Comparison of short-term efficacy and safety of the first generation versus second generation basal insulin analogues for inpatient management of patients with type 2 diabetes undergoing coronary artery bypass surgery: initial insight from an interim analysis of a retrospective observational cohort study from eastern India using ambulatory glucose profile data
- Journal of Diabetes, Metabolic Disorders & Control
Soumyabrata Roy Chaudhuri,1 SomaChakraborty,2Anirban Majumder,1 Debmalya Sanya,1 Susama Chuyan,3 Ajoy Biswas,1 Barun Chandra Roy4
Aims: There is paucity of data about the use of second- generation basal insulin analogues in hospitalized patients. Few studies have looked at the use of glargine U300 versus glargine U100 or glargine U100 versus degludec U100 in hospitalized patients using glucometerbased monitoring. One recent publication has also compared between two groups of type 2 diabetic (T2DM) patients in post-operative period of coronary artery bypass grafting (CABG) receiving glargine U300 as opposed to degludec U100 using multiple glucometry data. However comparative analysis between glargine U100 and the two second generation basal insulin analogues in similar subset of patients using continuous glucose monitoring (CGM) data is sparse.
Methods: As a pilot study, a retrospective analysis of retrieved ambulatory glucose profile (AGP) data of a small number of patients receiving glargine U300, glargine U100 or degludec U100 in the postoperative period after off-pump CABG was taken up for statistical analysis. AGP derived mean glucose was the primary endpoint and the glycemic metrices time in range (TIR), time below range (TBR) and time above range (TAR) were also analyzed to assess immediate glycemic control and glycemic variability. Safety data were analyzed using the discrete every 5 min data which was downloaded from the sensors. Level 2 (blood glucose less than 54mg/dl) hypoglycemia was searched for in the TBR regions and nocturnal hypoglycemia (blood glucose less than 70mg/dl) was searched for in the period from 1200 midnight to 6 AM.
Results: The primary outcome that is AGP based mean glucose, was similar between the 3 groups, as the p value was 0.705 that was greater than 0.05, the usual cut off value laid for significance. Similarly, the p values for the TIR, TBR and TAR were above the cut off for significance laid at 0.05 implying there was no significant difference in the immediate glucose control and the glycemic variability between the patients treated with either of the three basal insulin analogues. There were no level 2 hypoglycemic episodes or nocturnal hypoglycemic episodes noted in either of the three groups.
Conclusion: There was no difference between the efficacy and safety outcomes noted with the in- hospital use of glargine U100, glargine U300 and degludec in this cohort of T2DM patients during the post operative period following off- pump CABG
type 2 diabetes, basal bolus therapy, glycemic control, bypass grafting