Metabolic Wellness and CGM

• Conditions: Cardiometabolic Risk Factors

• Registration Number: NCT06790472
• Lead Sponsor: David Kerr

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).

Detailed Description

The Metabolic Wellness Program (MWP) is an established 8-week program that provides participants with digitally delivered health education focusing on metabolic health. The program content is based on nutrition education, promotion of physical activity, stress reduction and the need for quality sleep. The MWP also includes the use of continuous glucose monitoring (CGM), The MWP is aimed at adults with pre-existing type 2 diabetes (T2D), prediabetes and also individuals who wish to retain their metabolic health. (More information about the program is available here: https://www.sutterhealth.org/classes-events/the-metabolic-wellness-program-34466

To evaluate the success (or otherwise) of the MWP, the aim of this pilot study is to assess the impact of participating in the MWP on glycemic control, with the primary outcome being the time-in-range between 70 and 140 mg/dl measured by CGM. Data from this pilot study will provide evidence for a larger future randomized controlled trial (RCTs).

The secondary objectives are to:

* Examine additional changes in CGM variables comparing before (at baseline)and after the intervention (at week 8 and at 3 months post-intervention) Examine changes in self-reported behavior changes related to food choices, physical activity, sleep quality, and stress levels.

* Examine changes in lab values (if available as part of routine clinical care from the previous 12 months and up to 6 months after the program): and

* Examine engagement with the program, engagement with CGM, and satisfaction with the program

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-05
• Study First Submitted: 2024-09-25
• Study First Submitted QC: 2025-01-17
• Last Update Submitted: 2025-01-17
• Study First Posted: 2025-01-24
• Last Update Posted: 2025-01-24
• Primary Completion: 2025-06-30
• Study Completion: 2025-10-11

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Glycemic Control (Time-in-Range)	Baseline and Weeks 2, 7-8	Time-in-range (TIR) between 70 and 140 mg/dl as measured by CGM.

Trial Locations

Locations (1)

Palo Alto Medical Foundation; 🇺🇸 Palo Alto, California, United States