Closed-Loop Insulin Delivery for Glycemic Control in Noncritical Care.

Bally, Lia; Thabit, Hood; Hartnell, Sara; Andereggen, Eveline; Ruan, Yue; Wilinska, Malgorzata E; Evans, Mark L; Wertli, Maria Monika; Coll, Anthony P; Stettler, Christoph; Hovorka, Roman (2018). Closed-Loop Insulin Delivery for Glycemic Control in Noncritical Care. The New England journal of medicine, 379(6), pp. 547-556. Massachusetts Medical Society 10.1056/NEJMoa1805233

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BACKGROUND In patients with diabetes, hospitalization can complicate the achievement of recommended glycemic targets. There is increasing evidence that a closed-loop delivery system (artificial pancreas) can improve glucose control in patients with type 1 diabetes. We wanted to investigate whether a closed-loop system could also improve glycemic control in patients with type 2 diabetes who were receiving noncritical care. METHODS In this randomized, open-label trial conducted on general wards in two tertiary hospitals located in the United Kingdom and Switzerland, we assigned 136 adults with type 2 diabetes who required subcutaneous insulin therapy to receive either closed-loop insulin delivery (70 patients) or conventional subcutaneous insulin therapy, according to local clinical practice (66 patients). The primary end point was the percentage of time that the sensor glucose measurement was within the target range of 100 to 180 mg per deciliter (5.6 to 10.0 mmol per liter) for up to 15 days or until hospital discharge. RESULTS The mean (±SD) percentage of time that the sensor glucose measurement was in the target range was 65.8±16.8% in the closed-loop group and 41.5±16.9% in the control group, a difference of 24.3±2.9 percentage points (95% confidence interval [CI], 18.6 to 30.0; P<0.001); values above the target range were found in 23.6±16.6% and 49.5±22.8% of the patients, respectively, a difference of 25.9±3.4 percentage points (95% CI, 19.2 to 32.7; P<0.001). The mean glucose level was 154 mg per deciliter (8.5 mmol per liter) in the closed-loop group and 188 mg per deciliter (10.4 mmol per liter) in the control group (P<0.001). There was no significant between-group difference in the duration of hypoglycemia (as defined by a sensor glucose measurement of <54 mg per deciliter; P=0.80) or in the amount of insulin that was delivered (median dose, 44.4 U and 40.2 U, respectively; P=0.50). No episode of severe hypoglycemia or clinically significant hyperglycemia with ketonemia occurred in either trial group. CONCLUSIONS Among inpatients with type 2 diabetes receiving noncritical care, the use of an automated, closed-loop insulin-delivery system resulted in significantly better glycemic control than conventional subcutaneous insulin therapy, without a higher risk of hypoglycemia. (Funded by Diabetes UK and others; ClinicalTrials.gov number, NCT01774565 .).

Item Type:

Journal Article (Original Article)

Division/Institute:

04 Faculty of Medicine > Department of General Internal Medicine (DAIM) > Clinic of General Internal Medicine
04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Endocrinology, Diabetology and Clinical Nutrition

UniBE Contributor:

Bally, Lia; Wertli, Maria Monika and Stettler, Christoph

Subjects:

600 Technology > 610 Medicine & health

ISSN:

1533-4406

Publisher:

Massachusetts Medical Society

Language:

English

Submitter:

Christine Baumgartner

Date Deposited:

18 Jan 2019 14:51

Last Modified:

24 Oct 2019 11:56

Publisher DOI:

10.1056/NEJMoa1805233

PubMed ID:

29940126

BORIS DOI:

10.7892/boris.123162

URI:

https://boris.unibe.ch/id/eprint/123162

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