Outpatient assessment of KADIS^®--based decision support

Abstract

Objective To assess the benefit of the Karlsburg Diabetes Management System (KADIS^®) in conjunction with continuous glucose monitoring (CGMS™) in an outpatient setting.

Research Design and Methods A multicentric trial was performed in insulin-treated outpatients (n=49), aged 21-70 years with a mean diabetes duration of 14.2 years. Subjects were recruited from 5 outpatient centers and randomized for CGMS™- or CGMS™/KADIS^®-based decision support and followed up for 3 months. After two CGMS™ monitorings, the outcome parameters HbA_1c (%), mean sensor glucose of the CGMS™ profile (MSG, mmol/L) and duration of hyperglycemia (h/day) were evaluated.

Results In contrast to the CGMS™ group (0.27 ± 0.67 %), mean change in HbA_1c (ΔHbA_1c), decreased in the CGMS™/KADIS^® group during the follow up (-0.34 ± 0.49 %; p<0.01). MSG levels were not affected in the CGMS™ group (7.75 ± 1.33 vs. 8.45 ± 2.46 mmol/L), but declined in the CGMS™/KADIS^® group (8.43 ± 1.33 vs. 7.59 ± 1.47 mmol/L; p<0.05). Net KADIS^® effect [-0.60 (95% CI -0.96 - -0.25 %); p<0.01] was associated with reduced duration of hyperglycemia (4.6 vs. 1.0 h/day; p<0.01) without increasing hypoglycemia. Multiple regression revealed that the HbA_1c outcome was dependent on KADIS^®-based decision support. Age, sex, physician's specialty, diabetes type and BMI had no measurable effect.

Conclusions If physicians were supported by CGMS™/KADIS^® in therapeutic decisions, they achieved a better glycemic control for their patients compared to CGMS™ alone. KADIS^® is a suitable decision support tool for physicians in outpatient diabetes care and has the potential to improve evidence-based management of diabetes.