1. Type 1 Diabetes Better Connecting the Patient, Provider and Data A Proposal to Bridge the Gaps ©Chris Beuning, Andrew Tice, Jim Martin, Kathy Culver 2011 Northwestern University Medical Informatics 403 June 2, 2011

2. Agenda Introduction Overview Problem Statement Proposed Solution Current State Patient Perspective Healthcare Provider Perspective Technology Challenges/Gaps Technology Solution Overview Requirements Device Interoperability Conclusion

3. Introduction Overview Type 1 diabetes statistics Problem Statement A technology gap exists in delivering a seamless approach to the collection, monitoring, reporting, and managing of the data to provide patients and their healthcare providers with a smooth flow of information.

4. Proposed Solution Device Seamless sharing of information Engage patient in their care Continuous measure of glucose levels throughout the day Insulin dose recommendation adjustments based on need Voice recognition for food and exercise entry Real-time data feeds to patient, their parents (if minor), healthcare provider

5. Current State – Patient Perspective Daily Management – Insulin use Basal insulin Insulin in response to meals – correctional – Frequent blood glucose monitoring – Awareness and monitoring of daily activities Food intake Exercise

6. Current State – Patient Perspective Minimizing impact of disease or minimizing effort needed – Minimize invasiveness of frequent blood sugar testing – Simplification of monitoring – Easier documentation, or ease of capturing more accurate and complete documentation – Recognition of the usual young age of patients with Type 1 Diabetes – Use of new technology already in use by these patients

7. Current State – Healthcare Provider Perspective Importance of tight glucose control How does the body work toward this? Current state of technology The Ideal state – Can we get there?

8. Current State – Technology Many devices or technology currently use by Type 1 Diabetics – Blood glucose meter – Insulin infusion pumps – Journals – paper and electronic – Integration with new technology such as voice recognition – Graphing or trending patient data and daily activities – Personal Health Records – Decision support for insulin dosing and adjustment

9. Current State – Challenges/Gaps Numerous tools currently available Integration of tools is still lacking Age of onset of Type 1 Diabetes patient

10. Technology Solution – Overview A number of technologies can be further exploited to assist with patient self-care – biggest opportunity is automation of: – Glucose monitoring – Insulin delivery in real time as a result of levels found in real time. An ‘artificial pancreas’ – if you will…

11. Requirements: Insulin Device Low glucose levels triggers reduction/stop to insulin release High glucose levels trigger release of insulin Creates steady state of metabolism Device self-monitors and self-corrects Patient prompted for additional insulin based on continuous input of glucose levels, exercise and diet, providing diabetes management decision support. Patient prompted if glucose levels are to low and additional intervention is needed Automatic periodic sampling of blood for glucose levels without finger prick, eliminating invasiveness of blood sugar measurements.

12. Patient enters information on the food and quantity eaten, and the device identifies its influence on their basal rate. E.g., 1 cup wheat pasta. Patient enters exercise and duration, and the device identifies its influence on their basal rate. E.g., playing soccer for 1 hour. Patient entry of food and exercise must be simple to use for kids and adults, regardless if manual entry, voice recognition, or automatic readings. Requirements: Diet/Exercise

13. Patient data is pushed (vs. pull) to the physician and the patient’s electronic device in real-time data feeds through wi-fi connections. Physician monitors incoming data periodically, and is alerted if a patient’s glucose levels are at a dangerous level. All patient information ion food, exercise, insulin and its impact on glucose levels is automatically collected into a single database for the patient, patient’s caregiver, and healthcare provider. Reminder/alert to log patient information if not received within a defined timeframe. Database is backed up daily. Requirements: Data Collection, Monitoring, Analysis

14. Technology Solution – Device The Artificial Pancreas is comprised of existing technologies: – Continuous glucose monitor (CGM) Reads glucose levels through a hair-thin sensor inserted just below the skin. CGM transmits the readings instantly to the insulin pump.

15. Technology Solution – Device The Artificial Pancreas is comprised of existing technologies: – Insulin pump Based on instruction from the CGM – insulin is delivered through a small tube or patch on the patients body. Insulin pump would be ‘smart’ in that it could address safety concerns by helping to prevent hypoglycemia or hyperglycemia. – Slow or stop insulin delivery if sugar level trending too low – Increase insulin delivery if sugar level trending too high – Return to a pre-set ‘basal’ rate once glucose levels out

16. Technology Solution – Device Challenges ahead for Artificial Pancreas – At present – the glucose monitor, insulin pump and wireless communication medium are mature technologies. Ability to ‘close the loop’ is nearing – where devices are connected and uploading patient data to interested parties – (PHR, EMR, Public Health, etc) Challenge currently is around improving the effectiveness of the fast acting insulin as needs to be at maximum effectiveness when delivered. – As a result, first generations of this solution will require manual input of patient meal and exercise data to ensure safe level management.

17. Technology Solution – Interoperability Even without the ‘artificial pancreas’ – data collection and sharing with interested entities is a key function of a successful self-care plan. – Is challenging as diabetics deal with a high volume of metrics daily, and need to maintain state on data collection constantly. – What is needed is an automated means to securely upload data captured on the CGM, delivery data from an insulin pump or from the ‘artificial pancreas’ acting in unison.

18. Technology Solution – Interoperability Interoperability model would allow for the patient to determine who his/her data would be shared with – Patients personal health record (PHR) – Provider(s) electronic health records. – Public health databases, etc.

19. Technology Solution – Interoperability Allow for similar monitoring capabilities as patients receive when present in the clinic or hospital setting. – Very critical data that is not consistently gathered via a high quality repeatable process. – Help liberate patients from manual reporting tasks. – The reporting component of the ‘artificial pancreas’ must not deter any freedom that the patient receives from the automated device.

20. Technology Solution – Interoperability The manufacturers of these automated monitor/delivery products need to collude on managing the device data collection space. – While devices may be proprietary – agree on a common standard for data collection and dissemination. – Consider deriving a data collection interoperability network: Gain scale from working together – worked for e-Prescribing..

21. Conclusion Currently there are many tools and technologies intended to assist diabetic patient’s document, track and adjust their therapy in concert with their provider. These tools hold promise for streamlining the management of diabetes, however the integration of these tools is still lacking, leaving the patient to learn multiple devices, programs or navigate various sites to manage their disease. This presents a challenge for all diabetics, but may be more problematic in type 1 diabetes where many of the patients are children who need to co- manage their condition with their parents or caregivers.

22. Questions?

23. References iPhone Application Connects to Glucose Meter via BlueTooth. (2011). Retrieved May 2011, from tudiabetes.com: http://digg.com/news/story/iPhone_application_connects_to_glucose_meter_via_Bluetoot h Athena. (2011). Normal Physiology of Insulin. Retrieved May 2011, from http://www.athenadiagnostics.com/content/diagnostic- ed/endocrinology/mody/physiologyRelease CDC. (2010). National Diabetes Fact Sheet. Retrieved May 2011, from Diabetes Public Health Resource: http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2011.pdf Juvenile Diabetes Research Foundation International. (2010). JDFR Forms Parntership with Animas to Develop First-Generation Automated System for Managing type 1 Diabetes.. New York: JDRF. Vaz, C. (2007, June 23). EMR and Device Integration. Retrieved May 12, 2011, from : http://charlesconradvaz.wordpress.com/category/glucometers/