Cardiometabolic Risk FactorsNCT06790472
Metabolic Wellness and CGM
An observational study of Cardiometabolic Risk Factors, run by David Kerr at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cardiometabolic Risk Factors
- What is being tested?
- Online Lifestyle Intervention and Continuous Glucose Monitoring
- Type of treatment
- Medical device, Lifestyle or therapy programme
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Sep 2024to 11 Oct 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Study participants will be adults who respond to email, newsletters and MHO messaging advertisements addressed to Sutter Health workforce members.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Palo Alto Medical Foundation
Palo Alto, California, 94301
About this study
Official title: 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).
Read the 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
- Conditions
- Cardiometabolic Risk Factors
- Being tested
- Online Lifestyle Intervention, Continuous Glucose Monitoring
- Keywords
- Lifestyle, Online, Metabolic wellness, Cardiometabolic risk, Digital health, Continuous glucose monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Lifestyle InterventionBehavioural
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 MonitoringDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online Lifestyle Intervention; Device: Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glycemic Control (Time-in-Range)
Time-in-range (TIR) between 70 and 140 mg/dl as measured by CGM.
Measured: Baseline and Weeks 2, 7-8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start5 Sep 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion11 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiometabolic Risk FactorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- David Kerr
- Sponsor type
- University, hospital or other
- Collaborators
- William Marsh Rice University, Abbott Diabetes Care
- Responsible party
- Sponsor-investigator, David Kerr, Palo Alto Medical Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790472
- Sponsor's protocol ID
- 2024.055-1
- Status last verified
- Sep 2024
- First submitted
- 25 Sep 2024
- Last updated
- 24 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: The investigators do not have approval to share IPD for this project.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Glycemic Impact of an Online Lifestyle Intervention Using CGM (Continuous Glucose Monitoring). a Pilot Study.
- ClinicalTrials.gov ID
- NCT06790472
- Acronym / sponsor ID
- 2024.055-1
- Conditions
- Cardiometabolic Risk Factors
- Keywords
- Lifestyle, Online, Metabolic wellness, Cardiometabolic risk, Digital health, Continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- David KerrUniversity, hospital or other
- Collaborators
- William Marsh Rice University, Abbott Diabetes Care
- Study start
- 5 Sep 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 11 Oct 2025 (estimated)
- First posted
- 24 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SH MWP Participants (Fall 2024) | – | Behavioral: Online Lifestyle Intervention, Device: Continuous Glucose MonitoringResearch 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Study participants will be adults who respond to email, newsletters and MHO messaging advertisements addressed to Sutter Health workforce members.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Lifestyle InterventionThe 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. | Behavioural | SH MWP Participants (Fall 2024) |
| Continuous Glucose MonitoringCGM 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. | Device | SH MWP Participants (Fall 2024) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2025.
- Sutter Health Metabolic Wellness ProgramLink provided by the sponsor.
- Individual participant dataSharing planned: No. The investigators do not have approval to share IPD for this project.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiometabolic Risk Factors, run by David Kerr at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glycemic Control (Time-in-Range) (time frame: Baseline and Weeks 2, 7-8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2025.