A Study to Understand How Continuous Glucose Monitors Impact Eating Behavior

A Consumer Pilot Study to Understand How Continuous Glucose Monitors Impact Eating Behavior in Individuals Attempting to Lose Weight

The purpose of this study is to evaluate if and how continuous glucose monitors (CGMs) impact food consumption, choice, and purchasing in individuals attempting to lose weight using their own weight management approach.

Study Overview

• Status: Completed
• Conditions: Weight Loss
• Intervention / Treatment: Other: CGM

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Addison, Illinois, United States, 60101
      • Biofortis, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. Male or female, 18-60 y of age.
2. Individual is attempting to lose ≥15 lbs.
3. Individual is able to articulate a weight loss plan.
4. Individual is a primary or co-primary grocery shopper (i.e., does all or most of the grocery shopping for the household or shares the responsibility with someone else).
5. Individual shops for household food and beverages at mainstream grocery stores (e.g., Walmart, Target, Publix, Aldi, Costco, Sam's Club, etc.).
6. Individual consumes packaged food within ≥2 General Mills categories (cereal, bars, yogurt, and soups).
7. Individual has attained a high school diploma or a General Educational Development (GED) equivalent.
8. Individual has a household income ≥$30,000 per year before taxes.
9. Individual has not participated in another research study within 1 month of the screening visit.
10. Individual has access to reliable technology and high-speed internet to attend virtual focus groups and review CGM data in real-time.
11. Individual is willing and able to undergo the scheduled study procedures, including use of a CGM for 6 weeks, complete food logs, answer weekly survey questions, and participate in online group discussions.
12. Individual understands the study procedures and signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.

Exclusion Criteria:

1. Individual or someone in the household works as a registered dietitian or fitness professional.
2. Individual or someone in the household works for a medical device company for diabetes management.
3. Individual or someone in the household works in the medical field as a nurse, medical doctor, physician assistant, or a close equivalent.
4. Individual or someone in the household currently uses a CGM.
5. Individual has a clinically significant endocrine (e.g., diabetes) or gastrointestinal condition that could interfere with the interpretation of the study results.
6. Individual has a history of cancer in the prior 2 years, except non-melanoma skin cancer or carcinoma in situ of the cervix.
7. Individual has uncontrolled hypertension (systolic blood pressure ≥160 mm Hg and/or diastolic blood pressure ≥100 mm Hg) at screening.
8. Individual has a history of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).
9. Individual has a history of bariatric surgery.
10. Individual is a female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period.
11. Individual has a current or recent history (past 12 months of screening) or strong potential for illicit drug or excessive alcohol intake defined as >14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1.5 oz hard liquor).
12. Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, or which might confound the interpretation of the study results or put the person at undue risk.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM	Other: CGM; CGM use for 6 weeks during virtual focus groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitative insights on consumer behavior	Discussions during the virtual focus groups will provide qualitative insights on if/how consumer behavior (related to food choice, eating behavior, and purchasing) changes when using a CGM.	6 weeks

Collaborators and Investigators

• Sponsor: Midwest Center for Metabolic and Cardiovascular Research
• Investigators: Study Director: Kevin Maki, PhD, MB Clinical Research and Consulting LLC

Study record dates

Study Major Dates

• Study Start (Actual): February 14, 2024
• Primary Completion (Actual): May 3, 2024
• Study Completion (Actual): May 3, 2024

Study Registration Dates

• First Submitted: February 13, 2024
• First Submitted That Met QC Criteria: February 13, 2024
• First Posted (Actual): February 21, 2024

Study Record Updates

• Last Update Posted (Actual): May 17, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Body Weight; Body Weight Changes; Weight Loss
• Other Study ID Numbers: MB-2312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No