GLucose Monitoring Programme SingaporE, Phase 2(GLiMPSE2)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 206
- 试验地点
- 4
- 主要终点
- Change from baseline HbA1c at week 24
研究概览
简要总结
Many with type 2 diabetes (T2D) remain sub-optimally controlled. Structured programmes requiring dietary and lifestyle intervention have been shown to improve control but are time-and labour-intensive. The role for self-monitoring of blood glucose with capillary blood glucose (CBG) readings is uncertain. The use of flash glucose monitoring (FGM) with education may effect improvements in awareness and self-management behaviour and hence glycaemic control.
The investigators aim to compare the effects of FGM versus CBG fingersticks in the context of a structured education programme over a 6-month period in adults with type 2 diabetes. 200 adults (>21y) with sub-optimally controlled T2D (7.5-10%) on either diet-controlled, oral glucose lowering drugs or background insulin will be enrolled and randomised into the intervention arm (FGM and education) or control arm (capillary glucose fingersticks and education). The intervention arm will monitor glucose using FGM continuously for 6 weeks and intermittently thereafter up to 24 weeks. The control group will monitor glucose using CBG fingersticks up to 24 weeks. During the intervention period(0-24w), both arms will undergo the same schedule of visits (-2w, 0w, 8w, 16w, 24w) and 6 education sessions. Both groups will be followed up at weeks 38 and 52. Primary outcome is HbA1c change from baseline at 24 weeks. This study will provide novel data on the use of FGM versus CBG in Type 2 diabetes and its impact on glycaemic control.
详细描述
Up to 200 adults will be recruited from 5 different sites in Singapore. Following screening, consent and enrolment, all participants wear a blinded flash glucose monitoring system that is masked to the user and asked to continue testing capillary glucose readings at least once daily for 2 weeks (week -2 to week -1).Participants who are able to wear the sensor for the 2 weeks, and are monitoring capillary glucose levels at least 70% of the time for the 2 weeks (≥10 readings/2weeks), will carry on to be randomised to intervention or control group (week 0).
Upon fulfilling the criteria of blinded sensor wear of 2 weeks and 70% capillary glucose monitoring over 2 weeks, participants will be randomised into the control or the intervention arm, using web- based retrieval of randomisation allocation.
At baseline (week 0), all participants in both groups will receive baseline education on diabetes self-management, including blood glucose targets, role and timing of diabetes medications, and individualised education on macronutrient composition of meals and the goals of nutritional therapy in type 2 diabetes. Both groups will use the blinded FGM data at baseline for education. In total, both groups will receive 6 education sessions over the 24 week period, delivered by diabetes nurse educators or nurses and dietitians. The diabetes educators and physicians will be aligned towards a standardised curriculum for consistency of education through a train-the-trainer workshop.
Participants randomised to the control arm will receive an education package and be given education on how to self-manage glucose levels using a standard capillary blood glucose device. They will be encouraged to test blood glucose readings at least twice a day but preferably 4 times daily. Participants randomised to the intervention arm will wear the flash glucose monitoring system, and will be given education on how to use sensor glucose data for self-management. Flash glucose monitoring will be used continuously for 6 weeks. From week 6 to week 24, the frequency of use of flash glucose monitoring will be reduced to one sensor every 4 weeks.
The intervention period is for 24 weeks, followed by an observation period up to 52 weeks. After the 24-week intervention period, participants from both arms will wear a blinded sensor for the last 2 weeks of the intervention period (week 25 to week 26). During the observation period (weeks 24 to 52), participants in both arms will be encouraged to continue monitoring glucose levels.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 75 Years（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 7.5 to 10% for 2 consecutive readings over the preceding 9 months 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)
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 for more than 3 times
结局指标
主要结局
Change from baseline HbA1c at week 24
时间窗: 24 weeks
Measurement of HbA1c will be performed at weeks 0 and 24
次要结局
- Number of individuals requiring medication up-titration from baseline to week 24(24 weeks)
- Change from baseline Time in Range at week 26(26 weeks)
- Change in Baseline % Time Below Range at week 26(26 weeks)
- Change in Weight from baseline at week 24(24 weeks)
- Change from baseline in Diabetes Distress Scale score(24 weeks)
- Change from baseline % CV glucose at week 26(26 weeks)
- Change in both systolic and diastolic blood pressure from baseline at week 24(24 weeks)
- Change in Body Mass Index from baseline at week 24(24 weeks)
- Change in score from baseline using the Work productivity and daily activity impairment questionnaire(24 weeks)
- Qualitative questionnaire(24 weeks)
- Change from baseline in EuroQol-5D-5L (5 level) utilities score.(24 weeks)