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Reducing acute adverse outcomes in youths with type 1 diabetes: a randomized, controlled trial.

OBJECTIVE
Both acute and chronic complications of diabetes account for a disproportionate percentage of US health care expenditures. Despite improvements in diabetes care, the incidence of adverse events in children with type 1 diabetes remains high, particularly for youths with poor glycemic control. Cost-effective intervention programs designed to reduce complications are needed. This study evaluated a low-intensity, nonmedical intervention using a case manager (called a "Care Ambassador"), with and without the supplementation of psychoeducational modules, designed to monitor and encourage routine diabetes care visits to reduce short-term adverse outcomes and improve glycemic control in youths with type 1 diabetes.


METHODS
We performed a 2-year prospective, randomized clinical trial in 299 youths with type 1 diabetes, aged 7 to 16 years, comparing 3 treatment programs (Care Ambassador [CA], Care Ambassador plus psychoeducational modules [CA+], and standard multidisciplinary diabetes care [SC]). The study was conducted in a large metropolitan US city from April 1997 through April 2000. Number of medical visits, frequency of hypoglycemic events, hospital/emergency department (ED) utilization, and glycosylated hemoglobin A1c were assessed during follow-up.


RESULTS
During the 2-year study period, both the CA and CA+ groups had significantly more routine visits (mean [standard deviation]: 7.3 [2.06] and 7.5 [2.02], respectively) compared with the SC group (5.4 [2.62]). The CA+ intervention group had significantly reduced rates of short-term adverse outcomes compared with the other 2 groups; 25% fewer total hypoglycemic events, 60% fewer severe hypoglycemic events, and 40% fewer hospitalizations and ED visits. "High-risk" youths in the CA+ group (baseline glycosylated hemoglobin A1c > or =8.7%) were 3.4-fold (1.57-7.41) more likely to improve their glycemic control compared with those at high risk in the other 2 groups.


CONCLUSIONS
For youths with type 1 diabetes, the CA and CA+ interventions increased visit frequency. Youths in the CA+ intervention had reduced rates of hypoglycemia and hospital/ED utilization with estimated annual cost savings of 80 000 dollars to 90 000 dollars. The CA+ intervention compared with the other 2 groups improved glycemic control in "high-risk" youths. Nonmedical case management incorporating psychoeducational modules seems to be a cost-effective approach to improving outcomes in youths with diabetes.