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Diabetes Obes Metab. 2018 Nov 26. doi: 10.1111/dom.13585. [Epub ahead of print]

DREAM5: An open-label, randomized, cross-over study to evaluate the safety and efficacy of day and night closed-loop control using the MD-Logic automated insulin delivery system compared to sensor augmented pump therapy in patients with type 1 diabetes at home.

Author information

1
Children's Hospital 'Auf der Bult', Diabetes-Center for Children and Adloescents, Hannover, Germany.
2
Schneider Children's Medical Center of Israel, Israel.
3
DreaMed Diabetes Ltd, Israel.
4
Department of Pediatric Endocrinology, Diabetes and Metabolic Diseases, University Children's Hospital, Ljubljana, Slovenia.

Abstract

AIMS:

Previous DREAM studies demonstrated the safety and efficacy of the CE marked MD-Logic closed-loop system (DreaMed GlucoSitterâ„¢) in different settings for overnight glycaemic control. The present study aims to evaluate the system for day and night use for 60 hours during weekend time at home compared to sensor-augmented pump (SAP) therapy in participants with type 1 diabetes.

METHODS:

This was a prospective, multicenter, crossover, controlled study. All participants were connected in randomized order for one weekend to SAP therapy or the MD-Logic System: in the intervention arm only the amount of carbohydrate was entered into the bolus calculator, the rest of insulin dosing was delivered automated and wirelessly by a tablet computer. The primary endpoint was the percentage of glucose values between 70-180 mg/dl.

RESULTS:

The ITT population comprised of 48 (19 males, 29 females) adolescents and adults experienced in sensor use: (median, [IQR]): age 16.1y [13.2-18.5], diabetes duration 9.4 y [5.0-12.7], pump use 5.4y [3.1-9.4], HbA1c 7.6% [7.0-8.1]. A significant increase in the percentage of time within target range (70-180mg/dl) (66.6 vs 59.9 %, P=0.002) was observed in the closed-loop system versus control weekends with unchanged percentage of time below 70mg/dl (2.3 vs. 1.5 %, p=0.369). The mean weekend glucose level per participant was significantly lower (153 [142-175] vs. 164 [150-186] mg/dl, p=0.003). No safety signals were observed.

CONCLUSIONS:

The MD-Logic system was safe and associated with better glycemic control over SAP therapy for day and night use. The lack of remote monitoring did not lead to safety signals in adapting basal rates as well as in administration of automated bolus corrections. This article is protected by copyright. All rights reserved.

KEYWORDS:

CSII; HbA1c; MDI; Type 1 diabetes; adolescents; closed loop; insulin pump; pediatric

PMID:
30478937
DOI:
10.1111/dom.13585

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