Ambulance clinician use of capillary blood ketone meters to improve emergency hyperglycaemia care: A stepped-wedged controlled, mixed-methods feasibility study.

AIM: To determine whether it was feasible, safe and acceptable for ambulance clinicians to use capillary blood ketone meters for 'high-risk' diabetic ketoacidosis (DKA) recognition and fluid initiation, to inform the need for a full-powered, multi-centre trial. METHODS: Adopting a stepped-wedge controlled design, participants with hyperglycaemia (capillary blood glucose >11.0 mmol/L) or diabetes and unwell were recruited. 'High-risk' DKA intervention participants (capillary blood ketones ≥3.0 mmol/L) received paramedic-led fluid therapy. Participant demographic and clinical data were collated from ambulance and hospital care records. Twenty ambulance and Emergency Department clinicians were interviewed to understand their hyperglycaemia and DKA care experiences. RESULTS: In this study, 388 participants were recruited (Control: n = 203; Intervention: n = 185). Most presented with hyperglycaemia, and incidence of type 1 and type 2 diabetes was 18.5% and 74.3%, respectively. Ketone meter use facilitated 'high-risk' DKA identification (control: 2.5%, n = 5; intervention: 6.5%, n = 12) and was associated with improved hospital pre-alerting. Ambulance clinicians appeared to have a high index of suspicion for hospital-diagnosed DKA participants. One third (33.3%; n = 3) of Control and almost half (45.5%; n = 5) of Intervention DKA participants received pre-hospital fluid therapy. Key interview themes included clinical assessment, ambulance DKA fluid therapy, clinical handovers; decision support tool; hospital DKA management; barriers to hospital DKA care. CONCLUSIONS: Ambulance capillary blood ketone meter use was deemed feasible, safe and acceptable. Opportunities for improved clinical decision making, support and safety-netting, as well as in-hospital DKA care, were recognised. As participant recruitment was below progression threshold, it is recommended that future-related research considers alternative trial designs. CLINICALTRIALS: gov: NCT04940897.

Proactive review for people with diabetes in hospital: a cluster randomised feasibility trial with process evaluation, protocol V3.1.

BACKGROUND: Diabetes inpatient specialist services vary across the country, with limited evidence to guide service delivery. Currently, referrals to diabetes inpatient specialists are usually 'reactive' after diabetes-related events have taken place, which are associated with an increased risk of morbidity/mortality and increased length of hospital stay. We propose that a proactive diabetes review model of care, delivered by diabetes inpatient specialist nurses, may contribute to the prevention of such diabetes-related events and result in a reduction in the risk of harm. METHOD: We will conduct a cluster randomised feasibility study with process evaluation. The proactive diabetes review model (PDRM) is a complex intervention that focuses on the prevention of potentially modifiable diabetes-related harms. All eligible patients will receive a comprehensive, structured diabetes review that aims to identify and prevent potentially modifiable diabetes-related harms through utilising a standardised review structure. Reviews are undertaken by a diabetes inpatient specialist nurse within one working day of admission. This differs from usual care where patients are often only seen after diabetes-related harms have taken place. The trial duration will be approximately 32 weeks, with intervention delivery throughout. There will be an initial 8-week run-in phase, followed by a 24-week data collection phase. Eight wards will be equally randomised to either PDRM or usual care. Adult patients with a known diagnosis of diabetes admitted to an included ward will be eligible. Data collection will be limited to that typically collected as part of usual care. Data collected will include descriptive data at both the ward and patient level and glucose measures, such as frequency and results of capillary glucose testing, ketonaemia and hypoglycaemic events. The analysis aims to determine the fidelity and acceptability of the intervention and the feasibility of a future definitive trial. Whilst this study is primarily about trial feasibility, the findings of the process evaluation may lead to changes to both trial processes and modifications to the intervention. A qualitative process evaluation will be conducted in parallel to the trial. A minimum of 22 patients, nurses, doctors, and managers will be recruited with methods including direct non-participant observation and semi-structured interviews. The feasibility of a future definitive trial will be assessed by evaluating recruitment and randomisation processes, staffing resources and quality of available data. DISCUSSION: The aim of this cluster randomised feasibility trial with a process evaluation is to explore the feasibility of a definitive trial and identify appropriate outcome measures. If a trial is feasible and the effectiveness of PDRM can be evaluated, this could inform the future development of inpatient diabetes services nationally. TRIAL REGISTRATION: UK Clinical Research Network, 51,167. ISRCTN, ISRCTN70402110. Registered on 21 February 2022.

A UK national survey of enteral feed use in people with diabetes 2022.

AIMS: Enteral feeding is commonly used to manage a variety of medical conditions in hospitals. For people with diabetes this can present a specific challenge for glucose management. To address gaps in our understanding of modern enteral feeding outcomes and to help with the development of more specific guidance on maintaining glycaemic control, we conducted a national survey on the management of enteral feeding against the standards in the nationally adopted Joint British Diabetes Societies for Inpatient Care (JBDS) guidelines. METHODS: A questionnaire was developed using the 2018 JBDS guideline as a template this questionnaire was sent out by email to all 220 UK specialist diabetes teams. Databases of Diabetes UK, the Association of British Diabetologists (ABCD) and the Diabetes Inpatient Specialist Nurse UK Group were used. RESULTS: Twenty-six hospitals responded, 11 had guidelines for the management of insulin with enteral feeding. There were three main feed regimens used: continuous 24-h feeding, a single feed with one break in 24 h, or multiple feeds in 24 h. There were five regimens in common use: premixed insulin, isophane insulin, analogue basal insulin, variable rate intravenous insulin or basal bolus insulin. Overall glucose control was poor for all regimens and combinations. Continuous feed showed better glucose control than a single feed with a break, mean (±SD) glucose 12.4 mmol/L (5.6) versus 15.1 mmol/L (6.9) p < 0.005, but no group showed optimal control. CONCLUSIONS: Managing diabetes control during enteral feeding remains a challenge. Our survey showed that glucose control during this treatment is suboptimal.

Implementation of fully closed-loop insulin delivery for inpatients with diabetes: Real-world outcomes.

AIMS: Fully closed-loop insulin delivery has been shown in clinical trials to be safe and improve glucose control compared with standard insulin therapy in the inpatient setting. We investigated the feasibility of implementing the approved CamAPS HX fully closed-loop system in a hospital setting. METHODS: This implementation project was conducted in a large teaching hospital in Cambridge, UK. Healthcare professional training was multimodal including face-to-face workshops, online learning modules and supported by standard operating procedures. Set-up and maintenance of closed-loop devices were undertaken by the inpatient diabetes team. Selection of suitable patients was multidisciplinary and prioritised those with more challenging diabetes management. Demographic and clinical data were collected from electronic health records and diabetes data management platforms. RESULTS: In the 12 months since the closed-loop system was implemented, 32 inpatients (mean ± SD age 61 ± 16 years, 8 females, 24 males) used closed-loop insulin delivery during their admission, across medical and surgical wards in the hospital with a total of 555 days of closed-loop glucose control (median [IQR]: 14 [6, 22] days per inpatient). The time spent in target glucose range 3.9-10.0 mmol/L was 53.3 ± 18.3%. Mean glucose was 10.7 ± 1.9 mmol/L with 46.0 ± 18.2% of time spent with glucose >10.0 mmol/L. Time spent with sensor glucose below 3.9 mmol/L was low (median [IQR]: 0.38 [0.00, 0.85]). There were no episodes of severe hypoglycaemia or diabetic ketoacidosis during closed-loop use. CONCLUSIONS: We have demonstrated that the fully closed-loop system can be safely and effectively implemented by a diabetes outreach team in complex medical and surgical inpatients with challenging glycaemic control.

Closed-loop insulin delivery in inpatients with type 2 diabetes: a randomised, parallel-group trial.

BACKGROUND: We assessed whether fully closed-loop insulin delivery (the so-called artificial pancreas) is safe and effective compared with standard subcutaneous insulin therapy in patients with type 2 diabetes in the general ward. METHODS: For this single-centre, open-label, parallel-group, randomised controlled trial, we enrolled patients aged 18 years or older with type 2 diabetes who were receiving insulin therapy. Patients were recruited from general wards at Addenbrooke's Hospital, Cambridge, UK. Participants were randomly assigned (1:1) by a computer-generated minimisation method to receive closed-loop insulin delivery (using a model-predictive control algorithm to direct subcutaneous delivery of rapid-acting insulin analogue without meal-time insulin boluses) or conventional subcutaneous insulin delivery according to local clinical guidelines. The primary outcome was time spent in the target glucose concentration range of 5·6-10·0 mmol/L during the 72 h study period. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01774565. FINDINGS: Between Feb 20, 2015, and March 24, 2016, we enrolled 40 participants, of whom 20 were randomly assigned to the closed-loop intervention group and 20 to the control group. The proportion of time spent in the target glucose range was 59·8% (SD 18·7) in the closed-loop group and 38·1% (16·7) in the control group (difference 21·8% [95% CI 10·4-33·1]; p=0·0004). No episodes of severe hypoglycaemia or hyperglycaemia with ketonaemia occurred in either group. One adverse event unrelated to study devices occurred during the study (gastrointestinal bleed). INTERPRETATION: Closed-loop insulin delivery without meal-time boluses is effective and safe in insulin-treated adults with type 2 diabetes in the general ward. FUNDING: Diabetes UK; European Foundation for the Study of Diabetes; JDRF; National Institute for Health Research Cambridge Biomedical Research Centre; Wellcome Trust.