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 ϭ 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 Ϯ 0.67%), mean change in A1C decreased in the CGMS/KADIS group during the follow-up (Ϫ0.34 Ϯ 0.49%; P Ͻ 0.01). MSG levels were not affected in the CGMS group (7.75 Ϯ 1.33 vs. 8.45 Ϯ 2.46 mmol/l) but declined in the CGMS/KADIS group (8.43 Ϯ 1.33 vs. 7.59 Ϯ 1.47 mmol/l; P Ͻ 0.05). Net KADIS effect (Ϫ0.60 [95% CI Ϫ0.96 to Ϫ 0.25%]; P Ͻ 0.01) was associated with reduced duration of hyperglycemia (4.6 vs. 1.0 h/day; P Ͻ 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.

The Karlsburg Diabetes Management System: Translation from Research to eHealth Application

“…These results confirm earlier findings of experimental studies performed to test and evaluate the efficacy and efficiency of the KADIS program. 12,15,25 Consistent with our findings here, the improved metabolic control, as demonstrated by a reduction in HbA1c levels, was accompanied by a reduction in both the mean blood glucose values and hyperglycemic episodes. 12,15,25 Of importance, these improvements did not enhance the risk of hypoglycemia.…”

“…12,15,25 For example, in a case-control study, KADIS-based PDS resulted in a 0.8% reduction in HbA1c for patients with HbA1c >8.0% at baseline within 3 months. The results obtained in our current retrospective outcome analysis confirm these findings.…”

“…10 The Karlsburg Diabetes Management System, KADIS ® , was developed to improve the quality and cost-effectiveness of diabetes care and management for patients with type 1 or type 2 diabetes. [11][12][13][14][15] KADIS is derived from the Karlsburg model of glucose-insulin interactions, 16 and it generates an in silico copy of the individual metabolic profile of a given patient (a personalized "metabolic fingerprint") on the computer and allows testing of different therapeutic measures by interactive in silico simulation procedures aimed at quickly and safely identifying a regimen that may provide individually optimal glucose control. 13,14,17 The results of the simulation procedure are summarized as patient-focused personalized decision support (PDS) for the responsible physicians.…”

Glucose concentrations in blood and tissue - a pilot study on variable time lag

“…In type 1 diabetes, software to adjust insulin dosage and adopt treatment regimens has been successfully introduced 30,31 . On the other hand, to generate computer-assisted decision support programs for type 2 diabetes has been difficult, because of its complex pathophysiology.…”

Patient-Reported Outcomes for an Integrated Real-Time Continuous Glucose Monitoring/Insulin Pump System

“…14 Another study found that patients whose physicians used a software decision-support system designed to guide them in helping patients make insulin dose adjustments had a greater reduction in A1C levels than patients whose physicians did not use the system. 15 Despite the potential benefits of technological advances in insulin therapy, few studies have examined outcomes for combined CSII/CGM technologies. In addition, the published literature tells us little about the experience of patients who use these new technologies.…”