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Randomized Controlled Trial
. 2014 Aug;37(8):2310-6.
doi: 10.2337/dc14-0147. Epub 2014 May 30.

Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp

Trang T Ly  1 , Marc D Breton  2 , Patrick Keith-Hynes  2 , Daniel De Salvo  3 , Paula Clinton  3 , Kari Benassi  3 , Benton Mize  2 , Daniel Chernavvsky  2 , Jéróme Place  4 , Darrell M Wilson  3 , Boris P Kovatchev  2 , Bruce A Buckingham  5
Affiliations
Randomized Controlled Trial

Overnight glucose control with an automated, unified safety system in children and adolescents with type 1 diabetes at diabetes camp

Trang T Ly et al. Diabetes Care. 2014 Aug.

Abstract

Objective: To determine the safety and efficacy of an automated unified safety system (USS) in providing overnight closed-loop (OCL) control in children and adolescents with type 1 diabetes attending diabetes summer camps.

Research design and methods: The Diabetes Assistant (DIAS) USS used the Dexcom G4 Platinum glucose sensor (Dexcom) and t:slim insulin pump (Tandem Diabetes Care). An initial inpatient study was completed for 12 participants to evaluate safety. For the main camp study, 20 participants with type 1 diabetes were randomized to either OCL or sensor-augmented therapy (control conditions) per night over the course of a 5- to 6-day diabetes camp.

Results: Subjects completed 54 OCL nights and 52 control nights. On an intention-to-treat basis, with glucose data analyzed regardless of system status, the median percent time in range, from 70-150 mg/dL, was 62% (29, 87) for OCL nights versus 55% (25, 80) for sensor-augmented pump therapy (P = 0.233). A per-protocol analysis allowed for assessment of algorithm performance. The median percent time in range, from 70-150 mg/dL, was 73% (50, 89) for OCL nights (n = 41) versus 52% (24, 83) for control conditions (n = 39) (P = 0.037). There was less time spent in the hypoglycemic range <50, <60, and <70 mg/dL during OCL compared with the control period (P = 0.019, P = 0.009, and P = 0.023, respectively).

Conclusions: The DIAS USS algorithm is effective in improving time spent in range as well as reducing nocturnal hypoglycemia during the overnight period in children and adolescents with type 1 diabetes in a diabetes camp setting.

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Figures

Figure 1
Figure 1
DIAS control to range system.
Figure 2
Figure 2
USS. Glycemic risk as a function of glycemia by time of night. Glycemic risk is depicted to be high (red), moderate (amber), or low (green).
Figure 3
Figure 3
Per-protocol analysis of percent time spent in range for OCL nights (n = 41) versus sensor-augmented pump nights (n = 39). Results are mean ± SD. *P < 0.05.
Figure 4
Figure 4
Per-protocol analysis of sensor glucose values over 8 h during OCL (n = 41) versus sensor-augmented pump nights (n = 39). Results are mean ± SD.
See this image and copyright information in PMC

References

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