Insulin pumps can be recommended for people with diabetes who have trouble managing their blood sugar levels or who have a lifestyle that makes it difficult to give themselves insulin injections. These devices can help people with diabetes achieve tighter blood glucose control, have fewer episodes of hypoglycemia, and experience more flexibility with their diet and exercise. ISO/IEEE 11073-10410: 2019—Health informatics – Personal health device communication – Part 10419: Device specialization – Insulin pump covers specifications for insulin pumps and compute engines (e.g., cell phones, personal computers, personal health appliances, set top boxes).
What Is Insulin?
Insulin is a hormone that affects the metabolism and other body functions. It regulates, together with glucagon, the glucose level in the blood. Failure to produce sufficient insulin to maintain the blood glucose in the normal range leads to conditions of temporarily or persistently high blood sugar (hyperglycemia). If left untreated, hyperglycemia can lead to serious complications, such as neurologic consequences, like seizures, brain damage, and even death.
Stability of blood glucose levels can be obtained with consistent dietary and exercise habits in addition to the appropriate timing of insulin therapy, such as the use of personal health devices (PHDs) to avoid drastic spikes or dips in blood glucose levels. ISO/IEEE 11073-10410:2019 outlines requirements for PHDs—specifically insulin pump agent devices.
For more information about diabetes, check out our blog post: Diabetes Treatment and Care Standards.
What Is ISO/IEEE 11073-10410?
ISO/IEEE 11073-10410:2019 establishes a normative definition of communication between personal telehealth insulin pump devices (agents) and managers (e.g., cell phones, personal computers, personal health appliances, set top boxes) in a manner that enables plug-and-play interoperability. The standard specifies the use of specific term codes, formats, and behaviors in telehealth environments, restricting optionality in base frameworks in favor of interoperability; it defines a common core functionality of personal telehealth insulin pump devices.
In the context of personal health devices (PHDs), ISO/IEEE 11073-10410:2019 notes that an insulin pump is a medical device used for the administration of insulin in the treatment of diabetes mellitus, also known as continuous subcutaneous insulin infusion (CSII) therapy.
What Are Insulin Pumps?
Insulin pumps help people with diabetes manage their blood sugar by delivering doses of insulin at specific times. These computerized medical devices are an alternative to multiple daily injection insulin therapy (e.g., syringe or pen injections), and as such, they generally designed to be small, portable, and permanently connected to the body. Insulin pumps integrate with continuous glucose monitoring (CGM) technology and offer the ability to automatically adjust insulin needs based on your current glucose levels. The structural shape of insulin pumps may vary, but insulin pump devices typically include the following components:
- The pump unit
- A disposable insulin reservoir
- A disposable infusion set.
There are different insulin pump devices on the market, each with unique features. ISO/IEEE 11073-10410:2019 details that insulin pump devices in its scope are primarily used in the continuous subcutaneous insulin infusion (CSII) therapy of type 1 diabetes mellitus—which is characterized by loss of the insulin-producing beta cells of the islets of Langerhans in the pancreas.
ISO/IEEE 11073-10410: 2019—Health informatics – Personal health device communication – Part 10419: Device specialization – Insulin pump is available on the ANSI Webstore.