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Diabetes Care. 2013 Dec;36(12):3882-7. doi: 10.2337/dc12-1956. Epub 2013 Oct 29.

Day and night closed-loop control in adults with type 1 diabetes: a comparison of two closed-loop algorithms driving continuous subcutaneous insulin infusion versus patient self-management.

Author information

1
Corresponding author: Yoeri M. Luijf, y.m.luijf@gmail.com.

Abstract

OBJECTIVE:

To compare two validated closed-loop (CL) algorithms versus patient self-control with CSII in terms of glycemic control.

RESEARCH DESIGN AND METHODS:

This study was a multicenter, randomized, three-way crossover, open-label trial in 48 patients with type 1 diabetes mellitus for at least 6 months, treated with continuous subcutaneous insulin infusion. Blood glucose was controlled for 23 h by the algorithm of the Universities of Pavia and Padova with a Safety Supervision Module developed at the Universities of Virginia and California at Santa Barbara (international artificial pancreas [iAP]), by the algorithm of University of Cambridge (CAM), or by patients themselves in open loop (OL) during three hospital admissions including meals and exercise. The main analysis was on an intention-to-treat basis. Main outcome measures included time spent in target (glucose levels between 3.9 and 8.0 mmol/L or between 3.9 and 10.0 mmol/L after meals).

RESULTS:

Time spent in the target range was similar in CL and OL: 62.6% for OL, 59.2% for iAP, and 58.3% for CAM. While mean glucose level was significantly lower in OL (7.19, 8.15, and 8.26 mmol/L, respectively) (overall P = 0.001), percentage of time spent in hypoglycemia (<3.9 mmol/L) was almost threefold reduced during CL (6.4%, 2.1%, and 2.0%) (overall P = 0.001) with less time ≤2.8 mmol/L (overall P = 0.038). There were no significant differences in outcomes between algorithms.

CONCLUSIONS:

Both CAM and iAP algorithms provide safe glycemic control.

PMID:
24170747
PMCID:
PMC3836152
DOI:
10.2337/dc12-1956
[Indexed for MEDLINE]
Free PMC Article

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