Background: There is limited evidence of continuous glucose monitoring (CGM) in patients with type 2 diabetes (T2D) . CGM use improves HbA1c and quality of life, however scant evidence exists on the effect of CGM use on hypoglycemia awareness in patients with T2D. Selecting patients with T2D at high risk and low risk for hypoglycemia, we hypothesized that CGM use would improve hypoglycemia awareness.
Methods: We conducted a 16 week, single center, randomized study on patients [n=40, 50% females, mean (SD) age 59 years (12.5) , BMI 34.kg/m2 (8.1) ] with T2D [screening HbA1c 7.6% (1.2) ] who were deemed to be either high risk (n=22) or low risk (n=18) for hypoglycemia over 5 years using our previously established scoring system. Each participant wore 2 CGM sensors. Within each risk category, participants were randomized to wearing either 1 unblinded+1 blinded sensor (Freestyle Libre/Freestyle Libre Pro) or 2 blinded sensors (2 Freestyle Libre Pro) . Every 2 weeks was an in-person visit for CGM replacement. Clarke and Gold questionnaires were performed at the screening visit (week 0) , visit 4 (week 8) and visit 8 (week 16) . Participants in the unblinded CGM group were instructed to use the CGM as they wished. Participants in the blinded CGM group were instructed to continue with their usual finger stick program.
Result: At baseline, there were no differences in the Gold or Clark questionnaires between participants at high or low risk for hypoglycemia over 5 years. At end-intervention, no differences were noted in the Gold or Clark questionnaires regardless of CGM assignment or baseline hypoglycemia risk category. The trajectory of Gold or Clark scores over the study were also not significantly different between groups regardless of CGM assignment or baseline hypoglycemia risk category.
Conclusion: In patients with T2D, the use of an unblinded CGM did not affect the awareness of hypoglycemia, even in patients at high risk for hypoglycemia, as assessed by Gold and Clark scores.
A.Mehfooz: None. Y.Lee: None. Q.Wang: None. L.S.Chow: Other Relationship; Dexcom, Inc.