Continuous Glucose Monitoring (CGM) in Prediabetes

Summary

Part 1 and 2 of study (For Patient Participants) The purpose of this study is to examine if the wearing of a medical device called a continuous glucose monitor (CGM) can guide adults with prediabetes modify their behaviors and manage their health, compared to traditional health coaching. Prediabetes means the study participants have a higher-than-normal blood sugar level which is not high enough to be considered type 2 diabetes yet but will put them at risk of developing it. CGM measures glucose levels without the participants having to prick fingers and involves wearing a small sensor on the back of the arm day and night which allows viewing of glucose levels on the mobile phone with a painless 1 second scan. This is the first time the investigators are trying to do research using CGM for adults with prediabetes. the study team want to learn how practical it is to do such a study. The study will explore if wearing of a CGM sensor makes a difference in terms of health outcomes compared to regular health coaching. It also aims to understand the users' experience with the CGM system. This study targets to recruit 76 participants from Pasir Ris Polyclinic. Part 1 of the study uses a research method called a randomized controlled trial. Participants who consent to join will be allocated to one of two groups based on chance. Half of the participants will receive the CGM sensor in addition to health coaching. This is called the intervention group. The other half of the participants will receive health coaching alone. This is called the control group. Participants in both groups will continue regular follow-up with their own primary care physicians. There will be 3 study touchpoints, which will mainly be at Pasir Ris Polyclinic. 1. Baseline visit: * Receive health coaching that will take 20-30 minutes. * Complete questionnaires about socio-demographic details, diet and physical activity which will take 20-30 minutes. * Measure weight, body mass index (BMI), and waist circumference. * Past medical history and medications will be retrieved from the electronic medical records. * If the participants are in the intervention group, the study team will assist them to apply the Abbott Freestyle Libre continuous glucose monitoring (CGM) sensor and link it to their smartphone. The study team will also set up the LibreLink app and Libreview account. 2. 1-month touchpoint * Complete follow up questionnaires to assess any changes in the diet and physical activity. * This touchpoint may be conducted either face-to-face or via a phone call. 3. 6-month touchpoint * Complete final questionnaires about the lifestyle. * Measure weight, BMI and waist circumference again * Uninstall the LibreLink app and Libreview account. Part 2 of the study is an in-depth interview to understand the experiences of the participants using the Abbott Freestyle Libre CGM System. This part of the study will be conducted either during the 3rd study touchpoint or on another day (within 9 months from start of intervention). The interview will last 60 minutes and will be audio-recorded. Questions asked will be regarding the general experience using the CGM, any difficulties with following the study instructions and suggestions to improve the study. Part 3 of study for Healthcare Providers Participants (HCP): The purpose of this study is to assess the effects of CGM on adults with prediabetes and to explore the facilitators and barriers of using CGM in prediabetes management from both patients and healthcare providers. The study aims to understand the perspectives of primary care providers on the potential benefits, challenges, and feasibility of integrating CGM into prediabetes management. The findings will help pave the way for broader integration of CGM technology into public health programs targeting specific populations at high risk of diabetes to improve health outcomes. If the participants agree to participate, they will be invited to fill in a data collection form on the demographics, qualifications and clinical experience. This will take 20-30 minutes. The participants will be interviewed either individually or in a group with other of their colleagues from the same polyclinic. During the interview, the researcher will ask questions pertaining to their experiences with prediabetes management, knowledge of CGM and their views of the potential challenges and opportunities in the utilization of CGM by prediabetic adults. The interviews will be audio recorded. participation in the study will last approximately 60 minutes.

Eligibility

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.

Conditions2

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