Continuous Glucose Monitoring as Adjunct to Lifestyle Modification in Prediabetes

NCT04588896 | Completed

• 1 other identifier: FlashLMP
• Study Type: interventional
• Target: 177
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 1-hour glucose from OGTT

  1-hour plasma glucose from a 75 g oral glucose tolerance test

  12 months

Secondary Outcomes (8)

• HbA1c

  12 months

• Fasting plasma glucose

  12 months

• Body weight

  12 months

• Body mass index

  12 months

• Waist circumference

  12 months

Study Arms (2)

CGM+LMP

EXPERIMENTAL

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

Device: Continuous glucose monitoring; Behavioral: Lifestyle modification programme

LMP only

OTHER

Lifestyle modification only

Behavioral: Lifestyle modification programme

Interventions

Continuous glucose monitoring DEVICE

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

CGM+LMP

Lifestyle modification programme BEHAVIORAL

Lifestyle modification programme

CGM+LMP; LMP only

Eligibility Criteria

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

You may qualify if:

• 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
• Male or female age ≥ 18 years old and ≤ 65 years old.
• BMI 18 to 40kg/m2
• Willingness, ability and commitment to comply with LMP
• Able to use a CGM as judged by investigator
• 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.
• Written informed consent to participate in the study provided by the patient.

You may not qualify if:

• Currently pregnant, lactating, as demonstrated by a positive pregnancy test at screening or planning pregnancy
• Known diabetes
• Current or previous use of glucose-lowering or weight loss drugs
• Concurrent participation in other weight loss or lifestyle intervention programmes
• Any active acute or chronic disease or condition that, in the opinion of the investigator, might interfere with the performance of this study.
• Any active acute or chronic infectious disease that, in the opinion of the investigator, would pose an excessive risk to study staff.
• 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.
• 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).
• Known uncontrolled thyrotoxicosis
• Current use of steroids
• Have a known allergy to medical-grade adhesives
• Known current or recent alcohol or drug abuse
• Currently participating in another investigational study protocol where the testing or results may interfere with study compliance, diagnostic results, or data collection.
• An identified protected vulnerable patient (including but not limited to those in detention, or a prisoner).

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Shatin, Hong Kong

Location

MeSH Terms

Conditions

Prediabetic State

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System 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

• Elaine Chow

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 10, 2020
• First Posted: October 19, 2020
• Study Start: December 1, 2020
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: March 5, 2025

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)