Continuous Glucose Monitoring As Adjunct to Lifestyle Modification in Prediabetes

Not Applicable

Completed

• Conditions: PreDiabetes
• Interventions: Device: Continuous glucose monitoring; Behavioral: Lifestyle modification programme

• Registration Number: NCT04588896
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-10
• Study First Submitted QC: 2020-10-10
• Study First Posted: 2020-10-19
• Status Verified: 2020-12
• Study Start: 2020-12-01
• Primary Completion: 2024-01-31
• Study Completion: 2024-01-31
• Last Update Submitted: 2025-03-01
• Last Update Posted: 2025-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 177

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CGM+LMP	Lifestyle modification programme	Continuous glucose monitoring (CGM) for 8 weeks in conjunction with lifestyle modification
LMP only	Lifestyle modification programme	Lifestyle modification only
CGM+LMP	Continuous glucose monitoring	Continuous glucose monitoring (CGM) for 8 weeks in conjunction with lifestyle modification

Primary Outcome Measures

Name	Time	Method
1-hour glucose from OGTT	12 months	1-hour plasma glucose from a 75 g oral glucose tolerance test

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Hong Kong, Shatin, Hong Kong