A Review of the Security of Insulin Pump Infusion Systems
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paper_title: The OmniPod Insulin Management System: the latest innovation in insulin pump therapy

paper_content:

This review of insulin pump therapy focuses on the OmniPod® Insulin Management System (Insulet Corp., Bedford, MA, USA). The OmniPod System is the first commercially available “patch pump.” It is a fully integrated wearable pump, controlled wirelessly through a handheld device containing a built-in blood glucose meter. This is an evaluation of the OmniPod System, with the aim of providing an educational tool for physicians who are considering recommending this product to their patients. The review includes a discussion of the traditional insulin pump configuration and its limitations, a detailed overview of the OmniPod System, references to clinical study data, planned product enhancements, its use as an insulin delivery system in the Juvenile Diabetes Research Foundation’s Artificial Pancreas Project, and its use to deliver additional compounds.
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paper_title: Compatibility of Insulin Lispro, Aspart, and Glulisine with the Solo™ MicroPump, a Novel Miniature Insulin Pump

paper_content:

Background: This study compared the stability of commercially available, rapid-acting insulin in the novel tubeless, skin-adhering Solo™ insulin pump over 6 days at extreme environmental conditions. Methods: Forty-eight pumps for each tested analog were loaded with three different insulin lots and operated at 30 U/day (three sets of 12 pumps) and 15 U/day (one set of 12 pumps) with basal/bolus delivery patterns for 6 days under extreme climatic (37°C, 40% relative humidity) and mechanical (35 strokes/min) stresses. The insulin solutions dispensed were sampled periodically and analyzed for potency, related substances, high molecular weight proteins (HMWP), and preservative content by high-performance liquid chromatography techniques. Biological activity (bioidentity) was demonstrated by an abrupt decrease in blood glucose in rabbits. Solutions were inspected for visual appearance and measured for pH levels. Results: During the 6-day sampling period, the potency of all insulin samples was maintained at 95.0–105.0% of the bulk solution concentration of the insulin vials. The levels of HMWP and related substances remained well below labeling limits. The preservative concentration decreased with time but remained bacteriostatic effective. Solutions maintained pH and clarity and were particulate free. The biological activity was verified. Conclusions: Insulin analogs lispro, aspart, and glulisine maintained physical, chemical, and biological properties for 6 days when used in the Solo MicroPump device.
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paper_title: Improving the Security and Privacy of Implantable Medical Devices

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Dr. William Maisel and Tadayoshi Kohno write that the complex and sophisticated features of medical devices have created a susceptibility to security breaches that could compromise the performance of such devices and the safety and privacy of patients.
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paper_title: Second Insulin Pump Safety Meeting: Summary Report

paper_content:

Diabetes Technology Society facilitated a second meeting of insulin pump experts at Mills-Peninsula Health Services, San Mateo, California on November 4, 2009, at the request of the Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories. The first such meeting was held in Bethesda, Maryland, on November 12, 2008. The group of physicians, nurses, diabetes educators, and engineers from across the United States discussed safety issues in insulin pump therapy and recommended adjustments to current insulin pump design and use to enhance overall safety. The meeting discussed safety issues in the context of pump operation; software; hardware; physical structure; electrical, biological, and chemical considerations; use; and environment from engineering, medical, nursing, and pump/user perspectives. There was consensus among meeting participants that insulin pump designs have made great progress in improving the quality of life of people with diabetes, but much more remains to be done.
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paper_title: Defective Awakening Response to Nocturnal Hypoglycemia in Patients with Type 1 Diabetes Mellitus

paper_content:

BACKGROUND ::: Nocturnal hypoglycemia frequently occurs in patients with type 1 diabetes mellitus (T1DM). It can be fatal and is believed to promote the development of the hypoglycemia-unawareness syndrome. Whether hypoglycemia normally provokes awakening from sleep in individuals who do not have diabetes, and whether this awakening response is impaired in T1DM patients, is unknown. ::: ::: ::: METHODS AND FINDINGS ::: We tested two groups of 16 T1DM patients and 16 healthy control participants, respectively, with comparable distributions of gender, age, and body mass index. In one night, a linear fall in plasma glucose to nadir levels of 2.2 mmol/l was induced by infusing insulin over a 1-h period starting as soon as polysomnographic recordings indicated that stage 2 sleep had been reached. In another night (control), euglycemia was maintained. Only one of the 16 T1DM patients, as compared to ten healthy control participants, awakened upon hypoglycemia (p = 0.001). In the control nights, none of the study participants in either of the two groups awakened during the corresponding time. Awakening during hypoglycemia was associated with increased hormonal counterregulation. In all the study participants (from both groups) who woke up, and in five of the study participants who did not awaken (three T1DM patients and two healthy control participants), plasma epinephrine concentration increased with hypoglycemia by at least 100% (p < 0.001). A temporal pattern was revealed such that increases in epinephrine in all participants who awakened started always before polysomnographic signs of wakefulness (mean +/- standard error of the mean: 7.5 +/- 1.6 min). ::: ::: ::: CONCLUSIONS ::: A fall in plasma glucose to 2.2 mmol/l provokes an awakening response in most healthy control participants, but this response is impaired in T1DM patients. The counterregulatory increase in plasma epinephrine that we observed to precede awakening suggests that awakening forms part of a central nervous system response launched in parallel with hormonal counterregulation. Failure to awaken increases the risk for T1DM patients to suffer prolonged and potentially fatal hypoglycemia.
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Title: A Review of the Security of Insulin Pump Infusion Systems

Section 1: Introduction
Description 1: Introduce the advancements in insulin pump technology, their clinical benefits, and emerging safety and security risks.

Section 2: Solutions Under a Risk-Management Approach
Description 2: Discuss identified insulin pump system vulnerabilities and proposed solutions to mitigate these risks while balancing safety, effectiveness, and user acceptance.

Section 3: Categorized Security Challenges Through a Risk-Based Analysis
Description 3: Detail specific security vulnerabilities in insulin pump systems categorized by device type, and recommend approaches to address these issues.

Section 4: Mitigating solutions
Description 4: Highlight potential solutions for improving the interaction and security of various insulin pump system components, focusing on wireless communication, confidentiality, and peripheral component issues.

Section 5: Device classification
Description 5: Discuss the categorization of medical devices within insulin pump systems based on security needs and regulatory burdens, proposing a classification for future research and regulation.

Section 6: Conclusion
Description 6: Summarize the key findings, emphasize the importance of cautious adoption of new devices, and suggest future directions for securing insulin pump systems.