February 12, 2021
4 min read
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Healio interview
Disclosure:
Shah reports that he has received research support from Abbott, Dexcom, Eli Lilly, Insulet, Novo Nordisk, and Sanofi and, through his establishment, received honoraria from Medscape and Sanofi.
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Hybrid closed-loop insulin delivery systems have revolutionized care and reduced the disease burden for people with type 1 diabetes. Next-generation devices promise even more improvements.
The data show that using an artificial pancreas can improve the time spent in the recommended glucose range and decrease hypoglycemia, particularly nocturnal hypoglycemia. However, analyzing patient data from such devices can be tedious due to the long reports on a variety of metrics, some of which may not be used as a treatment decision aid at all.
Shah is a Associate Professor of Medicine and Pediatrics at the Barbara Davis Center for Diabetes and the School of Medicine at the University of Colorado’s Anschutz Medical Campus.
Healio spoke to Viral Shah, MD, Associate Professor of Medicine and Pediatrics at the Barbara Davis Center for Diabetes and the School of Medicine at the University of Colorado’s Anschutz Medical Campus, on the need to generate a standardized, one-page data report for all hybrid, closed-loop insulin delivery systems to accommodate device intake increase and improve the understanding of providers. Shah and Satish K. Garg, MD, Professor of Medicine and Pediatrics at the Barbara Davis Center for Diabetes at the University of Colorado, Denver, wrote a report on the need for an artificial pancreas dashboard in a recent issue of Diabetes Technology & Therapeutics.
Why is standardization necessary for artificial pancreatic systems?
Shah: Here is a very specific example. If I have a patient with diabetes on the Medtronic 670G and download all of the data, it will be a 12-page report. If I do the same for a patient using Tandem Control IQ, it will be a 20 page report. When I look at a report for the Omnipod [Insulet] A Dexcom Continuous Glucose Monitor using Glooko will produce a 27-page report. Now, I’m an endocrinologist who specializes in type 1 diabetes, working specifically with hybrid closed-loop systems. I look through these 12 or 27 page reports and I know where to find the information I might need. But think about it. This will need time. A lot of endocrinologists don’t have time for it, let alone GPs who don’t have enough patients who use a hybrid closed loop to know where to look at these reports.
Throughout medical school and residency programs, we all learn to use and read an EKG. There are several computers available to do this, but they all generate the same report. Any doctor can read an EKG. This type of analogy has been used in the diabetes field. For the past 8 to 10 years, all of these smart people, through funds from the Helmsley Charitable Trust, the American Diabetes Association, and others, came together and worked to standardize glucose reporting. Today we call it an Ambulatory Glucose Profile or an AGP. Why can’t we use a similar approach for the hybrid closed loop system? I got this idea with Dr. Garg to post my opinion and suggestions on standardizing system reporting in Diabetes Technology & Therapeutics, where he serves as Editor-in-Chief.
You and Dr. Garg suggest several components for inclusion in a standardized report. What are they and how did you choose them?
Shah: We propose seven components in an artificial pancreas “dashboard” that include information on: Glucose Metrics, Hypoglycemia, Insulin, User Experience, Hyperglycemia, Glucose Modal Day Profile, and Insights. In this article we describe the optimal sampling time for data download. For example, we recommend reporting hypoglycemia where the CGM glucose level is below 70 mg / dL for at least 15 minutes to avoid over-reporting of hypoglycemic events due to sensor errors. We also recommend color coding the report to make it easier to interpret.
Ultimately, the idea is to provide information that is digestible and meaningful for the patient and provider so that they can make therapeutic changes. We don’t want information that isn’t helpful at all. For example, with the Medtronic 670G System, you can only change two things: the carbohydrate ratio and the insulin time. For example, you cannot change the basal rate. There is no point in including the basal rate in the AP dashboard, which we cannot change to optimize blood sugar control. What data makes the most sense for the clinician to incorporate into glucose data?
We conducted a literature review of patient and provider perspectives to download and report preferences, and included standard reports for glucose profiles.
Would the longer reports serve any purpose?
Shah: Yeah. We have no objection to these lengthy reports. This information is really important. You need to provide these daily profiles. I have some patients who work part-time, work day and night, and need day and night data. We understand the importance of these 27 pages. But how many patients will you see who need a full review of these 27 pages? I would dare say less than 5% of the patients. For the other 90%, they can be guided with a single page. That’s what device manufacturers should think about so we don’t have to scroll through the pages and spend all the time.
Have device manufacturers responded to these efforts?
Shah: We hope to work with manufacturers. First, this is our opinion and not an evidence-based guide. The best way to do this is similar to how consensus has been reached on AGP – bring the FDA, industry, patient organizations, and professional associations to the table and go through this together. I am sure there is a disagreement. Why, for example, seven components? Why not six components? Maybe eight? That kind of debate is healthy. This brings ideas to the table and helps generate consensus. We would like to involve the industry and experts in the field to reach consensus in the future. Another important lesson from the past was that consensus-building efforts for AGP began around 2012 and were not formalized until years later. Consensus building takes time.
Reference:
Shah VN et al. Diabetes Technol Ther. 2020; doi: 10.1089 / dia.2020.0622.
For more informations:
Viral Shah, MDcan be reached at viral.shah@cuanschutz.edu.
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