Artificial Pancreas Development -- #DData Academic Update
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Transcript of Artificial Pancreas Development -- #DData Academic Update
Automated Insulin Delivery Systems - Academic Update
Trang Ly MBBS FRACP PhD Pediatric Endocrinologist, Clinical Assistant Professor
Stanford University, Buckingham Group
DiabetesMine D-Data Exchange 10 June 2016
Disclosures• Investigator for studies sponsored by Medtronic and
Tandem• Co-investigator on studies with:• Boris Kovatchev - University of Virginia• Roman Hovorka - Cambridge University• Edward Damiano - Boston University• Doyle and Dassau - Harvard University• B. Wayne Bequette - Rensselaer Polytechnic Institute
Design
Medtronic - Hybrid Closed Loop
BetaBionics - iLet
Type Zero - inControl
Insulin delivery
Medtronic Diabetes University of Virginia Cambridge University Boston University Harvard University
Algorithm PID-IFB Control to range MPC MPC - insulin; PD - glucagon MPC
Dosing Microbolus5 minutes
Basal - 5 minutes, Correction - 1h
Insulin infusion rate - 10 minutes 5 minutes 5 minutes
System calculated meal dosing
Glucagon - 5 minutes
Automated Component
Initialization
Medtronic Diabetes University of Virginia Cambridge University Boston University Harvard University
TDD - Total daily insulin Basal, I:CHO, ISF Basal, I:CHO, ISF Weight Basal, I:CHO, ISF
Sensor for 48 hours TDD TDD TDD
Basal, I:CHO, ISF Weight Weight
Initialization Parameters
Setpoint
Medtronic Diabetes University of Virginia Cambridge University Boston University Harvard University
Setpoint 120mg/dL Day: 160mg/dL Treat-to-target: 104-131 mg/dL
Insulin and glucagon setpoint is 100 mg/dL
Day: 80-140 mg/dL
Night: 120mg/dL Optional individual
setpointAdjustable by user up
to 130 mg/dLNight: 90-140 mg/dL
Exercise Temp target - 150mg/dL
Safety: no more than usual basal
Exercise specific setpoint
Setpoint
Insulin on Board
Medtronic Diabetes University of Virginia Cambridge University Boston University Harvard University
Meals Set by user 2-8h 6h
Basal System derived 4h System derived Insulin clearance 6.5h; Peak 65 minutes
Insulin decay curve depends on glucose:>300 – 2h200-300 - 4h 140-200 - 6h<140 - 8h
Insulin on Board
Performance
Comparison• Different settings: free-living vs. monitored• Different hypoglycemia treatment thresholds• Different patient population: A1C, hypoglycemia
awareness
7:00 8:10 9:20 10:30 11:40 12:50 14:00 15:10 16:20 17:30 18:40 19:50 21:00 22:10 23:20 0:30 1:40 2:50 3:59 5:09 6:190
50
100
150
200
250 Sensor-augmented pump
Hybrid closed-loop
Time
Sens
or G
luco
se -
mg/
dLJDRF Hotel 670G Adolescents
n=15, Mean A1C 9.0%, 70% in range 70-180 mg/dL
Ref - Ly, Weinzimer, Maahs et. al. Pediatric Diabetes 2016
Ref - Thabit, Hovorka et. al. NEJM 2015
Cambridge Group - 3 monthsAdult n=33, 68% in range 70-180 mg/dL, A1C 7.6% to 7.3%
Meals
Medtronic Diabetes University of Virginia Cambridge University Boston University Harvard University
I:CHO I:CHO I:CHO Gives 75% of 4h postprandial insulin needed for that meal size and type. First meal-priming bolus is based on the patients weight (0.05u/kg).
If BG <120 or no BG entered, give 80% If BG >120, give 100%
Meals
Strengths
Medtronic Diabetes University of Virginia Cambridge University Boston University Harvard University
Integrated system124 pts - 3 months
Pivotal trial
13 pts - 6 monthsRemote monitoringSoftware updates
Pump agnostic
33 pts - 3 months 48 pts - 12 daysIntegrated
DesignAdjustable setpoint
Meal adaptation
Run-to-run optimization currently being tested
Strengths
Challenges
Medtronic Diabetes University of Virginia Cambridge University Boston University Harvard University
• Managing expectations
• Need remote monitoring
• Adjustable setpoint
• Moving to a commercial platform
• Need to maintain connectivity
• Setpoint may be too high during day
• No commercial partner
• No remote monitoring
• System not integrated
• Glucagon long-term• Design - IOB• Need longer studies
• No commercial partner
• No remote monitoring
• Need longer studies
Challenges
Summary• Closed-loop therapies will be transformative for
diabetes care• First generation systems will be conservative• Need longer term safety and efficacy trials• Next challenges – • User interface• Human factors • Fail-safe modes
Thank you
Anirban Roy + Benyamin GrosmanMarc Breton
Ed Damiano + Firas El-KhatibRoman Hovorka
Eyal Dassau