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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CGM+LMP | Experimental | Continuous glucose monitoring (CGM) for 8 weeks in conjunction with lifestyle modification |
|
| LMP only | Other | Lifestyle modification only |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Continuous glucose monitoring | Device | Abbott Freestyle Libre CGM for 8 weeks in adjunct to lifestyle modification programme |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-hour glucose from OGTT | 1-hour plasma glucose from a 75 g oral glucose tolerance test | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Between-group differences in HbA1c | 12 months |
| Fasting plasma glucose | Between-group differences in fasting plasma glucose | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elaine Chow | Chinese University of Hong Kong | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Prince of Wales Hospital | Hong Kong | Shatin | Hong Kong |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000095583 | Continuous Glucose Monitoring |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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| Lifestyle modification programme | Behavioral | Lifestyle modification programme |
|
| Body weight | Between-group differences in body weight | 12 months |
| Body mass index | Between-group differences in body mass index | 12 months |
| Waist circumference | Between-group differences in waist circumference | 12 months |
| 3 day diet record | Differences in daily nutrient intake between groups | 12 months |
| Physical activity levels | Daily number of steps as measured by a sealed pedometer | 12 months |
| Socio-cognitive measures | Self-efficacy questionnaire | 12 months |
| D004700 | Endocrine System Diseases |
| D003933 | Diagnosis |
| D003940 | Diagnostic Techniques, Endocrine |
| D008991 | Monitoring, Physiologic |
| D008919 | Investigative Techniques |