Continuous Glucose Monitoring As an Adjunct to Lifestyle Modification in Individuals with Impaired Glucose Tolerance: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 177
- 试验地点
- 1
- 主要终点
- 1-hour glucose from OGTT
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
1-hour glucose from OGTT
时间窗: 12 months
1-hour plasma glucose from a 75 g oral glucose tolerance test
次要结局
- Socio-cognitive measures(12 months)
- Fasting plasma glucose(12 months)
- Physical activity levels(12 months)
- Body weight(12 months)
- HbA1c(12 months)
- Body mass index(12 months)
- Waist circumference(12 months)
- 3 day diet record(12 months)
研究者
Elaine Chow
Clinical Assistant Professor
Chinese University of Hong Kong