February 01, 2023
2 min read
Weiner reports stock ownership in AbbVie, Amgen, Boston Scientific Corp., Bristol Myers Squibb, IBM, Integer Holdings Corp., Johnson & Johnson, Mallinckrodt PLC, Mead Johnson & Co., Medtronic, Mylan N.V., Novo Nordisk, Perspecta, Pfizer, Roche, Senseonics, Stryker, Teva and Walgreens Boots Alliance. Please see the study for all other authors’ relevant financial disclosures.
Researchers highlighted challenges with continuous glucose monitoring devices, including trouble interpreting results, device adhesion and smartphone access, among adults aged 50 to 85 years with type 1 or type 2 diabetes.
Findings were published in Applied Clinical Informatics.
“This is a whole area of health technology that needs study,” Michael Weiner, MD, MPH, research scientist at the Center for Health Services Research at the Regenstrief Institute and the department of medicine at Indiana University and the department of Veterans Affairs, Veteran Health Administration, Health Services Research and Development Service at the Center for Health Information and Communication, Indianapolis, said in a related press release. “There’s hardware involved, which is the device itself. There’s software involved, which is reading, organizing, interpreting and communicating the data from the device. Knowing how the technology works in the real world and the impact of the technology on usability and ultimately on health outcomes is important.”
In a small pilot study, researchers enrolled seven Black and three white adults with diabetes aged 50 to 85 years who were patients at a safety-net institution in central Indiana. Participants were helped to use a CGM, physical activity monitor, electronic medication bottles and smartphones facilitating prompts about medications, behaviors and symptoms for 10 to 14 days.
Next, researchers enrolled 70 adults with diabetes (mean age, 60 years; 59% women; 67% Black, 31% white and 1.4% other) for a similar study. At entry 23% reported never checking their blood glucose prior to the study period, about half reported no regular meal routine, 67% reported previous hypoglycemia. Almost all (97%) reported using a smartphone at least twice in the week before enrollment, but 19% reported never having used the internet. Participants wore CGM devices and activity monitors and used smartphones and smart medication bottles for 2 weeks. All participants provided feedback on the devices.
In the first pilot study, the 10 participants reported problems related to the failure of the CGM device adhesive and understanding graphs that required assistance to interpret.
In the second study with 70 participants, during the 2-week period, 73% of participants had hypoglycemia with a glucose level of 70 mg/dL or lower, and 42% had clinically significant hypoglycemia with a glucose level below 54 mg/dL. Hypoglycemia was also identified among eight participants by home-based blood glucose measurement. Almost 33% of daytime smartphone prompts went unanswered by participants due to many participants not carrying their smartphones as instructed, and 24% of participants reported that CGM devices became detached unintentionally.
In addition, worry or fear about low blood glucose was reported as worse during the study by 1.4% of participants, unchanged in 79% and better in 20%.
“We identified opportunities to decrease the frequency of [hypoglycemia], including shared monitoring results, tailored recommendations and automated prompts based on triggers from continuous monitoring, but successful prompting will require more attention to engineering the workflow of activity to promote adherence and ease of reporting,” the researchers wrote.