NP-Supported Multidisciplinary Diabetes Management During Perioperative Period

Diabetes Clinical Trial

— NPMDM-PP  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05293015
• Other study ID #: M2021609
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: December 2021
• Source: Peking University Third Hospital
• Contact: Qun Wang
• Phone: 13901280942
• Email: wq3025[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 170
• Est. completion date: March 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Other:
• NP-Supported Multidisciplinary Diabetes Management
NP establishes files to evaluate and manage patients before hospital and visits patients after hospitalization. Then set blood glucose control goals with endocrinology and orthopedic doctors together, initiates consultation with endocrinologists for patients with postoperative hyperglycemia, and is responsible for post-hospital follow-up.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Peking University Third Hospital	Roche Pharma AG

References & Publications (6)

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. — View 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. Review. Erratum in: Diabetes Care. 2004 Mar;27(3):856. Hirsh, Irl B [corrected to Hirsch, Irl B]. Diabetes Care. 2004 May;27(5):1255. — View 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. — View 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. Erratum in: Diabetes Care. 2017 Jun 14;:. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EFFICACY: TIR(Time in Range)	Time in range	From into the group to the first hospital day; First day in hospital to the day of discharge
Secondary	EFFICACY: Glycated Serum Protein	Glycated Serum Protein would be conducted to measure glucose control	baseline and 1 month after discharged
Secondary	EFFICACY: Incidence of perioperative hypoglycemia	Incidence of perioperative hypoglycemia would be conducted to measure glucose control	From into the grop to 1 month after surgery. And confirmed based on the patient's main complaint and monitoring records.
Secondary	EFFICACY: Time required for blood glucose standard before surgery	The time from the patient's enrollment to the blood glucose reaching the blood glucose control target	the first hospital day
Secondary	EFFICACY: Diabetes self-management behavior	measured by Summary of Diabetes Self-Care Activities(SDSCA). SDSCA scores from 0 to 77 and higher score means better self-management behaviors.	Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
Secondary	EFFICACY: Incidence of perioperative adverse events	Adverse events included wound infection, prolonged wound healing time, and death within 1 month after surgery.	1 month after discharge
Secondary	EFFICACY: Blood pressure	A calibrated electronic blood pressure meter of the same brand was used to measure systolic pressure and diastolic pressure in the same arm at the same time daily	baseline, day of hospitalization, during hospitalization and 1 month after discharge
Secondary	EFFICACY: Body weight	The same scale was used to measure after patients got up in the morning.	baseline, day of hospitalization, during hospitalization and 1 month after discharge
Secondary	EFFICACY: Anxiety and depression	measured by Hospital Anxiety and Depression Scale (HADS) scale. HADS contains two subscales: anxiety and depression, and each subscale have 7 items. Total scores were from 0 to 42(anxiety: 21 scores; depression: 21 scores), higher score means more severe anxiety and/or depression.	Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
Secondary	QUALITY OF LIFE:living quality	measured by Short Form 36 Health Survey (SF-36) which contains 8 modules with different score formula. Higher total scores mean better living quality.	Measurements were taken at baseline, day of hospitalization, and 1 month after discharge