Continuous Glucose Monitoring (CGM) in Prediabetes

NCT07371546 | Recruiting

• 1 other identifier: 2025-0022-APP1
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 2

Brief 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.

• 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.
• 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.
• 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.

Conditions

Pre-diabetes

Keywords

Primary care; Continuous glucose monitoring; Behavioural change; Pre-diabetes

Outcome Measures

Primary Outcomes (6)

• 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.

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

• 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.

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

• Body weight

  Weight in kilograms

  0 week, 24-28 weeks

• Height

  Height in meters

  0 week, 24-28 weeks

• Body Mass Index

  Weight and Height will be combined to report Body Mass Index in kg/m\^2

  0 week, 24-28 weeks

• Waist circumference

  Waist circumference in centimeters: Waist circumference is measured at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest with a measuring tape. The mean value of two waist circumference measurements is used. Both measurements are repeated if there is a difference of more than 1 cm.

  0 week, 24-28 weeks

Secondary Outcomes (10)

• Participant recruitment numbers

  6 months recruitment period

• Drop-out rate

  18 months study duration

• Adherence rate to the sensor

  2-6 weeks

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

  24-28 weeks, to allow up to 36 weeks

• Views and experiences of using CGM with the Abbott Freestyle Libre system

  24-28 weeks, to allow up to 36 weeks

Other Outcomes (2)

• CGM data

  2-6 weeks

• No of participants with reportable adverse outcomes

  2-6 weeks

Study Arms (2)

Intervention

ACTIVE COMPARATOR

Participants in the intervention arm will wear the Abbott Freestyle Libre system for 2 weeks, in addition to usual care.

Device: Continuous Glucose Monitoring

Control

NO INTERVENTION

Interventions

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.

Intervention

Eligibility Criteria

• Age: 21 Years - 69 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• a. Can be conservatively managed, or medically managed with metformin
• Owns a mobile phone that can download the Singapore FreeStyle LibreLink App
• 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.

You may not qualify if:

• 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
• Currently enrolled in another study or program that involves weight loss or dietary modifications, or novel therapeutic drug or device
• Planned surgery in the next six months
• Not able to use smartphone or the Singapore FreeStyle LibreLink App despite coaching
• Any end-stage disease with life prognosis of \< 2 years
• 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.

Sponsors & Collaborators

• SingHealth Polyclinics: lead

Study Sites (2)

Pasir Ris Polyclinic

Singapore, 519466, Singapore

RECRUITING

Pasir Ris Polyclinic

Singapore, Singapore

RECRUITING

Related Publications (26)

• Yadav R, Jain N, Raizada N, Jhamb R, Rohatgi J, Madhu SV. Prevalence of diabetes related vascular complications in subjects with normal glucose tolerance, prediabetes, newly detected diabetes and known diabetes. Diabetes Metab Syndr. 2021 Sep-Oct;15(5):102226. doi: 10.1016/j.dsx.2021.102226. Epub 2021 Jul 20.

  PMID: 34303917 BACKGROUND

• Whitehead AL, Julious SA, Cooper CL, Campbell MJ. 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. Stat Methods Med Res. 2016 Jun;25(3):1057-73. doi: 10.1177/0962280215588241. Epub 2015 Jun 19.

  PMID: 26092476 BACKGROUND

• Unger J, Kushner P, Anderson JE. Practical guidance for using the FreeStyle Libre flash continuous glucose monitoring in primary care. Postgrad Med. 2020 May;132(4):305-313. doi: 10.1080/00325481.2020.1744393. Epub 2020 Mar 30.

  PMID: 32223687 BACKGROUND

• Schmidt K, Faerch K, Zoffmann V, Amadid H, Varming AR. The process of health behaviour change following participation in a randomised controlled trial targeting prediabetes: A qualitative study. Diabet Med. 2022 Apr;39(4):e14748. doi: 10.1111/dme.14748. Epub 2021 Dec 7.

  PMID: 34806793 BACKGROUND

• Rooney MR, Fang M, Ogurtsova K, Ozkan B, Echouffo-Tcheugui JB, Boyko EJ, Magliano DJ, Selvin E. Global Prevalence of Prediabetes. Diabetes Care. 2023 Jul 1;46(7):1388-1394. doi: 10.2337/dc22-2376.

  PMID: 37196350 BACKGROUND

• Richardson KM, Schembre SM, da Silva V, Blew RM, Behrens N, Roe DJ, Marvasti FF, Hingle M. Adding a Brief Continuous Glucose Monitoring Intervention to the National Diabetes Prevention Program: A Multimethod Feasibility Study. J Diabetes Res. 2024 May 16;2024:7687694. doi: 10.1155/2024/7687694. eCollection 2024.

  PMID: 38919262 BACKGROUND

• Palladino R, Tabak AG, Khunti K, Valabhji J, Majeed A, Millett C, Vamos EP. Association between pre-diabetes and microvascular and macrovascular disease in newly diagnosed type 2 diabetes. BMJ Open Diabetes Res Care. 2020 Apr;8(1):e001061. doi: 10.1136/bmjdrc-2019-001061.

  PMID: 32332069 BACKGROUND

• Morse, J. M. (2000). Determining Sample Size. Qualitative Health Research, 10(1), 3-5.

  BACKGROUND

• Lim RBT, Wee WK, For WC, Ananthanarayanan JA, Soh YH, Goh LML, Tham DKT, Wong ML. Correlates, Facilitators and Barriers of Healthy Eating Among Primary Care Patients with Prediabetes in Singapore-A Mixed Methods Approach. Nutrients. 2019 May 6;11(5):1014. doi: 10.3390/nu11051014.

  PMID: 31064063 BACKGROUND

• Lee JY, Nguyen JT, Arroyo J, Tran T, Hanami D, Mayorga J. Feasibility and Acceptability of Using Flash Glucose Monitoring System Sensors to Empower Lifestyle Changes in People With Prediabetes. Diabetes Care. 2023 Jan 1;46(1):e10-e11. doi: 10.2337/dc22-0612. No abstract available.

  PMID: 36398782 BACKGROUND

• Kerrison G, Gillis RB, Jiwani SI, Alzahrani Q, Kok S, Harding SE, Shaw I, Adams GG. The Effectiveness of Lifestyle Adaptation for the Prevention of Prediabetes in Adults: A Systematic Review. J Diabetes Res. 2017;2017:8493145. doi: 10.1155/2017/8493145. Epub 2017 Apr 16.

  PMID: 28567425 BACKGROUND

• IPAQ Group. (2005, November). Guidelines for data processing and analysis of the international physical activity questionnaire (IPAQ_-short and long forms. (2005).

  BACKGROUND

• Health Promotion Board. (2024, November 14). HEALTH PROMOTION BOARD COLLABORATES WITH TECHNOLOGY AND HEALTHCARE PARTNERS TO INCUBATE SOLUTIONS THAT WILL HELP SINGAPOREANS PREVENT AND MANAGE CHRONIC CONDITIONS. Health Promotion Board

  BACKGROUND

• Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.

  PMID: 18929686 BACKGROUND

• Harris PA, Taylor R, Minor BL, Elliott V, Fernandez M, O'Neal L, McLeod L, Delacqua G, Delacqua F, Kirby J, Duda SN; REDCap Consortium. The REDCap consortium: Building an international community of software platform partners. J Biomed Inform. 2019 Jul;95:103208. doi: 10.1016/j.jbi.2019.103208. Epub 2019 May 9.

  PMID: 31078660 BACKGROUND

• How Many Interviews Are Enough?: An Experiment with Data Saturation and Variability Greg Guest, Arwen Bunce, and Laura JohnsonView all authors and affiliations Volume 18, Issue 1

  BACKGROUND

• Glechner A, Keuchel L, Affengruber L, Titscher V, Sommer I, Matyas N, Wagner G, Kien C, Klerings I, Gartlehner G. Effects of lifestyle changes on adults with prediabetes: A systematic review and meta-analysis. Prim Care Diabetes. 2018 Oct;12(5):393-408. doi: 10.1016/j.pcd.2018.07.003. Epub 2018 Aug 1.

  PMID: 30076075 BACKGROUND

• Qualitative inquiry and research design: Choosing among five approaches. JW Creswell, CN Poth - 2016

  BACKGROUND

• Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

  PMID: 12900694 BACKGROUND

• Carlson AL, Mullen DM, Bergenstal RM. Clinical Use of Continuous Glucose Monitoring in Adults with Type 2 Diabetes. Diabetes Technol Ther. 2017 May;19(S2):S4-S11. doi: 10.1089/dia.2017.0024.

  PMID: 28541137 BACKGROUND

• Browne RH. On the use of a pilot sample for sample size determination. Stat Med. 1995 Sep 15;14(17):1933-40. doi: 10.1002/sim.4780141709.

  PMID: 8532986 BACKGROUND

• Bertaux, D. (1981). From the life-history approach to the transformation of sociological practice. In Biography and society: The life history approach in the social sciences (pp. 29-45). London : Sage.

  BACKGROUND

• Beaglehole R, Bonita R, Horton R, Adams C, Alleyne G, Asaria P, Baugh V, Bekedam H, Billo N, Casswell S, Cecchini M, Colagiuri R, Colagiuri S, Collins T, Ebrahim S, Engelgau M, Galea G, Gaziano T, Geneau R, Haines A, Hospedales J, Jha P, Keeling A, Leeder S, Lincoln P, McKee M, Mackay J, Magnusson R, Moodie R, Mwatsama M, Nishtar S, Norrving B, Patterson D, Piot P, Ralston J, Rani M, Reddy KS, Sassi F, Sheron N, Stuckler D, Suh I, Torode J, Varghese C, Watt J; Lancet NCD Action Group; NCD Alliance. Priority actions for the non-communicable disease crisis. Lancet. 2011 Apr 23;377(9775):1438-47. doi: 10.1016/S0140-6736(11)60393-0. Epub 2011 Apr 5.

  PMID: 21474174 BACKGROUND

• Battelino T, Alexander CM, Amiel SA, Arreaza-Rubin G, Beck RW, Bergenstal RM, Buckingham BA, Carroll J, Ceriello A, Chow E, Choudhary P, Close K, Danne T, Dutta S, Gabbay R, Garg S, Heverly J, Hirsch IB, Kader T, Kenney J, Kovatchev B, Laffel L, Maahs D, Mathieu C, Mauricio D, Nimri R, Nishimura R, Scharf M, Del Prato S, Renard E, Rosenstock J, Saboo B, Ueki K, Umpierrez GE, Weinzimer SA, Phillip M. Continuous glucose monitoring and metrics for clinical trials: an international consensus statement. Lancet Diabetes Endocrinol. 2023 Jan;11(1):42-57. doi: 10.1016/S2213-8587(22)00319-9. Epub 2022 Dec 6.

  PMID: 36493795 BACKGROUND

• Bailey KJ, Little JP, Jung ME. Self-Monitoring Using Continuous Glucose Monitors with Real-Time Feedback Improves Exercise Adherence in Individuals with Impaired Blood Glucose: A Pilot Study. Diabetes Technol Ther. 2016 Mar;18(3):185-93. doi: 10.1089/dia.2015.0285. Epub 2016 Feb 17.

  PMID: 26885934 BACKGROUND

• Appropriate Care Guide. (2021). Agency for Care Effectiveness (ACE). Managing pre-diabetes - a growing health concern. Ministry of Health, Singapore. go.gov.sg/acg-managing-pre-diabetes-a-growing-health-concern

  BACKGROUND

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Officials

• Ying Jun Lim, BScHons, MD

  SingHealth Polyclinics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Cindy MY Wong, MBBS, Mmed (Family Medicine)

CONTACT

+6563507600; cindy.wong@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: January 28, 2026
• Study Start: October 16, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: January 28, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)