Overnight Glucose Control With an Automated, Unified Safety System in Children and Adolescents With Type 1 Diabetes at Diabetes Camp

Abstract

OBJECTIVETo 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 METHODSThe 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.RESULTSSubjects 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).CONCLUSIONSThe 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.

Randomized Summer Camp Crossover Trial in 5- to 9-Year-Old Children: Outpatient Wearable Artificial Pancreas Is Feasible and Safe

“…This study shows that outpatient closedloop glucose control using the DiAs wearable platform is feasible in young children, complementing the evidence collected in adults (10) and adolescents (11). Furthermore, this study reinforces the evidence of diluted-insulin usability in AP, as previously reported (2).…”

Day and Night Closed-Loop Control Using the Integrated Medtronic Hybrid Closed-Loop System in Type 1 Diabetes at Diabetes Camp

“…The system configuration places the closedloop controller on the pump and removes the need for an intermediary device that contains the algorithm, such as a phone or portable computer. This reduces the need for connectivity between a controller and the insulin pump as well as between the controller and sensor, two points of potential interrupted communication in a multidevice system (3)(4)(5).…”

Insulin delivery and nocturnal glucose control in children and adolescents with type 1 diabetes

“…Depending on control algorithm and the population, mean overnight glucose is lower [29,31,34,36,38], similar [27,32,35,37] or slightly elevated [28,33] than during control therapy.…”

“…The use of a closed-loop system with an MPC control algorithm in a diabetes camp in children and adolescents over 5–6 nights significantly reduced the time spent in hypoglycemia overnight (<2.8, <3.3, and <3.9 mmol/l) but did not improve time spent in the target range from 3.9 to 8.3 mmol/l nor mean glucose levels compared to sensor augmented pump therapy as per intention-to-treat analysis [37]. Using a similar system day-and-night in a diabetes camp over 5–6 days in adolescents with type 1 diabetes, the percentage of time spent with sensor readings below 3.9 mmol/l overnight was significantly reduced with the closed-loop system compared to sensor augmented pump therapy, as were mean overnight glucose and time spent in hyperglycemic glucose ranges, while overnight time in target between 3.9 and 10.0 mmol/l was increased [30].…”