Metabolic Wellness and CGM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Online Lifestyle Intervention, Continuous Glucose Monitoring.
- Who it may be relevant to
- Registry conditions: Cardiometabolic Risk Factors. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Assessing the Glycemic Impact of an Online Lifestyle Intervention Using CGM (Continuous Glucose Monitoring). a Pilot Study.
Overview
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
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 - 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
Primary outcome measures
- Glycemic Control (Time-in-Range) [Time frame: Baseline and Weeks 2, 7-8]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Palo Alto Medical Foundation — Palo Alto
Identifiers
NCT: NCT06790472 · 2024.055-1