Educator support facilitates safe use of do-it-yourself artificial pancreas
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People with diabetes who use a “hacked” hybrid closed-loop insulin delivery system continue to need clinical support to create initial settings, adjust settings over time and ensure such settings promote safety, according to a speaker.
Even before FDA approval of the first hybrid closed-loop insulin delivery system for type 1 diabetes in November 2016, savvy users wanting better glucose response “hacked” older insulin pumps to create such devices on their own, and an online community offering tips and tricks has only continued to grow. “Looped,” a Facebook group created in November 2016 designed to make basic, do-it-yourself closed-loop technology widely available, currently has 22,800 members, according to Laura M. Nally, MD, FAAP, a pediatric endocrinologist and instructor of pediatrics in the division of pediatric endocrinology at Yale University School of Medicine.
“I was initially quite skeptical that DIY systems could do a better job than I could by micromanaging my settings using a pump and glucose sensor,” Nally, who also has type 1 diabetes and has used a DIY system for more than 2 years, told Healio. “I watched my colleagues and friends use DIY systems and followed the Facebook group for about a year before deciding to take the DIY plunge.”
DIY systems are considered an off-label use of diabetes devices and are not approved by the FDA, Nally said. Still, many patients with type 1 diabetes seeking optimal glucose management want to give such systems a try, and diabetes care and education specialists should be open to discussing their use, Nally said during an online presentation at the virtual Association of Diabetes Care & Education Specialists annual meeting.
“That means open communication and setting appropriate expectations with patients and their families prior to starting a DIY system is also extremely important,” Nally said.
Supportive care is key
People with diabetes who find their way to the “looper” community typically seek a hybrid closed-loop system that has flexible glucose targets; flexible override settings for exercise, illness or menstrual cycles; and passive insulin pump and glucose sensor data collection with easy accessibility through free cloud software, such as Nightscout and Tidepool. Hybrid closed-loop systems are also not currently approved for pregnant women and very young children, Nally said.
“In the world of diabetes, patients are doing the bulk of the work to manage their glycemic control,” Nally said. “It’s 24/7 and they are checking in with clinicians intermittently for help. Those patients are going to be much less likely to reach out for help if they feel their concerns are not being listened to. If someone comes to you interested in this, being transparent about your knowledge of the system and being willing to learn are important.”
Set appropriate expectations
An adjustment of expectations may be needed for a person planning to build and use a DIY system, Nally said. For example, a DIY system does not reduce HBA1c to non-diabetic range — despite what some may read on social media. Highs and lows will still occur, and users still need to bolus for carbohydrates and check for ketone, she said. A safety plan is also necessary in case of insulin pump or sensor failure.
“Many people may be under the impression that using the DIY system will automatically manage all aspects of diabetes, but that is not true,” Nally said. “But you will see people with dramatic results. An HbA1c in the 5% range for someone with type 1 diabetes, I don’t think that is a reasonable expectation for everyone ... but 70% to 80% time in [recommended blood glucose] range can be done with well-tuned settings.”
Ensure the patient or family is engaged and makes sound treatment decisions routinely, and that the patient or family is aware of the benefits and risks of DIY use, Nally said.
“You still have to eat healthy, bolus for meals, monitor your blood glucose trends and check for ketones,” Nally said. “That said, these systems can significantly reduce the mental burden of managing diabetes and improve sleep.”
Guidelines for providers
Nally advised diabetes care and education specialists to become familiar with DIY systems by joining the “Looped” Facebook group and reading Loop and Open APS websites and considering their own concerns with a patient or family doing something off-label.
“If you are part of a large group, one or two people could consider being the champions at your clinic, where they can learn more about the systems and relay it to the group,” Nally said.
The risk for a patient having their DIY device “hacked” by someone else is low, Nally said.
“Someone would have to be within 20 feet of you and know the serial number of your pump or your pod in order to hack into your system, so it is very unlikely that is going to happen,” Nally said.
It is important for clinicians and diabetes care and education specialists to help people using DIY systems make safe, appropriate setting changes at a reasonable pace, Nally said.
“It is important to help them set a maximum hourly basal rate and a reasonable ‘suspend threshold’ that will suspend all basal insulin,” Nally said. “The clinician or educator can also help them set up ‘override’ settings for exercise, illnesses and menses.”
Additionally, users may not be familiar with how to adjust an insulin-to-carbohydrate ratio, an insulin sensitivity factor, or basal rates, and helping them adjust those settings will prevent them from making changes that “overshoot or undershoot” dramatically, Nally said.
“Some families and patients may want to readjust these settings every day, so counseling them on waiting a few days to make a change and adjusting one or two settings at a time with your help, is important,” Nally said.
Reference:
- Cheat sheet for nurses. Available at: https://loopkit.github.io/loopdocs/faqs/FAQs/#is-there-a-cheat-sheet-for-a-school-nurse-to-use. Accessed on: Aug. 16.
- General introduction to OpenAPS for clinicians. Available at: https://openaps.readthedocs.io/en/latest/docs/Resources/clinician-guide-to-OpenAPS.html. Accessed: Aug. 16.
- Looped FAQ for clinicians. Available at: https://loopkit.github.io/loopdocs/faqs/FAQs/. Accessed: Aug. 16.
Perspective
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Steven Edelman, MD
The presenter here is a pediatric endocrinologist; unfortunately, the situation is much different for adults with type 1 diabetes, who typically do not have this kind of support from the professionals. If the patient is lucky enough to have an endocrinologist who knows enough to suggest a DIY hybrid closed-loop system, all of the support is online and the adult is pretty much on their own. I have never met a diabetes care and education specialist who knows about them.
Checking for ketones among adults is extremely rare. I have not prescribed ketone sticks or a meter in 30 years and, as someone with type 1 diabetes, have not used them myself. Perhaps if someone is prescribed an SGLT2 inhibitor, that may be recommended; however, I am not sure why this would be needed for looping.
Dr. Nally is correct that pump settings are important. Additionally, there only needs to be one basal insulin rate since the modulation basal rate takes care of changes in daily insulin needs.
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Nally L. Supporting people who choose do-it-yourself closed-loop systems. Presented at: Association of Diabetes Care & Education Specialists Annual Meeting; Aug. 13 - 16, 2020; (virtual meeting).
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