Metabolic Wellness and CGM

NCT06790472 | Enrolling By Invitation FDA Device

• 1 other identifier: 2024.055-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of this study is to determine the impact of participating in an online lifestyle intervention program on glycemic control as measured by Continuous Glucose Monitoring (CGM), with the primary outcome being the time-in-range (TIR) between 70 and 140 mg/dl comparing before the intervention, at the start of the program (week 1), and after the intervention (week 8).

Conditions

Cardiometabolic Risk Factors

Keywords

Lifestyle; Online; Metabolic wellness; Cardiometabolic risk; Digital health; Continuous glucose monitoring

Outcome Measures

Primary Outcomes (1)

• Glycemic Control (Time-in-Range)

  Time-in-range (TIR) between 70 and 140 mg/dl as measured by CGM.

  Baseline and Weeks 2, 7-8

Study Arms (1)

SH MWP Participants (Fall 2024)

Research participants will be Sutter Health employees and their dependents who enroll in the MWP and are invited to participate in a research study about the program. Over 8 weeks, program participants will engage in an online program focusing on evidence-based lifestyle interventions which include education related to food choices, physical activity, sleep, and stress guidance.

Behavioral: Online Lifestyle Intervention; Device: Continuous Glucose Monitoring

Interventions

Online Lifestyle Intervention BEHAVIORAL

The Metabolic Wellness Program (MWP) is an established 8-week program that provides participants with health education videos and webinars that focus on evidence-based nutrition, fitness, sleep, and stress intervention, including with CGM, allowing participants to monitor their real-time glucose data and to learn which lifestyle choices are best for their glycemic control and personal metabolic health. The program is also intended to help healthy participants maintain their metabolic health and lower their potential risk of developing cardiometabolic disease, as well as at-risk and pre-diabetic participants preventing the progression to T2D and people with established T2D reverse their condition.

SH MWP Participants (Fall 2024)

Continuous Glucose Monitoring DEVICE

CGM measurements begin at enrollment with training provided digitally Participants will be asked to "live life as usual" whilst wearing the device with initial 10-14 day readings providing baseline data. Participants will participate in the online lifestyle program, which the investigators refer to as the "intervention stage." Participants will also receive questionnaires on behavior change at the beginning of week 5. During the final two weeks of the program (weeks 7-8), the final 10-14 days of CGM will be used as comparison data with baseline information.

SH MWP Participants (Fall 2024)

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

Study participants will be adults who respond to email, newsletters and MHO messaging advertisements addressed to Sutter Health workforce members.

You may qualify if:

• Adults who are enrolled in the MWP
• Adults ≥ 18 years of age at enrollment.
• Willing to wear a CGM device.
• Sutter Health employee or employee's dependent enrolled in SutterSelect Employee Medical Benefits

You may not qualify if:

• Pregnancy
• Taking insulin
• Chronic kidney disease and on dialysis
• Any active clinically significant disease or disorder which, in the investigator's opinion, could interfere with participation in the study

Sponsors & Collaborators

• David Kerr: lead
• William Marsh Rice University: collaborator
• Abbott Diabetes Care: collaborator

Study Sites (1)

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

Location

Related Links

• Sutter Health Metabolic Wellness Program

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Investigator, Diabetes and Digital Health Equity

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: January 24, 2025
• Study Start: September 5, 2024
• Primary Completion: June 30, 2025
• Study Completion: October 11, 2025
• Last Updated: January 24, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)