PreDiabetes
Conditions
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.
Interventions
DEVICEContinuous glucose monitoring
Abbott Freestyle Libre CGM for 8 weeks in adjunct to lifestyle modification programme
BEHAVIORALLifestyle modification programme
Lifestyle modification programme
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 1-hour glucose from OGTT | 12 months | 1-hour plasma glucose from a 75 g oral glucose tolerance test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fasting plasma glucose | 12 months | Between-group differences in fasting plasma glucose |
| Body weight | 12 months | Between-group differences in body weight |
| Body mass index | 12 months | Between-group differences in body mass index |
| HbA1c | 12 months | Between-group differences in HbA1c |
| 3 day diet record | 12 months | Differences in daily nutrient intake between groups |
| Physical activity levels | 12 months | Daily number of steps as measured by a sealed pedometer |
| Socio-cognitive measures | 12 months | Self-efficacy questionnaire |
| Waist circumference | 12 months | Between-group differences in waist circumference |
Countries
Hong Kong
Outcome results
None listed