Metabolic Wellness and CGM

January 17, 2025 updated by: David Kerr

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

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Palo Alto, California, United States, 94301
        • Palo Alto Medical Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Kerr

Collaborators

William Marsh Rice University
Abbott Diabetes Care

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 5, 2024

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

October 11, 2025

Study Registration Dates

First Submitted

September 25, 2024

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 17, 2025

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2024.055-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The investigators do not have approval to share IPD for this project.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cardiometabolic Risk Factors

Clinical Trials on Online Lifestyle Intervention

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Türkiye

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe