Continuous Glucose Monitoring as Adjunct to Lifestyle Modification in Prediabetes

PreDiabetes Clinical Trial

— FlashLMP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04588896
• Other study ID #: FlashLMP
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: January 2021
• Source: Chinese University of Hong Kong
• Contact: Elaine Chow, MBChB
• Phone: +85235051549
• Email: e.chow[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 218
• Est. completion date: December 31, 2023
• Est. primary completion date: October 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Glucose Intolerance
• PreDiabetes
• Prediabetic State

Intervention

Device:
• Continuous glucose monitoring
Abbott Freestyle Libre CGM for 8 weeks in adjunct to lifestyle modification programme

Behavioral:
• Lifestyle modification programme
Lifestyle modification programme

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Hong Kong	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	1-hour glucose from OGTT	1-hour plasma glucose from a 75 g oral glucose tolerance test	12 months
Secondary	HbA1c	Between-group differences in HbA1c	12 months
Secondary	Fasting plasma glucose	Between-group differences in fasting plasma glucose	12 months
Secondary	Body weight	Between-group differences in body weight	12 months
Secondary	Body mass index	Between-group differences in body mass index	12 months
Secondary	Waist circumference	Between-group differences in waist circumference	12 months
Secondary	3 day diet record	Differences in daily nutrient intake between groups	12 months
Secondary	Physical activity levels	Daily number of steps as measured by a sealed pedometer	12 months
Secondary	Socio-cognitive measures	Self-efficacy questionnaire	12 months