DiabetesNPMDM-PPNCT05293015
NP-Supported Multidisciplinary Diabetes Management During Perioperative Period
A study testing NP-Supported Multidisciplinary Diabetes Management in people with Diabetes, run by Peking University Third Hospital.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- NP-Supported Multidisciplinary Diabetes Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2022to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Cognitive and communication disorders;
- Pregnancy;
- Participate in other intervention studies.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: NP-Supported Multidisciplinary Diabetes Management During Perioperative Period in Patient With Diabetes Mellitus
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
Read the 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
- Being tested
- NP-Supported Multidisciplinary Diabetes Management
- Keywords
- nurse practitioners, Multidisciplinary Diabetes Management, perioperative period
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NP-Supported Multidisciplinary Diabetes ManagementOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
EFFICACY: TIR（Time in Range）
Time in range
Measured: 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
Glycated Serum Protein would be conducted to measure glucose control
Measured: baseline and 1 month after discharged
EFFICACY: Incidence of perioperative hypoglycemia
Incidence of perioperative hypoglycemia would be conducted to measure glucose control
Measured: 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 time from the patient's enrollment to the blood glucose reaching the blood glucose control target
Measured: the first hospital day
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.
Measured: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
EFFICACY: Incidence of perioperative adverse events
Adverse events included wound infection, prolonged wound healing time, and death within 1 month after surgery.
Measured: 1 month after discharge
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
Measured: baseline, day of hospitalization, during hospitalization and 1 month after discharge
EFFICACY: Body weight
The same scale was used to measure after patients got up in the morning.
Measured: baseline, day of hospitalization, during hospitalization and 1 month after discharge
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.
Measured: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
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.
Measured: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2022
- Study start1 Apr 2022 (estimated)
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05293015
- Sponsor's protocol ID
- M2021609
- Acronym
- NPMDM-PP
- Status last verified
- Dec 2021
- First submitted
- 29 Dec 2021
- Last updated
- 23 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24804698Meneghini 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.
PubMed 19880837Clement 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.
PubMed 14747243Sebranek 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.
PubMed 24335396Aminian 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.
PubMed 26822327Golden 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.
PubMed 10480501
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NP-Supported Multidisciplinary Diabetes Management During Perioperative Period in Patient With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05293015
- Acronym / sponsor ID
- NPMDM-PP / M2021609
- Conditions
- Diabetes
- Keywords
- nurse practitioners, Multidisciplinary Diabetes Management, perioperative period
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 1 Apr 2022 (estimated)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 23 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NP-Supported Multidisciplinary Diabetes Management | Experimental | Other: NP-Supported Multidisciplinary Diabetes ManagementNP 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 | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Cognitive and communication disorders;
- Pregnancy;
- Participate in other intervention studies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NP-Supported Multidisciplinary Diabetes ManagementNP 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 |
Primary outcome
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
9 secondary outcomes
EFFICACY: Glycated Serum Protein
Time frame: baseline and 1 month after discharged
EFFICACY: Incidence of perioperative hypoglycemia
Time frame: 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
Time frame: the first hospital day
EFFICACY: Diabetes self-management behavior
Time frame: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
EFFICACY: Incidence of perioperative adverse events
Time frame: 1 month after discharge
EFFICACY: Blood pressure
Time frame: baseline, day of hospitalization, during hospitalization and 1 month after discharge
EFFICACY: Body weight
Time frame: baseline, day of hospitalization, during hospitalization and 1 month after discharge
EFFICACY: Anxiety and depression
Time frame: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
QUALITY OF LIFE:living quality
Time frame: Measurements were taken at baseline, day of hospitalization, and 1 month after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2022.
- Background: PubMed 24804698Liao 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.
- Background: PubMed 19880837Meneghini 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.
- Background: PubMed 14747243Clement 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.
- Background: PubMed 24335396Sebranek 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.
- Background: PubMed 26822327Aminian 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.
- Background: PubMed 10480501Golden 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing NP-Supported Multidisciplinary Diabetes Management in people with Diabetes, run by Peking University Third Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qun Wang (13901280942, wq3025@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05293015, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2022.