Closed-loop insulin improves time in range for inpatients receiving nutritional support
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Inpatients receiving enteral or parenteral nutrition in a noncritical care setting who required insulin therapy spent significantly more time in the recommended blood glucose range when assigned to a fully closed-loop insulin delivery system vs. standard subcutaneous therapy, according to findings published in The Lancet Diabetes & Endocrinology.
“Hyperglycemia is common in patients receiving nutritional support in noncritical care, occurring in up to half of those receiving parenteral nutrition and in a third of those receiving enteral nutrition,” Roman Hovorka, PhD, FMedSci, professor at the Wellcome Trust-MRC Institute of Metabolic Science, Addenbrooke’s Hospital, Cambridge, U.K., and colleagues wrote in the study background. “The carbohydrate content of nutritional support can exacerbate other causes of hyperglycemia in hospital inpatients, such as metabolic responses to acute illness and medications that alter insulin sensitivity.”
In a two-center, open-label, randomized controlled trial, researchers analyzed data from 43 adult inpatients without type 1 diabetes receiving enteral or parenteral nutrition (or both) who required subcutaneous insulin therapy between February and September 2018. Inpatients who required insulin therapy were recruited from noncritical care surgical and medical wards and were randomly assigned to fully closed-loop insulin delivery with faster-acting insulin aspart (n = 21; mean age, 66 years; 67% men; mean HbA1c, 7.3%) or to conventional subcutaneous insulin therapy (controls; n = 22; mean age, 69 years; 77% men; mean HbA1c, 7.4%), stratified by the type of nutritional support (on or off parenteral nutrition) and pre-study total daily insulin dose (< 50 U or 50 U). Continuous glucose monitoring in the control group was masked to patients, ward staff and investigators. Researchers followed patients for up to 15 days or until hospital discharge. Primary endpoint was the proportion of time spent in the target glucose range (100-180 mg/dL), assessed in the intention-to-treat population.
Researchers observed a marked difference in time in range for patients in the closed-loop group vs. controls (68.4% vs. 36.4%; P < .0001). One patient in each group experienced a serious adverse event that was unrelated to the study. There were no adverse events related to study interventions in either group and no documented episodes of severe hypoglycemia or hyperglycemia with ketonemia, according to researchers.
“Recommended glucose targets in noncritical care are not attainable by many health care institutions with conventional insulin therapy,” the researchers wrote. “In this study, the benefits of fully closed-loop glycemic control suggest that this technology has the potential to substantially improve management of hyperglycemia in one of the most challenging inpatient populations.”
In commentary accompanying the study, Pieter Gillard, MD, PhD, of the department of endocrinology at University Hospitals Leuven, Belgium, and colleagues wrote that closed-loop systems have the potential to reduce workload because of automation of both insulin delivery and glucose measurements, but might also increase the burden on diabetes teams.
“For example, technical issues or defects might occur, and backup protocols will need to be activated to avoid unsafe dysregulation of glycemic control,” Gillard and colleagues wrote. “In a quarter of patients, the study was suspended temporarily because of transfer to intensive care, surgery or other procedures (eg, radiology). In these cases, backup protocols should be in place, which might lead to an increase in workload.” – by Regina Schaffer
Disclosures: Hovorka reports he received speaker honoraria from Eli Lilly and Novo Nordisk, served on advisory panels for Eli Lilly and Novo Nordisk, and received license fees from B. Braun and Medtronic. Hovorka and another author report patents and patent applications related to closed-loop insulin therapy. Gillard reports he has received personal fees from Abbott, Bayer, Boehringer Ingelheim, Janssen and Novo Nordisk and nonfinancial support for travel from Menarini, Roche and Sanofi. Please see the study and commentary for all other authors’ relevant financial disclosures.