In-hospital Diabetes Management With Flash Glucose Monitoring (isCGM) - the INDIGO Study, Part B
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Glucose time in range (3,9-10 mmol/l) (% pr day)
研究概览
简要总结
The aim of the study is to investigate the applicability of a Flash glucose monitoring sensor (Freestyle Libre, isCGM) for in-hospital glucose monitoring in patients with diabetes and hypoglycemia (<3,9 mmol/l) during the hospitalization
详细描述
All patients who meet study criteria will be invited to participate in the study. All patients included in the study will be followed by a trained clinical diabetes specialist and a trained study nurse (study personnel) for glucose management during their hospitalization. All patients included in the study will receive a Freestyle Libre isCGM. The patients will be randomized to control (blinded isCGM glucose values to patient and study personnel and POC (point-of-care) plasma glucose will be used for adjusting diabetes treatment) or intervention (isCGM blood glucose values will be used to aid with glucose management during the hospitalization). The study personnel will work with the patient's care team.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
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
- •Expected length of hospital stay of at least 48 hours
- •Diagnosed with diabetes
- •Literate in Danish
- •In-hospital hypoglycemia with at least one POC glucose < 3,9 mmol/l (current hospitalization)
- •In-hospital treatment with insulin or sulfonylurea
- •Admission to Department of Gastrointestinal Surgery or Department of Heart-, Lung-, and Vascular surgery, both at Aarhus University Hospital, Denmark.
排除标准
- •Pregnancy
- •Patient unable to provide informed consent
- •Patient unable to use mobile phone for reading isCGM sensor
- •Known allergy to adhesives
- •Anticipated MRI during the hospital admission
- •Patients using CGM prior to hospital admission
结局指标
主要结局
Glucose time in range (3,9-10 mmol/l) (% pr day)
时间窗: 2-14 days
Glucose time in range (3,9-10 mmol/l) when diabetes treatment is adjusted using isCGM compared with standard care using POC plasma glucose monitoring (PG) (% pr day)
次要结局
- Mean glucose (mmol/l) isCGM versus POC PG(2-14 days)
- Time with active isCGM(2-14 days)
- Number and duration of events with hypoglycemia (<3 mmol/L and <3,9 mmol/l) (time in hypoglycemia)(2-14 days)
- Glycemic variability; coefficient of variation (CV) and standard deviation (SD)(2-14 days)
- Time in hyperglycemia (>10 mmol/l)(2-14 days)
- Glucose out of range: Time in hypoglycemia and time in hyperglycemia (<3,9 and >10 mmol/l) undetected with POC PG (use of data from blinded CGM in control group)(2-14 days)
- Daily total insulin dosage (IE)(2-14 days)
研究者
Julie Støy
Clinical diabetes specialist
University of Aarhus