Clinical trial NCT05293015: NP-Supported Multidisciplinary Diabetes Management During Perioperative Period
Official title: NP-Supported Multidisciplinary Diabetes Management During Perioperative Period in Patient With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes
Keywords: nurse practitioners, Multidisciplinary Diabetes Management, perioperative period
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
Collaborators: name: Roche Pharma AG
First posted: 2022-03-23
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: EFFICACY: TIR（Time in Range）
timeFrame: From into the group to the first hospital day; First day in hospital to the day of discharge
Secondary outcomes:
measure: EFFICACY: Glycated Serum Protein
timeFrame: baseline and 1 month after discharged
measure: EFFICACY: Incidence of perioperative hypoglycemia
timeFrame: From into the grop to 1 month after surgery. And confirmed based on the patient's main complaint and monitoring records.
measure: EFFICACY: Time required for blood glucose standard before surgery
timeFrame: the first hospital day
measure: EFFICACY: Diabetes self-management behavior
timeFrame: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
measure: EFFICACY: Incidence of perioperative adverse events
timeFrame: 1 month after discharge
measure: EFFICACY: Blood pressure
timeFrame: baseline, day of hospitalization, during hospitalization and 1 month after discharge
measure: EFFICACY: Body weight
timeFrame: baseline, day of hospitalization, during hospitalization and 1 month after discharge
measure: EFFICACY: Anxiety and depression
timeFrame: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
measure: QUALITY OF LIFE:living quality
timeFrame: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
Other outcomes:
Locations:
Study officials:
References:
citation: Liao CC, Lin CS, Shih CC, Yeh CC, Chang YC, Lee YW, Chen TL. Increased risk of fracture and postfracture adverse events in patients with diabetes: two nationwide population-based retrospective cohort studies. Diabetes Care. 2014 Aug;37(8):2246-52. doi: 10.2337/dc13-2957. Epub 2014 May 7.
citation: Meneghini LF. Perioperative management of diabetes: translating evidence into practice. Cleve Clin J Med. 2009 Nov;76 Suppl 4:S53-9. doi: 10.3949/ccjm.76.s4.09.
citation: Clement S, Braithwaite SS, Magee MF, Ahmann A, Smith EP, Schafer RG, Hirsch IB; American Diabetes Association Diabetes in Hospitals Writing Committee. Management of diabetes and hyperglycemia in hospitals. Diabetes Care. 2004 Feb;27(2):553-91. doi: 10.2337/diacare.27.2.553. No abstract available.
citation: Sebranek JJ, Lugli AK, Coursin DB. Glycaemic control in the perioperative period. Br J Anaesth. 2013 Dec;111 Suppl 1:i18-34. doi: 10.1093/bja/aet381.
citation: Aminian A, Kashyap SR, Burguera B, Punchai S, Sharma G, Froylich D, Brethauer SA, Schauer PR. Incidence and Clinical Features of Diabetic Ketoacidosis After Bariatric and Metabolic Surgery. Diabetes Care. 2016 Apr;39(4):e50-3. doi: 10.2337/dc15-2647. Epub 2016 Jan 28. No abstract available.
citation: Golden SH, Peart-Vigilance C, Kao WH, Brancati FL. Perioperative glycemic control and the risk of infectious complications in a cohort of adults with diabetes. Diabetes Care. 1999 Sep;22(9):1408-14. doi: 10.2337/diacare.22.9.1408.