Specialist Treatment of Inpatients: Caring for Diabetes (STOIC-D) - A single centre, randomised, controlled trial assessing the impact of a proactive specialist inpatient diabetes service on outcomes in inpatients with diabetes or hyperglycaemia.

The complex process-of-care intervention is described in detail: Description of sub-studies - STOIC-D trial comprises a three trials recruiting different cohorts but using the same underlying trial methodology. The three trials are: 1) STOIC-D Surgery. Including inpatients admitted under surgical teams. Primary outcomes are as specified elsewhere. 2) STOIC-D Medicine. Including inpatients admitted under medical teams. Primary outcomes are as specified elsewhere. 3) STOIC-T1D. Including inpatients with Type 1 diabetes regardless of admission team. Primary outcomes are as specified elsewhere. Trial entry All patients who are admitted to the Royal Melbourne Hospital (RMH) during the trial period will be assessed for eligibility for the trial. If they meet the inclusion criteria they will be randomised at the time of admission to the RMH to either the intervention or the control arm of the trial. Randomisation will occur automatically and electronically through the Electronic Medical Record (EMR) software. Proactive specialist care (intervention arm) First electronic review + Home team management Within 24 hours of admission to hospital for business day admissions (Monday to Friday, excluding public holidays) and within 48 hours of admission to hospital for non-business day admissions (Saturday, Sunday, and public holidays) after entering the trial, a participant’s EMR record for the admission will be reviewed electronically and remotely by a member of the Inpatient Diabetes Service (IDS). A standardised Electronic Diabetes Review (EDR) document will be completed and entered into the clinical record. The participant’s home team junior doctor will also be alerted of this review directly through the RMH’s internal communications systems. No direct changes to the participant’s inpatient management will be made during the first electronic review. The participant’s home team will manage their diabetes and glucose as per their clinical judgement. Ongoing electronic review + Home team management Following the first electronic review a participant will remain on the remote review list. Their glucose and medication record will be reviewed at least every second business day for the duration of their participation in the trial. If a change in glycaemic management is indicated, the IDS team member will complete a follow-up EDR document enter this into the clinical record. If this occurs the participant’s home team junior doctor will also be alerted of this review directly. No direct changes to the participant’s inpatient management will be made during ongoing electronic reviews. The participant’s home team will manage their diabetes and glucose as per their clinical judgement. Indications for a change in management include glucose outside of the target range for that patient or a change in clinical circumstances that are likely to cause glucose to move outside of the target range e.g. glucocorticoid commencement, patient fasting for surgery, and thus a proactive change in glycaemic management is required. The specific glycaemic range targeted for most individuals will be between 5.0 – 10.0 mmol/L as recommended by national and international inpatient diabetes guidelines but may differ for some individuals based on the clinical context. Escalation to Bedside Diabetes Review (BDR) If any of the following criteria are met the participant will be escalated by an IDS team member for a Bedside Diabetes Review (BDR) by the IDS using a direct review EMR list: • Request from the home team that the participant be reviewed directly by the IDS. • A diabetes diagnosis type that is anything other than type 2 diabetes (T2DM) e.g. type 1 diabetes (T1DM), type 3c diabetes (T3cDM), Latent Autoimmune Diabetes in Adults (LADA). • Commencement of a significant dose of oral glucocorticoids i.e. equal to or greater than prednisolone 5mg total daily dose or equivalent. • If on oral glucocorticoids at the time of admission, an increase in dose above the regular outpatient dose. • Commencement of supplemental or replacement therapeutic nutrition i.e. parenteral nutrition or enteral feeds administered via an enteral access tube e.g. nasogastric tube (NGT), percutaneous endoscopic gastrostomy (PEG) tube. This does not include supplemental nutrition that a participant ingests orally e.g. Fortisip® nutritional supplement, regardless of whether this is prescribed by a dietitian. • A major hypoglycaemic event i.e. BGL less than or equal to 3.0 mmol/L. • A major hyperglycaemic event i.e. BGL greater than or equal to 20.0 mmol/L. • Persistent hyperglycaemia i.e. 2 days on which there is any BGL greater than or equal to 15.0 mmol/L or 3 days on which there is any BGL greater than or equal to 12.0 mmol/L. • For STOIC-D Surgery and STOIC-T1D: HbA1c = 8.0%. • For STOIC-D Medicine: HbA1c =9.0% Bedside Diabetes Review (BDR) A BDR involves a member of the IDS performing an inpatient consultation at the participant’s bedside. This may involve modification of the participant’s inpatient management, communication with their home team, and communication with the treating nurse unit. The participant will be seen directly as frequently and as long as they continue to derive benefit from this intensity of management. This will be determined clinically by the IDS according to each individual’s clinical context based on the criteria described below. De-escalation to ongoing electronic review At any point following the initial direct review an IDS team member may determine that the participant’s diabetes and glucose management are stable and that they no longer require ongoing bedside review by the IDS. They will then de-escalate the participant to electronic review, which shall occur at least every second business day. Criteria for this de-escalation include: • No major hypoglycaemic events i.e. BGL less than or equal to 3.0 mmol/L and fewer episodes of hypoglycaemia. • No major hyperglycaemic events i.e. BGL greater than or equal to 20.0 mmol/L and fewer episodes of hyperglycaemia. • A greater proportion of glucose levels within the patient’s individualised target range. If following this the participant again meets criteria for escalation to direct IDS review, this re-escalation to bedside review will occur at that time. Duration of intervention administration The trial will continue for 12 months such that the intervention will be administered for a total of 12 months. Inpatient Diabetes Service (IDS) members The IDS will be comprised of a endocrinology consultant, endocrinology registrar, endocrinology resident, diabetes nurse practitioner, dietitian, and on occasion a credentialled diabetes educator. While all members of the IDS will be able to collect information and consult upon patients, only the endocrinology consultant, endocrinology registrar, endocrinology resident, and diabetes nurse practitioner will be able to change medication prescriptions as per standard scopes of practice.