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Diabetes Care. 2016 Jul;39(7):1151-60. doi: 10.2337/dc16-0008. Epub 2016 May 5.

Day-and-Night Closed-Loop Glucose Control in Patients With Type 1 Diabetes Under Free-Living Conditions: Results of a Single-Arm 1-Month Experience Compared With a Previously Reported Feasibility Study of Evening and Night at Home.

Author information

1
Department of Endocrinology, Diabetes, Nutrition, Montpellier University Hospital; INSERM Clinical Investigation Centre 1411; Institute of Functional Genomics, CNRS UMR 5203, INSERM U1191, University of Montpellier, Montpellier, France e-renard@chu-montpellier.fr.
2
Department of Endocrinology, Diabetes, Nutrition, Montpellier University Hospital; INSERM Clinical Investigation Centre 1411; Institute of Functional Genomics, CNRS UMR 5203, INSERM U1191, University of Montpellier, Montpellier, France.
3
Department of Endocrinology, Academic Medical Center, University of Amsterdam, Amsterdam, the Netherlands.
4
Unit of Metabolic Diseases, Department of Internal Medicine, University of Padova, Padova, Italy.
5
Department of Civil Engineering and Architecture, University of Pavia, Pavia, Italy.
6
Department of Information Engineering, University of Padova, Padova, Italy.
7
Department of Electrical, Computer and Biomedical Engineering, University of Pavia, Pavia, Italy.
8
Center for Diabetes Technology, University of Virginia, Charlottesville, VA.

Abstract

OBJECTIVE:

After testing of a wearable artificial pancreas (AP) during evening and night (E/N-AP) under free-living conditions in patients with type 1 diabetes (T1D), we investigated AP during day and night (D/N-AP) for 1 month.

RESEARCH DESIGN AND METHODS:

Twenty adult patients with T1D who completed a previous randomized crossover study comparing 2-month E/N-AP versus 2-month sensor augmented pump (SAP) volunteered for 1-month D/N-AP nonrandomized extension. AP was executed by a model predictive control algorithm run by a modified smartphone wirelessly connected to a continuous glucose monitor (CGM) and insulin pump. CGM data were analyzed by intention-to-treat with percentage time-in-target (3.9-10 mmol/L) over 24 h as the primary end point.

RESULTS:

Time-in-target (mean ± SD, %) was similar over 24 h with D/N-AP versus E/N-AP: 64.7 ± 7.6 vs. 63.6 ± 9.9 (P = 0.79), and both were higher than with SAP: 59.7 ± 9.6 (P = 0.01 and P = 0.06, respectively). Time below 3.9 mmol/L was similarly and significantly reduced by D/N-AP and E/N-AP versus SAP (both P < 0.001). SD of blood glucose concentration (mmol/L) was lower with D/N-AP versus E/N-AP during whole daytime: 3.2 ± 0.6 vs. 3.4 ± 0.7 (P = 0.003), morning: 2.7 ± 0.5 vs. 3.1 ± 0.5 (P = 0.02), and afternoon: 3.3 ± 0.6 vs. 3.5 ± 0.8 (P = 0.07), and was lower with D/N-AP versus SAP over 24 h: 3.1 ± 0.5 vs. 3.3 ± 0.6 (P = 0.049). Insulin delivery (IU) over 24 h was higher with D/N-AP and SAP than with E/N-AP: 40.6 ± 15.5 and 42.3 ± 15.5 vs. 36.6 ± 11.6 (P = 0.03 and P = 0.0004, respectively).

CONCLUSIONS:

D/N-AP and E/N-AP both achieved better glucose control than SAP under free-living conditions. Although time in the different glycemic ranges was similar between D/N-AP and E/N-AP, D/N-AP further reduces glucose variability.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT02153190.

PMID:
27208331
DOI:
10.2337/dc16-0008
[Indexed for MEDLINE]

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