Abstract
SummaryBackgroundGlucose management is challenging in patients who require nutritional support in hospital. We aimed to assess whether fully closed-loop insulin delivery would improve glycaemic control compared with conventional subcutaneous insulin therapy in inpatients receiving enteral or parenteral nutrition or both.MethodsWe did a two-centre (UK and Switzerland), open-label, randomised controlled trial in adult inpatients receiving enteral or parenteral nutrition (or both) who required subcutaneous insulin therapy. Patients recruited from non-critical care surgical and medical wards were randomly assigned (1:1) using a computer-generated minimisation schedule (stratified by type of nutritional support [parenteral nutrition on or off] and pre-study total daily insulin dose [<50 or ≥50 units]) to receive fully closed-loop insulin delivery with faster-acting insulin aspart (closed-loop group) or conventional subcutaneous insulin therapy (control group) given in accordance with local clinical practice. Continuous glucose monitoring in the control group was masked to patients, ward staff, and investigators. Patients were followed up for a maximum of 15 days or until hospital discharge. The primary endpoint was the proportion of time that sensor glucose concentration was in target range (5·6–10·0 mmol/L), assessed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, number NCT01774565.FindingsBetween Feb 8, 2018, and Sept 21, 2018, 90 patients were assessed for eligibility, of whom 43 were enrolled and randomly assigned to the closed-loop group (n=21) or the control group (n=22). The proportion of time that sensor glucose was in the target range was 68·4% [SD 15·5] in the closed-loop group and 36·4% [26·6] in the control group (difference 32·0 percentage points [95% CI 18·5–45·5; p<0·0001]). One serious adverse event occurred in each group (one cardiac arrest in the control group and one episode of acute respiratory failure in the closed-loop group), both of which were unrelated to study interventions. There were no adverse events related to study interventions in either group. No episodes of severe hypoglycaemia or hyperglycaemia with ketonaemia occurred in either study group.InterpretationClosed-loop insulin delivery is an effective treatment option to improve glycaemic control in patients receiving nutritional support in hospital.FundingDiabetes UK, Swiss National Science Foundation, National Institute for Health Research Cambridge Biomedical Research Centre, Wellcome Trust, and European Foundation for the Study of Diabetes.
Highlights
Nutritional support with enteral or parenteral nutrition is an important component of medical care.[1]
Unanticipated dislodgement of feeding tubes, temporary discontinuation of nutrition because of nausea or for administration of medication or diagnostic testing, and cycling of nutritional support with oral intake all necessitate a high level of vigilance among health-care professionals, including frequent blood glucose monitoring, regular adjustment of insulin doses, and pre-emptive administration of carbohydrates to minimise the risk of hypoglycaemia
We showed that an increased proportion of time was spent in the target glucose range and mean glucose was reduced with fully closed-loop insulin delivery compared with standard insulin therapy, without an increase in the time spent in hypoglycaemia or the total daily insulin dose
Summary
Nutritional support with enteral or parenteral nutrition is an important component of medical care.[1] Hyperglycaemia is common in patients receiving nutritional support in non-critical care, occurring in up to half of those receiving parenteral nutrition and in a third of those receiving enteral nutrition.[2,3] The carbohydrate content of nutritional support can exacerbate other causes of hyperglycaemia in hospital inpatients, such as metabolic responses to acute illness and medications that alter insulin sensitivity (eg, glucocorticoids). Hyperglycaemia occurring in inpatients receiving parenteral or enteral nutrition, with or without a history of diabetes, is associated with increased morbidity and mortality.[4,5,6] Observational studies[4,5,7,8,9] have shown that the risks of infection, cardiac complications, acute renal failure, respiratory failure, and mortality increase as mean blood glucose increases in patients receiving parenteral nutrition.
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