Continuous glucose monitoring to help adults with prediabetes manage blood sugar
Continuous Glucose Monitoring (CGM) in Prediabetes: A Mixed-Methods Study Exploring Behavioural Impact, Patient Experiences and Provider Perspectives
This study will try wearing a continuous glucose monitor to help adults in Singapore with prediabetes change behaviors and manage blood sugar compared with usual health coaching.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 21 Years to 69 Years |
| Sex | All |
| Sponsor | SingHealth Polyclinics Academic / other |
| Locations | 2 sites (Singapore and 1 other locations) |
| Trial ID | NCT07371546 on ClinicalTrials.gov |
What this trial studies
Participants with prediabetes will wear a small continuous glucose monitor (CGM) sensor on the back of the arm and view glucose data on their phone using the FreeStyle LibreLink app, while a comparison group receives traditional health coaching. The team will compare behavioral changes and short-term health outcomes between the CGM group and the coaching group and will collect feasibility data on using CGM in this population. Eligible participants are Singapore citizens or permanent residents aged 21–69 with prediabetes by fasting glucose or 2-hour OGTT criteria, able to use the app, and not pregnant or cognitively impaired. This is an initial pilot effort to see if CGM use is practical and whether real-time glucose feedback can influence lifestyle choices in people with prediabetes.
Who should consider this trial
Good fit: Adults 21–69 who are Singapore citizens or permanent residents with prediabetes (fasting glucose 6.1–6.9 mmol/L and/or 2-hour OGTT 7.8–11.0 mmol/L), own a smartphone compatible with the FreeStyle LibreLink app, and are willing to use the device and follow study procedures are ideal candidates.
Not a fit: People who are pregnant or planning pregnancy, have physical or cognitive limitations that prevent engagement with the program, are not proficient in English, already have diabetes, or cannot attend the Pasir Ris clinic are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, real-time glucose feedback from CGM could motivate healthier eating and activity habits and reduce the risk of progression to type 2 diabetes.
How similar studies have performed: CGM has demonstrated behavior-change benefits in people with diabetes, but using CGM specifically for adults with prediabetes is novel and has limited prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
Patient Participants Inclusion Criteria: 1. Singaporean Citizen or Permanent Resident 2. Age 21 - 69 years old 3. Clinical diagnosis of prediabetes defined as a fasting glucose of 6.1-6.9 mmol/L and/or 2-hour glucose level of 7.8-11.0 mmol/L after an oral glucose tolerance test (Appropriate Care Guide, 2021) a. Can be conservatively managed, or medically managed with metformin 4. Owns a mobile phone that can download the Singapore FreeStyle LibreLink App 5. Expressed willingness to use participate in the study, use the devices according to the study protocol during the study period, and to sign informed consent. Exclusion Criteria: 1. Pregnant or planned pregnancy within the next six months 2. Physical limitation that prevents the patient from engaging in physical exercise 3. Cognitively impaired based on diagnosis of dementia or mild cognitive impairment (MCI) in the electronic health records (EHR) 4. Not adequately proficient in English 5. Currently enrolled in another study or program that involves weight loss or dietary modifications, or novel therapeutic drug or device 6. Planned surgery in the next six months 7. Not able to use smartphone or the Singapore FreeStyle LibreLink App despite coaching 8. Any end-stage disease with life prognosis of \< 2 years 9. Patients who are not willing or are not able to commit to the entire study program Healthcare Providers (HCP) Participants HCPs from Pasir Ris Polyclinic who self-reported to have treated adults with prediabetes will be enrolled for the interviews.
Where this trial is running
Singapore and 1 other locations
- Pasir Ris Polyclinic — Singapore, Singapore (Recruiting)
- Pasir Ris Polyclinic — Singapore, Singapore (Recruiting)
Study contacts
- Principal investigator: Ying Jun Lim, BScHons, MD — SingHealth Polyclinics
- Study coordinator: Cindy MY Wong, MBBS, Mmed (Family Medicine)
- Email: cindy.wong@singhealth.com.sg
- Phone: +6563507600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.