New clinical guidelines on diabetes technology
The latest guidance on the use of insulin pumps, continuous glucose monitoring and other technology in diabetes care was presented at December’s World Congress on Insulin Resistance, Diabetes and Cardiovascular Disease, as Dr Susan Aldridge reports.
Technology has now penetrated diabetes care. Insulin pumps have been around now since the late 1970s, the growth of continuous glucose monitoring (CGM) has been exponential over the last decade, while devices which integrate pumps and CGM have been on the market in the US since 2013. This is why clinical practice guidelines are needed, according to George Grunberger, Professor of Internal Medicine, Molecular Medicine and Genetics at Wayne State University School of Medicine. And there is now enough evidence on diabetes technology from clinical trials and real-world data to put together a set of guidelines. This was first done by the Diabetes Scientific Committee of the American Association of Clinical Endocrinologists (AACE) in 2018. Professor Grunberger presented the AACE’s 2021 updated guidelines on the use of advanced technology in management of people with diabetes in clinical practice.
Advanced diabetes technology covers glucose monitoring, both real-time and intermittent, and insulin delivery by smart pens or pumps. Then there are the integrated systems, including low-glucose suspend, predicted low-glucose suspend and hybrid closed-loop, as well as a large number of apps.
The new AACE guidelines are based on a high-quality literature search over the last 10 years. After careful sifting and review of the evidence, the final document has 37 recommendations, 357 literature citations and eight web links. “We put together the guidelines by asking hundreds of relevant questions. To give one key example, we recommended using diabetes technology to maximise time in range and reduce time below range as a basis for glycaemic control and therapy adjustment.”
CGM is ‘strongly recommended’ for all people with diabetes who are on intensive insulin therapy – that is, three or more injections a day or using a pump. For those who choose not to, or cannot afford, CGM, structured self-monitoring of blood glucose should be done. “Structured here means not just pricking your finger, but knowing what to do with the results.” It is also recommended for anyone who has problematic hypoglycaemia – that is, nocturnal hypos, frequent, severe hypos and hypo unawareness, as well as for children and adolescents with type 1 diabetes. Finally, pregnant women with type 1 or 2 diabetes on intensive insulin therapy and those with gestational diabetes, whether or not they are on insulin therapy, should also be on CGM. Professor Grunberger pointed out that the level of evidence found for these CGM recommendations was particularly high.
When it comes to interpreting the CGM data, the ambulatory glucose profile is useful to assess glycaemic status, because you can nicely visualise with the patient what is going on, he added. And real-time CGM is preferred over intermittent CGM for those who have problematic hypoglycaemia and so require the predictive alarms and alerts that the former provides. Intermittent CGM is better for those who are newly diagnosed and those who are motivated to scan several times a day.
Then there is diagnostic CGM, which is useful for the newly diagnosed who “have no idea what their glucose is doing”, for those with problematic hypoglycaemia who have no access to CGM, and for people with type 2 diabetes who are not on insulin and might benefit from it as an educational tool. It also has a place for those who want to learn more before they go on CGM and those who have it, but don’t really need to use it all the time.
Smart pens may be recommended for people on intensive insulin therapy who are not already on a pump to avoid ‘stacking’ and hypos. And for pumps, Professor Grunberger outlined three scenarios. First, a pump without GCM could be recommended for those achieving their targets with minimal time below range and minimal hypos, who are self-monitoring their blood glucose at least four times a day. Second, the use of a pump and CGM that don’t ‘talk’ to one another could be useful for people on intensive insulin therapy who can’t afford or don’t have access to an integrated system. Finally, what about more advanced technology? “The low-glucose suspend and predictive low-glucose suspend systems are strongly recommended for people with type 1 diabetes who need to mitigate problematic hypoglycaemia,” he said.
And then there is the hybrid closed-loop. “Automated insulin-dosing systems are strongly recommended for people with type 1 diabetes, as their use is associated with increased time in range, especially overnight. They should at least be considered for people with type 1 diabetes who have significant glucose variability, impaired hypoglycaemia awareness or those who allow permissive hyperglycaemia because of fear of hypos. These automated insulin-dosing systems are the most advanced things on the market.”
Telemedicine and apps
Moving on, in the last two years telemedicine has been used increasingly in diabetes care of necessity during the pandemic. So what role does it play in the implementation and ongoing use of diabetes technology? “The telemedicine approach is strongly recommended because it can provide diabetes education and we can monitor glucose or insulin remotely for therapy adjustment and improving outcomes,” said Professor Grunberger.
Smart phone apps are also being used increasingly in diabetes management. Unfortunately, very few of these have been clinically validated. Those that have been should be recommended to people with diabetes to reinforce their self-management skills and support healthy living behaviours. There is some evidence now that they do help.
Safety of diabetes technology
It’s important that people realise that CGM output can be inaccurate or interrupted and how and when this might happen. Pumps can also malfunction. So, people with diabetes should always have proper training in the care and use of these devices. Professor Grunberger also added: “The use of clinically validated smartphone bolus calculators is strongly recommended to decrease hypoglycaemia or post-prandial hyperglycaemia.”
Then there is the very sensitive subject of the do-it-yourself artificial pancreas. Is it safe and effective? What do you do as a physician when the patient wants to use this system? “You should caution people that these devices are not approved by the FDA and they have not undergone a rigorous review.”
Implementation of technology
So, these are the recommendations. But how should healthcare professionals be implementing the use of technology in diabetes care, as its popularity grows? “In the guidelines, we emphasise that you have to have the infrastructure – if you don’t have the infrastructure to support the needs of the person with diabetes using the technology at all times, then don’t get into it,” said Professor Grunberger. A lot of education is required for a person with diabetes to use this technology safely and effectively, so the prescribing healthcare professionals must themselves be trained, competent and experienced in its use.
“In summary, diabetes technology may afford people with diabetes a wealth of benefits, so education, setting realistic expectations and ensuring access is essential,” concluded Professor Grunberger. Finally, the task force that put these guidelines together recognised the rapid development of diabetes technology – hundreds of new papers have come out since the document was published earlier this year. So they want it to be a ‘living document’ with regular updates.
The full AACE clinical practice guideline is free to access at: Grunberger G, Sherr J, Allende M, Blevins T, Bode B, Handelsman Y, Hellman R, Lajara R, Roberts VL, Rodbard D, Stec C, Unger J. American Association for Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons with Diabetes Mellitus. Endocrine Practice. 2021. 27(6) 505–537.
For more on technology and diabetes management, why not enrol on our courses ‘Time in range’ and ‘Technology and type 1 diabetes’. ‘Basics of insulin pumping’, which is module 1 in our ‘Technology and type 1 diabetes’ course, was recently accredited for continuing professional development by the UK’s Royal College of General Practitioners (RCGP).
See also the recent instalment of our series ‘The long and the short of it’ – ‘Do novel technologies really lighten the load?’ – in which Professors Moshe Philip and Tadej Battelino review the impact of new technologies on people with diabetes and the healthcare professionals involved in their care.
Any opinions expressed in this article are the responsibility of the EASD e-Learning Programme Director, Dr Eleanor D Kennedy.