A new consensus statement offers detailed guidelines for inpatient use of continuous glucose monitors (CGM) and automated insulin delivery (AID) systems.
Aimed at clinicians, researchers, and hospital administrators, the open-access document was recently published by a multidisciplinary international panel of 24 experts in the Journal of Diabetes Science and Technology.
The statement includes 77 separate recommendations under five headings: 1) continued use of CGM by patients already using them at home, 2) initiation of CGM in hospital, 3) continuation of AID systems in hospital by patients already using them at home, 4) logistics and hands-on care of hospitalized patients using CGM and AID systems, and 5) data management of CGM and AID systems in hospital.
"This is the most comprehensive and up-to-date guideline on the use of diabetes technology in the hospital now," lead author Rodolfo J. Galindo, MD, told Medscape Medical News in an interview.
"Overall, most experts believe that CGM and AID have the potential to overcome the current limitations of glycemic monitoring in the hospital to improve patient outcomes but we need research, first to get the approval and second to get widespread use," said Galindo, medical chair of the hospital diabetes taskforce at Emory Healthcare System, Atlanta, Georgia.
"COVID-19 Changed Everything"
The guideline is an update of a 2017 statement on hospital use of CGM. The new guideine adds AID systems — sometimes referred to as an artificial pancreas, which combines a CGM and insulin pump and uses an algorithm to guide insulin delivery — and is the first to be developed during the COVID-19 era.
The update had been planned prior to the pandemic, but the actual panel meeting took place in April 2020, after the US Food and Drug Administration allowed inpatient use of CGM despite lack of official approval.
"COVID-19 changed everything...We had to be more specific about how to implement CGM in these patients. The standard of care is hourly point-of-care glucose monitoring in the [ICU], and at least every 4 hours outside the ICU. With limited [personal protective equipment] and the burden on nursing it was unachievable," Galindo explained.
In June 2020, Galindo and other guideline authors developed a COVID-19-specific document (also open-access), which goes more into detail about CGM and how to implement in-hospital use during the pandemic.
The current consensus guideline "provides a high-level review of the evidence by experts," Galindo added.
Recommendations Cover Different Technologies and Hospital Settings
The panel "strongly" advises that hospital providers consult with an inpatient diabetes team, if available, to help manage patients already using CGM prior to admission. Among other recommendations, they list several situations in which CGM data should not be relied upon for management decisions, including severe hyper- or hypoglycemia, diabetic ketoacidosis, or in patients with skin infections near the sensor site.
The panel also call for more research into outcomes for CGM continuation in the hospital and optimal implementation of both CGM and point-of-care glucose testing. For hospitals, strong recommendations include developing standard CGM data reports and workflows, and policies for CGM use.
Galindo pointed out: "A lot of hospitals have policies on that, but there aren't many studies. It's just that patients like it and it's very hard to take it away from patients when they're doing well."
The section on CGM inpatient initiation is where COVID-19 plays the greatest role, which includes just one strong clinical practice recommendation: "Healthcare providers should consider prescribing CGM to reduce the need for frequent nurse contact for point-of-care glucose testing and the use of personal protective equipment for patients on isolation with highly contagious infectious diseases (eg, COVID-19)."
Strong recommendations also include a call for outcomes research and for hospitals to develop CGM protocols and educational tools for staff.
"We can do a study for approval but if administration and hospital policies aren't there we're not going to be able to use them," Galindo noted.
For patients who already use AID systems — either the Medtronic 670G or Tandem Control IQ in the United States — the panel advises assessment to ensure the AID system is the most appropriate inpatient treatment, and the development of an alternate plan for diabetes management, if necessary. They also strongly recommend research in this area, and for hospitals to develop protocols for use of AID systems in various clinical situations.
Most Detailed Guidance Addresses Logistics and Data Management
Most of the strong recommendations regarding logistics are aimed at nursing staff, including receiving training in use of CGM and AID systems, confirming patient capacity, inspection of devices, and understanding when to administer a point-of-care glucose test.
Again, the panel calls for more data and for hospitals to develop policies and protocols for ensuring safe CGM and AID systems use, and when to avoid use.
Finally, they make one strong clinical recommendation regarding data management: "Healthcare providers should develop a set of core data elements and definitions for CGM data for inclusion in common data models and the electronic health record EHR."
That's followed by a long list of relevant recommendations for research in the area, and for hospitals to integrate CGM and AID system data into their EHR systems.
This last area has proven particularly challenging, Galindo said. "Right now we do four point-of-care glucoses a day, and that goes right into the HER, but with CGM it's much more than that. How do we get all those data into the EHR and interpret it? Many steps need to be taken into consideration."
Studies are being conducted in order to fulfill requirements for FDA approval of inpatient CGM use, he said, with data on implementation and inpatient AID system use to follow.
"More data will be available, triggered by the COVID-19 pandemic. However, the use of technology in the hospital goes beyond COVID-19," he said
Galindo has reported receiving unrestricted research support to Emory for investigator-initiated studies from Novo Nordisk and Dexcom, and consulting fees from Abbott Diabetes Care, Sanofi, Novo Nordisk, Eli Lilly, and Valeritas. He is partially supported by research grants from the NIH/NIDDK.
J Diabetes Sci Technol. Published online September 28, 2020. Full text
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Cite this: Consensus Guidelines Address Inpatient Diabetes Technology - Medscape - Oct 27, 2020.