Outpatient Assessment of Karlsburg Diabetes Management System–Based Decision Support

Abstract

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. 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. 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 < 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 to − 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 A1C 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 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.