Diabetes Mellitus, Type 2NCT04991142
Models of Nutrition From Continuous Glucose Monitors
An observational study of Diabetes Mellitus, Type 2 and Pre-diabetes, run by Texas A&M University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2, Pre-diabetes, Diet Habit
- How many people
- 45 participants
- Where
- 2 sitesUnited States
- Study dates
- 17 Sep 2021to 1 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas A&M University
College Station, Texas, 77843
Sansum Diabetes Research Institute
Santa Barbara, California, 93105
About this study
Official title: 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.
Read the 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.
- Conditions
- Diabetes Mellitus, Type 2, Pre-diabetes, Diet Habit, Diet, Healthy
- Medical subject headings
- Diabetes Mellitus, Type 2, Glucose Intolerance, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 14 days
Secondary outcomes (2)
Feasibility of measuring impact of physical activity on estimations of meal composition using CGMs and smart watches
Unit of measure: Correlation and regression error in estimating meal composition from post-prandial glucose measurements and physical activity data
Measured: up to 14 days
Feasibility of measuring impact of gut microbiota on estimations of meal composition using CGMs
Unit of measure: Correlation and regression error in estimating meal composition from post-prandial glucose measurements and identification of active gut microbiome pathways
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start17 Sep 2021
- Primary completion1 Aug 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Sansum Diabetes Research Institute
- Responsible party
- Sponsor
- Investigators
- Kristin Castorino, DO, Principal investigator, Sansum Diabetes Research InstituteBobak J Mortazavi, PhD, Principal investigator, Texas A&M UniversityRicardo Gutierrez-Osuna, PhD, Principal investigator, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991142
- Sponsor's protocol ID
- IIS2014475
- Status last verified
- Aug 2024
- First submitted
- 27 Jul 2021
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All de-identified individual participant data (IDP) that underlie results in publications.
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCH: INT: Personalized Models of Nutrition Intake From Continuous Glucose Monitors
- ClinicalTrials.gov ID
- NCT04991142
- Acronym / sponsor ID
- IIS2014475
- Conditions
- Diabetes Mellitus, Type 2, Pre-diabetes, Diet Habit, Diet, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Sansum Diabetes Research Institute
- Study start
- 17 Sep 2021 (actual)
- Primary completion
- 1 Aug 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
Feasibility of measuring impact of physical activity on estimations of meal composition using CGMs and smart watches
Time frame: up to 14 days
Feasibility of measuring impact of gut microbiota on estimations of meal composition using CGMs
Time frame: up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- Individual participant dataSharing planned: Yes. All de-identified individual participant data (IDP) that underlie results in publications.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristin Castorino, DO principal investigator
Sansum Diabetes Research Institute
Bobak J Mortazavi, PhD principal investigator
Texas A&M University
Ricardo Gutierrez-Osuna, PhD principal investigator
Texas A&M University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes Mellitus, Type 2 and Pre-diabetes, run by Texas A&M University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of measuring meal quantity and composition using CGMs (time frame: up to 14 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.