Insulin pumps have drawn plenty of attention over the past few years for increasing user adoption, collaborations between diabetes device makers, and their hackability. Now, two major diabetes societies are asking regulators, manufacturers, and societies to address the limited data and research available on real-world use and adverse events with the pumps.
By delivering insulin subcutaneously, insulin pumps have replaced multiple daily injections for what the authors estimate are 750,000–1 million insulin pump users worldwide. The pumps are used mainly by Type I diabetics, but are used by some insulin-dependent Type II diabetics, as well as pediatric patients.
But for all the popularity of insulin pumps and technological advances being made in their development, there is plenty of room for improvement, according to a joint statement issued earlier this week by the European Association for the Study of Diabetes (EASD) and the American Diabetes Association (ADA) Diabetes Technology Working Group.
The authors, including Dr. Anne L. Peters, director of the University of Southern California Clinical Diabetes Program, and Dr. John R. Petrie, professor of diabetic medicine at the University of Glasgow’s Institute of Cardiovascular and Medical Sciences, believe that data on adverse events with the pumps is not accessible enough to be useful to the public. In addition, regulatory review of new insulin pumps depends too much on comparison to predicate pumps, there is not enough known about long-term use of pumps in the real world, and more attention should be given to device usability, the authors write.
Information on adverse events is housed in FDA’s Manufacturer and User Facility Device Experience (MAUDE) database, but the authors say it is not used to its fullest extent because the system can only be searched using already-determined categories, not a user’s specific keywords. Even worse, the European Databank on Medical Devices (EUDAMED) is not open to the public.
It seems that many of the adverse events reported are caused by human factors and user mistakes. The authors question why makers aren’t required to focus more on usability, and the statement recommends more careful attention to appropriate patient selection and patient training.
Other areas that the statement pinpoints for improvement include the regulatory review of insulin pumps. Regulatory requirements for new insulin pumps put too much emphasis on comparison to predicate products the authors say, since many pumps are classified by FDA as Class II devices and are not required to undergo the premarket approval process nor be studied in large clinical trials. Insulin pumps, like many medical devices, are constantly being updated with incremental changes in technology, and the societies believe more transparency and understanding of these changes should be available.
Finally, once the insulin pump is in commercial use, not enough is known about its long-term and real-world performance. The statement calls for more publicly-funded research through observation studies and clinical trials, as well as changes to the European pre- and postmarketing rules.
Peters said in a press release, “We need to make sure we have sufficient data about how the devices are working once they hit the market, so that we can support patients by helping them understand how to prevent errors in using them.”
The full set of recommended actions from the joint statement is reproduced below:
1) The regulators (EU/FDA) should:
- a) harmonize standards to be met by pump manufacturing companies at both pre- and postmarketing stages
- b) provide, publicize, and maintain a single publicly accessible international database (expanded from the current MAUDE system) for AE reporting. This should be searchable according to clinically relevant keywords such as demographics, user errors, components involved (hardware, software, IIS), consequences of event (diabetic ketoacidosis, hypoglycemia, etc.), and model/year of pump manufacture.
- c) publish an annual summary of regulatory activities
2) Pump manufacturing companies should be required to provide with transparency to the regulators:
- a) annual estimates of the number of individuals who use their insulin pumps (including basic demographic data)
- b) the results of clinical research conducting into the human factors associated with newly introduced features of pump design
- c) updated data on the compatibility of their pumps with specific insulin formulations and infusion sets
- d) systematic data on the durability and precision of insulin pumping over years of real-world clinical usage
- e) open data on the results of testing pumps that are recalled or returned
- f) open listings of changes in device function, features, and specifications reported to authorities
- g) fully anonymized reports of all AEs categorized according to 1b above
3) International and national professional societies should:
- a) provide updated evidence-based guidelines on indications for insulin pump therapy
- b) recommend appropriate forms of structured education required for new and established pump users
- c) set standards for levels of staffing and skills required by teams of health care professionals providing initial and ongoing education and support for pump users (supporting reimbursement of these activities by payers)
4) International and national research funding bodies should:
- a) provide or facilitate funding for well-designed independent clinical trials of safety, efficacy, outcomes, and adherence under real-world conditions
- b) provide or facilitate significant financial support for long-term data collection within new and existing registries
5) Health care teams should:
- a) encourage and support pump users under their care to report all AEs
- b) provide structured trainings/regular updates for pump users under their care according to standards set by national and international guidelines
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