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Enrolling by Invitation

NCT Number: NCT06790472

Metabolic Wellness and CGM

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).

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Key information

Conditions

Cardiometabolic Risk Factors

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Palo Alto Medical Foundation

Palo Alto, California, 94301, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

David Kerr

Other

Collaborators

  • Abbott Diabetes Care
  • William Marsh Rice University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 24, 2025
Registry last updated
Jan 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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