Description:
<jats:p>OBJECTIVE— We sought to assess the benefit of the Karlsburg Diabetes Management System (KADIS) in conjunction with the continuous glucose monitoring system (CGMS) in an outpatient setting.</jats:p>
<jats:p>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 five 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 A1C (%), mean sensor glucose of the CGMS profile (MSG) (mmol/l), and duration of hyperglycemia (h/day) were evaluated.</jats:p>
<jats:p>RESULTS— In contrast with the CGMS group (0.27 ± 0.67%), mean change in A1C decreased in the CGMS/KADIS group during the follow-up (−0.34 ± 0.49%; P &lt; 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 &lt; 0.05). Net KADIS effect (−0.60 [95% CI −0.96 to − 0.25%]; P &lt; 0.01) was associated with reduced duration of hyperglycemia (4.6 vs. 1.0 h/day; P &lt; 0.01) without increasing hypoglycemia. Multiple regression revealed that the A1C outcome was dependent on KADIS-based decision support. Age, sex, physician's specialty, diabetes type, and BMI had no measurable effect.</jats:p>
<jats:p>CONCLUSIONS— If physicians were supported by CGMS/KADIS in therapeutic decisions, they achieved better glycemic control for their patients compared with support by 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.</jats:p>