Evaluation of the Accuracy of Current Tubeless Pumps for Continuous Subcutaneous Insulin Infusion

Abstract

Background Recently two new tubeless pumps for insulin therapy were introduced. They were tested for accuracy and occlusion detection and compared to the established patch pump Omnipod ® (OP). Methods Using a modified setup for tubeless pumps based on IEC 60601-2-24, the basal rate and bolus delivery of the Accu-Chek ® Solo micropump system (ACS) and the A6 TouchCare ® System (A6) were measured with a microgravimetric method. Bolus sizes of 0.2 U,

Evaluation of the Accuracy and Reliability of a Tubeless Insulin Infusion System Under Laboratory Conditions

“…Regarding the detection of occlusion, the median (minimum-maximum) times of insulin delivery in hh:mm until an occlusion alarm was triggered were 27:37 (26:59-28:29) and 03:16 (03:06-04:40) for basal rates of 0.1 U/h and 1 U/h, respectively. These results are comparable to other tubeless pumps 5 and indicate a decreased reliability of occlusion detection for smaller basal rates.…”

“…For basal delivery, the total dose over the 72-hour period was found to be accurate with low mean deviations, but variability between non-overlapping, consecutive 1-hour windows was observed. Compared with the results of the OP, 4,5 the OP-D shows similar results, but increased accuracy during bolus and basal delivery of 0.1 U and 0.1 U/h, respectively. Comparing the results of bolus and basal delivery with the accuracy limits specified by the manufacturer, more than half of 1 U boluses were found outside these limits of ±5%.…”

Beyond the barriers of the use of continuous subcutaneous insulin therapy in type 1 diabetes: a new opportunity from catheter-less insulin pumps

“…Per quanto riguarda l'accuratezza della velocità di flusso di erogazione della basale, ACS in particolare ha dimostrato una somministrazione significativamente più accurata alla velocità di 1 U/h (percentuale finestra di 1 h entro il ± 15% dal target: ACS = 98% vs A6 = 60% e vs OP = 81%). I risultati tra i due modelli ACS e A6 sono risultati simili nel caso della velocità di 0,1 U/h (ACS = 51% vs A6 = 48%), ma, comunque, superiori a quelli del dispositivo OP (32%) (35).…”

Patch Pumps: Periodic Insulin Delivery Patterns

“…1 In recent in vitro experiments with different PP, their accuracy of insulin delivery during basal rate and bolus infusion was evaluated. [2][3][4][5] In particular, the following PP were examined: Omnipod (OP) (Insulet Corp, Billerica, MA, USA), Omnipod DASH (OP-D) (Insulet Corp), A6 TouchCare System (A6) (Medtrum Technologies, Inc, Shanghai, China) and Accu-Chek Solo micropump system (ACS) (Roche Diabetes Care GmbH, Mannheim, Germany).…”