Feasibility and Safety of "Flash Glucose Monitoring-FGM" in an Adult and Selected Pediatric Population.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Severe hypoglycemia rate
研究概览
简要总结
Diabetes is reaching epidemic proportions and a targeted glucose control is key to prevent microvascular complications as well as long-term macrovascular disease.
Self-monitoring of blood glucose (SMBG) in type 1 diabetes (T1D) is mandatory to implement safe and effective adjustments in insulin therapy in order to reduce glucose levels and prevent hypoglycemic episodes. It is known that a higher rate of glucose testing (up to 8 times/day) is associated with improved glucose control, however, long-term repeated daily glucose tests are painful, inconvenient and difficult to pursue.
Continuous glucose monitoring (CGM) is an alternative to SMBG, but the use of conventional CGM has been limited by the need of repeated calibration using capillary glucose testing, relatively short sensor lifespan and high costs. The recently introduced CGM FreeStyle Libre™ (Abbott Diabetes Care, Witney, UK) flash glucose monitoring (FGM), a new generation of glucose testing device, has the advantage to be user friendly by just scanning the reader over the sensor.
The FGM system does not require calibration, has a long sensor lifetime of 14 days and it's relatively affordable, explaining the widespread use of the device.
The Flash Glucose Monitoring-FGM is a real-time glycemic monitoring system called "hybrid" as it is not equipped with alarms capable of alerting the patient to cut-off value for the hypo- or hyperglycemia, but allows the glycemic trend to be viewed at request.
详细描述
Patients will be identified and enrolled in the Diabetes Departments of different hospitals/clinics in the Emilia Romagna region, Italy. Patients will be divided in two groups A (naive patients,) and B (patients already using the device at enrollment) and followed for 12 months.
Study design is observational prospective and includes 3-months follow up visits until the 12-month final evaluation.
At each visit, patient clinical data, adherence and side effects will be recorded and data download from the device will be performed.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Diagnosis of Diabetes Mellitus type 1 for at least 12 months
- •Multi-injection insulin therapy
- •C-peptide <0.2 nmol/L
- •At least 1 documented episode in the last 12 months of hospitalization (emergency room or ordinary hospitalization) for severe hypoglycemia; hospitalization (emergency room. or ordinary hospitalization) for diabetic ketoacidosis; documented severe hypoglycemia (i.e. with blood glucose measurement).
排除标准
- •Diabetes Mellitus type 2
- •Other types of diabetes
- •Other diseases (excluding endocrinopathies, hypertension and dyslipidemia) that required chronic intake of drugs that may interfere with the glucose-insulin system.
结局指标
主要结局
Severe hypoglycemia rate
时间窗: 12 months
Percentage (%) of patients with at least 1 episode of severe hypoglycemia.
次要结局
- Safety of the device(12 months)
- Feasibility of the device(12 months)
- Glucose control(12 months)
- Flash Glucose Monitoring treatment satisfaction(12 months)
研究者
Riccardo Bonadonna
Director of Endocrinology and Metabolic disease Unit
Azienda Ospedaliero-Universitaria di Parma