Continuous Glucose Monitoring as Adjunct to Lifestyle Modification in Prediabetes

NCT ID: NCT04588896

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 177 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-01
• Study Completion Date: 2024-01-31

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.

Conditions

PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

CGM+LMP

Continuous glucose monitoring (CGM) for 8 weeks in conjunction with lifestyle modification

Group Type: EXPERIMENTAL

Continuous glucose monitoring

Intervention Type: DEVICE

Abbott Freestyle Libre CGM for 8 weeks in adjunct to lifestyle modification programme

Lifestyle modification programme

Intervention Type: BEHAVIORAL

Lifestyle modification programme

LMP only

Lifestyle modification only

Group Type: OTHER

Lifestyle modification programme

Intervention Type: BEHAVIORAL

Lifestyle modification programme

Interventions

Continuous glucose monitoring

Abbott Freestyle Libre CGM for 8 weeks in adjunct to lifestyle modification programme

Intervention Type: DEVICE

Lifestyle modification programme

Lifestyle modification programme

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Elaine Chow

Clinical Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elaine Chow

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Hong Kong, Shatin, Hong Kong

Countries

Hong Kong

Other Identifiers

FlashLMP

Identifier Type: -

Identifier Source: org_study_id