Time below Range

Abstract

Background: Patients with diabetes mellitus (DM) need to be regularly monitored for analyzing their levels of glycemic control as well as for ruling out the risk of hypoglycemia. Assessing the time in range (TIR) (70–180 mg/dL) is a novel measure of pointing out these risks. Aim: This research aims to detect hypoglycemia in routine clinical practice based on continuous glucose monitoring (CGM). Besides detecting hypoglycemia in patients with near-normal A1C levels, this study also aims to look at the incidence and occurrence of hypoglycemia in individuals with higher A1C. Methodology: HbA1c levels were recorded for n = 227 adult participants and used to categorize them into groups based on their levels of diabetes control (HbA1c groups of <7%, 7%–8%, 8%–9%, and >9%). Their 24-h blood glucose levels were measured through CGM with a flash glucose monitor (FGM) device. Data from the FGM device were downloaded, and TIR values in different participant groups were further determined. Statistical analysis of these results was done to calculate their significance in terms of P value. Results: 17.6% of participants had good glycemic control (HbA1c below 7%), 22.5% had HbA1c levels within the range of 7%–8%, 33.5% had their HbA1c within the range of 8%–9%, and 26% of the participants presented with poor glycemic control with HbA1c above 9%. Participants with HbA1c levels below 7% spent the maximum time below range (TBR) compared with participants in the other groups (P = 0.0016). Participants with poor glycemic control spent the minimum TBR (P = 0.0001). Those having HbA1c levels within the range of 7–8 (P = 1.00) and 8–9 (P = 0.0008) spent nearly 10% of their TBR indicating time spent in hypoglycemia and the risk of more severe hypoglycemia. No statistical differences in the time spent below range were found between male and female participants and based on treatment regimen. 77.5% of patients having A1C levels below 7%, 54% of patients with A1C levels between 7% and 8%, between 8-9%, and 40.6% of patients with A1C levels above 9% spent more than 5% of their TBR. Conclusion: In our research, it was found that although individuals with HbA1c levels below 7% were at maximum risk of hypoglycemia spending more than 5% of their TBR, patients with poor glycemic control also spent a significant amount of TBR. Thus, all patients with DM are at an increased risk of hypoglycemia regardless of their levels of glycemic control and the type of treatment regimen.