1. In a randomized, crossover trial of continuous closed-loop insulin delivery program (artificial pancreas) versus a traditional sensor-guided pump in type I diabetic (T1DM) children, the artificial pancreas demonstrated lower rates of overnight time-in-hypoglycemia
2. There was a significant increase in mean glucose levels in the artificial pancreas group
Evidence Rating Level: 1 (Excellent)
Study Rundown: Artificial pancreas refers to a continuous, automated, closed-loop glucose monitoring and insulin delivery program that provides a novel new method for glycemic control in patients with T1DM. Although previous studies have demonstrated improved efficacy of the artificial pancreas in adults and adolescents, there has been a paucity of data in children. The purpose of this randomized, cross-over trial was to elucidate the effectiveness of the artificial pancreas in outpatient children.
This trial enrolled 30 T1DM children, aged 5 to 9 years old, to a 6-day cross-over trial of both the artificial pancreas as well as the traditional parent-managed, sensory-augmented pump (SAP). At the conclusion of the study, there was a significant reduction in the overnight hypoglycemia duration in the artificial pancreas group compared to SAP. Additionally, there was no significant change with the overall time within glycemic target between both groups. The artificial pancreas group did demonstrate a significantly higher mean serum glucose level compared to SAP. The results of this trial highlight a potential benefit on artificial pancreas in providing robust glycemic control in children. This was the first study to determine the efficacy of the artificial pancreas in this patient population in an outpatient setting. Additional longer trials are warranted to confirm the efficacy of the artificial pancreas in the real-world setting. Additionally, the current study used an insulin delivery algorithm developed in adults; a modified algorithm for children may further improve the side effect profile, including a reduction in the mean serum glucose levels for children who use an artificial pancreas.
In-Depth [randomized controlled trial]: The Pediatric Artificial Pancreas (PedArPan) is an open-labeled, randomized, cross-over trial of artificial pancreas versus SAP in the pediatric outpatient population from 5 pediatric centers in Italy. The cross-over trial occurred over six days in an outpatient camp setting. The key inclusion criteria included children aged 5 to 9 with a diagnosis of T1DM, use of insulin pump and sensor >3 months, and HbA1c <10%. Children were provided the randomized to either artificial pancreas or SAP and cross-over in three days after a 24-hour washout period. Structured diet and exercise programs were maintained in the camp settings for both interventions. The primary outcomes of glucose control was the percentage of time spent in the target glycemic range and the percent of time spent below 70mg/dL (time-in-hypoglycemia). Overall, 30 children (19 boys, 11 girls; average age: 7.6 years) were included in the study. At the conclusion of the study, there was a significant reduction in overnight time-in-hypoglycemia in the artificial pancreas group compared to SAP (0.0% vs. 2.2%; p = 0.002) without a reduction in the time spent in target glycemic range (56.0% vs. 59.7%; p = 0.430). The artificial pancreas group did demonstrate significant higher mean glucose levels compared to SAP during the study (169 mg/dL versus 147mg/dL; p < 0.001).
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