Weight LossOWL-CGMNCT05890209
Optimizing Weight Loss. Can Continuous Glucose Monitoring Play a Role
A study testing Continuous Glucose Monitoring device in people with Weight Loss and Obesity, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
The goal of this clinical trial is to determine the potential effectiveness of adding Continuous Glucose Monitoring to a personalized weight loss maintenance program in improving weight loss maintenance. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Obesity
- What is being tested?
- Continuous Glucose Monitoring device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Apr 2023to 15 Oct 2024
- Phase
- Interventional
- 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
Who may be able to join
- Age ≥18 years old.
- Intentionally lost ≥5 kg within the past 6 months
- Have a BMI of >25kg/m2 prior to weight loss
- Have access to and be able to use a smartphone or tablet running iOS or Android and be able to use the Freestyle Libre app and MyFood24 app OR access and ability to use a telephone.
- Participants should be willing to use CGM.
- Participants must be able to read, understand and communicate in English
Who cannot join
- Have been diagnosed with Type 1 and Type 2 Diabetes
- Pregnant or planning pregnancy in the next 6 months, or currently breastfeeding.
- Participants who are currently on any pharmacological treatments for weight loss or any drugs may affect body weight.
- Participants who have previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy.
- Participants with known hypersensitivity to CGM sensors.
- Participants with any other serious medical condition, in the opinion of the investigators, would compromise their safety or adherence to the study.
- Participants diagnosed with an eating disorder (e.g., anorexia nervosa, bulimia nervosa, or purging disorder).
- Participants who lack capacity or are unable to read or understand written or verbal instructions in English.
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this clinical trial is to determine the potential effectiveness of adding Continuous Glucose Monitoring to a personalized weight loss maintenance program in improving weight loss maintenance.
The main questions it aims to answer are:
Read more
- What is the feasibility and acceptability of wearing a continuous glucose monitoring device in people maintaining weight loss?
- Is using continuous glucose monitoring will help to change the food and physical activity behavior in people maintaining weight loss?
Participants will be randomized into control and intervention groups where the researchers will compare the effects of wearing continuous glucose monitoring devices on behavior change in both groups.
Read the detailed description
The study is a 24-week study conducted at the University of Glasgow. It is a randomized, non-blinded, feasibility trial with 48 adults randomized into one of two groups (24 adults in each group):
- Personalized Weight Management Group (PWM): The group will receive a personalized diet and physical activity plan and five one-to-one online support meetings with a trained dietitian over the first 12 weeks of the program (in weeks 1, 2, 4, 8, and 12). The participants also will be given an evidence-based weight loss maintenance information booklet and advice (e.g.: dietary advice, physical activity recommendation, the importance of self-monitoring weight, diet, and physical activity). Participants will be asked to self-manage during weeks 12 - 24 and asked to maintain the diet, PA recommendations, and monitoring based on the advice and training provided in the first 12 weeks of the program.
- PWM + CGM: This group will receive the same support as the PWM group. The participants also will be given an evidence-based weight loss maintenance information booklet and advice (e.g.: dietary advice, physical activity recommendation, the importance of self-monitoring weight, diet, physical activity, and glucose level). In addition, participants will be provided with a CGM device and guidance on how to use this to support weight loss maintenance. They will be provided with CGM devices for the whole study duration.
- Conditions
- Weight Loss, Obesity
- Being tested
- Continuous Glucose Monitoring device
- Medical subject headings
- Weight Loss, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose Monitoring deviceDevice
A small wearable transdermal sensor that tracks glucose levels in interstitial fluid by taking measurements at regular and frequent intervals throughout the day and night.
| Study group | Role | What they receive |
|---|---|---|
| Personalized Weight Management group (PWM) | No intervention | The group will receive a personalized diet and physical activity plan and five one-to-one online support meetings with a trained dietitian over the first 12 weeks of the program (in weeks 1, 2, 4, 8, and 12). The participants also will be given an evidence-based weight loss maintenance information booklet and advice (e.g.: dietary advice, physical activity recommendation, the importance of self-monitoring weight, diet, and physical activity). Participants will be asked to self-manage during weeks 12 - 24 and asked to maintain the diet, PA recommendations, and monitoring based on the advice and training provided in the first 12 weeks of the program. |
| PWM + Continuous Glucose Monitoring (CGM) | Experimental | This group will receive the same support as the PWM group. The participants also will be given an evidence-based weight loss maintenance information booklet and advice (e.g.: dietary advice, physical activity recommendation, the importance of self-monitoring weight, diet, physical activity, and glucose level). In addition, participants will be provided with a CGM device and guidance on how to use this to support weight loss maintenance. They will be provided with CGM devices for the whole study duration. Receives: Device: Continuous Glucose Monitoring device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Research recruitment rate
The number of adults being recruited over the course of recruitment phase.
Measured: 24 weeks
Research retention rate
Retention is the number of participants that remain till the end of the trial at the end of 24 weeks.
Measured: 24 weeks
Adherence of CGM use
The proportion of days for which valid CGM data are obtained from the CGM group.
Measured: 24 weeks
Changes in dietary intake
Dietary Intake monitored for 3 days at 0, 12, 24 weeks using the MyFood24 online diaries where the participants will have to log their daily dietary intake.
Measured: 24 weeks
Changes in physical activity
Physical Activity level monitored objectively for a day using an accelerometer at 0, 12, 24 weeks.
Measured: 24 weeks
Changes in weight
Weight will be monitored using weight scale from baseline Week 0, Week 12 and Week 24
Measured: 24 weeks
Changes in body composition
Body composition will be measured using bioelectrical impedance at Week 0, 12, 24
Measured: 24 weeks
Secondary outcomes (2)
Qualitative evaluation of participant's experiences
Qualitative evaluation of participant's experiences will be conducted through a semi structured interview with 8-12 of participants
Measured: 24 weeks
Changes in biomarkers of cardio-metabolic disease risk
Biomarkers measurement will be measured at the 0, 12, 24 weeks. The blood will be taken from the participant to test on biomarkers of cardio-metabolic risk which include Fasting insulin level, fasting glucose, triglyceride, cholesterol
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start15 Apr 2023
- Primary completion15 Jul 2024 (estimated)
- Study completion15 Oct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nurul Zafirah Binti Mohd Hatta, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890209
- Sponsor's protocol ID
- 200220068
- Acronym
- OWL-CGM
- Status last verified
- May 2024
- First submitted
- 28 Apr 2023
- Last updated
- 16 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hatta NZM, Gray CM, Harvie M, Brosnahan N, Sattar N, Gray SR, Gill JMR. Optimizing Weight Loss Maintenance: Can Continuous Glucose Monitoring Play a Role (OWL-CGM)? A Randomized Controlled Feasibility Trial. Clin Nutr. 2026 Jul 21;64:106738. doi: 10.1016/j.clnu.2026.106738. Online ahead of print.
PubMed 42541977
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Weight Loss. Can Continuous Glucose Monitoring Play a Role
- ClinicalTrials.gov ID
- NCT05890209
- Acronym / sponsor ID
- OWL-CGM / 200220068
- Conditions
- Weight Loss, Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 49 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Study start
- 15 Apr 2023 (actual)
- Primary completion
- 15 Jul 2024 (estimated)
- Study completion
- 15 Oct 2024 (estimated)
- First posted
- 6 Jun 2023 (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 goal of this clinical trial is to determine the potential effectiveness of adding Continuous Glucose Monitoring to a personalized weight loss maintenance program in improving weight loss maintenance.
The main questions it aims to answer are:
- What is the feasibility and acceptability of wearing a continuous glucose monitoring device in people maintaining weight loss?
- Is using continuous glucose monitoring will help to change the food and physical activity behavior in people maintaining weight loss?
Participants will be randomized into control and intervention groups where the researchers will compare the effects of wearing continuous glucose monitoring devices on behavior change in both groups.
Detailed description
The study is a 24-week study conducted at the University of Glasgow. It is a randomized, non-blinded, feasibility trial with 48 adults randomized into one of two groups (24 adults in each group):
- Personalized Weight Management Group (PWM): The group will receive a personalized diet and physical activity plan and five one-to-one online support meetings with a trained dietitian over the first 12 weeks of the program (in weeks 1, 2, 4, 8, and 12). The participants also will be given an evidence-based weight loss maintenance information booklet and advice (e.g.: dietary advice, physical activity recommendation, the importance of self-monitoring weight, diet, and physical activity). Participants will be asked to self-manage during weeks 12 - 24 and asked to maintain the diet, PA recommendations, and monitoring based on the advice and training provided in the first 12 weeks of the program.
- PWM + CGM: This group will receive the same support as the PWM group. The participants also will be given an evidence-based weight loss maintenance information booklet and advice (e.g.: dietary advice, physical activity recommendation, the importance of self-monitoring weight, diet, physical activity, and glucose level). In addition, participants will be provided with a CGM device and guidance on how to use this to support weight loss maintenance. They will be provided with CGM devices for the whole study duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Personalized Weight Management group (PWM) | No intervention | –The group will receive a personalized diet and physical activity plan and five one-to-one online support meetings with a trained dietitian over the first 12 weeks of the program (in weeks 1, 2, 4, 8, and 12). The participants also will be given an evidence-based weight loss maintenance information booklet and advice (e.g.: dietary advice, physical activity recommendation, the importance of self-monitoring weight, diet, and physical activity). Participants will be asked to self-manage during weeks 12 - 24 and asked to maintain the diet, PA recommendations, and monitoring based on the advice and training provided in the first 12 weeks of the program. |
| PWM + Continuous Glucose Monitoring (CGM) | Experimental | Device: Continuous Glucose Monitoring deviceThis group will receive the same support as the PWM group. The participants also will be given an evidence-based weight loss maintenance information booklet and advice (e.g.: dietary advice, physical activity recommendation, the importance of self-monitoring weight, diet, physical activity, and glucose level). In addition, participants will be provided with a CGM device and guidance on how to use this to support weight loss maintenance. They will be provided with CGM devices for the whole study duration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age ≥18 years old.
- Intentionally lost ≥5 kg within the past 6 months
- Have a BMI of >25kg/m2 prior to weight loss
- Have access to and be able to use a smartphone or tablet running iOS or Android and be able to use the Freestyle Libre app and MyFood24 app OR access and ability to use a telephone.
- Participants should be willing to use CGM.
Key exclusion criteria (8 listed)
- Have been diagnosed with Type 1 and Type 2 Diabetes
- Pregnant or planning pregnancy in the next 6 months, or currently breastfeeding.
- Participants who are currently on any pharmacological treatments for weight loss or any drugs may affect body weight.
- Participants who have previously had bariatric surgery for weight loss including gastric bypass and sleeve gastrectomy.
- Participants with known hypersensitivity to CGM sensors.
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 |
|---|---|---|
| Continuous Glucose Monitoring deviceA small wearable transdermal sensor that tracks glucose levels in interstitial fluid by taking measurements at regular and frequent intervals throughout the day and night. | Device | PWM + Continuous Glucose Monitoring (CGM) |
Primary outcome
Research recruitment rate
Time frame: 24 weeks
The number of adults being recruited over the course of recruitment phase.
Research retention rate
Time frame: 24 weeks
Retention is the number of participants that remain till the end of the trial at the end of 24 weeks.
Adherence of CGM use
Time frame: 24 weeks
The proportion of days for which valid CGM data are obtained from the CGM group.
Changes in dietary intake
Time frame: 24 weeks
Dietary Intake monitored for 3 days at 0, 12, 24 weeks using the MyFood24 online diaries where the participants will have to log their daily dietary intake.
Changes in physical activity
Time frame: 24 weeks
Physical Activity level monitored objectively for a day using an accelerometer at 0, 12, 24 weeks.
Changes in weight
Time frame: 24 weeks
Weight will be monitored using weight scale from baseline Week 0, Week 12 and Week 24
Changes in body composition
Time frame: 24 weeks
Body composition will be measured using bioelectrical impedance at Week 0, 12, 24
2 secondary outcomes
Qualitative evaluation of participant's experiences
Time frame: 24 weeks
Changes in biomarkers of cardio-metabolic disease risk
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Derived from this study: PubMed 42541977Hatta NZM, Gray CM, Harvie M, Brosnahan N, Sattar N, Gray SR, Gill JMR. Optimizing Weight Loss Maintenance: Can Continuous Glucose Monitoring Play a Role (OWL-CGM)? A Randomized Controlled Feasibility Trial. Clin Nutr. 2026 Jul 21;64:106738. doi: 10.1016/j.clnu.2026.106738. Online ahead of print.
- 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.
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?
A study testing Continuous Glucose Monitoring device in people with Weight Loss and Obesity, run by University of Glasgow at 1 site in United Kingdom.
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 6 inclusion and 8 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 16 May 2024. 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 Kingdom. 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?
Research recruitment rate (time frame: 24 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05890209, which also lists 1 linked publication.
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 16 May 2024.