https://diabetes.acponline.org/archives/2020/08/14/8.htm

CGM system reduced hypoglycemia in high-risk inpatients with type 2 diabetes

In a randomized trial, insulin-treated patients who had real-time continuous glucose monitoring (CGM) data sent to a nursing station experienced fewer hypoglycemic events than those who received point-of-care blood glucose testing.


Real-time continuous glucose monitoring (CGM) in which data is transmitted wirelessly from the patient's bedside to a centralized monitor at the nursing station decreased hypoglycemia in high-risk inpatients with type 2 diabetes when combined with a simplified hypoglycemia prevention protocol, a randomized trial found.

Researchers randomly assigned insulin-treated patients with type 2 diabetes who were admitted to the general medicine service at the Baltimore Veterans Affairs Medical Center and judged to be at high risk for hypoglycemia to receive CGM (intervention/unblinded group) or point-of-care blood glucose testing (standard-of-care/blinded group). All patients had a CGM device placed. Patients in the intervention group had a smartphone at the bedside that transmitted glucose values to a tablet at the nursing station. In this group, low-glucose alerts were set to less than 85 mg/dL (4.7 mmol/L), and nursing staff were instructed to obtain a point-of-care blood glucose test for hypoglycemia alarms as permitted and to provide at least 15 g of carbohydrates for impending hypoglycemia. In the standard-of-care group, glucometric data were collected using blinded CGM systems with alerts disabled. If the point-of-care reading was less than 85 mg/dL (4.7 mmol/L), nursing staff provided 15 g of carbohydrates. The primary outcome was inpatient hypoglycemia. Results from a planned interim analysis for safety monitoring were published online on Aug. 5 by Diabetes Care.

Seventy-two participants were included in the interim analysis, 36 in the intervention group and 36 in the standard-of-care group. The intervention group experienced fewer hypoglycemic events (<70 mg/dL [3.9 mmol/L]) per patient (0.67 events/patient [95% CI, 0.34 to 1.30] vs. 1.69 events/patient [95% CI, 1.11 to 2.58]; P=0.024), fewer clinically significant hypoglycemic events (<54 mg/dL [3.0 mmol/L) per patient (0.08 events/patient [95% CI, 0.03 to 0.26] vs. 0.75 events/patient [95% CI, 0.51 to 1.09]; P=0.003), and a lower percentage of time spent below 70 mg/dL (3.9 mmol/L) (0.40% [95% CI, 0.18% to 0.92%] vs. 1.88% [95% CI, 1.26% to 2.81%]; P=0.002) and below 54 mg/dL (3.0 mmol/L) (0.05% [95% CI, 0.01% to 0.43%] vs. 0.82% [95% CI, 0.47% to 1.43%], P=0.017) compared with the standard-of-care group. There were no differences between groups in nocturnal hypoglycemia or time in ranges of 70 to 180 mg/dL (3.9 to 10 mmol/L), 180 to 250 mg/dL (10 to 13.9 mmol/L), and greater than 250 mg/dL (13.9 mmol/L).

One limitation was that 93% of patients were men, although there are no known sex-specific differences in the incidence of inpatient hypoglycemia or in the prevention of hypoglycemia with CGM, the study authors noted. They added that because of the COVID-19 pandemic, the trial was halted shortly after they completed the interim analysis.

“We believe that widespread dissemination of these findings in the context of this health crisis could be important. During this emergency, providers have implemented inpatient use of CGM devices, which is still considered investigational,” the authors concluded, adding that the intervention may be beneficial in this environment to help reduce the need for frequent entry of staff into patient rooms and, consequently, personal protective equipment utilization and risk of exposure and transmission.