Abstract
Background: Recently two new tubeless pumps for insulin therapy were introduced. They were tested for accuracy and occlusion detection and compared with 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, 1, and 10 U, and basal rates of 0.1 and 1 U/h were evaluated in nine repetitions. For each parameter, mean deviation and number of individual boluses or 1-h basal rate windows within ±15% from target were calculated. In addition, occlusion detection time at basal rates of 0.1 and 1 U/h was determined.Results: Mean deviation of boluses of different volumes in the pumps ranged from −3.3% to +4.0% and 40%–100% of individual boluses were within ±15% of the target. During basal rate delivery, 48% to 98% of 1-h windows were within ±15% of the target with a mean deviation between -5.3% and +6.5%. In general, considerable differences between pump models were observed and deviations decreased with increasing doses. In most parameters, ACS was more accurate, and A6 less accurate, than OP. Mean occlusion detection time ranged from ∼3 to 7.5 h at 1 U/h and was >24 h or absent at 0.1 U/h.Conclusions: In this evaluation, significant differences between the tested tubeless pump models were observed that became most evident when regarding delivery errors over short time and small volumes.
Highlights
Continuous subcutaneous insulin infusion (CSII) is an effective method of insulin therapy in people with type 1 diabetes.[1]
Accuracy of bolus delivery was tested for bolus volumes of 0.2, 1, and 10 U and is described by the mean deviation from target of all boluses, as well as the percentage of individual boluses within the range of –15% of the target (Table 1)
None of the tubeless pumps tested fully matched the accuracy of the best durable pumps for all parameters tested,[10] the results of our evaluation indicate that acceptable accuracy can be achieved by tubeless pumps, with different pumping or manufacturing mechanisms potentially determining delivery performance
Summary
Continuous subcutaneous insulin infusion (CSII) is an effective method of insulin therapy in people with type 1 diabetes.[1]. Two new tubeless pumps for insulin therapy were introduced They were tested for accuracy and occlusion detection and compared with the established patch pump OmnipodÒ (OP). Mean deviation and number of individual boluses or 1-h basal rate windows within –15% from target were calculated. Results: Mean deviation of boluses of different volumes in the pumps ranged from -3.3% to +4.0% and 40%– 100% of individual boluses were within –15% of the target. 41% to 98% of 1-h windows were within –15% of the target with a mean deviation between -8.9% and +4.8%. Conclusions: In this evaluation, significant differences between the tested tubeless pump models were observed that became most evident when regarding delivery errors over short time and small volumes
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