Models of Nutrition From Continuous Glucose Monitors

August 19, 2024 updated by: Texas A&M University

SCH: INT: Personalized Models of Nutrition Intake From Continuous Glucose Monitors

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

Poor diet contributes to more than half of premature deaths related to cardiovascular and metabolic disease, including type 2 diabetes (T2D). At present, the number of adults developing T2D continues to rise, with over 30 million Americans living with T2D. Another 80 million are currently at-risk of progressing from pre-diabetes to T2D. Improving food choices remains a cornerstone of modern diabetes care and can decrease the risk of progression to T2D. However, at present, achieving timely and appropriate lifestyle change in adults with or at-risk of T2D is challenging. Conventional methods to record meal choice and track nutritional composition can be inaccurate (e.g., estimating protein content of a meal) and burdensome (i.e., individuals must manually enter information into a food diary). Interestingly, the blood glucose profile after a meal depends not only on the carbohydrate content but also on the amount of fat, protein, and fiber; as an example, adding fat and protein to carbohydrates generally leads to smaller increases and slower decreases in achieved glucose levels, lowering risk. This suggests that the shape of the glucose response to a meal may have the potential to indicate meal content. A unique opportunity to exploit this information is to use one or more continuous glucose monitors (CGMs). A CGM is a small sensor that attaches to the skin and measures glucose continuously every 1-15 minutes, making it possible to automatically record the glucose responses to meals. Researchers anticipate that findings will help clinicians provide new information to support positive behavior change to reduce the risk of or progression from pre-diabetes to T2D, and make it easier for patients to passively and accurately track nutritional components of their diet, potentially leading to healthier diets and improved health.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • Santa Barbara, California, United States, 93105
        • Sansum Diabetes Research Institute
    • Texas
      • College Station, Texas, United States, 77843
        • Texas A&M University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

Inclusion Criteria:

  1. Adults ≥ 18 years of age at enrollment visit.
  2. Ability to walk, sit down and stand up independently.
  3. 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.
  4. 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.
  5. Live or work within range of the study's meal delivery service.
  6. Able to speak and read English sufficiently to engage in study activities.
  7. Ability to refrigerate provided meals.

Exclusion Criteria:

  1. Under 18 years of age.
  2. Type 1 diabetes or a history of diabetic ketoacidosis.
  3. Type 2 diabetes treated with oral medicines (other than Metformin) or any injectable GLP-1 receptor agonist or insulin.
  4. Life expectancy < 12 months.
  5. Any active clinically significant physical or mental disease or disorder that, in the investigator's opinion, could interfere with the participation in the study.
  6. 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).
  7. Renal impairment, defined as estimated glomerular filtration rate <60 mL/min/1.73 m2 as per Chronic Kidney Disease Epidemiology Collaboration formula.
  8. Known or suspected abuse of alcohol, narcotics, or illicit drugs.
  9. Language and/or technology barriers precluding comprehension of study activities and informed consent.
  10. Any food allergies that, in the investigator's opinion, could interfere with participation in the study.
  11. Pregnant (self-reported).
  12. Current participation in other trials involving medications or devices.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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%

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of measuring meal quantity and composition using CGMs
Time Frame: up to 14 days
Unit of measure: Correlation and regression error in estimating meal composition from post-prandial glucose measurements
up to 14 days

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility of measuring impact of physical activity on estimations of meal composition using CGMs and smart watches
Time Frame: up to 14 days
Unit of measure: Correlation and regression error in estimating meal composition from post-prandial glucose measurements and physical activity data
up to 14 days
Feasibility of measuring impact of gut microbiota on estimations of meal composition using CGMs
Time Frame: up to 14 days
Unit of measure: Correlation and regression error in estimating meal composition from post-prandial glucose measurements and identification of active gut microbiome pathways
up to 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas A&M University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Sansum Diabetes Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Bobak J Mortazavi, PhD, Texas A&M University
  • Principal Investigator: Ricardo Gutierrez-Osuna, PhD, Texas A&M University
  • Principal Investigator: Kristin Castorino, DO, Sansum Diabetes Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 17, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 27, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 5, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IIS2014475

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All de-identified individual participant data (IDP) that underlie results in publications.

IPD Sharing Time Frame

Data will be made available after the primary publication of each analysis.

IPD Sharing Access Criteria

Data Sharing Agreements will be formulated by a committee of study investigators and community and industry partners.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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