NP-Supported Multidisciplinary Diabetes Management During Perioperative Period

NCT ID: NCT05293015

Last Updated: 2022-03-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 170 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-03-31

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.

Conditions

Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NP-Supported Multidisciplinary Diabetes Management

Intervention Type: OTHER

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.

Regular diabetes management

The patient would go to the endocrinology outpatient clinic before hospitalization to regulate blood glucose, and be managed by by orthopedic medical staff through hospitalization. If necessary, the endocrinologist is consulted. And after the hospital, patients would be followed up by orthopedic medical staff.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Pharma AG

INDUSTRY

Sponsor Role: collaborator

Peking University Third Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Qun Wang

Role: CONTACT

wq3025@sina.com

13901280942

References

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.

Reference Type: BACKGROUND

PMID: 24804698 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19880837 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14747243 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24335396 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26822327 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10480501 (View on PubMed)

Other Identifiers

M2021609

Identifier Type: -

Identifier Source: org_study_id