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ENROLLING BY INVITATION
NCT06790472

Metabolic Wellness and CGM

Sponsor: David Kerr

View on ClinicalTrials.gov

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).

Official title: Assessing the Glycemic Impact of an Online Lifestyle Intervention Using CGM (Continuous Glucose Monitoring). a Pilot Study.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2024-09-05

Completion Date

2025-10-11

Last Updated

2025-01-24

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Online Lifestyle Intervention

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.

DEVICE

Continuous Glucose Monitoring

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.

Locations (1)

Palo Alto Medical Foundation

Palo Alto, California, United States