of meal composition using CGMs and smart watches;Feasibility of measuring impact of gut microbiota on estimations of meal composition using CGMs