Effects of Novel Flash Glucose Monitoring System on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Glycosylated Hemoglobin A1c
研究概览
简要总结
This trial is a randomized, multi-center, parallel-group, efficacy and safety study with a 26-weeks follow- up(after 2-week recruitment). The study aims to: 1)compare the effects of novel flash glucose monitoring system (FGMS) and conventional Self Measurement of Blood Glucose (SMBG); and 2) optimize integrated management for glycaemic control in adult patients with type 1 diabetes who are sub-optimally controlled.
详细描述
Subjects with Type 1 diabetes who meet criteria will be enrolled at up to eight clinical research sites in China. Subjects will be randomized to either flash glucose monitoring system(Freestyle Libre®;Abbott Diabetes Care,Witney, Oxon,UK) or conventional Self Measurement of Blood Glucose (Bayer®)alone at least three times per day. Primary outcome variable is the difference in HbA1c which will be analyzed in a central laboratory between baseline and the 26weeks follow-up. Secondary outcome variables such as time-in-range, frequency and duration of and hyperglycemic episodes etc. will be assessed at baseline (Week 0 to 2), Week 12-14 and Week 24-26 via professional continuous glucose system (Ipro2®; Medtronic). At the same time, demographic factors, clinical data, patient reported outcome (PROs) will be collected. Assessment of Adverse Events will occur via self-reporting at each visit and/or phone call. All patients will receive same ordinary diabetes education.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years and older;
- •Diagnosed with type 1 diabetes with the criteria established by WHO in 1999,with duration more than 1 year;
- •Glycosylated Hemoglobin A1c concentration between 7% and 10%;
- •Self-monitor of blood glucose levels on a regular basis for 2 months previous( at least 3 times per day) and have willing to insist for at least 6 months
- •Using CSII or MDI for at least 3 months, stable diabetes medication regimen for 3 months prior to study entry(change in insulin ≦20%).
- •Willing to wear CGM;
- •Able to speak, read, and write Chinese
排除标准
- •Having used CGM 3 months prior to study entry;
- •Had severe diabetic complications such as PDR in diabetic retinopathy and ESRD of diabetic nephropathy, assessed by investigators;
- •Receiving oral steroid therapy for any disorders and continuous use of paracetamol.
- •Had known allergy to medical-grade adhesives or CGM and its affiliated components;
- •Being pregnant or planning pregnancy (as demonstrated by a positive test at study entry);
- •Recent severe diseases like myocardial infarction,stroke,psychiatric diseases(historical/recent),malignant tumor, kidney disease(defined as eGFR<45), dermatosis, decided by investigator.
- •Current participation in another investigational study (must have completed any previous studies at least 30 days prior to being enrolled in this study);
- •Currently abusing illicit drugs, alcohol, or prescription drugs;
- •Any condition that could impact reliability of the HbA1C measurement,（e.g.hemoglobinopathy, hemolytic anemia, chronic liver disease),decided by investigator.
结局指标
主要结局
Glycosylated Hemoglobin A1c
时间窗: baseline,week14,week26
Difference in HbA1c at week 14 and week26 adjusted for baseline(week 0)
次要结局
- Time in Range(baseline,week12-14,week24-26)
- Mean glucose levels(baseline,week12-14,week24-26)
- Percentage of HbA1c in Range(baseline,week14,week26)
- Time in Hyperglycaemia(baseline,week12-14,week24-26)
- Standard deviation of glucose(baseline,week12-14,week24-26)
- Frequency in adverse events about device(26weeks)
- Frequency in severe hypoglycaemia(baseline,week12-14,week24-26)
- Frequency in using FGM(24 weeks)
- Time in Hypoglycemia(baseline,week12-14,week24-26)
- The area under the curve of hypoglycemia/ hyperglycaemia(baseline,week12-14,week24-26)
- Frequency in hypoglycemia/ hyperglycaemia(baseline,week12-14,week24-26)
- Frequency in SMBG(26 weeks)
- Total daily dose of insulin(26 weeks)
- The Diabetes Distress Scale (DDS)(baseline,week 14 and week 26)
- Hypoglycaemia Fear Scale(HFS)(baseline,week 14 and week 26)
- EQ-5D-5L(baseline,week 14 and week 26)
研究者
Jianping Weng
Professor,Principal Investigator,Department of Endocrinology and Metabolism，The Third Affiliated Hospital
Sun Yat-sen University