Models of Nutrition From Continuous Glucose Monitors

NCT04991142 | Completed

• 1 other identifier: IIS2014475
• Study Type: observational
• Target: 45
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Feasibility of measuring meal quantity and composition using CGMs

  Unit of measure: Correlation and regression error in estimating meal composition from post-prandial glucose measurements

  up to 14 days

Secondary Outcomes (2)

• Feasibility of measuring impact of physical activity on estimations of meal composition using CGMs and smart watches

  up to 14 days

• Feasibility of measuring impact of gut microbiota on estimations of meal composition using CGMs

  up to 14 days

Study Arms (3)

Persons with Diabetes Mellitus, Type 2

Venous blood draw of fasting HbA1c greater than or equal to 6.5%

Persons with Pre-diabetes

Venous blood draw of fasting HbA1c greater than or equal to 5.7% and less than 6.5%

Persons without Pre-diabetes or Diabetes Mellitus, Type 2

Venous blood draw of fasting HbA1c less than 5.7%

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adults without or with type 2 diabetes, or at high risk of developing type 2 diabetes and who currently use a compatible smartphone will be enrolled.

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.

Sponsors & Collaborators

• Texas A&M University: lead
• Sansum Diabetes Research Institute: collaborator

Study Sites (2)

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

Texas A&M University

College Station, Texas, 77843, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Glucose Intolerance; Feeding Behavior

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Hyperglycemia; Behavior, Animal; Behavior

Study Officials

• Kristin Castorino, DO

  Sansum Diabetes Research Institute

  PRINCIPAL INVESTIGATOR

• Bobak J Mortazavi, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

• Ricardo Gutierrez-Osuna, PhD

  Texas A&M University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2021
• First Posted: August 5, 2021
• Study Start: September 17, 2021
• Primary Completion: August 1, 2024
• Study Completion: August 1, 2024
• Last Updated: August 21, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• Time Frame: Data will be made available after the primary publication of each analysis.
• Access Criteria: Data Sharing Agreements will be formulated by a committee of study investigators and community and industry partners.

Locations

US (2)