The Quantified Self on Steroids: Innovation in Devices, Pumps and Monitors
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1 The Quantified Self on Steroids: Innovation in Devices, Pumps and Monitors Howard A. Wolpert, MD 1
2 Diabetes is different to many other conditions Patient/Self Managed 2
3 To achieve the therapeutic goals Patient/Self Managed Balance: Insulin, Food, Exercise Maintain Glucose levels in Near- Normal Range Reduce Long-term Complications/Cost 3
4 The requirements for success Knowledge & Skills Motivation Guidance Coaching/ Support Goal-setting Feedback Change in Self-care Behavior: Food, Exercise, etc. Sustained Adherence: 24/7/365 Need for an infrastructure to support this process Implications for technology development, and device design and features 4
5 The Quantified Self on Steroids: Innovation in Devices, Pumps and Monitors How effective is the technology for diabetes management? What is the future of technology in diabetes management? 5
6 Diabetes Technology Timeline: Convergence of insulin pumps & continuous glucose monitoring (CGM) to a feedback loop Insulin Delivery 1922 Insulin 1978 Insulin pump CLOSED LOOP: Artificial beta cell Mechanical system Stem cell Glucose Monitoring 1970 Ames meter Blood test 1912 Benedict Urine test TODAY 6
7 Diabetes Technology Timeline: Convergence of insulin pumps & continuous glucose monitoring (CGM) to a feedback loop Insulin Delivery 1922 Insulin Smart/Patch pump 1978 Insulin pump CLOSED LOOP: Artificial beta cell Mechanical system Stem cell Glucose Monitoring 1912 Benedict Urine test 1970 Ames meter Blood test Retrospective CGM Real-time CGM TODAY 7
8 Trade-off between Complications & Hypoglycemia (Low Glucose) Rate pf progression of retinopathy (per 100 patient years) Rate of severe hypoglycaemia (per 100 patient years) HbA 1c (%) DCCT Research Group,
9 Hypoglycemia is a Barrier to Improved Glucose Control Concerns of motivated patients: More frequent hypoglycemic reactions 73% Weight gain 60% Maintaining long-term effort 45% More frequent home glucose monitoring 22% Thompson,
10 Glucose infusion rate Limitation of Injection Therapy Variability in absorption of basal insulins: Glucose infusion rate profiles following four non-consecutive injections of identical doses (0.4U/kg, thigh) in the same patient NPH insulin Insulin glargine Insulin detemir Glucose infusion rate Glucose infusion rate 0 Time (hours) 2 0 Time (hours) 2 0 Time (hours) Heise,
11 Insulin Pharmacodynamics are more Predictable with the Insulin Pump (CSII): Translates into less risk for hypoglycemia CSII Gold Standard Detemir 27% Glargine Intrasubject Variability in Pharmacodynamics 46% NPH 59% Lepore, 2000 Heise,
12 Meta-Analysis Severe Hypoglycemia: MDI versus CSII Study Bode (poor control) Bode (good control) Kaderman Maniatis Rizvi Litton Linkeschova Bruttomesso Rudolph, Hirsch Plotnick Cohen Hunger-Dathe Weintrob Weinzimer McMahon Siegel-Czarkowski Alemzadeh Mack-Fogg Sciaffini Rodrigues Lepore Hoogma Overall (r 2 = 84.2% p=0.00) Rate ratio (95%) 5.55 (3.57, 8.61) (4.24, 26.01) 6.47 (3.09, 13.55) 1.29 (0.31, 5.42) 8.00 (1.84, 34.79) 5.75 (0.72, 45.97) (6.95, 27.86) 3.44 (1.62, 7.33) 3.81 (2.49, 5.84) 2.18 (1.05, 4.52) 4.69 (0.52, 41.98) 3.62 (2.23, 5.85) 3.00 (0.62, 14.44) 2.11 (1.50, 2.96) 2.89 (1.67, 4.98) 7.07 (0.87, 57.46) 2.51 (0.67, 9.47) 2.09 (1.12, 3.92) 1.25 (0.34, 4.65) (29.94, 57.15) 3.50 (2.04, 6.01) 2.50 (1.53, 4.08) 4.19 (2.86, 6.13) Weight (%) Favors MDI Favors CSII Pickup,
13 Continuous Glucose Monitoring (CGM): Device Features More complete picture of glucose patterns than intermittent, capillary blood glucose monitoring Glucose trend/rate of change Glucose alarms - threshold & predictive 13
14 Intermittent fingerstick blood glucose monitoring provides a limited view of glucose concentration 400 Glucose (mg/dl) Glucose measurement Insulin bolus Target Range 0 12:00 am 6:00 am 12:00 6:00 pm 12:00 am 14
15 Continuous glucose monitoring provides a more comprehensive picture of the patterns 400 Glucose (mg/dl) Glucose measurement Insulin bolus Target Range 0 12:00 am 6:00 am 12:00 6:00 pm 12:00 am Patient needs to interpret CGM output and adjust insulin delivery, food intake, etc. to keep glucoses in target range 15
16 Potential Benefits of Real-Time CGM Fine tune daily management of diabetes Detection & prevention of hypoglycemia Behavior modification tool Bridge to the development of a hybrid pump/sensor 16
17 Clinical Sites Atlanta Diabetes Associates Joslin Diabetes Center - Adults Joslin Diabetes Center - Pediatrics Kaiser Permanente So. California Nemours Clinic Stanford University U. Colorado/Barbara Davis Diabetes Center U. Iowa U. Washington Yale University 17
18 Changes in HbA1c in 25-year olds RT-CGM Control Change in HbA1c Difference: 0.53% p value < JDRF CGM Study Group,
19 2.5 Percent Values 50mg/dL Age 25 years 2.2 p=0.10 Percent p= Baseline 26 weeks RT-CGM Baseline 26 weeks Control JDRF CGM Study Group,
20 Phases in the Adoption of Technology Introduction Ames meter Establish efficacy in RCT Diabetes Complications & Control Trial (DCCT) Insurance coverage/ Translation into clinical practice Blood glucose monitoring strips & Insulin pumps: Standard of Care
21 Phases in the Adoption of Technology Introduction Establish efficacy in RCT Translation into clinical practice Retrospective CGMS JDRF CGM Trial Insurance coverage for CGM: YES Widespread adoption of CGM: NO
22 What are the Barriers to CGM Adoption? System Device Patient 22
23 What are the Barriers to CGM Adoption? Challenges in sustaining adherence in the CGM-user : CGM use Potential Complications Sensor Burnout: Information overload Alarm fatigue Hardware hassles Potential Barriers Reducing risk for Sensor Burnout should be a major focus in clinical care of the CGM-user & technology development 23
24 Why not just link the CGM to an insulin pump to develop a biomechanical pancreas? INSULIN PUMP CONTINUOUS GLUCOSE MONITOR
25 Mechanical Systems can t Compete with Normal Physiology Insulin Glucose Bonner-Weir,
26 Delayed Absorption Kinetics of Subcutaneous Delivered Insulin 400 Insulin (pmol/l) Time (minutes) Insulin levels after mixed meal in a non-diabetic subject Insulin levels after subcutaneous injection of Aspart insulin Ahrén, 2001; Heinemann,
27 Blood vs Interstitial Glucose Monitoring: Effect of Physiologic Lag Continuous sensors measure interstitial glucose Blood & interstitial glucose do not always correspond: ~ 5-30 minute delay in equilibration glucose after meals - capillary before interstitium glucose with insulin & exercise - sometimes interstitium before capillary From Koschinsky, 2001 (modified after Rebrin, 1999) 27
28 Mechanical Closed Loop responds very slowly to changes in the glucose concentration Absorption of insulin (~50 min) Insulin action (~30 min) INSULIN PUMP CONTINUOUS GLUCOSE MONITOR Physiologic lag & signal processing delay (0-30 min) 28
29 Continuous interstitial glucose monitor Continuous subcutaneous insulin pump PID control algorithm Adults with T1D, in CRC Steil,
30 Continuous interstitial glucose monitor Continuous subcutaneous insulin pump Use of manual priming bolus ( Hybrid CL ) to improve postprandial glucose excursions Children with T1D, in CRC Weinzimer,
31 Steps ahead to Facilitate fully Automated Mechanical Closed Loop Control Faster acting-insulins/more rapid absorption Improved sensor reliability and accuracy, especially in low glucose range Multi-hormone control systems - glucagon to prevent/treat hypoglycemia - pramlintide to delay gastric emptying/attenuate postprandial spikes Both efficacy and safety will need to be established 31
32 The patient s brain needs to be the pancreas: linking glucose sensor output to insulin pump to maintain glucose levels in the target range INSULIN PUMP CONTINUOUS GLUCOSE MONITOR
33 What are the additional Unmet Needs to support CGM Adoption? Infrastructure to support patient education: More than just button pushing, how to use information to improve diabetes management and control Tools to sustain long-term patient engagement in self-care Tools for data analysis and decision support: Identify patterns/trouble-spots guide therapeutic decision making Focus on human factors in device design: Diabetes medical devices are consumer items 33
34 Infrastructure for Intensive Diabetes Management Weight 34
35 Thank You 35
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