Clinical Validity of Insulin Bolus Calculators
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1 Clinical Validity of Insulin Bolus Calculators Howard A. Wolpert, MD Senior Physician, Joslin Diabetes Center Associate Professor, Harvard Medical School Director, Joslin Institute for Technology Translation FDA Public Workshop: Regulatory Science Considerations for Software Used in Diabetes Management November 13 th 2014 Harvard Medical School
2 Presenter Disclosure Information Abbott Diabetes Care Glooko Tidepool
3 Topics for Discussion QUESTION 1: How can patients and providers be confident that the insulin bolus values obtained from the calculators are accurate and appropriate for their use? QUESTION 2: What information do patients and providers need about how a particular calculator works so that they may appropriately use the calculator for diabetes management? QUESTION 3: How can FDA foster both innovation and safety of insulin dose calculators intended for use by healthcare practitioners? QUESTION 4: How can FDA foster both innovation and safety of insulin dose calculators intended for use by patients?
4 Topics for Discussion QUESTION 1: How can patients and providers be confident that the insulin bolus values obtained from the calculators are accurate and appropriate for their use? How is insulin often dosed in practice?
5 Book dedicated to Karl B. Smith, Jr. ( ) Diagnosed with diabetes summer 1922, aged 6 Died winter 2006, three weeks before 90 th birthday: tennis in the morning, followed by lunch, failed to wake up from afternoon siesta Personal experience informs what is best for individual patients Patient is the ultimate decision-maker in day-to-day diabetes management Clinician s role is not simply to prescribe insulin doses, but to guide the patient in making informed dosing and diabetes self-management decisions Collaborative - instead of prescriptive - model of care required in diabetes has implications for how many patients can be expected to use bolus calculators
6 Standard Insulin Replacement Regimen in T1D Early 1990 s Breakfast Lunch Dinner Regular insulin NPH insulin 4:00 8:00 12:00 16:00 20:00 24:00 4:00 Constraints: Eating had to organized around the insulin profiles Insulin dosing: Relatively fixed Trade-off: Less flexibility in eating often poorer adherence
7 Basal-Bolus/Flexible Insulin Therapy: Past 2 decades Breakfast Lunch Dinner Aspart/Glulisine/Lispro Detemir/Glargine 4:00 8:00 12:00 16:00 20:00 24:00 4:00 Milestones in the evolution of intensive insulin therapy: 1993: DCCT 1995: Introduction of 1 st analog insulin (Lispro) 2003: Introduction of 1 st pump with Time bolus calculator (Deltec Cozmo)
8 The Current Approach: Food Insulin Dose Calculation Carbohydrate quantity Insulin-to-Carb ratio X = Insulin dose This dosing formula - which is incorporated in current insulin bolus calculators - has never been scientifically validated Does this approach work in practice? Yes.but, not as well as is supposed
9 Limitations and Assumptions.. Carbohydrate quantity Insulin-to-Carb ratio X = Insulin dose Is accuracy in carb counting a realistic goal for most patients?
10 Carbohydrate counting skills 2D Graph 1 in adult pump patients at Joslin grams 40 HbA1c 30 Y Data X Data Patient estimated quantity (grams) Col 3 vs 7.0 Col
11 Limitations and Assumptions.. Carbohydrate quantity Insulin-to-Carb ratio X = Insulin dose Is accuracy in carb counting a realistic goal for most patients? Assumes that carbs are the only dietary ingredient that affects insulin requirements. Is there any scientific validity to carb-based insulin dosing? Assumes that getting the insulin dose correct is all that matters. To achieve optimal postprandial glucose control insulin action needs to match carb absorption
12 Insulin Pharmacodynamics Aspart Lispro Cheerios Glycemic Index = 83
13 Insulin Pharmacodynamics Aspart Lispro Oatmeal Glycemic Index = 49 To optimize postprandial glucose control, sometimes need to change food choices Highlights the limitations of focusing on accuracy of bolus calculator settings alone as a key therapeutic endpoint in intensive diabetes management
14 Insulin Pharmacodynamics Aspart Lispro Steak & fries Free fatty acids induce insulin resistance Does dietary fat increase insulin requirements? Roden et al, J Clin Invest 1996; 97:2859 Belfort et al, Diabetes 2005; 54:1640 Boden et al, Diabetes 2001; 50:1612 Frias et al, Diabetes 2001; 50:1344
15 Closed Loop Protocol in CRC CRC protocol Day 1 Day 2 Day 3 Admit Open Loop Closed Loop 12 6p 11p 8a 12 6p 11p 8a 12 Lunch Dinner High Fat or Low Fat Wolpert et al, Diabetes Care 2013; 36:810
16 Closed Loop Protocol in CRC Day 1 Day 2 Day 3 Admit Open Loop Closed Loop Open Loop Closed Loop 12 6p 11p 8a 12 6p 11p 8a 12 Lunch Dinner Breakfast Lunch Dinner Breakfast High Fat or Low Fat High Fat or Low Fat Wolpert et al, Diabetes Care 2013; 36:810
17 300 **** High Fat Dinner Low Fat Dinner Glucose (mg/dl) **** p < p 8p 10p mid 2a 4a 6a 8a 10a noon Time 15 Insulin Delivery (U/h) 10 5 ** ** p < p 8p 10p mid 2a 4a 6a 8a 10a noon Time Wolpert et al, Diabetes Care 2013; 36:810
18 Carbohydrate quantity Insulin-to-Carb ratio X = Insulin dose The current approach to food insulin dose calculation incorporated into current bolus calculators is not scientifically valid In practice, to achieve optimal glycemic control patients need to adjust the insulin dose based on other factors, including activity, dietary fat, alcohol, etc
19 Carbohydrate quantity Insulin-to-Carb ratio X = Insulin dose QUESTION 1: How can patients and providers be confident that the insulin bolus values obtained from the calculators are accurate and appropriate for their use? All bolus dose recommendations whether generated by a bolus calculator or derived from a paper-based algorithm are inherently inaccurate since do not incorporate adjustments for other factors affecting prandial insulin requirements In practice, these bolus recommendations are starting point in insulin dosing decisions. Based on experience, patients learn whether dose is appropriate for their use
20 Use Cases for Insulin Bolus Calculators All time Most time Some time Rarely None Newly-diagnosed T1D T1D during intensification phase (not yet confident in self-adjustment) Physiologically changing insulin requirements e.g. childhood/adolescence, pregnancy Initial dose titration e.g introduction of basal insulin in T2D Hospital-based protocols Limited numeracy Impaired cognition Low self-management confidence T1D with improving self-mastery of DM management T1D: Maintenance phase Independently minded Precontemplative/ Disengaged from self-care
21 QUESTION 2: What information do patients and providers need about how a particular calculator works so that they may appropriately use the calculator for diabetes management? CORRECTION INSULIN BOLUS CALCULATION: Current glucose Target glucose Sensitivity factor = Correction dose Insulin on board = Recommended Insulin dose
22 Effect of Different Target Glucose Goals in Bolus Calculators on Correction Dose Target Current glucose glucose Sensitivity factor = Correction dose Insulin on board = Recommended Insulin dose Animas & Roche bolus calculators use mid-point of programmed target range in dose calculation Medtronic MiniMed bolus calculator uses upper limit of programmed target range in dose calculation Zisser et al, DT&T 2010; 12:955
23 Effect of Different Target Glucose Goals in Bolus Calculators on Correction Dose Protocol: Under-bolused for meal, corrected 2 hours later using boluses recommended by pump dose calculator Head-to-head comparison of Animas, Medtronic MiniMed and Roche Hypo Events Zisser et al, DT&T 2010; 12:955
24 Considerations in the Settings for Insulin-on-Board Function in Bolus Calculators Target Current glucose glucose Sensitivity factor 100% = Correction dose Insulin on board = Recommended Insulin dose Compensates for active insulin from previous bolus Reduces risk for hypoglycemia from dose stacking 75% 55% on board 50% 25% 20% on board 0% TIME (min) Bolus Bolus Bolus
25 Considerations in Calculating IOB 1. Insulin duration of action PK Pharmacokinetic data (package inserts) is misleading about insulin action profile PD Aspart (NovoLog) insulin Marked inter- and intra-individual variability Other factors include: - Insulin dose - Temperature - Exercise - SC fat thickness Østerberg et al, J Pharmacokinetics & Pharmacodynamics 2003; 30:221
26 Considerations in Calculating IOB 2. Pump differences in insulin action curve Linear Curvilinear Driven by IP considerations and competitive marketing, little practical relevance Zisser et al, DT&T 2008; 10:441
27 Practical Considerations in Setting Insulin Duration of Action Primary consideration in selecting insulin duration of action is risk for hypoglycemia from dose stacking If priority is avoidance of hypoglycemia (e.g. hx of severe hypoglycemia, hypoglycemia unawareness) set duration longer Reduces risk for stacking and hypoglycemia But may overcompensate for IOB, leading to under-dosing and failure to adequately correct
28 What Insulin Bolus Should the IOB Calculation Consider? When calculating correction bolus: Approach #1: Subtract out IOB from previous correction bolus only, or Approach #2: Subtract out IOB from previous correction + carbohydrate bolus Depends on type of carbohydrate load consumed: Approach #1 assumes carbohydrate-on-board at time correction dose is taken i.e. low glycemic index meal Approach #2 assumes NO carbohydrate-on-board at time correction dose is taken i.e. high glycemic index meal In practice: #2 will lead to more aggressive reduction in correction dose, protecting against hypoglycemia
29 QUESTION 2: What information do patients and providers need about how a particular calculator works so that they may appropriately use the calculator for diabetes management? 1. While patients need to know the key elements in dose calculation, not realistic to expect most patients or clinicians to understand complexities and nuances of IOB calculations 2. In practice, important to know whether particular IOB settings are biased to aggressive vs cautious insulin delivery
30 QUESTION 2: What information do patients and providers need about how a particular calculator works so that they may appropriately use the calculator for diabetes management? 3. Impossible to perform scientifically-valid studies to evaluate bolus calculators that would be generalizable to real-world use Experimental challenges include: Appropriate attention control group Difficulty in isolating benefit of bolus calculator from other variables (such as carb counting skills) that are determinants of success in using the technology Appropriate characterization of study population (likely benefit from/need for bolus calculator depend on diabetes self-management mastery) Inherent bias of algorithms related to food choices
31 QUESTION 3: How can FDA foster both innovation and safety of insulin dose calculators intended for use by healthcare practitioners? QUESTION 4: How can FDA foster both innovation and safety of insulin dose calculators intended for use by patients?
32 QUESTION 3: How can FDA foster both innovation and safety of insulin dose calculators intended for use by healthcare practitioners? QUESTION 4: How can FDA foster both innovation and safety of insulin dose calculators intended for use by patients? Break down the questions: How can FDA foster both innovation and safety of bolus calculators?
33 QUESTION 3: How can FDA foster both innovation and safety of insulin dose calculators intended for use by healthcare practitioners? QUESTION 4: How can FDA foster both innovation and safety of insulin dose calculators intended for use by patients? Break down the questions: How can FDA foster both innovation and safety of bolus calculators? How does intended use of bolus calculators by healthcare practitioners and patients differ?
34 How Does Intended Use of Bolus Calculators by Health Care Practitioners and Patients Differ? Healthcare practitioners and patients use bolus calculators in different environments > challenges and priorities in diabetes management in medical facilities are different to home/outpatient setting In outpatient diabetes management precedence is on flexibility in dosing with deviation from prescribed boluses to account for other factors (such as activity, alcohol, etc), whereas in the hospital the focus is on close adherence to prescribed medication dosing protocols In ICU: fewer confounding factors affecting glucose (food intake, exercise) + faster insulin action time (iv) > tight glycemic control easier to accomplish with less need for deviation from prescribed protocols Scientific validity of dosing algorithms used by health care practitioners in ICU can be evaluated much more readily than that of insulin bolus calculators used by patients in home environment These differences need to be factored into regulatory requirements
35 Bolus Calculator Tools: Today Regulated Medical Devices Smartphone Apps Innovation, no regulation
36 Bolus Calculator Tools: Today Regulated Medical Devices Smartphone Apps Innovation, no regulation
37 Bolus Calculator Tools: Today Regulated Medical Devices Smartphone Apps Innovation, no regulation
38 Bolus Calculator Tools: Today Regulated Medical Devices Smartphone Apps Innovation, no regulation
39 Bolus Calculator Tools: Tomorrow Balancing Innovation and Safety Regulated Medical Devices Regulated Diabetes Data Management and Decision Support Platforms Diabetes Management Apps: Software Validated Smartphone Apps Data Inputs
40 Regulatory Science Considerations for Software Used in Diabetes Management Concluding Comment Different risk mitigation approaches and regulatory pathways are required for: 1) Software that operationalizes paper-based insulin dosing instructions, including algorithms, prescribed by HCPs in routine diabetes management versus 2) Software incorporating more sophisticated insulin delivery algorithms that automatically optimize insulin doses without HCP verification (such as AP) Case 2) requires full clinical trials since HCP is not in the loop, whereas for Case 1) strict adherence of the software company to quality control, including extensive testing and usability studies with patients and HCPs, would be adequate
41 Thank you
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