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Original Research Diabetes A Comparative Pulse Accuracy Study of Two Commercially Available Patch Insulin Infusion Pumps Jenna L Bowen and Chris J Allender School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Cardiff, UK B ackground: Patch pumps are a relatively new method of insulin delivery. This study explores the accuracy of patch-pumps by reporting on comparative pulse-accuracy study of two patch pumps. Methods: The accuracy of two patch pumps (Cellnovo, [Cellnovo Ltd., Swansea, UK] and OmniPod ® [Ypsomed Ltd, Escrick, UK]) was evaluated micro-gravimetrically. Pulse accuracy was analysed by comparing single and time-averaged pulses for each device. Results: Single-pulses outside accuracy thresholds ±5%, ±10%, ±15%, ±20%, ±25% and ±30% were: Cellnovo; 79.6%, 55.6%, 35.0%, 19.9%, 9.7% and 4.3%; OmniPod; 86.2%, 71.6%, 57.4%, 45.5%, 35.2% and 25.4%. For 10, 20 and 40 pulse-windows mean values outside ±15% accuracy level were: Cellnovo; 7.3%, 1.5% and 0.4%, OmniPod; 37.6%, 31.8% and 25.9. Conclusions: This study showed that not all patch pumps are the same. The pumping mechanisms employed in these pumps play a significant role in the accuracy and precision of such devices. Keywords Insulin, patch, pump, pulse, accuracy, subcutaneous insulin infusion Disclosure: Jenna L Bowen and Chris J Allender have nothing to disclose in relation to this manuscript. Acknowledgments: Medical writing assistance was provided by Deborah Glover MBE, Freelance Medical Editor/Writer, this was supported by Cellnovo Ltd. Compliance with Ethics: This article does not contain any new studies with human or animal subjects performed by any of the authors. Open Access: This article is published under the Creative Commons Attribution Noncommercial License, which permits any non-commercial use, distribution, adaptation and reproduction provided the original author(s) and source are given appropriate credit. Received: 15 April 2016 Accepted: 18 May 2016 Citation: European Endocrinology, 2016;12(2):79–84 Corresponding Author: Chris J Allender, School of Pharmacy and Pharmaceutical Sciences, Cardiff University, Redwood Building, King Edward VII Ave, Cardiff, UK, CF10 3NB. E: allendercj@cf.ac.uk Support: This study and the publication of this article was supported by Cellnovo Ltd. Insulin pumps provide a convenient way of delivering a continuous subcutaneous insulin infusion (CSII). Devices are highly flexible to individual patient needs, allowing personalised 24-hour basal infusions and on-demand bolus delivery for acute periods of elevated blood glucose (for example, carbohydrate consumption during meals). Insulin pumps offer patients certain advantages over multiple daily injection (MDI) regimens including fewer injections, more flexibility and the ability to better fine-tune regimens to their personal lifestyle/needs. 1 Clinically, they have been shown in randomised, controlled trials to provide improved glycaemic control (lower glycated haemoglobin [HbA 1c ]) 2,3 reduce the frequency of hypoglycaemic episodes, 3,4 and enhance quality of life versus specific MDI regimens in type 1 diabetes mellitus. 2 For the paediatric population, quality of life gains, extend beyond pump users to their families and carers. 5 Several varieties of insulin pump are commercially available, with the two main products being durable pumps and patch pumps. Durable pumps are the most common and include an infusion set that connects the subcutaneous cannula to the pump device via an infusion line (~30-100 cm). Examples include the Animas Vibe ® and the Animas Ping ® (Animas, West Chester, Pennsylvania, US), the Accu-Chek ® Combo (Roche, Basel, Switzerland), the MiniMed Paradigm ® Veo™ (Medtronic, Dublin, Republic of Ireland) and the DANA Diabecare R ® (Advanced Therapeutics, Sooil, Seoul, Korea). Unlike durable pumps, patch pumps are free of infusion sets as the cannula and delivery system are built into the device. They are worn directly on the body and controlled by a wireless device making them more discrete than the traditional durable pumps. Patch pumps aim to increase patient compliance by providing freedom from long-tubing, increased flexibility, easier technical operation and a smaller, lightweight device capable of being manipulated discretely. 6 Examples include the OmniPod ® (Insulet Corporation, Billerica, Massachusetts, US) and the Cellnovo system (Cellnovo Ltd., Swansea, UK). Whilst patch pumps offer clear aesthetic advantages, a recent study found the dosing accuracy of the OmniPod patch pump to be unfavourable when compared to several durable pumps. 7 Jahn et al. 7 demonstrated that the patch pump was significantly less accurate in terms of both single- pulse and averaged-pulse accuracy, than the traditional durable pumps. Unfortunately, only one patch pump (OmniPod) was investigated versus three durable pumps (OneTouch Ping, Accu-Chek Combo and the MiniMed Paradigm Revel™/ Veo). In another study, Cappuro et al. 8 sought to compare the dose precision performance of the Animas Vibe and t:slim ® (Tandem ® Diabetes Care, San Diego, California, US) durable pumps and the OmniPod patch pump over three delivery phases in a 20 hour test. Results showed that across all delivery stages and in terms of dose variability, the OmniPod did not perform as well as the Animas Vibe. TOU CH MED ICA L MEDIA 79