Insulin Pumps Need More Scrutiny, Say American and European Diabetes Groups

Insulin pumps have been promoted as an important technological advancement in diabetes care. Yet the reliability and safety of these medical devices, used mainly by patients with Type 1 diabetes,[1] have not been well established.[2]

The Food and Drug Administration (FDA) has approved several of these devices. The agency has even promoted the products’ use in a consumer educational update posted on its website last December.[3] Estimates suggest that up to a million people worldwide use these devices; however, the accuracy of this estimate is not known because insulin pump companies currently are not required to report the number of devices sold or in use.[4]

Insulin pumps appear to offer a convenient and flexible way to regulate blood sugar levels by delivering short-acting insulin throughout the day, in either a steady continuous dose or increased doses close to mealtimes, through a catheter (thin tube) placed under the skin.[5] Additionally, a few short-term studies that included small numbers of patients suggested that insulin pumps may improve blood sugar control in patients with Type 1 diabetes (a condition usually diagnosed in children and young adults in which the body does not produce insulin).[6],[7]

Nonetheless, the pump remains an incomplete tool for managing diabetes: While it can be programmed to deliver insulin, it cannot replace the need for patients to estimate the amount of carbohydrates they consume, monitor blood glucose levels frequently and adjust insulin doses accordingly.[8]

Two diabetes patient advocacy groups — the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) — issued a joint statement expressing concerns over the safety and regulation of insulin pumps and offering recommendations to improve the devices’ standards. The statement was published in the April and May issues of the journals Diabetes Care and Diabetologia, respectively.[9],[10]

Safety risks

Errors in insulin dosing can occur even with the most modern pumps due to a variety of factors: pump failures or blockages, infusion site problems (for example, the catheter becoming displaced from the skin), insulin stability issues or user errors.

Such errors can expose patients to two life-threatening conditions that may require hospitalization. One is hyperglycemia (high blood sugar), which in Type 1 diabetes can result in a condition called ketoacidosis (the accumulation of acidic substances called ketone bodies and increased acidity in the blood), due to an interruption of insulin delivery. The other is hypoglycemia (low blood sugar), due to excessive insulin delivery.

The ADA/EASD’s analysis of insulin-pump-related adverse events reported to the FDA showed that there were over 24,000 such adverse event reports, spanning various pump models, in 2013 alone. From 2001 to 2009, the number of serious and fatal adverse events reported to the FDA related to insulin pumps increased by 17 percent per year.

Similarly, a study published in May in the U.K.-based journal Acta Diabetologica showed that adverse events occurred in over 40 percent of insulin pump users each year.[11]

These devices also have been the subject of multiple recalls. For example, a single recent recall by a major company called Medtronic Inc. involved nearly 60 percent of its U.S. insulin pump users (more than 400,000 patients).[12]

Lax regulation

The FDA classifies most insulin pumps as Class II (moderate- to high-risk) devices.[13] However, pumps that are part of continuous glucose monitors, features that stop insulin delivery if blood glucose reaches a pre-specified value, are classified as Class III (the highest risk category).

The agency does not require companies that manufacture Class II pumps to conduct clinical trials to prove that the devices are safe and effective prior to marketing. Instead, the FDA requires the companies only to demonstrate that the devices are substantially similar to an already-marketed insulin pump and to perform small usability studies to show that patients can understand and use the pump properly.

In contrast, the agency requires companies that make Class III pumps to conduct clinical trials as part of their premarket approval process. But even these trials examine only the safety and functionality of the pump's programming logic rather than the performance of the pump as a whole.

The approval standards for insulin pumps are even more lax in the EU, where regulation of the devices is delegated to various "notified bodies" (private organizations hired by device companies) that can exercise considerable discretion in their approval requirements.[14]

Notably, companies in the U.S. or the EU are not typically required to conduct real-world follow-up studies about the durability of their insulin pumps for long-term use. This is a troubling practice because acceptable pump performance levels, such as the precision in dosing, at the time Insulin Pumps Need More Scrutiny, of manufacturing cannot guarantee similar levels after several years of real-world use.

After pumps are approved, both the FDA and the EU require pump companies to provide information only on serious adverse events and device malfunctions reported by pump users or their health care providers.[15],[16],[17] However, each company has its own procedure for reviewing and classifying incoming reports and is entrusted with identifying patterns of serious harm associated with using its products. This practice improperly delegates much of the responsibility for ensuring pump safety to the industry instead of regulators.

ADA/EASD recommendations

The ADA and EASD called on FDA and EU regulators to strengthen and harmonize their safety and quality standards for insulin pump companies at both the approval and post-approval stages.[18]

They recommended that regulators require these companies to provide them with:

• The results of clinical research conducted on new pump devices or features.
• Updated data on the compatibility of their pumps with specific insulin formulations.
• Data on the durability and precision of insulin pumps based on real-world clinical usage.
• The results of tests on pumps that are recalled or returned.
• Listings of changes in device function, features and specifications.
• Annual estimates of the numbers of individuals using their pumps.

To increase data transparency and permit independent research, the ADA and EASD recommended the adoption of a single publicly available international database for reported adverse events associated with the use of insulin pumps. They recommended the FDA’s database for medical device adverse events be used as an initial framework for this system.

The groups called on professional societies to provide evidence-based guidelines for the indications of insulin pump therapy, appropriate education for both new and established pump users, and standards for health care professionals who provide education for pump users.

They also recommended more funding for independent studies of insulin pumps in real-world conditions, because these studies are necessary for understanding the long-term safety and durability of the devices.

What You Can DO

The ADA/EASD statement does not offer a position regarding whether patients should use insulin pumps. Others within the diabetes community recommend insulin pumps only for individuals who can handle the technology well and advise them to have a backup supply of long-acting insulin and syringes to inject themselves in case of a pump failure.

It is clear that insulin pump technology is still far from safe for regular, long-term use. Therefore, Public Citizen’s Health Research Group recommends that patients not use insulin pumps.

We recommend reporting all serious adverse events related to insulin pumps to the FDA's MedWatch adverse event reporting program at www.fda.gov/medwatch or by calling 800-FDA-1088.

References

[1] Ross PL, Milburn J, Reith DM, et al. Clinical review: Insulin pump-associated adverse events in adults and children. Acta Diabetol. 2015; Advance online publication. doi:10.1007/s00592-015-0784-2.

[2] Heinemann L, Fleming GA, Petrie JR, et al. Insulin pump risks and benefits: A clinical appraisal of pump safety standards, adverse event reporting, and research needs. Diabetes Care. 2015;38(4):716-722.

[3] Food and Drug Administration Consumer Health Information. More choices available for diabetes management. December 2014. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm424219.htm. Accessed August 10, 2015.

[4] Heinemann L, Fleming GA, Petrie JR, et al. Insulin pump risks and benefits: A clinical appraisal of pump safety standards, adverse event reporting, and research needs. Diabetes Care. 2015;38(4):716-722.

[5] American Diabetes Association. Insulin pumps. 2015. http://www.diabetes.org/living-with-diabetes/treatment-and-care/medication/insulin/insulin-pumps.html. Accessed August 19, 2015.

[6] Doyle EA, Weinzimer SA, Steffen AT, et al. A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine. Diabetes Care. 2004;27(7):1554–1558.

[7] Litton J, Rice A, Friedman N, Oden J, et al. Insulin pump therapy in toddlers and preschool children with type 1 diabetes mellitus. J Pediatr. 2002;141(4):490-495.

[8] Betschart Roemer J. Tips and tools for insulin pump use. http://www.diabetesselfmanagement.com/about-diabetes/kids-diabetes/tips-and-tools-for-insulin-pump-use/. Accessed August 19, 2015.

[9] Heinemann L, Fleming GA, Petrie JR, et al. Insulin pump risks and benefits: A clinical appraisal of pump safety standards, adverse event reporting, and research needs. Diabetes Care. 2015;38(4):716-722.

[10] Heinemann L, Fleming GA, Petrie JR, et al. Insulin pump risks and benefits: A clinical appraisal of pump safety standards, adverse event reporting and research needs. A joint statement of the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group. Diabetologia. 2015;58(5):862-870.

[11] Ross PL, Milburn J, Reith DM, et al. Clinical review: Insulin pump-associated adverse events in adults and children. Acta Diabetol. 2015. Advance online publication. doi:10.1007/s00592-015-0784-2.

[12] Close Concerns. Medtronic issues class II recall for MiniMed Paradigm and 530G systems. https://www.closeconcerns.com/knowledgebase/r/846b6e3d. Accessed August 19, 2015.

[13] Heinemann L, Fleming GA, Petrie JR, et al. Insulin pump risks and benefits: A clinical appraisal of pump safety standards, adverse event reporting, and research needs. Diabetes Care. 2015;38(4):716-722.

[14] Ibid.

[15] Ibid.

[16] Food and Drug Administration, Center for Devices and Radiological Health. Infusion Pumps Total Product Life Cycle: Guidance for Industry and FDA Staff. 2014. http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM209337.pdf. Accessed September 25, 2015.

[17] European Commission, DG Health and Consumers. Guidelines on A Medical Devices Vigilance System. 2013. http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1_ol_en.pdf. Accessed September 25, 2015.

[18] Heinemann L, Fleming GA, Petrie JR, et al. Insulin pump risks and benefits: A clinical appraisal of pump safety standards, adverse event reporting, and research needs. Diabetes Care. 2015;38(4):716-722.