Models of Nutrition From Continuous Glucose Monitors

NCT ID: NCT04991142

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 45 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-09-17
• Study Completion Date: 2024-08-01

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Persons with Diabetes Mellitus, Type 2

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

No interventions assigned to this group

Persons with Pre-diabetes

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

No interventions assigned to this group

Persons without Pre-diabetes or Diabetes Mellitus, Type 2

Venous blood draw of fasting HbA1c less than 5.7%

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Sansum Diabetes Research Institute

OTHER

Sponsor Role: collaborator

Texas A&M University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Castorino, DO

Role: PRINCIPAL_INVESTIGATOR

Sansum Diabetes Research Institute

Bobak J Mortazavi, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Ricardo Gutierrez-Osuna, PhD

Role: PRINCIPAL_INVESTIGATOR

Texas A&M University

Locations

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Texas A&M University

College Station, Texas, United States

Countries

United States

Other Identifiers

IIS2014475

Identifier Type: -

Identifier Source: org_study_id