Abstract
BACKGROUND: The Karlsburg Diabetes Management System (KADIS) was developed over almost two decades by modeling physiological glucose-insulin interactions. When combined with the telemedicine-based communication system TeleDIAB and a continuous glucose monitoring system (CGMS), KADIS has the potential to provide effective, evidence-based support to doctors in their daily efforts to optimize glycemic control. METHODS: To demonstrate the feasibility of improving diabetes control with the KADIS system, an experimental version of a telemedicine-based diabetes care network was established, and an international, multicenter, pilot study of 44 insulin-treated patients with type 1 and 2 diabetes was performed. Patients were recruited from five outpatient settings where they were treated by general practitioners or diabetologists. Each patient underwent CGMS monitoring under daily life conditions by a mobile monitoring team of the Karlsburg diabetes center at baseline and 3 months following participation in the KADIS advisory system and telemedicine-based diabetes care network. The current metabolic status of each patient was estimated in the form of an individualized "metabolic fingerprint." The fingerprint characterized glycemic status by KADIS-supported visualization of relationships between the monitored glucose profile and causal endogenous and exogenous factors and enabled evidence-based identification of "weak points" in glycemic control. Using KADIS-based simulations, physician recommendations were generated in the form of patient-centered decision support that enabled elimination of weak points. The analytical outcome was provided in a KADIS report that could be accessed at any time through TeleDIAB. The outcome of KADIS-based support was evaluated by comparing glycosylated hemoglobin (HbA1c) levels and 24-hour glucose profiles before and after the intervention. RESULTS: Application of KADIS-based decision support reduced HbA1c by 0.62% within 3 months. The reduction was strongly related to the level of baseline HbA1c, diabetes type, and outpatient treatment setting. The greatest benefit was obtained in the group with baseline HbA1c levels >9% (1.22% reduction), and the smallest benefit was obtained in the group with baseline HbA1c levels of 6-7% (0.13% reduction). KADIS was more beneficial for patients with type 1 diabetes (0.79% vs 0.48% reduction) and patients treated by general practitioners (1.02% vs 0.26% reduction). Changes in HbA1c levels were paralleled by changes in mean daily 24-hour glucose profiles and fluctuations in daily glucose. CONCLUSION: Application of KADIS in combination with CGMS and the telemedicine-based communication system TeleDIAB successfully improved outpatient diabetes care and management.