Weight LossNCT03844646
Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes
A study testing CGM and Dietitian in people with Weight Loss and PreDiabetes, run by Stanford University at 1 site in United States.
Trial summary
The primary objective of this study is to determine whether intermittent use of continuous glucose monitor will facilitate weight loss in individuals who are overweight/obese with prediabetes. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, PreDiabetes
- What is being tested?
- CGM and Dietitian
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2019to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Overweight/obese (BMI 25-40 kg/m2)
- Prediabetes (fasting glucose 100-125 mg/dL and/or HbA1c 5.7-6.4%)
Who cannot join
- On glucose-lowering medications (e.g., metformin)
- On weight-loss medications
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Real-Time Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes
The primary objective of this study is to determine whether intermittent use of continuous glucose monitor will facilitate weight loss in individuals who are overweight/obese with prediabetes.
Read the detailed description
Continuous glucose monitoring (CGM) has revolutionized the treatment of patients on intensive insulin therapy and its utility can also be harnessed to help individuals with prediabetes make healthful lifestyle changes. Successful weight loss requires adherence to lower calories, regular exercise, and self-monitoring. This proposal will test the hypothesis that intermittent CGM will facilitate all of these components for successful weight loss by functioning as a continuous self-monitor and guiding healthful food choices and physical activity.
- Conditions
- Weight Loss, PreDiabetes
- Being tested
- CGM, Dietitian
- Medical subject headings
- Weight Loss, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CGMDevice
Intermittent use of a continuous glucose monitor (CGM)
DietitianOther
Monthly meetings with a dietitian
| Study group | Role | What they receive |
|---|---|---|
| CGM plus dietitian | Experimental | Intermittent use of a continuous glucose monitor (CGM) plus dietitian support Receives: Device: CGM; Other: Dietitian |
| Dietitian only | Other | Dietitian support only Receives: Other: Dietitian |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of Weight Lost (kg)
Weight lost during the study
Measured: Baseline to end of study (3 months)
Secondary outcomes (1)
Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More
Measured: Baseline to end of study (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start1 Aug 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Why it stopped: COVID-19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Weight LossStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sun H Kim, Stanford University
- Investigators
- Sun Kim, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03844646
- Sponsor's protocol ID
- 49402
- Other IDs
- P30DK116074
- Status last verified
- Jan 2023
- First submitted
- 14 Feb 2019
- Last updated
- 31 Jan 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-Time Continuous Glucose Monitoring to Aid Weight Loss in Prediabetes
- ClinicalTrials.gov ID
- NCT03844646
- Acronym / sponsor ID
- 49402
- Conditions
- Weight Loss, PreDiabetes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: COVID-19
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Feb 2019 (actual)
- Results
- Posted 31 Jan 2023
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 whether intermittent use of continuous glucose monitor will facilitate weight loss in individuals who are overweight/obese with prediabetes.
Detailed description
Continuous glucose monitoring (CGM) has revolutionized the treatment of patients on intensive insulin therapy and its utility can also be harnessed to help individuals with prediabetes make healthful lifestyle changes. Successful weight loss requires adherence to lower calories, regular exercise, and self-monitoring. This proposal will test the hypothesis that intermittent CGM will facilitate all of these components for successful weight loss by functioning as a continuous self-monitor and guiding healthful food choices and physical activity.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM plus dietitian | Experimental | Device: CGM, Other: DietitianIntermittent use of a continuous glucose monitor (CGM) plus dietitian support |
| Dietitian only | Other | Other: DietitianDietitian support only |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Overweight/obese (BMI 25-40 kg/m2)
- Prediabetes (fasting glucose 100-125 mg/dL and/or HbA1c 5.7-6.4%)
Key exclusion criteria (2 listed)
- On glucose-lowering medications (e.g., metformin)
- On weight-loss medications
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 |
|---|---|---|
| CGMIntermittent use of a continuous glucose monitor (CGM) | Device | CGM plus dietitian |
| DietitianMonthly meetings with a dietitian | Other | CGM plus dietitian, Dietitian only |
Primary outcome
Amount of Weight Lost (kg)
Time frame: Baseline to end of study (3 months)
Weight lost during the study
1 secondary outcome
Number of Participants Reporting at Least 5 Days of Moderate Physical Activity of 30 Minutes or More
Time frame: Baseline to end of study (3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sun Kim, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CGM and Dietitian in people with Weight Loss and PreDiabetes, run by Stanford University 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 2 inclusion and 2 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: stopped early, as of the sponsor's last update on 31 Jan 2023. 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?
Yes. Results are posted in the registry (first posted 31 Jan 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Amount of Weight Lost (kg) (time frame: Baseline to end of study (3 months)). 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 31 Jan 2023.