PreDiabetesFlashLMPNCT04588896
Continuous Glucose Monitoring as Adjunct to Lifestyle Modification in Prediabetes
A study testing Continuous glucose monitoring and Lifestyle modification programme in people with PreDiabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
This is a 12-month prospective, open-label, non-masked, two arm randomized controlled trial comparing intermittently-viewed continuous glucose monitoring (iCGM) in addition to lifestyle modification programme (LMP) as compared with a LMP alone in individulas with impaired glucose tolerance (IGT). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Continuous glucose monitoring and Lifestyle modification programme
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 177 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2020to 31 Jan 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Impaired glucose tolerance as defined by will be defined as per the American Diabetes Association criteria based on 75g oral glucose tolerance test (OGTT) 2-hour glucose of between 7.8 and less than 11 mmol/L
- Male or female age ≥ 18 years old and ≤ 65 years old.
- BMI 18 to 40kg/m2
- Willingness, ability and commitment to comply with LMP
- Able to use a CGM as judged by investigator
- In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
- Written informed consent to participate in the study provided by the patient.
Who cannot join
- Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy
- Known diabetes
- Current or previous use of glucose-lowering or weight loss drugs
- Concurrent participation in other weight loss or lifestyle intervention programmes
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
- Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
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- Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
- Extensive skin changes/diseases that preclude wearing the FGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
- Known uncontrolled thyrotoxicosis
- Current use of steroids
- Have a known allergy to medical-grade adhesives
- Known current or recent alcohol or drug abuse
- Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
- An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Continuous Glucose Monitoring as an Adjunct to Lifestyle Modification in Individuals With Impaired Glucose Tolerance: a Randomised Controlled Trial
This is a 12-month prospective, open-label, non-masked, two arm randomized controlled trial comparing intermittently-viewed continuous glucose monitoring (iCGM) in addition to lifestyle modification programme (LMP) as compared with a LMP alone in individulas with impaired glucose tolerance (IGT). Following informed consent, participants will undergo screening where a fasting glucose, 75g OGTT, HbA1c, fasting lipid profile along with comprehensive medical and drug history to confirm eligibility. At week 0, participants will be randomised to CGM plus LMP versus LMP alone. Both groups will receive individualized structured LMP programme delivered by a dietitian and a fitness instructor. Outcomes will be evaluated by laboratory tests, physical measurement, physical activity and dietary compliance and questionnaires at Month 0, 4, 8, 12.
- Conditions
- PreDiabetes
- Being tested
- Continuous glucose monitoring, Lifestyle modification programme
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous glucose monitoringDevice
Abbott Freestyle Libre CGM for 8 weeks in adjunct to lifestyle modification programme
Lifestyle modification programmeBehavioural
Lifestyle modification programme
| Study group | Role | What they receive |
|---|---|---|
| CGM+LMP | Experimental | Continuous glucose monitoring (CGM) for 8 weeks in conjunction with lifestyle modification Receives: Device: Continuous glucose monitoring; Behavioral: Lifestyle modification programme |
| LMP only | Other | Lifestyle modification only Receives: Behavioral: Lifestyle modification programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
1-hour glucose from OGTT
1-hour plasma glucose from a 75 g oral glucose tolerance test
Measured: 12 months
Secondary outcomes (8)
HbA1c
Between-group differences in HbA1c
Measured: 12 months
Fasting plasma glucose
Between-group differences in fasting plasma glucose
Measured: 12 months
Body weight
Between-group differences in body weight
Measured: 12 months
Body mass index
Between-group differences in body mass index
Measured: 12 months
Waist circumference
Between-group differences in waist circumference
Measured: 12 months
3 day diet record
Differences in daily nutrient intake between groups
Measured: 12 months
Physical activity levels
Daily number of steps as measured by a sealed pedometer
Measured: 12 months
Socio-cognitive measures
Self-efficacy questionnaire
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start1 Dec 2020
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaine Chow, Chinese University of Hong Kong
- Investigators
- Elaine Chow, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04588896
- Sponsor's protocol ID
- FlashLMP
- Acronym
- FlashLMP
- Status last verified
- Dec 2020
- First submitted
- 10 Oct 2020
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring as an Adjunct to Lifestyle Modification in Individuals With Impaired Glucose Tolerance: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT04588896
- Acronym / sponsor ID
- FlashLMP / FlashLMP
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 19 Oct 2020 (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.
This is a 12-month prospective, open-label, non-masked, two arm randomized controlled trial comparing intermittently-viewed continuous glucose monitoring (iCGM) in addition to lifestyle modification programme (LMP) as compared with a LMP alone in individulas with impaired glucose tolerance (IGT). Following informed consent, participants will undergo screening where a fasting glucose, 75g OGTT, HbA1c, fasting lipid profile along with comprehensive medical and drug history to confirm eligibility. At week 0, participants will be randomised to CGM plus LMP versus LMP alone. Both groups will receive individualized structured LMP programme delivered by a dietitian and a fitness instructor. Outcomes will be evaluated by laboratory tests, physical measurement, physical activity and dietary compliance and questionnaires at Month 0, 4, 8, 12.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CGM+LMP | Experimental | Device: Continuous glucose monitoring, Behavioral: Lifestyle modification programmeContinuous glucose monitoring (CGM) for 8 weeks in conjunction with lifestyle modification |
| LMP only | Other | Behavioral: Lifestyle modification programmeLifestyle modification only |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Impaired glucose tolerance as defined by will be defined as per the American Diabetes Association criteria based on 75g oral glucose tolerance test (OGTT) 2-hour glucose of between 7.8 and less than 11 mmol/L
- Male or female age ≥ 18 years old and ≤ 65 years old.
- BMI 18 to 40kg/m2
- Willingness, ability and commitment to comply with LMP
- Able to use a CGM as judged by investigator
Key exclusion criteria (14 listed)
- Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy
- Known diabetes
- Current or previous use of glucose-lowering or weight loss drugs
- Concurrent participation in other weight loss or lifestyle intervention programmes
- Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this 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 |
|---|---|---|
| Continuous glucose monitoringAbbott Freestyle Libre CGM for 8 weeks in adjunct to lifestyle modification programme | Device | CGM+LMP |
| Lifestyle modification programmeLifestyle modification programme | Behavioural | CGM+LMP, LMP only |
Primary outcome
1-hour glucose from OGTT
Time frame: 12 months
1-hour plasma glucose from a 75 g oral glucose tolerance test
8 secondary outcomes
HbA1c
Time frame: 12 months
Fasting plasma glucose
Time frame: 12 months
Body weight
Time frame: 12 months
Body mass index
Time frame: 12 months
Waist circumference
Time frame: 12 months
3 day diet record
Time frame: 12 months
Physical activity levels
Time frame: 12 months
Socio-cognitive measures
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- 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.
Elaine Chow principal investigator
Chinese University of Hong Kong
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 and Lifestyle modification programme in people with PreDiabetes, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 14 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: finished, as of the sponsor's last update on 5 Mar 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 Hong Kong. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1-hour glucose from OGTT (time frame: 12 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 5 Mar 2025.