Even though I don’t work with insulin pumps on a daily basis, I have always been amazed by their advancing technology. This weekend I was talking to a high school student with type 1 who wore a pump without tubing. It just made me think of what a big deal it is especially for a high school student to have a tube-free pump for social reasons. He is a senior this year and about to go away to college. That is usually a trust test to see how a freshman in college handles all the newness and stress of their first year and also works every day to manage his blood glucose and insulin.
A statement from the European Association for the Study of Diabetes and the American Diabetes Association Diabetes Technology Working Group was just published in the “Online Ahead of Print” section in Diabetes Care describing their efforts. As diabetes educators we know all the benefits of a pump and how life changing it can be. We also know with any type of insulin therapy, there are major life threatening risks. This group asserts that we need to be doing a better job looking at the safety of pumps from a clinical perspective. The “adverse events” (AE) reports on the US Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database is not being used to its potential and the European Databank on Medical Devices (EUDAMED) is not publicly available. They want more real life usage data and AEs to be public so that public observational studies and clinical trials can be ongoing reviewing the safety of a particular pump.
Based on their assessment of current standards, they recommend:
1. The regulators (EU/FDA) should:
a) harmonize standards to be met by pump manufacturing companies at both pre- and post-marketing 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 conducted 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 healthcare 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. Healthcare teams should:
a) encourage and support pump users under their care to report all AEs
b) provide structured training/regular updates for pump users under their care according to standards set by national and international guidelines
How do you feel the industry is doing to continually review their pumps and provide education to users and healthcare professionals? If you have given feedback to a pump company, was action taken? Again, I am truly in awe of the advances in technology from pump companies and am excited about the future, but equal effort needs to be given to ensure safety and training for current pump users.