!! IMPROVING!!! LIVES.!CURING!!TYPE!1DIABETES.

Robert Kircher, Jr.

VP of Engineering and Regulatory Affairs

bob@dosesafety.com

FALL 2014 DiabetesMine D-Data ExChange Thursday, Nov. 20, 1-7:30pm

University Club of Palo Alto, CA

Artificial Pancreas (AP) Case Studies:

“Automating Diabetes Care”

www.dosesafety.com

Working to improve the lives of those with diabetes

2

What does a Boeing jet have in common with T1D?

3 Airplane Closed Loop Control Systems

4

How Dose Safety Started

Laura Matheson Diagnosed T1D

(1999)

Boeing 777 autothrotle presentation

Initial dosing algorithm prototype

Initial closed loop studies in Rick Mauseth’s clinic

Every 15 min: 1) Draw blood sample 2) Enter into computer 3) Pt doses on own pump

2002 2002 2003 2003-2004 www.dosesafety.com

4

5 Original Dose Safety FL1 Closed Loop Algorithm

www.dosesafety.com

(1) Fuzzy Logic: A really bad name for really good technology

“If glucose is normal and steady I would dose Shawn 0.2 units every 15 minutes”

Codified expertise

R. Mauseth, MD

6

Dose Safety Team

6 www.dosesafety.com

2008 2010 2011 2012-2013

!! IMPROVING!!! LIVES.!CURING!!TYPE!1DIABETES.

!! IMPROVING!!! LIVES.!CURING!!TYPE!1DIABETES.

I.Hirsch, MD

Benaroya Research Institute Poster DTM Bethesda

7 Algorithm Clinical Evaluation: Exercise studies

No pre-meal bolus No exercise announcement

Overall Results: 80% time in 70-180 mg/dL

0.5% time < 70 mg/dL

www.dosesafety.com 7

22 hrs

8

No pre-meal bolus

Overall Results: Mean glucose = 205 mg/dL 20% time > 250 mg/dL

0.5% time < 70 mg/dL www.dosesafety.com

8

9 hrs

Algorithm Clinical Evaluation: Pizza studies

9

Closed Loop Autodosing is Not Enough

9 www.dosesafety.com

User dose override Sensor change CGM comm error Infusion set change Insulin refill Battery change

10 Operating Modes (controller v3.0)

Auto-dosing Manual bolus

Hypo predicted

Day-to day Interuptions

Disabled

Pump only. No automation

10 www.dosesafety.com

Suspended

11

Clinical Evaluation (1Q 2015)

24-hr study visit on the CRC

3 weeks Guarded Outpatient 3-days at hotel 18-days at home

3 months remotely monitored at home

11 www.dosesafety.com

12 Call to Action

•  CGM, pump, algorithms

•  Regulatory guidance

Private insurance companies and government payers need to say: “If you (FDA, device mfgrs, …) do this, we will pay for AP pumps.”

AP pump!

13 Thank-­‐You  

14

Back Up Slides

15

References

  Matlab FL tutorial: http://www.mathworks.com/help/pdf_doc/fuzzy/fuzzy.pdf

  2008 DTM poster http://www.dosesafety.com/resources/DTS_2008_Poster_revD.pdf