Continuous Glucose Monitoring As Adjunct to Lifestyle Modification in Prediabetes (FlashLMP)

Continuous Glucose Monitoring As an Adjunct to Lifestyle Modification in Individuals with Impaired Glucose Tolerance: a Randomised Controlled Trial

This is a 12-month prospective, open-label, non-masked, two arm randomized controlled trial comparing intermittently-viewed continuous glucose monitoring (iCGM) in addition to lifestyle modification programme (LMP) as compared with a LMP alone in individulas with impaired glucose tolerance (IGT). Following informed consent, participants will undergo screening where a fasting glucose, 75g OGTT, HbA1c, fasting lipid profile along with comprehensive medical and drug history to confirm eligibility. At week 0, participants will be randomised to CGM plus LMP versus LMP alone. Both groups will receive individualized structured LMP programme delivered by a dietitian and a fitness instructor. Outcomes will be evaluated by laboratory tests, physical measurement, physical activity and dietary compliance and questionnaires at Month 0, 4, 8, 12.

Study Overview

• Status: Completed
• Conditions: PreDiabetes
• Intervention / Treatment: Device: Continuous glucose monitoring; Behavioral: Lifestyle modification programme

• Study Type: Interventional
• Enrollment (Actual): 177
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Shatin
    • Hong Kong, Shatin, Hong Kong
      • Prince of Wales Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 61 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Impaired glucose tolerance as defined by will be defined as per the American Diabetes Association criteria based on 75g oral glucose tolerance test (OGTT) 2-hour glucose of between 7.8 and less than 11 mmol/L
2. Male or female age ≥ 18 years old and ≤ 65 years old.
3. BMI 18 to 40kg/m2
4. Willingness, ability and commitment to comply with LMP
5. Able to use a CGM as judged by investigator
6. In the opinion of the investigator, absence of any physical limitations, addictive diseases, or underlying medical conditions (including mental health) that may preclude the patient from being a suitable study candidate.
7. Written informed consent to participate in the study provided by the patient.

Exclusion Criteria:

1. Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy
2. Known diabetes
3. Current or previous use of glucose-lowering or weight loss drugs
4. Concurrent participation in other weight loss or lifestyle intervention programmes
5. Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
6. Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
7. Current use or recent exposure to any medication that in the opinion of the investigator could have an influence on the patient's ability to participate in this study or on the performance of the test device.
8. Extensive skin changes/diseases that preclude wearing the FGM on normal skin at the proposed application sites (e.g., extensive psoriasis, recent burns or severe sunburn, extensive eczema, extensive scarring, extensive tattoos, dermatitis herpetiformis).
9. Known uncontrolled thyrotoxicosis
10. Current use of steroids
11. Have a known allergy to medical-grade adhesives
12. Known current or recent alcohol or drug abuse
13. Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
14. An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CGM+LMP; Continuous glucose monitoring (CGM) for 8 weeks in conjunction with lifestyle modification	Device: Continuous glucose monitoring; Abbott Freestyle Libre CGM for 8 weeks in adjunct to lifestyle modification programme; Behavioral: Lifestyle modification programme; Lifestyle modification programme
Other: LMP only; Lifestyle modification only	Behavioral: Lifestyle modification programme; Lifestyle modification programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1-hour glucose from OGTT	1-hour plasma glucose from a 75 g oral glucose tolerance test	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Between-group differences in HbA1c	12 months
Fasting plasma glucose	Between-group differences in fasting plasma glucose	12 months
Body weight	Between-group differences in body weight	12 months
Body mass index	Between-group differences in body mass index	12 months
Waist circumference	Between-group differences in waist circumference	12 months
3 day diet record	Differences in daily nutrient intake between groups	12 months
Physical activity levels	Daily number of steps as measured by a sealed pedometer	12 months
Socio-cognitive measures	Self-efficacy questionnaire	12 months

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Elaine Chow, Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): January 31, 2024
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: October 10, 2020
• First Submitted That Met QC Criteria: October 10, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 1, 2025
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Hyperglycemia; Prediabetic State; Glucose Intolerance
• Other Study ID Numbers: FlashLMP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No