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Please Note: The technology listed below is not available to the public at this time. This technology is in the early stage of research and requires further development before it is ready for the marketplace. The VA is currently in the process of identifying potential companies who may be interested in licensing and/or further developing the technology through Cooperative Research and Development Agreements (CRADA). Through cooperative research initiatives such as these, it is our hope and goal that commercial products will be fully developed and made available to benefit veterans and others.
VA TECHNOLOGY OPPORTUNITY BRIEF
Automated Diabetes Control in the ICU
(#08-002)
Development Opportunity
The Department of Veterans Affairs (VA) is seeking to further develop the Glucose GENIE (Glycemic Expert for Nurse Implemented Euglycemia) through a Cooperative Research & Development Agreement (CRADA).
The Department of Veteran's Affairs seeks a commercial partner with strengths in software validation, device integration, and distribution. Developers of automated glucose monitoring equipment are preferred partners, considering that integration of Glucose GENIE into an existing blood sugar monitoring device would further increase the benefits of Glucose GENIE, and allow further development. VA offers to development partners not only this innovative medical tool, but access to a nation-wide patient base for testing and validation.
Glucose GENIE is a software tool that enables precise blood sugar management for hospitalized patients in several settings: in the ICU, as well as post-ICU transition (in the Step Down Unit). It provides recommendations for insulin administration, via both drip and bolus, using a unique algorithm based on several parameters, including the magnitude and rate of change in the patient's blood sugar, the existing and preceding blood glucose (as an index of prior insulin responsiveness), and the existing insulin drip rate (as an index of prevailing insulin sensitivity). Glucose GENIE has demonstrated effectiveness in VA hospitals, but will reach its full potential and widespread adaptation through partnership with one or more commercial licensees, particularly providers of automated glucose monitoring devices.
Benefits of Glucose GENIE
- Controls glucose levels within 120 minutes for 95% of ICU patients
- Improves patient outcomes with much better control
- Maintains safe glucose levels in ICU patients better than traditional methods, and better than existing software tools
- Easy to use, seamless transition to the ward based protocol (Transitional Genie)
- Microsoft Excel based, compatible with all windows based platforms and service
Existing glucose monitoring software erroneously assumes a linear relationship between glucose levels and insulin administration. Glucose GENIE accounts for factors that contribute to non-linear glucose response, providing an insulin administration protocol that is more accurate, and tailored to the patient's individual glucose metabolism. Glucose GENIE not only provides a better insulin regimen, it does it faster than other tools currently in use.
Performance of GENIE at VAPHS
GENIE has been used successfully in its most current version (3.5) in over 300 patients, with unequivocally good results. A preliminary analysis of the first 114 patients showed that the traditional measure of glycemic control (mean blood glucose) confirmed that glycemic control was substantially improved compared to an otherwise similar cohort managed with a standard "formula-driven" insulin algorithm, who underwent surgery during the six month period prior to the institution of GENIE (110 ± 2 mg/dl vs 133 ± 4, p < 0.001). Of particular note, there was a marked reduction in degree of exposure to potentially damaging hyperglycemia, as shown by Time Weighted Excess Glucose or TWEG (calculated as the integrated area under the curve of blood glucose in excess of 140 over time): 42 ± 12 with GENIE vs 4571 ± 1461 with a standard drip protocol (p < 0.001).
The most striking benefit from the achievement of this high degree of glycemic control lay in the elimination of deaths from mediastinitis in patients undergoing cardiac surgery (none since the implementation of GENIE in 2005, compared to 6 fatal cases among 113 patients at our center in 2003-04 before implementation).
An unexpected and hitherto unrecognized benefit was discovered after the implementation of GENIE: a decreased need for one or more intravenous medications used for the emergency treatment of clinically significant low blood pressure, reflected in the fact that patients who needed such treatment required the medication for half the duration compared to before the implementation of GENIE (1.9 ± 0.3 days vs 3.4 ± 0.9 days, p < 0.01)
These improved outcomes were achieved without compromising safety: despite the fact that the target blood glucose was very tight and aggressive, a low blood glucose (< 50mg/dl) was found in 0.09% of readings with GENIE, compared to 0.74 % in the standard protocol.
Glucose GENIE Overview
Blood sugar level is established upon admittance to the ICU. If the patient's blood sugar elevated, at least 110, the nurse starts Glucose GENIE. [Insert screenshot] The nurse enters the blood sugar value, based upon which Glucose GENIE then provides a recommendation for starting an intravenous insulin drip and administering an intravenous insulin bolus dose. Subsequent blood sugars (one hour apart, initially, then 2 hours apart once goal has been achieved) are entered individually, along with the elapsed time, and the nurse then receives further recommendations for adjustment to the insulin drip and additional bolus insulin doses. Glucose GENIE provides a dynamic insulin administration plan throughout the duration of the patients ICU stay. Upon discharge, post-ICU insulin administration is governed by the Transitional GENIE, which recommends the best dose of subcutaneous insulin to be given in the form of basal and bolus insulin, depending on the amount of food consumed and the current and previous blood sugar.
Glucose GENIE's rule-based algorithm is the program's innovative core, and is expected to evolve over time. The following are some likely extensions to the system:
- Glucose GENIE can be modified to retain preceding blood sugar values and insulin doses, and compute the elapsed time automatically. Currently these values are entered manually.
- The underlying algorithm can be extended to consider other patient factors that might impact blood sugar by changing the rule base and the user interface
- Target blood sugar levels can be adjusted if guidelines change
- Integration with an automated blood glucose testing device will stabilize the patient even more rapidly, with effort extended by staff, and with the possibility of monitoring from a centralized location.
PATENT STATUS
Provisional patent filed on 5/12/08 (S/N: 61/071,672)
FOR MORE INFORMATION CONTACT
Jeffrey Moore, Ph.D.
Technology Transfer Specialist
Technology Transfer Program
Department of Veterans Affairs
Office of Research & Development (12TT)
Phone: 202-701-7628
E-mail: jeffrey.moore@va.gov
Last Updated - August 18, 2008