Continuous GLUCOse Monitoring System With a SENSor Compared to Fingerstick Glucose Monitoring in Surgical Wards (GLUCOSENS)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 329
- 试验地点
- 4
- 主要终点
- Substudy 1: Mean daytime and nocturnal point-of-care glucose levels
研究概览
简要总结
This clinical trial aims to compare a continuous glucose monitoring system with traditional fingerstick blood glucose monitoring. The study focuses on adult patients in general surgical wards who need regular blood glucose checks due to the risk of low or high blood sugar levels.
The goal is to learn if using a continuous glucose monitoring system is better than fingerstick monitoring in managing glucose levels, preventing complications, improving patient satisfaction and experience, reducing nursing staff workload, and improving nursing staff' experience. The study also compares the accuracy of glucose readings from the continuous glucose monitoring system with those from fingerstick tests and blood samples.
The hypothesis is that CGMS is accurate and effective for monitoring glucose levels in surgical patients. This could lead to better blood sugar control, fewer complications, shorter hospital stays, and improved experiences for both patients and nursing staff.
详细描述
Glucose control in surgical patients at risk of hyperglycemia and hypoglycemia is essential, as these conditions can lead to infections, poor surgical outcomes, prolonged hospital stays, and death. In 2022, the prevalence of diagnosed diabetes in Denmark was 6.2%. With the global incidence of diabetes on the rise, the number of patients requiring glucose control during surgical admissions is increasing.
Point-of-care (POC) fingerstick capillary glucose monitoring (FSGM) is standard in many hospitals; however, FSGM can be painful, disrupt sleep, and increase postoperative stress for patients. Additionally, it can be time-consuming, requiring up to two hours of nursing work per patient daily. This makes timely and prescribed glucose monitoring challenging in busy surgical wards, potentially leading to untreated hyperglycemia and hypoglycemia. Moreover, FSGM provides only a snapshot of glucose levels, without indicating whether glucose is stable, rising, or falling.
An alternative to FSGM is continuous glucose monitoring systems (CGMS), which measure glucose levels via a subcutaneous sensor every few minutes. CGMS is predominantly used in ambulatory settings and has been shown to improve glucose regulation. Several studies have confirmed the accuracy of CGMS compared to FSGM in surgical and medical wards, reporting an overall mean absolute relative difference ranging from 9.4 to 12.9, making it acceptable for use in surgical wards. Other studies have reported that CGMS in surgical and medical wards results in superior glycemic control, reduced hypoglycemia, insulin usage, and in-hospital complications, and detected significant duration of both hypo- and hyperglycemia despite protocolized perioperative diabetes management compared to FSGM.
Studies on patients' perspectives of CGMS have been limited to everyday life and outpatient settings. One review on patients with type 1 and 2 diabetes experienced improved convenience, control, and freedom by the use of CGMS but were also overwhelmed by data and frustrated by inaccuracy, and technical issues, which is consistent with findings from another review of patients with diabetes type 2. Another study reported that patients with type 2 diabetes found the technology helpful for disease management, although it could also serve as an unpleasant reminder of disease progression and cause discomfort.
One case report has described nurses' experiences with CGMS in hospital wards for patients with type 1 diabetes. The nurses experienced an increased workload due to difficulties hearing the device receiver, leading to more frequent patient observations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients (≥ 18 years old) in surgical wards
- •Glucose measurements at least 4 times (OUH) and 3 times (SUH) daily for at least three days, prescribed by surgeon
- •Expected hospitalization for at least three days
- •Communicates in Danish
- •Signed a declaration of consent to study participation
- •At risk of hypo- and hyperglycemia (with or without a diabetes diagnosis)
- •Specific for substudy 4 inclusion criteria as above with the following add on: Patients being treated with insulin at discharge and patients residing within the OUH admission area.
排除标准
- •Cognitively impaired patients
- •Indication for glucose monitoring solely because of parenteral nutrition treatment
- •Patients admitted with a CGMS
- •Patients from the point-of-care fingerstick capillary glucose monitoring group cannot be included in the continuous glucose monitoring system group
- •Eligibility criteria solely for substudy 7
- •Inclusion Criteria:
- •Nursing staff with at least one month of experience with both point-of-care fingerstick capillary glucose monitoring and continuous glucose monitoring system and are registered nurses or certified nursing assistants
结局指标
主要结局
Substudy 1: Mean daytime and nocturnal point-of-care glucose levels
时间窗: During hospitalization (up to 30 days)
Point-of-care glucose levels measured by point-of-care continuous glucose monitoring system (CGMS) or point-of-care fingerstick capillary glucose monitoring (FSGM) Arm allocation: Period 1: FSGM Period 2: CGMS Number of measurements: minimum four times daily, hourly if fasting. Blood glucose measurement: mmol/L
Substudy 2: Patient-reported outcome on the convenience of glucose monitoring
时间窗: During hospitalization (up to 30 days)
Using the validated Danish version of the 22-item questionnaire: The Diabetes Treatment Satisfaction Questionnaire for Inpatients (DTSQ-IP), item 4: How convenient did you think the diabetes treatment was at hospitalization? Ranging from 0 - 6 0 represents 'At no time' 6 represents 'At most of the time'
Substudy 3: Mean minutes surgical nursing staff spent on bedside glucose monitoring
时间窗: During hospitalization (up to 30 days)
Mean time: minutes. Data include: * Profession * Preparation (gathering materials, handwashing, disinfecting hands, putting on gloves, etc.) * Time for fingerstick or scanning of the continuous glucose monitor sensor * Display time of glucose level on device * Glucose level (mmol/L) * Actions taken after measurement (insulin injection, handwashing, documentation, disinfection, etc.) * Time for leaving the room * Time for completed procedure including documentation * Other observations made during the measurement
Substudy 5: Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay
时间窗: During hospitalization (up to 30 days)
Percentage of time in range (3.9-10.0 mmol/l) during the entire hospital stay
Substudy 6: Differences in interstitial and plasma glucose
时间窗: During hospitalization (up to 30 days)
Glucose levels from CGMS are compared to plasma glucose, which are co-analyzed in blood tests.
次要结局
- Substudy 1: Mean dose of long-acting insulin (IE)(During hospitalization (up to 30 days))
- Substudy 1: Complication: Sepsis(During hospitalization (up to 30 days))
- Substudy 1: Complication: Second acute transfer to intensive care unit(During hospitalization (up to 30 days))
- Substudy 1: Complication: Infections(During hospitalization (up to 30 days))
- Substudy 1: TIR and other established outcome derived from CGM(90-days after discharge from hospital)
- Substudy 2: DTSQ-IP, treatment satisfaction (item 1)(During hospitalization (up to 30 days))
- eGFR(During hospitalization (up to 30 days))
- Substudy 1: Complication: Antibiotics(During hospitalization (up to 30 days))
- Substudy 1: Complication: Bedsore(During hospitalization (up to 30 days))
- Substudy 1: Complication: Diabetes ketoacidosis(During hospitalization (up to 30 days))
- Substudy 1: Complication: Anastomotic leak(During hospitalization (up to 30 days))
- Substudy 1: Readmission(30-days after discharge from hospital)
- Substudy 1: Mortality during hospitalization(During hospitalization (up to 30 days))
- Substudy 1: • Mean dose of short-acting insulin (IE)(During hospitalization (up to 30 days))
- Substudy 3: Mean minutes surgical nursing staff spent on reporting glucose levels and management to diabetes nurses(During hospitalization (up to 30 days))
- Substudy 1: Complication: Acute kidney failure(During hospitalization (up to 30 days))
- Substudy 1: Complication: First acute transfer to intensive care unit(During hospitalization (up to 30 days))
- Substudy 2: DTSQ-IP, treatment surveillance and flexibility (items 5+9),(During hospitalization (up to 30 days))
- Substudy 2: DTSQ-IP, treatment information, knowledge, and communication (items 15-18)(During hospitalization (up to 30 days))
- Substudy 2: DTSQ-IP, contact with specialized diabetes nurses (items 20-21)(During hospitalization (up to 30 days))
- Substudy 1: Mortality after discharge from hospital(90-days after discharge from hospital)
- Substudy 1: HbA1c three months after discharge(90-days after discharge from hospital)
- Substudy 2: DTSQ-IP, experience with hyper- and hypoglycemia (items 2-3)(During hospitalization (up to 30 days))
- Substudy 3: Mean minutes the diabetes nurse spent in relation to the surgical patients(During hospitalization (up to 30 days))
- Substudy 5: CGMS, time above range (TAR) 10,1-13.9 mmol/l(During hospitalization (up to 30 days))
- Substudy 5: CGMS, time above range (TAR) >13.9 mmol/l(During hospitalization (up to 30 days))
- Substudy 5: CGMS, time below range 3.0-3.9 mmol/l(During hospitalization (up to 30 days))
- Substudy 5: CGMS, time below range <3.0(During hospitalization (up to 30 days))
- Substudy 5: CGMS, standard deviation (SD)(During hospitalization (up to 30 days))
- Substudy 5: CGMS, coefficient of variation (CV)(During hospitalization (up to 30 days))
- Substudy 5: CGMS, mean glucose level daytime(During hospitalization (up to 30 days))
- Substudy 5: CGMS, mean glucose level night-time(During hospitalization (up to 30 days))
- Substudy 5: CGMS, Hypoglycemia level 1 (3.0-3.9 mmol/l)(During hospitalization (up to 30 days))
- Substudy 5: CGMS, hypoglycemia level 2 (<3.0 mmol/l)(During hospitalization (up to 30 days))
- Substudy 5: CGMS, number of hypoglycemic events in level 1 and 2, respectively(During hospitalization (up to 30 days))
- Substudy 6: Differences in interstitial and capillary glucose(During hospitalization (up to 30 days))