Prevalence of diabetes related vascular complications in subjects with normal glucose tolerance, prediabetes, newly detected diabetes and known diabetes.
Rini Yadav, Nishesh Jain, Nishant Raizada...
https://pubmed.ncbi.nlm.nih.gov/34303917Actively Recruiting
Phase Not Applicable
Age: 21Years - 69Years
All Genders
ID07371546
Continuous Glucose Monitoring (CGM) in Prediabetes: A Mixed-Methods Study Exploring Behavioural Impact, Patient Experiences and Provider Perspectives
Led by SingHealth Polyclinics · Updated on 2026-01-28
76
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of continuous glucose monitoring (CGM) on adults with prediabetes, a condition where blood sugar levels are higher than normal but not yet high enough to be classified as type 2 diabetes. This study aims to see if wearing a CGM device can help guide behavior changes and health management better than traditional health coaching. It also explores the experiences of both patients and healthcare providers using CGM in prediabetes care. The study involves a randomized controlled trial where participants are assigned to either wear the Abbott Freestyle Libre CGM sensor along with receiving health coaching or to receive health coaching alone. The CGM sensor is worn on the back of the arm for two weeks and linked to a smartphone app for glucose monitoring. The study includes three main visits over about six months, with baseline measurements, follow-up questionnaires, and final assessments. In-depth interviews will be conducted with some participants and healthcare providers to gather feedback on using CGM. Participants will attend three scheduled visits to complete questionnaires about diet and physical activity, have their weight, body mass index, and waist circumference measured, and receive health coaching. Those in the CGM group will be taught how to use the device and app and encouraged to make lifestyle changes based on glucose data. The study will measure changes in diet, physical activity, and body measurements over 24 to 28 weeks while monitoring adherence to the device and gathering qualitative feedback. Healthcare providers will also share their perspectives on CGM integration in prediabetes care.
CONDITIONS
Brief Title
Continuous Glucose Monitoring (CGM) in Prediabetes
Who Can Participate
Age: 21Years - 69Years
All Genders
Eligibility Criteria
You may qualify if you...
- Singaporean Citizen or Permanent Resident
- Age 21 to 69 years old
- Clinical diagnosis of prediabetes with fasting glucose of 6.1-6.9 mmol/L and/or 2-hour glucose level of 7.8-11.0 mmol/L after oral glucose tolerance test
- Can be managed conservatively or with metformin
- Owns a mobile phone that can download the Singapore FreeStyle LibreLink App
- Willing to participate, use the devices as instructed, and sign informed consent
You will not qualify if you...
- Pregnant or planning pregnancy within the next six months
- Physical limitations preventing physical exercise
- Cognitive impairment such as dementia or mild cognitive impairment
- Not proficient in English
- Currently enrolled in another weight loss, dietary modification, or novel therapy study
- Planned surgery within the next six months
- Unable to use smartphone or the FreeStyle LibreLink App despite coaching
- Has end-stage disease with life expectancy less than 2 years
- Unwilling or unable to commit to the full study program
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 24 to 28 weeks
Participants receive lifestyle education and may use the Abbott Freestyle Libre continuous glucose monitoring system for 2 weeks to help guide their dietary and physical activity changes. Questionnaires and measurements are collected at baseline, 2-6 weeks, and 24-28 weeks.
3 visits (in-person) at baseline, 2-6 weeks, and 24-28 weeks
Follow-up
Duration - Up to 36 weeks from start of intervention
Participants in the intervention group who consent will participate in in-depth interviews to share their experiences using the continuous glucose monitoring system and lifestyle changes. These interviews may occur up to 36 weeks from the start of the intervention.
1 visit (in-person) for interview, may be rescheduled if needed
Trial Site Locations
Total: 2 locations
1
Pasir Ris Polyclinic
Singapore, Singapore, 519466
Actively Recruiting
2
Pasir Ris Polyclinic
Singapore, Singapore
Actively Recruiting
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Research Team
C
Cindy MY Wong, MBBS, Mmed (Family Medicine)
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable.
Amy L Whitehead, Steven A Julious, Cindy L Cooper...
https://pubmed.ncbi.nlm.nih.gov/26092476Practical guidance for using the FreeStyle Libre flash continuous glucose monitoring in primary care.
Jeff Unger, Pamela Kushner, John E Anderson
https://pubmed.ncbi.nlm.nih.gov/32223687The process of health behaviour change following participation in a randomised controlled trial targeting prediabetes: A qualitative study.
Kirstine Schmidt, Kristine Faerch, Vibeke Zoffmann...
https://pubmed.ncbi.nlm.nih.gov/34806793Global Prevalence of Prediabetes.
Mary R Rooney, Michael Fang, Katherine Ogurtsova...
https://pubmed.ncbi.nlm.nih.gov/37196350Adding a Brief Continuous Glucose Monitoring Intervention to the National Diabetes Prevention Program: A Multimethod Feasibility Study.
Kelli M Richardson, Susan M Schembre, Vanessa da Silva...
https://pubmed.ncbi.nlm.nih.gov/38919262Association between pre-diabetes and microvascular and macrovascular disease in newly diagnosed type 2 diabetes.
Raffaele Palladino, Adam G Tabak, Kamlesh Khunti...
https://pubmed.ncbi.nlm.nih.gov/32332069Correlates, Facilitators and Barriers of Healthy Eating Among Primary Care Patients with Prediabetes in Singapore-A Mixed Methods Approach.
Raymond Boon Tar Lim, Wei Keong Wee, Wei Chek For...
https://pubmed.ncbi.nlm.nih.gov/31064063Feasibility and Acceptability of Using Flash Glucose Monitoring System Sensors to Empower Lifestyle Changes in People With Prediabetes.
Joyce Y Lee, Jenny T Nguyen, Jeffrey Arroyo...
https://pubmed.ncbi.nlm.nih.gov/36398782The Effectiveness of Lifestyle Adaptation for the Prevention of Prediabetes in Adults: A Systematic Review.
George Kerrison, Richard B Gillis, Shahwar I Jiwani...
https://pubmed.ncbi.nlm.nih.gov/28567425