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Continuous Glucose Monitoring to support behaviour change in adults with new-onset prediabetes

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12625000801415
Acronym
FLiP
Enrollment
24
Registered
2025-07-28
Start date
2025-08-01
Completion date
2025-11-30
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Prediabetes is a common condition of slightly high blood sugar levels, before full diabetes occurs. Developing full diabetes can be prevented by losing weight, eating healthy and being physically active. We propose that using continuous glucose monitoring (CGM), a small device that measures sugar levels continuously for 2-weeks, will help people with prediabetes to make healthier lifestyle choices. Participants (24 people) will have standard blood tests and answer questionnaires about their lifestyle (Visit 1). The CGM will be applied/set-up and participants taught how to understand their sugar data (how sugar levels go up or down with different foods, activities, sleep, stress, medicines). The same information will be collected 3-months later (Visit 3). There will be regular telephone (Visit 2/4) and/or email contact. We are interested to see if participants lose weight, have better sugar levels and/or have healthier lifestyles. This study could support use of CGM as a convenient and cheap way to prevent diabetes.

Interventions

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 qualit

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.

Sponsors

Sydney Local Health District
Lead SponsorGovernment body

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

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.

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.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026