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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
177
Abbott Freestyle Libre CGM for 8 weeks in adjunct to lifestyle modification programme
Lifestyle modification programme
Prince of Wales Hospital
Hong Kong, Shatin, Hong Kong
1-hour glucose from OGTT
1-hour plasma glucose from a 75 g oral glucose tolerance test
Time frame: 12 months
HbA1c
Between-group differences in HbA1c
Time frame: 12 months
Fasting plasma glucose
Between-group differences in fasting plasma glucose
Time frame: 12 months
Body weight
Between-group differences in body weight
Time frame: 12 months
Body mass index
Between-group differences in body mass index
Time frame: 12 months
Waist circumference
Between-group differences in waist circumference
Time frame: 12 months
3 day diet record
Differences in daily nutrient intake between groups
Time frame: 12 months
Physical activity levels
Daily number of steps as measured by a sealed pedometer
Time frame: 12 months
Socio-cognitive measures
Self-efficacy questionnaire
Time frame: 12 months
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