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 forCGMS- 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.
RCT Entities:
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 outpatientdiabetes care and has the potential to improve evidence-based management of diabetes.
Authors: Pavel S Roshanov; Hertzel C Gerstein; Dereck L Hunt; Rolf J Sebaldt; R Brian Haynes Journal: BMC Med Inform Decis Mak Date: 2012-07-07 Impact factor: 2.796
Authors: Pavel S Roshanov; Shikha Misra; Hertzel C Gerstein; Amit X Garg; Rolf J Sebaldt; Jean A Mackay; Lorraine Weise-Kelly; Tamara Navarro; Nancy L Wilczynski; R Brian Haynes Journal: Implement Sci Date: 2011-08-03 Impact factor: 7.327