About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Singaporean Citizen or Permanent Resident

Age 21 - 69 years old

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)

Owns a mobile phone that can download the Singapore FreeStyle LibreLink App

Disqualifiers

Pregnant or planned pregnancy within the next six months

Physical limitation that prevents the patient from engaging in physical exercise

Cognitively impaired based on diagnosis of dementia or mild cognitive impairment (MCI) in the electronic health records (EHR)

Not adequately proficient in English

Trial design

Design model

Parallel

Treatments tested in this trial

Continuous Glucose Monitoring
Device
Participants will also receive the Abbott Freestyle Libre system, which is a sensor-based flash glucose monitoring system that has been approved by the U.S. Food and Drug Administration for personal use by patients since September 2017 (Office of the Commissioner, 2020). Participants will also receive device-specific education and be taught how they can use CGM data to identify foods or physical activities more likely to affect their glucose levels.

Treatment groups

76 Participants

are divided into 2 treatment groups

Group A: InterventionActive comparator 1 intervention

Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Dietary intake

37-item Diet Screener (DS) The DS was designed and validated in a multi-ethnic population locally aged 18-79 years to assess intakes of selected food groups that could represent overall dietary patterns. The screener covers intakes of whole grains, soya protein, fruit, vegetables, oily fish and dairy fat and demonstrates reasonably good validity and reproducibility relative to the more accepted but longer 163-item Food Frequency Questionnaire. It is therefore easier to administer during the study with minimal participant burden.

Time frame

0 weeks, 2-6 weeks, 24-28 weeks

2

Physical activity using International Physical Activity Questionnaire Short Form

a validated 7-item instrument that measures an individual's physical activity in the last 7 days; measures metabolic equivalent of task (MET)-minutes per week. Participants are asked to report the days and time they spent in the last 7 days in 4 categories: vigorous activity (heavy lifting, aerobics, fast bicycling), moderate activity (light lifting, moderate bicycling), walking, and sitting (watching TV, reading). The total physical activity was calculated as the sum of the vigorous, moderate, and walking categories in metabolic equivalent minutes per week (MET-min per week scores). Questions on sitting are related to sedentariness and are scored separately. MET minutes represent the amount of energy expended carrying out physical activity. One MET is what the participants expend when they rest. To get a continuous variable score it is considered walking to be 3.3 METS, moderate physical activity to be 4 METS and vigorous physical activity to be 8 METS. Higher score, better outcome.

Time frame

0 weeks, 2-6 weeks, 24-28 weeks

3

Body weight

Weight in kilograms

Time frame

0 week, 24-28 weeks

4

Height

Height in meters

Time frame

0 week, 24-28 weeks

Secondary outcomes

1

Participant recruitment numbers

Number of participants recruited for the control and intervention arm. The study targets to recruit 76 participants over a 6-month recruitment period.

Time frame

6 months recruitment period

2

Drop-out rate

Number of participants that dropped out of the study. Drop-out rate is calculated based on the proportion of enrolled participants who do not complete the intervention/1-month follow-up/6-month follow-up. The study targets for a drop-out rate of \< 20%.

Time frame

18 months study duration

3

Adherence rate to the sensor

Intervention group participants usage of CGM over the two-week period. Statistics on sensor adherence will be obtained from the Abbott Freestyle Libre system and is determined as \>70% CGM use in the 2 weeks it is worn (≥10 readings over 2 weeks).

Time frame

2-6 weeks

4

Exploring views on the facilitators and barriers of behavioral change with CGM

In-depth interviews with the intervention group participants

Time frame

24-28 weeks, to allow up to 36 weeks

Other outcomes

1

CGM data

Clinical CGM metrics extracted will consist of percentage of time CGM is active, number of glucose readings in 2 weeks, average glucose, time in range (TIR) of 3.9 to 10 mmol/l, time in tight range (TITR) of 3.9-7.8 mmol/l, time above range \> 7.8 mmol/l (%TAR 7.8 mmol/l), time above range \>10 mmol/l (%TAR 10 mmol/l), glycemic variability (GV, as standard deviation \[SD\] and the coefficient of variation \[CV\]) (Battelino et al., 2023).

Time frame

2-6 weeks

2

No of participants with reportable adverse outcomes

All device or study-related adverse events, and sensor insertion or sensor wear-related symptoms

Time frame

2-6 weeks

Continuous Glucose Monitoring (CGM) in Prediabetes

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Sponsors and contacts