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Clinical Trials/NCT05293015
NCT05293015
Unknown
Not Applicable

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

Peking University Third Hospital0 sites170 target enrollmentApril 1, 2022
ConditionsDiabetes

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetes
Sponsor
Peking University Third Hospital
Enrollment
170
Primary Endpoint
EFFICACY: TIR(Time in Range)
Last Updated
4 years ago

Overview

Brief Summary

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

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2022
End Date
March 31, 2023
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

EFFICACY: TIR(Time in Range)

Time Frame: From into the group to the first hospital day; First day in hospital to the day of discharge

Time in range

Secondary Outcomes

  • 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)

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