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Trial registered on ANZCTR


Registration number
ACTRN12624000787583
Ethics application status
Approved
Date submitted
30/05/2024
Date registered
26/06/2024
Date last updated
26/06/2024
Date data sharing statement initially provided
26/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Optimising Glycaemic Control with Automated Glucose Monitoring: Impact on Hospital Length of Stay and Surgical Outcomes in Patients with Diabetes Mellitus
Scientific title
Evaluating the Impact of Technology-Assisted Glucose Monitoring on Glycaemic Control, Hospital Length of Stay, Readmission Rates and Post-operative Complications in Surgical Patients with Diabetes Mellitus
Secondary ID [1] 312114 0
None
Universal Trial Number (UTN)
U1111-1307-8629
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diabetes mellitus 333755 0
Hyperglycaemia 333756 0
Hypoglycaemia 333757 0
Surgical site infections 333759 0
Hospital admission 333918 0
Hospital readmission 333919 0
Condition category
Condition code
Metabolic and Endocrine 330438 330438 0 0
Diabetes
Infection 330778 330778 0 0
Other infectious diseases
Public Health 330779 330779 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to evaluate whether prompt assessment and management intervention by the diabetes glucose control team can improve the average length of stay, 28 day readmission rate or post-operative complications in surgical inpatients with diabetes mellitus. Prompt delivery of the intervention will be facilitated by use of a Point of Care (POC) glucose meter with Wi-Fi connectivity (Nova Biomedical Statstrip Connectivity meter), which has been approved by the Therapeutic Goods Administration and Nepean Blue Mountains Local Health District for inpatient blood glucose monitoring. Both glucose meters work by detecting the blood sugar in capillary blood taken via a lancet needle. For the Wi-Fi connectivity meters, nurses will need to scan their staff barcode and the patient barcode. Once measured, these Wi-Fi enabled glucose meters can automatically upload blood glucose levels (BGL) into patients' Electronic Medical Records (eMR). BGL are routinely performed at least 4 times a day (e.g. pre-meals, before bed and 2am), and more frequently if indicated (e.g. hyperglycaemia, hypoglycaemia or clinical deterioration).

When BGLs are uploaded by the Wi-Fi enabled glucose meters, patients with any BGL measurement that falls outside the hospital inpatient target range (5-10mmol/L) are flagged and emailed to the glucose control team, enabling rapid identification of patients with blood glucose levels (BGLs) which fall outside of this range, indicative of hyperglycaemia or hypoglycaemia. These flagged patients can then be assess by trained glucose control team medical and/or nursing staff. Thus, using this BGL monitoring system, patients can be rapidly identified such that reviews and management can be promptly undertaken to treat dysglycaemia. The standard glucose meters will be removed from the wards once the intervention has started.
Intervention code [1] 328555 0
Diagnosis / Prognosis
Intervention code [2] 328823 0
Prevention
Comparator / control treatment
The control group involves all inpatients on the surgical wards at Nepean Hospital with pre-existing diabetes who require regular blood glucose testing using the standard glucose meters in the preceding months prior to use of the POC connectivity glucose meter. The current standard of clinical care uses POC glucose meters which require nursing staff to manually enter BGLs into eMR, which can lead to delays and transcription errors. Additionally, current standard of care does not include a mechanism to rapidly alert glucose control team staff of patients with BGLs outside of the inpatient target range.

The control data will be retrospective and data over the preceding 24 months will be audited. In the first 2 months of using the Connectivity glucose meters the automated alert system messages will not be sent to the glucose control team but sent to and retained by the non-clinical research assistant. The purpose of this is to clarify the baseline level of glycaemic control with the current glucose control team.
Control group
Active

Outcomes
Primary outcome [1] 338300 0
Change in percentage of time during which the BGL is in the target range of 5-10mmol/L. I.e. percentage of time in range (TIR)
Timepoint [1] 338300 0
BGLs throughout the patient participant admission will be assessed for TIR at the end of the hospital inpatient stay
Secondary outcome [1] 435353 0
Mean or median hospital length of stay, depending on data distribution (i.e. normally or non-parametrically distributed)
Timepoint [1] 435353 0
Calculated per patient participant, then mean or median derived for control and intervention groups, assessed at the end of the hospital stay.
Secondary outcome [2] 435354 0
28 day readmission rate
Timepoint [2] 435354 0
Outcome will be assessed for each patient at 28 days post hospital admission to allow time for all eMR information to be updated over the 28 day period following hospital discharge
Secondary outcome [3] 435355 0
Surgical site infection requiring antibiotics
Timepoint [3] 435355 0
Patient's eMR will be audited daily over the hospital inpatient stay and for the 28 days following discharge from hospital
Secondary outcome [4] 435356 0
Post-operative pneumonia
Timepoint [4] 435356 0
The EMR audit will be performed over the hospital inpatient stay and for the 28 days following discharge from hospital.
Secondary outcome [5] 435357 0
Poor post-operative wound healing requiring re-admission
Timepoint [5] 435357 0
The EMR audit will be performed over the hospital inpatient stay and for the 28 days following discharge from hospital.
Secondary outcome [6] 436324 0
Post-operative sepsis
Timepoint [6] 436324 0
The EMR audit will be performed over the hospital inpatient stay and for the 28 days following discharge from hospital.
Secondary outcome [7] 436325 0
Post-operative urinary tract infection
Timepoint [7] 436325 0
The EMR audit will be performed over the hospital inpatient stay and for the 28 days following discharge from hospital.
Secondary outcome [8] 436326 0
Post-operative candiasis
Timepoint [8] 436326 0
The EMR audit will be performed over the hospital inpatient stay and for the 28 days following discharge from hospital.
Secondary outcome [9] 436327 0
Composite outcome of all post-operative infections
Timepoint [9] 436327 0
The EMR audit will be performed over the hospital inpatient stay and for the 28 days following discharge from hospital.
Secondary outcome [10] 436328 0
Proportion of patients with diabetes seen by the glucose control team when they are notified by automated alert compared with when they do not receive an automated alert
Timepoint [10] 436328 0
The EMR audit will be performed over the hospital inpatient stay and for the 28 days following discharge from hospital.
Secondary outcome [11] 436329 0
Mortality during hospital admission
Timepoint [11] 436329 0
The EMR audit will be performed over the hospital inpatient stay
Secondary outcome [12] 436330 0
12 months mortality, defined as 12 months after hospital discharge
Timepoint [12] 436330 0
The EMR audit will be performed at 12 months post discharge
Secondary outcome [13] 436331 0
In those patients who have documented hypoglycaemia in hospital (BGL< 4mmol/l), the mortality during hospital admission.
Timepoint [13] 436331 0
The EMR audit will be performed over the hospital inpatient stay
Secondary outcome [14] 436332 0
In those patients who have documented hypoglycaemia in hospital (BGL< 4mmol/l), the 12 months mortality after hospital discharge
Timepoint [14] 436332 0
The EMR audit will be performed at 12 months post discharge
Secondary outcome [15] 436333 0
The difference between the 2 groups in the proportion of patients with hypoglycaemia during hospital admission
Timepoint [15] 436333 0
The EMR audit will be performed over the hospital inpatient stay
Secondary outcome [16] 436334 0
The difference between the 2 groups in the number of episodes of hypoglycaemia per 100 patient days
Timepoint [16] 436334 0
The EMR audit will be performed over the hospital inpatient stay
Secondary outcome [17] 436335 0
The difference between the 2 groups in the proportion of patients with BGL > 10 mmol/l during hospital admission
Timepoint [17] 436335 0
The EMR audit will be performed over the hospital inpatient stay
Secondary outcome [18] 436336 0
The difference between the 2 groups in the number of episodes of hypoglycaemia per 100 patient days
Timepoint [18] 436336 0
The EMR audit will be performed over the hospital inpatient stay
Secondary outcome [19] 436337 0
The difference between the 2 groups in the proportion of patients with BGL > 13.9mmol/l during hospital admission
Timepoint [19] 436337 0
The EMR audit will be performed over the hospital inpatient stay
Secondary outcome [20] 436338 0
The difference between the 2 groups in the number of episodes of BGL >13.9 mmol/l per 100 patient days
Timepoint [20] 436338 0
The EMR audit will be performed over the hospital inpatient stay

Eligibility
Key inclusion criteria
Adults who are admitted on the surgical wards at Nepean Hospital with pre-existing diabetes (type 1, type 2 or other types of diabetes, excluding gestational diabetes) treated with diet alone, oral tablets or injectable therapy (e.g. insulin, GLP-1 agonists), who require regular blood glucose testing as part of the standard clinical care, including those already on continuous glucose monitoring.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Age under 16 years
2. Patients admitted under a non-surgical team
3. Patients with gestational diabetes or without diabetes
4. Blood glucose measurements by nursing staff who are not trained to use the different types of glucometers (e.g. agency nurses, nursing students)

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
22/07/2024
Actual
Date of last participant enrolment
Anticipated
3/02/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 316472 0
Hospital
Name [1] 316472 0
In kind support from the medical and nursing staff at Nepean Hospital
Country [1] 316472 0
Australia
Primary sponsor type
Hospital
Name
Nepean Hospital
Address
Country
Australia
Secondary sponsor category [1] 318745 0
None
Name [1] 318745 0
Address [1] 318745 0
Country [1] 318745 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315262 0
Nepean Blue Mountains Local Health District
Ethics committee address [1] 315262 0
https://www.nbmlhd.health.nsw.gov.au/researchoffice
Ethics committee country [1] 315262 0
Australia
Date submitted for ethics approval [1] 315262 0
16/02/2018
Approval date [1] 315262 0
05/03/2018
Ethics approval number [1] 315262 0

Summary
Brief summary
In the inpatient peri-operative setting, people with diabetes are at risk of dysglycaemia precipitated by a number of factors, for example prolonged fasting, use of blood glucose lowering agents, stress, fever, infection and pro-inflammatory state. In addition, delayed BGL monitoring and medication errors relating to insulin and oral hypoglycaemic agent doses and administration can cause further fluctuations in BGLs and contribute to increased hospital length of stay and surgical complications. Standard POC glucose testing requires manual input by nurses into the EMR, which can lead to error and delay in transcription of the BGL value. The standard POC BGL testing also does not enable easy auditing of BGL data, so that interventions to improve BGLs are difficult as they require time consuming manual audits of sequential BGLs over time e.g. to assess adherence to protocol in treatment of hypoglycaemia. This is a prospective pre- and post-intervention observational study to determine whether early identification of dysglycaemia, using a blood glucose meter with Wi-Fi connectivity to the EMR and an early identification system can facilitate prompt assessment and management to improve patient outcomes. The patient outcomes are, comparing use standard care POC BGL testing with Wi-Fi connectivity glucose meters, the mean proportion of BGLs per patient in the hospital inpatient target range of 5-10 mmol/l , the mean proportion and number of patient days with hypoglycemic incidents and with hyperglycaemic incidents, the average length of stay, 28 day readmission rates, and post-operative complications including but not limited to surgical site infections. We will also measure time to first assessment of dysglycaemia by the glucose control team, both from admission and from arrival on one of the surgical wards. We hypothesise that use of the connectivity glucose meter will identify patients who require clinical intervention earlier and will improve glycaemic control, post-operative surgical outcomes, decrease the mean length of stay and decrease 28-day readmission rates.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134166 0
A/Prof Emily Hibbert
Address 134166 0
Endocrinology Department Nepean Hospital, Derby St, Kingswood, NSW, 2747
Country 134166 0
Australia
Phone 134166 0
+61 0419606608
Fax 134166 0
Email 134166 0
emily.hibbert@sydney.edu.au
Contact person for public queries
Name 134167 0
Laura Conway
Address 134167 0
Endocrinology Department Nepean Hospital, Derby St, Kingswood, NSW, 2747
Country 134167 0
Australia
Phone 134167 0
+61 47344754
Fax 134167 0
Email 134167 0
laura.conway@health.nsw.gov.au
Contact person for scientific queries
Name 134168 0
Emily Hibbert
Address 134168 0
Endocrinology Department Nepean Hospital, Derby St, Kingswood, NSW, 2747
Country 134168 0
Australia
Phone 134168 0
+61 0419606608
Fax 134168 0
Email 134168 0
emily.hibbert@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.