1. Alan B Cortez, MD May 14, 2016 Pediatric Endocrinology Kaiser Permanente Orange County

2.  Education  Nutrition  Medicine  Devices  Software/Apps  Awareness  Sharing

3.  Ultra Slow Long Acting Insulins  10+ billion dollar market  Lantus to go generic soon  Ultra Fast Inhaled Insulin is back  Sales not brisk and the loss of Al Mann looms big  SGLT2 inhibitors (all the agliflozins) and DKA  DPP- 4 inhibitors (except alogliptin) and Heart Failure  DPP-4 inhibitors and severe joint pain  New Cholesterol Meds- 71% LDL reduction possible with PCSK9 inhibitors evolocumab and alirocumab and may bypass statin resistance.

5.  Toujeo- U300 with special pen for safety (Sanofi and the FDA remembered mistakes of the pre-1970 insulin era)  Studies in the low to mid A1c 8% range- non-inferior improvement compared to Lantus  450 units in a pen but only ½ the liquid  Less hypoglycemia for most and less weight gain (by 2 pounds over 6 months)  Demonstrated a good FDA process in the EDITION1-4 studies  T2DM- basal and bolus insulin  T2DM- basal insulin plus OADs  T2DM- naïve to insulin (didn’t show hypo reduction)  T1DM- (didn’t show hypo reduction)  Similar price per unit but may need 12% more units

7.  42 hour duration of action  Comes in Pens only- U100 (300 units) and U200 (600 units) Pens  Also comes as Ryzodeg- 70/30 with aspart and may soon be combined with liraglutide  Approved for 8 weeks use per Pen (under 86 deg)  BEGIN studies compared it to glargine  In Type 1, 25% less nocturnal hypoglycemia and similar a1c reduction. For various categories of type 2, non-inferior  Safety concern with use of TZDs.

9.  Smaller and more flexible to dose  Unmatched prandial insulin profile compared to the nondiabetic state  Should not be used in children, COPD, asthma  Caution with smoking, other higher risk of lung cancer, use of TZDs  Mannkind’s marketing partner, Sanofi, has discontinued their relationship but Mannkind says they will keep the product available and now is able to move forward again.

11.  100 cases in 500,000 patient years of use  Too small to be seen in initial FDA studies but to large to ignore its significance.  DKA May be “euglycemic”  Urinary glucose loss of 50-100 grams per day leads to low glucose availability in a background of low insulin availability and may lead to enhanced fat oxidation  Use in unrecognized type 1 and off-label use in type 1 may also be factors

13.  FDA changes approval process of secondary display platforms on devices and the cloud  Apple, Google, IBM, Samsung are now Diabetes companies too.  More Pump features – integration of sensor data, more touch screen, larger reservoirs  Better Sensors  Loss of Asante Snap Pump- purely business reasons

15.  Universal Device Uploader  Tidepool (Blip) and Glooko partnering with non- profits and for-profits.  Enhanced patient access to data and data analysis  Providers need to develop new revenue generating mechanisms to deal with extra time burden placed on them.  More industry intercommunication  More web based platforms for providers  Glycemic index apps more prevalaent

17.  Miss Idaho 2015 wears an insulin pump and is using her celebrity to promote awareness. Was just in OC for a big fund raiser last week along with 3 Miss Americas including Miss America 1999 who also won with wearing an insulin pump.  Reegan’s Rule (N Carolina and now other states on the way including California)- encourages primary care providers to provide information on diabetes at well child visits. Issue has raised awareness of DKA in toddlers who have a much higher risk of death form unrecognized diabetes and DKA, as well as the difficulty in preventing it.

19.  Has the largest bang for the buck of any intervention but sadly never much in the big picture to report in the Year in Review.  Feinman et al, Nutrition Vol 31, Issue 1, Jan 2015, 1-13 is a good review as well as presenting arguments to set the bar lower for carbohydrate intake

21.  Please share something you have been doing in the last year that you think others in the room will want to know about.