GOAL
ADICOL shall improve diabetes therapy with an innovative set-up comprising an insulin infusion pump and a monitor for the continuous measurement of glucose. Both components are combined by sophisticated adaptive control algorithms running on a main control platform.
ACHIEVEMENTSDuring the second year of the project the major work was focussed on the development of suitable devices (hardware and software development) as well as on clinical trials (ADICOL01 through 03). The goal of clinical trials was to validate two different control algorithms regarding to both the safety and the efficacy. Moreover a feedback control was investigated to prepare a continuous glucose monitor input.
ADICOL01: Investigation of a decision support system (DSS) over a period of 4 months included 4 visits (25 h each) with 8 subjects with diabetes, major results: 1. decrease of a most important long-term parameter HbA1c by 0.6% from 9.0% to 8.4% (i.e. minus 0.6%), 2. significantly fewer SMBG out of normoglycaemic range, 3. significant decrease of average glucose value during all time (from 165 mg/dL to 150 mg/dL)
ADICOL02: Multi-centre study on 6 individuals each with an adaptive feedback control (MPC algorithm) of people with diabetes type 1 during fasting time based on intravenous blood sampling. Adaptation of the pump basal rate was performed every 15 min. Major results: 1. no hypoglycaemia occurred (glucose concentration < 3.3. mM ), 2. the normoglycaemic target value of 6 mM (108 mg/dL) could be attained in all cases, 3. proof of iv-sc control capabilities.
ADICOL03: As the minimally invasive measurement of glucose is accompanied by a time delay compared to intravenous glucose determination the control capabilities of the MPC algorithm has been tested at the clinical sites on 2 times 6 patients during fasting state. The trials have shown that 1. no hypoglycaemic event has occurred, 2. the algorithm was capable of achieving the glucose target value reliably.Beyond the stable control, the algorithm's robustness was tested by intake of defined meal in combination with an additional insulin bolus. A modified insulin infusion pump has been tested with remote control capabilities.In terms of hardware development a pocket PC based overall control program has been developed and tested. A glucose monitor based on the minimally invasive sampling procedure 'open flow microperfusion' and on extracorporeal glucose determination by amperometric glucose biosensors was developed and preliminarily tested.A continuous update on the project progress is being provided on the internet homepage
http://www.adicol.org
