NP-Supported Multidisciplinary Diabetes Management During Perioperative Period

NCT05293015 | Unknown

• 1 other identifier: M2021609
• Study Type: interventional
• Target: 170
• Locations: 0 countries
• Sites: N/A

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

Conditions

Diabetes

Keywords

nurse practitioners, Multidisciplinary Diabetes Management, perioperative period

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• EFFICACY: Glycated Serum Protein

  baseline and 1 month after discharged

• 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: 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: Incidence of perioperative adverse events

  1 month after discharge

Study Arms (2)

NP-Supported Multidisciplinary Diabetes Management

EXPERIMENTAL

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.

Other: NP-Supported Multidisciplinary Diabetes Management

Regular diabetes management

NO INTERVENTION

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.

Interventions

NP-Supported Multidisciplinary Diabetes Management 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.

NP-Supported Multidisciplinary Diabetes Management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking University Third Hospital: lead
• Roche Pharma AG: collaborator

Related Publications (6)

• 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.

  PMID: 24804698 BACKGROUND

• 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.

  PMID: 19880837 BACKGROUND

• 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.

  PMID: 14747243 BACKGROUND

• 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.

  PMID: 24335396 BACKGROUND

• 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.

  PMID: 26822327 BACKGROUND

• 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.

  PMID: 10480501 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Qun Wang

CONTACT

13901280942; wq3025@sina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2021
• First Posted: March 23, 2022
• Study Start: April 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: March 23, 2022

Record last verified: 2021-12