Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000801415
Ethics application status
Approved
Date submitted
11/07/2025
Date registered
28/07/2025
Date last updated
28/07/2025
Date data sharing statement initially provided
28/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Continuous Glucose Monitoring to support behaviour change in adults with new-onset prediabetes
Scientific title
Biofeedback from Freestyle Libre Continuous Glucose Monitoring to support behaviour change as an early intervention in adults with new-onset prediabetes: The Flash in Prediabetes (FLiP) Pilot Study
Secondary ID [1] 314468 0
None
Universal Trial Number (UTN)
Trial acronym
FLiP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Prediabetes 337503 0
Condition category
Condition code
Metabolic and Endocrine 333869 333869 0 0
Metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single-centre, non-blinded, single-arm, prospective, interventional pilot study conducted at Royal Prince Alfred HealthOne Green Square. At Visit 1, all participants (n=24) will undergo physical examination (height, weight, waist circumference, blood pressure) and have routine pathology performed at our onsite pathology collection service (NSW Health Pathology). They will complete questionnaires about their demographics, medical history, food habits, physical activity habits and quality of life. Participants will formally record their dietary and physical activity habits and quality of life at baseline and end-of-study using validated questionnaires ("Starting the Conversation Diet", "International Physical Activity Questionnaire short", and Medical Outcomes Study SF-20 Questionnaire", respectively). They will be provided with National Diabetes Services Scheme fact sheets on “Understanding Prediabetes”, “Healthy Food Choices”, “The Glycaemic Index”, and “Physical Activity” to help them understand their prediabetes and how to manage it. Healthy lifestyle goals will be discussed, agreed upon, and documented for the participant. A Freestyle Libre 2 Continuous Glucose Monitoring (CGM) sensor (the intervention) will be applied to the back of the arm of each participant by an experienced clinic doctor or nurse. Participants will be provided verbal and written ("Your Complete Guide to Freestyle Libre 2") information on how to scan the sensor with their own compatible smartphone and how to interpret their glucose data on the LibreLink App. They will also be shown how to notate activities/events (e.g. went for a hike, birthday party, stressful day at work, etc) on the LibreLink App. Participants will be encouraged to engage in real time with their glucose data, and recognise how different factors (e.g. food, activity, sleep, stress, medicines) affect blood glucose levels. This forms the basis for biofeedback from CGM to promote behaviour change.

After the sensor has expired (two weeks) participants can remove the sensor (peeled off the skin), and they will be followed up by phone call (Visit 2). Libre 2 CGM data will be downloaded via the LibreView Dashboard, reviewed and discussed with the participant. Participants will answer a “CGM Experience Survey” describing their experience using the Libre 2 sensor.

Between Visit 2 and Visit 3, participants will be given the option to undertake “Achievement Check-ins”, where each fortnight, they can email their self-reported bodyweight and progress with behaviour change. A generic feedback email will be sent in reply.

The process of Visit 1 and Visit 2 will then be repeated three months later, as Visit 3 and Visit 4. The second Libre 2 sensor will be applied during Visit 3 for the purpose of capturing detailed glucose metrics (unlike during Visit 1, where the sensor was used as the study intervention) and the “CGM Experience Survey” will be repeated. Participants will also be asked to complete an “End of Study Survey”.

Visit 1 and 3 will be face-to-face in the outpatient clinic and will take ~1 hour each. Visit 2 and 4 will be offered via telehealth and will take 15-30 minutes each.

We will use a session attendance checklist to monitor adherence to the intervention and the study protocol.
Intervention code [1] 331091 0
Treatment: Devices
Comparator / control treatment
As this is a pilot study, there will be no control or comparator group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342148 0
Change in fasting blood glucose level
Timepoint [1] 342148 0
Baseline and 3 months after the intervention (wearing Libre 2 CGM sensor)
Primary outcome [2] 342149 0
Change in HbA1c (glycated haemoglobin)
Timepoint [2] 342149 0
Baseline and 3 months after the intervention (wearing Libre 2 CGM sensor)
Primary outcome [3] 342150 0
Change in bodyweight
Timepoint [3] 342150 0
Baseline and 3 months after the intervention (wearing Libre 2 CGM sensor)
Secondary outcome [1] 449755 0
Diet quality
Timepoint [1] 449755 0
Baseline and 3 months after the intervention (wearing Libre 2 CGM sensor)
Secondary outcome [2] 449756 0
Physical activity
Timepoint [2] 449756 0
Baseline and 3 months after the intervention (wearing Libre 2 CGM sensor)
Secondary outcome [3] 449757 0
Quality of life
Timepoint [3] 449757 0
Baseline and 3 months after the intervention (wearing Libre 2 CGM sensor)

Eligibility
Key inclusion criteria
• Adults 18 years old and over
• Diagnosed with prediabetes in the previous 6 months (defined as fasting plasma glucose 6.1-6.9 mmol/L, 2 hr glucose level on 75 g oral glucose tolerance test 7.8-11.0 mmol/L, and/or HbA1c 6.0-6.4%).
• Willingness to wear the FreeStyle Libre 2 CGM sensor.
• Own a compatible smartphone for use of the Freestyle LibreLink app.
• Willingness to provide informed consent and willingness to participate and comply with the study requirements.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Individuals with type 1 or type 2 diabetes.
• Bodyweight change of >5% in the past 3 months.
• Taking glucose-lowering or weight loss pharmacotherapy in the past 6 months.
• Individuals with recent cardiovascular event (heart attack or stroke in the past 6 months).
• Non-English speaking (if appropriate interpreter services or support person with adequate English language skills are not available).
• Physical or cognitive inability to operate the Freestyle LibreLink app.
• Currently pregnant or planning pregnancy in the next 3 months.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
As this is only a Pilot Study, we have not performed power calculations to estimate sample sizes required to show a statistical difference. We anticipate that results from this Pilot Study will inform power calculations for a larger, randomised study.

Data from baseline and 3 months after intervention (wearing Libre 2 CGM sensor) will be compared. Quantitative data will be tested for normality and then log transformed if not normally distributed. Paired data will be analysed by a paired t-test (parametric) or Wilcoxon matched-pairs signed rank test (non-parametric). Unpaired data will be analysed by an unpaired t-test (parametric) or Mann Whitney U-test (non-parametric). Categorical data will be analysed by Fisher’s exact test. Statistical significance will be set at p <0.05. Adjustment for multiple comparisons will be performed using the Bonferroni correction.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/08/2025
Actual
Date of last participant enrolment
Anticipated
30/11/2025
Actual
Date of last data collection
Anticipated
15/03/2026
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 319005 0
Other
Name [1] 319005 0
Sydney Health Partners Diabetes and Obesity Clinical Academic Group
Country [1] 319005 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 321933 0
None
Name [1] 321933 0
Address [1] 321933 0
Country [1] 321933 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317618 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 317618 0
Ethics committee country [1] 317618 0
Australia
Date submitted for ethics approval [1] 317618 0
28/01/2025
Approval date [1] 317618 0
30/04/2025
Ethics approval number [1] 317618 0
X25-0012

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 141582 0
Dr Sarah Parry
Address 141582 0
Diabetes Centre, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW 2050
Country 141582 0
Australia
Phone 141582 0
+61 4 1148 2351
Fax 141582 0
Email 141582 0
[email protected]
Contact person for public queries
Name 141583 0
Sarah Parry
Address 141583 0
Diabetes Centre, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW 2050
Country 141583 0
Australia
Phone 141583 0
+61 295155888
Fax 141583 0
Email 141583 0
[email protected]
Contact person for scientific queries
Name 141584 0
Sarah Parry
Address 141584 0
Diabetes Centre, Royal Prince Alfred Hospital, Missenden Rd, Camperdown, NSW 2050
Country 141584 0
Australia
Phone 141584 0
+61 295155888
Fax 141584 0
Email 141584 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: In line with HREC conditions.



What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.