NCT04991142Completed
Models of Nutrition From Continuous Glucose Monitors
SCH: INT: Personalized Models of Nutrition Intake From Continuous Glucose Monitors
Source: ClinicalTrials.gov · Last updated 21 Aug 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 45 (actual)
- First submitted
- 27 Jul 2021
- Start date
- 17 Sept 2021
- Primary completion date
- 1 Aug 2024
- Lead sponsor
- Texas A&M University
- Diseases
- Type 2 diabetes
- NCT number
- NCT04991142
What you commit to
- Study type: Observational
- Participants enrolled: 45
- From 17 Sept 2021 to the primary completion date, 1 Aug 2024
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Type 2 diabetes treated with oral medicines (other than Metformin) or any injectable GLP-1 receptor agonist or insulin.
- Known or suspected abuse of alcohol, narcotics, or illicit drugs.
- Current participation in other trials involving medications or devices.
Other illness
- Type 1 diabetes or a history of diabetic ketoacidosis.
- 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.
- Any food allergies that, in the investigator's opinion, could interfere with participation in the study.
Age
- Under 18 years of age.
Other
- Life expectancy \< 12 months.
- Language and/or technology barriers precluding comprehension of study activities and informed consent.
- Pregnant (self-reported).
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas A&M University Coordinator of this site? Confirm its status | College Station | United States | Unknown status |
| Sansum Diabetes Research Institute Coordinator of this site? Confirm its status | Santa Barbara | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.