Acute Adverse Events in Pediatric T1DM and Their Association with Intensification of Therapy over Time
Abstract Number: 1007-P
Authors: BRITTA M. SVOREN, LISA K. VOLKENING, ELAINE C. MORELAND, KERRY M. MILASZEWSKI, BARBARA J. ANDERSON, LORI M. B. LAFFEL
Institutions: Boston, MA
Results: Intensive therapy of T1DM has been shown to delay the appearance and slow the progression of chronic microvascular and macrovascular complications. The impact of intensive therapy on the occurrence of acute adverse outcomes, particularly in the pediatric population, requires more study. We compared the rates of acute adverse events in two pediatric cohorts separated in time by 5 years. In 1997, cohort 1, comprised of 299 youth (44% male) ages 7-16 years (x+sd; 11.9+2.5 years) with T1DM for 5.2+3.0 years, was enrolled in a 2-year trial. At baseline, 35% of patients were performing <2 injections/day, and 24% were performing blood glucose monitoring (BGM) <2x/day. No one was using CSII. In 2002, cohort 2, comprised of 152 youth (43% male) ages 8-16 years (12.9+2.3 years) with T1DM for 6.3+3.5 years, was also enrolled in a 2-year trial. In comparison to cohort 1, at baseline, only 15% of patients in cohort 2 were performing <2 injections/day(χ2=92.9, df=3, p<0.0001), and only 12% were performing BGM <2x/day (χ2=48.8, df=3, p<0.0001); 23% of enrolled subjects were using CSII. The mean A1c of cohort 1 was significantly higher than that of cohort 2 (8.7+1.4% vs. 8.4+1.3%, p=0.03). The rates of acute adverse outcomes occurring over a two-year period were compared between the two cohorts and are shown in the Table.
Rates of Acute Adverse Events In the post DCCT era, intensification of therapy, with multiple daily injections, CSII, and more frequent BGM, has improved mean A1c and reduced ER use and total hypoglycemic events in the pediatric T1DM population.
|Acute Adverse Event Rate||Cohort 1||Cohort 2||P value|
|Hospitalization (events/100 p-y)||12.9||11.2||0.38|
|ER visits (events/100 p-y)||29.3||22.0||0.02|
|Hypoglycemic events requiring enteral therapy (events/100 p-y)||47.1||18.5||<0.0001|
|Hypoglycemic events requiring parenteral therapy (events/100 p-y)||8.4||10.9||0.24|
|Total hypoglycemic events (events/100 p-y)||55.4||29.4||<0.0001|