For decades, one of the ways that researchers and others in the diabetes community imagined that a “cure” might exist is through an artificial pancreas. Among other functions, your pancreas produces and releases insulin and other hormones to regulate your blood glucose levels — a process that is severely disturbed or totally broken in type 1 diabetes, with pancreatic beta cells unable to produce any significant amount of insulin. An artificial pancreas would be any device that performs this pancreatic function, sensing your blood glucose levels and adjusting the release of insulin in your body accordingly.
Right now, artificial pancreases — in the form of what’s known as a hybrid closed-loop system — are used by many people with type 1 diabetes. “Hybrid” refers to the fact that these systems aren’t a completely “closed loop” that automatically regulates glucose levels without any input from the person using them. Instead, users enter some information related to mealtime insulin doses, while the system works automatically to adjust basal (background) insulin doses throughout the day. This is done using input data from a continuous glucose monitoring (CGM) system, which is fed into a computer program that controls insulin delivery by an insulin pump.
While hybrid closed-loop (HCL) systems are enormously helpful to many people with diabetes, they’re still relatively new and, in the view of some users and their doctors, could use some improvement to be more user-friendly. One area that can be improved on, according to two researchers, is how these systems display data representing a person’s blood glucose control, which is the subject of a recent journal article.
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Seven core numbers to display
The article, published in the journal Diabetes Technology & Therapeutics, offered guidance on how HCL systems should report numbers in a standardized way. This is important for a number of reasons — including the fact that doctors are likely to see patients who use different systems, and may find it difficult to navigate the different ways numbers are reported. A standardized reporting system could also make it easier for patients to switch from one system to another.
The article’s authors, both professors of medicine and pediatrics at the University of Colorado, wrote that HCL systems should all create a standardized, one-page data report to help users and their doctors make sense of how well they’re working. They believe this single-page report, which they call a “dashboard,” should include seven components: glucose metrics, hypoglycemia (low blood glucose), insulin, hyperglycemia (high blood glucose), user experience, glucose modal-day profile and insight.
Some of these items are likely to be familiar concepts to people with diabetes, especially those with type 1 or who manage type 2 intensively. But others require some explanation, which was included in the article.
As proposed, “glucose metrics” shows how much of the time the user stays in their target range, and how much is spent with low, high or very high blood glucose. “Hypoglycemia” shows the amount of time spent with low blood glucose each day, as well as how many episodes of low blood glucose the user has. “Insulin” shows the amount of insulin delivered as basal and bolus doses, as well as any missed mealtime doses or correction doses. “Hyperglycemia” shows the amount of time spent with high blood glucose each day.
“User experience” shows how much of the time a user has their HCL system turned on, how often they suspend its use, and how often they change their infusion sets, among other items. “Glucose modal-day profile” shows how the user’s glucose levels change throughout the day, allowing them to spot patterns that may be worth addressing. And “insight” gives computer-generated feedback and tips about using the HCL system based on the person’s overall data.
“To the best of our knowledge, there is no guidance for the standardized reporting of HCL systems,” the authors wrote. “We believe it is time to standardize the terminology and reporting of different HCL systems.”
Challenges to adopting proposed dashboard
As simple as the idea of a standardized “dashboard’ for HCL systems sounds, there are many barriers to its adoption, as noted in the article. One is that manufacturers of these systems have invested heavily in proprietary software that may not easily be adapted to create such a dashboard. Another is that manufacturers would have to agree on exactly what a standardized dashboard should contain — and on how to make any changes to it going forward. The U.S. Food and Drug Administration would most likely need to play a role in fostering agreements among various manufacturers.
But the benefits of a standardized dashboard could be significant. It could improve how doctors use data reports from these systems to help patients manage their diabetes. It could help researchers compare different HCL systems. And it could even help manufacturers develop more sophisticated data analysis.
For now, though, standardized reporting for HCL systems is an idea that pretty much everyone agrees on in principle, but with no agreement on how to make it a reality.
Want to learn more about hybrid closed-loop systems? Read “Hybrid Closed-Loop Insulin Pump Systems.”