Postoperative Glucose Control with a Basal Bolus Versus Sliding Scale Insulin Regimen and Its Effect on the Incidence of Surgical Site Infections in People with Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,008
- 试验地点
- 1
- 主要终点
- Surgical site infection
研究概览
简要总结
A multicentre, matched-pair, cluster randomised controlled superiority trial to investigate the effect of a proactive basal bolus insulin regimen compared to the reactive sliding scale insulin regimen, targeting a glucose level of 3.9-10.0 mmol/L, to reduce the number of surgical site infections within the first 30 days postoperatively in adult patients with diabetes mellitus type 2.
详细描述
People with type 2 diabetes mellitus (PWT2D) are at increased risk of postoperative complications, especially surgical site infections (SSI).
The aim of this study to reduce SSI in PWT2D by implementing a proactive basal-bolus insulin regimen, compared to the reactive sliding scale regimen.
Adult patients with type 2 diabetes will be included in this multi-centre study.
Participants will receive a blind CGM, i.e. glucose data are masked for the participants and study team, from admission to the ward until discharge from the hospital. In addition, all participants are asked to complete several questionnaires 30 days after surgery.
Both regimens are currently used in clinical practice. Therefore, there is no additional trial-related burden depending on the intervention group allocation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Patients aged 18 or older
- •Diagnosed with type 2 diabetes mellitus
- •Undergoing gastointestinal or vascular surgery
- •Admitted to one of the participating surgical wards
- •Expected duration of stay at least one overnight stay
- •Willing and able to provide informed consent
排除标准
- •Diagnosed with type 1 diabetes mellitus
- •Female of child-bearing potential who is pregnant or breastfeeding.
- •Undergoing complete pancreatectomy
- •Undergoing bariatric surgery
- •Patients using a continuous insulin pump at home
- •Patients undergoing a necrotectomy/wound debridement from a pre-existent wound.
结局指标
主要结局
Surgical site infection
时间窗: Until 30 days after surgery
Incidence of postoperative surgical site infection, according to the criteria of the centres of disease control (CDC) for superficial incisional SSI, deep incisional SSI and organ / space SSI. SSIs will be measured at 30 days postoperatively via BLUEBELLE questionnaire, diagnosis by surgeon during standard postoperative visit at the surgery clinic 3-5 weeks after surgery and chart review.
次要结局
- Postoperative hospital-acquired infections (non-SSI)(Recorded at 30 days postoperatively)
- Length of stay in the hospital (LoS-Hos)(Recorded at 30 days postoperatively)
- Hospital readmission(Recorded 30 days postoperatively)
- Days at home (DAH30)(Recorded 30 days postoperatively)
- Postoperative disability(Recorded 30 days postoperatively)
- Quality of life (QoL) after surgery(Recorded 30 days postoperatively)
- Glucose 2(Measured 4 times a day, until discharge from the hospital, up to 30 days.)
- Glucose 3(Measured 4 times a day, until discharge from the hospital, up to 30 days.)
- Glucose 4(Measured 4 times a day, until discharge from the hospital, up to 30 days.)
- CGM1(Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.)
- CGM2(Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.)
- CGM3(Measured with a 5-minute interval, until discharge from the hospital, up to 30 days.)
- Cost-effectiveness 1(Until 30 days after surgery)
- Cost-effectiveness 2(Up to 30 days after surgery.)
- Protocol adherence(During the hospital stay, until discharge)
研究者
Abraham Hulst, MD, PhD
Clinical investigator, anesthesiologist
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)