GLucose Monitoring Programme SingaporeE (GLiMPSE) - Phase 1
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 6
- 主要终点
- Recruitment and retention
研究概览
简要总结
This phase 1 study is a non-randomized, single-arm, multi-center study that is designed to evaluate the feasibility and acceptability of the flash glucose monitoring system together with a structured education programme in individuals with Type 2 Diabetes.
详细描述
Up to 30 adults and 15 children will be recruited from 3 different sites in Singapore.
For Adults, this phase consists of screening and intervention periods.
Screening Period (Week -2 to -1):
Participants will be asked to wear a blinded flash glucose monitoring system and will be asked to continue testing their capillary glucose readings at least once daily for 2 weeks (week -2 to week -1). Sensor glucose measurements are not available to both participants and investigators during this screening period. Participants who are able to wear the sensor for the 2 weeks, and are monitoring their capillary glucose levels at least 70% of the time for the 2 weeks (>10 readings/2weeks), will proceed on with the intervention period.
Intervention Period (Week 0 - 26):
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (Age > 21 years) with Type 2 diabetes (HbA1c 8 to 10% at time of enrolment)
- •Singapore Citizen or Permanent Resident
- •Treatment with diet and exercise alone or other glucose-lowering therapies except prandial insulin. GLP-1 agonists and / or basal insulin (NPH insulin, Insulin Lantus, Insulin Toujeo, Insulin Detemir) are permitted.
- •Self-reported regular blood glucose testing via CBG (more than 3/week)
- •Children and adolescents (Age between 12 and 21 years old) with Type 2 diabetes and HbA1c >8% at the time of enrolment
- •Singapore Citizen or Permanent Resident
- •Insulin replacement as part of diabetes management
排除标准
- •Age above 75 years
- •Type 1 diabetes, monogenic diabetes
- •Prandial insulin (quick-acting insulin or premixed insulin)
- •Cancer requiring treatment in the past 5 years
- •Chronic renal failure (eGFR<45ml/min) or dialysis
- •Amputation of lower limbs (excluding toe amputations)
- •Bariatric surgery for weight loss
- •Current systemic treatment with steroids
- •Pregnancy, attempting pregnancy or lactation.
- •Haemolytic anaemia or haemoglobinopathy
- •Prior use of the flash glucose monitoring system
结局指标
主要结局
Recruitment and retention
时间窗: 26 weeks
Record of the number of subjects screened, enrolled and subsequently retained through the 26 weeks of follow up at 3 sites
次要结局
- Questionnaire(24 weeks)
- HbA1c(24 weeks)
- WPAI questionnaire(24 weeks)
- DSS questionnaire(24 weeks)
- EQ-5D-5L Questionnaire(24 weeks)