Diabetes Technology Update

By Marina Krymskaya, NP, CDE
January, 2010

Financial Disclosures

No conflict of interest to disclose.

³The past is behind, learn from it. The future is ahead, prepare for it. The present is here, live it.´ Thomas S. Monson

‡ Glucose Monitoring Systems
- Glucose Meters - Continuous Gglucose Monitoring Systems (CGMS)

‡ Insulin Delivery Modes
Syringes Insulin Pens Jet Injectors Insulin Pumps

³The past is a foreign country; they do things differently there.´
Leslie Poles Hartley

Glucose Monitoring
anTcient method modern method

Glucose Monitoring
First Glucose Meter

Glucose Monitoring
‡ Home blood glucose meters measure the glucose in whole blood, while most lab tests measure the glucose in plasma. ‡ Plasma glucose levels are generally 10%±15% higher than glucose measurements in whole blood. ‡ Most of the modern meters on the market give results as "plasma equivalent," even though they are measuring whole blood glucose. ‡ Sample sizes vary from 30 to 0.3 l. ‡ Test times vary from 5 seconds to 2 minutes.

Glucose Monitoring

CGMS
Continuous Glucose Monitoring System

‡ test glucose in the IF every few minutes for up to 7 days ‡ alarm system warns if glucose rapidly changes ‡ real time results

Glucose Monitoring - CGMS

‡ by analyzing the trends, the patient or the physician can adjust insulin ‡ leads to better glycemic control

Trends Better Than Points

Insight

No clue what to do

Benefits of CGMS
‡ Increased security from alarms & alerts ‡ Immediate feedback - look and learn BG trend provides more information than static readings

‡

‡ Control + safety

Limitations of CGMS*
‡Interference with glucose readings by sensor can occur with certain substances
- i.e.gluthatione, ascorbic acid, uric acid, salicylates ± can cause
co-oxidation, which will lead to overestimation of glucose levels

‡Lag-time for up to 15 minutes when glucose changes rapidly ‡Overall percentage of error ± near 15%
‡ Guardian REAL-Time ± 17% ‡ DexCom 11-16% ‡ Navigator 12-14%

* E. Cenzic, MD and William tamboriane, MD. A Tale of Two Compartments: Interstitial Versus Blood Glucose Monitoring. DIABETES TECHNOLOGY & THERAPEUTICS. Volume 11, September 2009.

Glucose Monitoring - CGMS

Abbott FreeStyle Navigator®

Medtronic MiniMed Paradigm® REAL-Time

DexComŒ SEVEN® PLUS

Insulin Delivery Modes
Syringes
Improved Technology: ‡ disposable ‡ thinner needles ‡ more sanitary

Insulin Delivery Modes
Insulin Pens/Devices
‡ ‡ ‡ ‡ Disposable Reusable 1 Unit increments 0.5 Unit increments

Insulin Delivery Modes
Insulin Pens/Devices
‡Ease of handling ‡More discrete use

Insulin Delivery Modes
Jet Injectors

‡ sends insulin through the skin , using high pressure mechanism ‡ an option for people with severe needle phobia

Insulin Delivery Modes
Insulin Pumps

The prototype of the first pump that delivered glucagon as well as insulin, backpack style, was in the early '60s.

Omni Pod - the world¶s first tubing-free insulin pump.

Insulin Delivery Modes
Insulin Pumps

‡provide continues insulin delivery ‡infusion site needs to be changed only every 2-3 days

Pump Advantages
‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ ‡ More reliable, precise insulin action Fewer missed doses Less insulin stacking Fewer lows, especially at night Easier to exercise Less glucose exposure and variability Less insulin Matches variable basal insulin need Fewer social limitations Better data access for providers and patients

Example 3-Step Temp Basal Reduction
For 3 hours of strenuous activity

1) 1 hr temp basal at 0% 2) 2.5 hr temp basal at 60% 3) temp basal at 85% overnight

Future

³Prediction is very difficult, especially about the future´. Niels Bohr

‡ Pump technology continues to advance ‡ On the horizon:
± Pumping and monitoring by cell phone ± Cooler styles ± Smaller sizes ± Improved human interface ± More helpful data analysis ± Gradual progress toward a closed loop

Closed Loop?
‡ Still needed: ‡ Faster insulins ‡ Better CGM accuracy ‡ Less sensor lag time ‡ Glucose control algorithms that won¶t fail Closing the loop will come in small steps over time

‡

Injectable Continuous Ostomotic Glucose Sensor
‡ LifeCare (Bergen, Norway) is working on a CGM that¶s so tiny it can be implanted without surgery. ‡ The company claims it¶s the ³new frontier in CGM!´ ‡ Currently undergoing testing to determine reactions from the immune system.

Non-invasive Continuous Blood Glucose Monitor
OrSense¶s NBM-200G ‡ A highly sensitive optical system, using an array of calibrated light sources, measures light absorption and scattering. The desktop monitor calculates the glucose level and displays the results. ± Exhibits comparable accuracy to invasive solutions, while providing superior ease of use and safety ± Tested on over 450 subjects ± At this stage, the NBM 200G glucose monitor is utilized for investigation and market awareness purpose only.

Emerging Research About Nanomedicine and Diabetes
‡ nanos (Greek) ± one-billionth part of something ‡ nanotechnology - engineering and manufacturing at the scale of a nanometer (10 - 9 ) ‡ Nanotechnology in Medicine:
± Nanoscale structured materials and devices ± Genomics, proteomics and artificial engineered microbes ± Medical nanorobots

Emerging Research About Nanomedicine and Diabetes
Mauro Ferrari (Ohio State University) and Tejal Desai (Boston University). *, ** ± implantable nanomedical device, which contains pancreatic beta cells from animals. A tiny silicon box surrounded by a material with a very specific nanopore size. The pores are big
enough for glucose and insulin molecules, but small enough to impede the passage of much larger immune system molecules (immunosuppressants will not be needed?)

SmartCell, which was originally developed at the Massachusetts Institute of Technology.*** - When glucose rises in the bloodstream, the structure of the SmartCell will be eaten away. This breakdown of the
SmartCell¶s protein matrix facilitates the release of insulin

Non-invasive glucose monitoring via implanted nanosensors.****
The key techniques include fluorescence resonance energy transfer (FRET) and fluorescence lifetime sensing as well as new nano-encapsulation technologies for sensors such as layer-by-layer (LBL) films.

*Martinac K, Metelko Z. Nanotechnology and diabetes. Diabetologia Croatica 2005; 34(4):105-110. ** Fritas RA. Current status of nanomedicine and medical nanorobotics. http://www.nanomedicine.com /Papers/NMRevMar05.pdf accessed January, 2010 ***Aaron K. Outsmarting Diabetes. Cornell Engineering Magazine 2003. http://eng-2k- web.engineering.cornell.edu/engrMagazine/magazine.cfm?issu..., accessed January, 2009

**** Pickup JC, Zhi ZL, Kan F, et al. Nanomedicine and its potential in diabetes research and practice. Diabetes Metab Res Rev 2008; 24(8):604-610.

21 December 2009 University of Western Ontario Tears of Joy for Diabetics The non-invasive technology uses extremely small nanoparticles embedded into the hydrogel lenses. These engineered nanoparticles react with glucose molecules found in tears, causing a chemical reaction that changes the color of the lenses.

Diabetes Care Enhancement Initiative
‡ ‡ ‡ ‡ Team: Leonid Poretsky, MD; Agustin Busta, MD; Morton Davidson, MD; Marina Krymskaya, RN, NP; Jason Park, MD; Carmen Schmidt, RN; Daniel Steinberg, MD; Goal: Improvement of diabetes care for both inpatients and outpatients throughout the Beth Israel System. Plan Educational aspects:
± ± ± ± To include physicians, nurses, house staff, patients and their significant others; The series of lectures, grand rounds, in-service events to be planned; The ³discharge kit´ with general and individualized instructions to be developed and piloted; Educational video materials for inpatient TV to be selected/created and used throughout BIMC; Review of all existing diabetes protocols for general wards; Review of current PRISM orders; Review of current diabetes-related protocols in CCU, MICU, CT ICU, SICU; Jointly with GMA, develop program for house staff Open for suggestions.

‡

Clinical aspects:
± ± ±

‡

Quality Improvement:
± ±

Diabetes Care Enhancement Initiative
Progress so far:

Educational Sessions for:
‡ ‡ ‡ ‡ ‡ nurses in three psychiatric units the hospitalists the surgical team cardiology NPs KHD

In collaboration with: Carmen Schmidt, RN; Angela Babayev, RN; Dahlia Rizk, DO; Steven Bergmann, MD; Jacqueline Lagazo-Guia, NP; Phillip Schmidt, MD

Diabetes Care Enhancement Initiative
Progress so far: Medical Grand Rounds:
‡ Successful Management of Inpatient Hyperglycemia. By Dr. Silvio E. of Yale University. (June 16th, 2009) Inzucchi,

‡ Diabetes: Diagnosis, Classification, Management. Controversies and News. * By Dr. Leonid Poretsky, Chief, Division of Endocrinology and Metabolism, Beth Israel Medical Center. (September 15th, 2009) ‡ Insulin therapy in outpatient and inpatient settings. * By Dr. Agustin Busta. (December 1st, 2009) ‡ Medical Nutrition Therapy for Diabetes. Does a perfect eating plan exist? * By Jennifer Regester, RD, CDN. Diabetes Technology Update. * Marina Krymskaya, ANP, CDE. (January 26, 2010)
* Slides available at www.friedmandiabetesinstitute.com

Thank You!