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临床试验/NCT05293015
NCT05293015Unknown不适用

NP-Supported Multidisciplinary Diabetes Management During Perioperative Period in Patient With Diabetes Mellitus

Peking University Third Hospital0 个研究点目标入组 170 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
170
主要终点
EFFICACY: TIR(Time in Range)

研究概览

简要总结

The primary objective of this study is to determine the benefits of interventions from a Multidisciplinary Diabetes Care team involved of diabetes nurse practitioners(DNP) on glucose control, perioperative outcomes and psychosocial outcomes for patients with Diabetes Mellitus

详细描述

About 50% of diabetic patients will undergo at least one surgical operation, and nearly 20% of surgical patients have diabetes.Compared with non-diabetic patients, diabetic patients face greater risks during the perioperative period. Stress factors such as preoperative preparation, anesthesia, surgical trauma, pain, drugs and negative emotions can induce blood glucose fluctuations, which could lead to complications such as hyperglycemia, diabetic ketosis, and hypoglycemia.Therefore, perioperative management has become an important part of diabetes management.

A multidisciplinary collaborative team led by NP can reduce the mortality of patients after inpatient surgery, help patients change their lifestyle, maintain self-management behavior, improve patient experience, and reduce hospitalization costs. This study intends to explore the application effect of NP-led multidisciplinary collaborative team in the perioperative comprehensive management of diabetic patients.

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

入选标准

  • Diagnosis meets World Health Organization (WHO) (1999) Diabetes Diagnostic Standards
  • Orthopedic assessment requires elective surgery and no surgical contraindications
  • HbA1c≥8.5% or intravenous fasting blood glucose (FBG)>10mmol/l
  • Informed consent.

排除标准

  • Cognitive and communication disorders;
  • Pregnancy;
  • Participate in other intervention studies.

结局指标

主要结局

EFFICACY: TIR(Time in Range)

时间窗: From into the group to the first hospital day; First day in hospital to the day of discharge

Time in range

次要结局

  • EFFICACY: Glycated Serum Protein(baseline and 1 month after discharged)
  • QUALITY OF LIFE:living quality(Measurements were taken at baseline, day of hospitalization, and 1 month after discharge)
  • EFFICACY: Incidence of perioperative hypoglycemia(From into the grop to 1 month after surgery. And confirmed based on the patient's main complaint and monitoring records.)
  • EFFICACY: Incidence of perioperative adverse events(1 month after discharge)
  • EFFICACY: Blood pressure(baseline, day of hospitalization, during hospitalization and 1 month after discharge)
  • EFFICACY: Anxiety and depression(Measurements were taken at baseline, day of hospitalization, and 1 month after discharge)
  • EFFICACY: Time required for blood glucose standard before surgery(the first hospital day)
  • EFFICACY: Diabetes self-management behavior(Measurements were taken at baseline, day of hospitalization, and 1 month after discharge)
  • EFFICACY: Body weight(baseline, day of hospitalization, during hospitalization and 1 month after discharge)

研究者

申办方类型
Other
责任方
Sponsor

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