Pumps & Sensors made easy. OPADA ALZOHAILI MD FACE Endocrinology Assistant Professor Wayne State University

Transcription

1 Pumps & Sensors made easy OPADA ALZOHAILI MD FACE Endocrinology Assistant Professor Wayne State University

2 DeFronzo RA. Diabetes. 2009;58: Ominous Octet

3 Relationship of b-cell Dysfunction and Development of Type 2 Diabetes Mellitus

4 Survival as a Function of A1C in Patients Type 2 Diabetes: A Retrospective Cohort Study* Oral Agents Insulin +/- Oral Agents Currie CJ, et al. Lancet. 2010;6(375): *28,000 patients 50 years and older

5 It s Not Just About A1C Anymore! Glycemic Variability A1C 7 Very high or very low blood glucose levels Missed with Fingersticks Missed with A1C Many HCP s strongly believe measuring glycemic variability in combination with A1C may be a more reliable indicator to reduce long term complications A1C 7.2

6 Glucose Fluctuations and Oxidative Stress Oxidative stress plays a major role in the pathogenesis of diabetic complications Oxidative stress measurement: daily urinary excretion of the F2 isoprostane 8-iso prostaglandin F2ά (8-iso PGF2ά) Glycemic disorders measurements: A1C and mean glucose: duration and magnitude of chronic sustained hyperglycemia AUCpp: duration and magnitude of post prandial hyperglycemia Mean Amplitude of Glycemic Excursions (MAGE): glycemic fluctuation through continuous glucose monitoring Monnier L. et al. Activation of Oxidative Stress by Acute Glucose Fluctuations Compared with Sustained Chronic Hyperglycemia in Patients with Sustained Chronic Hyperglycemia in Patients with Type 2 Diabetes. JAMA 2006;295 (14):

7 Insulin Normal Insulin Production The Pancreas A healthy pancreas releases insulin automatically in amounts appropriate for your varying blood glucose levels Schematic representation only. Marchetti P, et al. Diabetes. 1994; 43:

8 Insulin Conventional Therapy: NPH and Short-Acting Insulin Injection Injection Normal Insulin Secretion Short-acting Insulin NPH Hours Schematic representation only. 8

9 Insulin Intensive Therapy: MDI With Lantus and Rapid-Acting Insulin Injection Injection Injection Injection Normal Insulin Secretion Rapid-acting Insulin Lantus Hours 9

10 Various type of Pumps in Market

11 AACE Guidelines: Indications for Insulin Pump Therapy Type 1 Diabetes Patients Uncontrolled on MDI Frequent hypoglycemia and/or hypoglycemia unawareness Pregnancy Extreme insulin sensitivity Dawn phenomenon Microvascular complications On MDI who are willing and able to do frequent SMBG, carbohydrate counting, and insulin adjustment Type 2 Diabetes Patients Consider use of CSII in insulin-treated patients AACE Diabetes Mellitus Guidelines. Endocr Pract. 2007;13(suppl 1):

12 HbA 1C, % 1. Bruttomesso D, et al. Diabet Med. 2002;19(8): Bell DSH, et al. Endocr Pract. 2000;6(5): Rudolph DS, et al. Endocr Pract. 2002;8(6): Chantelau E, et al. Diabetologia. 1989;32(7): Boland EA, et al. Diabetes Care. 1999;22(11): Maniatis AK, et al. Pediatrics. 2001;107(2): Litton J, et al. J Pediatr. 2002;141(4): Continuous Subcutaneous Insulin Infusion (CSII) Improves Control Compared with MDI, insulin pumps are more effective at reducing HbA 1C Type 1 Patients MDI CSII Bruttomesso 1 Bell 2 Rudolph 3 Chantelau 4 Boland 5 Maniatis 6 Litton 7 (n=138) (n=58) (n=107) (n=116) (n=25) (n=56) (n= 9) Duration 89 months 36 months 36 months 54 months 12 months 12 months 13 months

13 1:00 AM 3:00 AM 5:00 AM 7:00 AM 9:00 AM 11:00 AM 1:00 PM 3:00 PM 5:00 PM 7:00 PM 9:00 PM 11:00 PM Units/Hour Basal Insulin Needs Vary Throughout the Day age 3-10 age age age > Hour Scheiner G, Boyer BA. Diabetes Research and Clinical Practice. 2005; 69:

14 GIR (mg/kg/min) GIR (mg/kg/min) GIR (mg/kg/min) Individual GIR profiles Levemir NPH-insulin Elapsed Time (hours) Each panel = 4 injections of the indicated formulation in an individual study subject. Insulin glargine T. Heise et al. Diabetes 2004;53:

15 Units of Insulin Insulin Pump Therapy (IPT) Programmable Insulin Delivery with Medtronic MiniMed Pump Therapy 6.0 Bolus insulin delivery Basal insulin delivery Dual Wave Bolus for brunch Basal reduced to help prevent nocturnal hypoglycemia Basal programmed to help prevent dawn phenomenon Temporary basal during walking to help prevent hypoglycemia Dinner Bolus am 4 am 8 am 12 pm 4 pm 8 pm 12 am Note: This is a schematic representation. 15

16 Events per Hundred Patient-Years Insulin Pump Therapy Reduces Number of Severe Hypoglycemic Episodes MDI vs CSII in type 1 patients MDI Pump Bode 1 Boland 2 Rudolph 3 (n=55) (n=25) (n=107) 1. Bode BW, et al. Diabetes Care. 1996;19(4): Boland EA, et al. Diabetes Care. 1999;22(11): Rudolph DS, et al. Endocr Pract. 2002;8(6):

17 The Bolus Wizard Calculator Individually customized with: Blood glucose targets Carbohydrate ratios Insulin-sensitivity factors Active Insulin Time Simplifies diabetes management Calculates estimated bolus for the patient Tracks active insulin Reduces hypoglycemic events resulting from stacking of insulin Bolus Wizard is a registered trademark of Medtronic Diabetes. Medtronic Minimed, Inc. Bolus Wizard Calculator. Accessed February 7,

18 Bolus Automatically Calculated The Gold Standard in Insulin Pump Therapy The Bolus Wizard Calculator MiniMed MiniMed Paradigm Insulin Pump 200 mg/dl Estimate Details Est total: 8.0 U Food intake: 60 gr BG: 200 Food: 6.0 U Correction: 2.0 U Active ins: 0.0 U ACT to proceed, ESC to back up ICR 1:10 gm = 2.0 U 50 (SF) Automatically calculates insulin bolus for the patient ICR=insulin/carbohydrate ratio. SF= sensitivity factor. 18

19 Addressing Postprandial Highs With Dual-Wave Bolus BG Change from Baseline in mg/dl Hours from Baseline One bolus Two bolus Square wave Dual wave Dual-wave = best method to address postprandial glucose Only possible with insulin pump therapy Gives superiority over MDI 1. Chase P, et al. Diabet Med. 2002;19(4): Wainstein J, et al. Diabet Med. 2005;22(8):

20 Calculate starting Doses Total daily dose (TDD) for Insulin Pump start Based on Pre-pump TDD On 30 lantus and 10 tid a/c of aspart: Total: 60 units, Reduce Pre-Pump TDD by 25% (60X 0.75= 45) Based on Patient Weight (80Kg) Weight: Kg X 0.5 ; or lbs. X 0.23= Pump TDD ( 80X0.5= 40) Clinical Guidelines: Use both methods and average the two values to determine the starting insulin pump TDD (eg: {45+40}/ 2= 42.5 For hypoglycemia or hypoglycemic unawareness, use the lower value. For consistent hyperglycemia, an elevated A1C, or in pregnancy, use the higher value. For erratic glucose control, or if starting insulin pump therapy at diagnosis or from oral medications, use the weight-based method.

21 basal rate Step#1: Total Daily Basal Requirement Divide Insulin Pump TDD in half eg: 42.5/2 = (total daily basal insulin) Step#2: Starting Hourly Basal Rate Divide total insulin pump basal requirement by 24 hours eg: /24 = 0.88/ hr Starting basal rate = 0.9 units/ hr Begin insulin pump therapy with one basal rate delivering evenly over 24 hours. Adjust or add additional basal rates based on glucose trends over two to three days.

22 Carbohydrate Ratio/ Meal Bolus Method # 1: 450 rule 450 divided by the Pump TDD= Carbohydrate ratio Eg: 450/ 42.5 = 11 grams 1 unit covers 11 grams of carbohydrate Method # 2: by weight Kg X 6/ Pump TDD or lbs X 2.8/ Pump TDD = Carb Ratio Eg: 80 X 6/42.5= 11 gms ( 1 unit covers 11 gms of carbohydrate). Method# 3: Fixed bolus ½ pump TDD divided by 3(equal meals) Eg: 42.5 x 0.5/3 = 7 units per meal

23 Insulin Sensitivity Factor (ISF)/ Correction bolus Sensitivity Factor: 1700 Rule 1700/ Pump TDD = ISF Eg: 1700/ 42.5 = 40 mg/dl One unit decreases BG = 40 mg/dl Correction dose Formula (Current BG Target BG)/ ISF= Correction Dose Eg: Current BG= 200, Target BG= 100 ( )/ 40 = 2.5 units (correction dose)

24 Pump

25 Pump

26 Pump

27 Pump

28 MiniMed Paradigm REAL-Time System Taken from medtronic.com

29 HbA1c Increased SMBG Testing Frequency is Associated With Lower HbA 1c Subcutaneous Insulin Insulin Pump Oral Medications No Insulin n=1255 patients n=552 no insulin Results indicate frequent BG testing reduces HbA 1C SMBG Frequency (BGpd) 7 8 Adapted with permission from Davidson PC, et al. J Diabet Sci Technol. 2007;1(6):

30 Logbook Diary Limitations: The Traditional Approach Problems faced with logbook approach 1,2 : Noncompliance: inconsistent record-keeping Incorrect transcription of glucose Missing data: I forgot at home or I left it in the car Adding data: falsification of information Illegibility of diary 1. Gonder-Frederick LA, et al. Diabetes Care. 1988;11(7): Ziegler O, et al. Diabetes Care. 1990;13(2):

31 The Value of REAL-Time Optimal Glucose Range Fingerstick Alert Schematic representation only. 31

32 Continuous Glucose Monitoring (CGM) CGMS ipro Recorder MiniMed Paradigm Guardian REAL-Time System HCP Patient Patient Provides real-time CGM information directly to an insulin pump 3 day test to provide retrospective CGM data Provides real-time CGM information to an external monitor SMBG is an integral part of all CGM products. 32

33

34 Meters and Sensors Measure in Different Places Blood and Interstitial Space Sensor Sensor and SMBG are testing at different sites Sensor mirrors its reading to match SMBG, a process called calibration Skin Interstitial Space Cells Capillary Medtronic Illustration: not to scale

35 How does a Glucose Sensor Work? * Example: Medtronic glucose sensor diagram Glucose Oxidase enzyme Glucose + O 2 H 2 O 2 + Gluconic Acid H 2 O 2 2H + + O e - Glucose utilized in chemical reaction Peroxide produced in reaction Peroxide yields electrons Electrons are electric signals More glucose yields more electrons which provide higher electric sensor signals Sensor signal

36

37

38

39

40

41

42 CGMS and Ramadan 190 patients with diabetes fasting in Ramadan had cgms place for 3-4 days Data collected on hypoglycemia hyperglycemia Most type 2 some type 1 even on pump

43 CGMS and Ramadan Most could fast without hypoglycemia during the day 18 type 1 patients were able to fast without complications 2 were on insulin pump Help predicted hypoglycemia, risk, different regimens Results?

44 U 500 Before

45 U 500 After

46

47

48 V- GO Before

49 V- GO After

50 / M MiniMed 530G with Enlite Featuring the World s First Breakthrough in Artificial Pancreas Technology* * that is approved in the United States by the Food and Drug Administration. Medtronic has a similar product already approved in Europe.

51

52 What is Threshold Suspend? Threshold Suspend automatically stops insulin delivery when sensor glucose values reach a preset low threshold 52

53 Threshold Suspend (TS) Automation Mimics some of the functionality of a healthy pancreas STOP Threshold Suspend automatically stops insulin delivery when sensor glucose values reach a pre-set low threshold Because the system stopped insulin delivery, glucose rises at a faster rate GO In absence of patient interaction, after 2 hours the system automatically resumes insulin delivery WARNING: The Threshold Suspend feature will cause the pump to temporarily suspend insulin delivery for two hours when the sensor glucose reaches a set threshold. Under some conditions of use the pump can suspend again resulting in very limited insulin delivery. Prolonged suspension can increase the risk of serious hyperglycemia, ketosis, and ketoacidosis. Before using the Threshold Suspend feature, it is important to read the Threshold Suspend information in the MiniMed 530G` System User Guide and discuss proper use of the Threshold Suspend feature with your healthcare provider.

54 INTRODUCING THE MINIMED 670G SYSTEM WARNING: Medtronic performed an evaluation of the MiniMed 670G closed loop system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin does of 8 units per day because the device requires a minimum of 8 units per day to operate safely. MiniMed, Guardian, and SmartGuard are registered trademarks of Medtronic MiniMed Inc. Ascensia, the Ascensia Diabetes Care logo, and Contour are trademarks of Ascensia Diabetes Care. The Bayer Cross is a registered trademark of Bayer 940M Medtronic MiniMed, Inc. All Rights Reserved.

55 THE MINIMED 670G SYSTEM* THE WORLD S FIRST HYBRID CLOSED LOOP SYSTEM Available Spring 2017! WARNING: Medtronic performed an evaluation of the MiniMed 670G close loop system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, this device should not be used in anyone under the age of 7 years old. This device should also not be used in patient who require less than a total daily insulin does of 8 units per day because the device requires a minimum of 8 units per day to operate safely.

56 INCREASING LEVELS OF SMARTGUARD AUTOMATION PERSONALIZED TO MEET PATIENT S NEEDS Suspend on low Suspend before low Auto Mode (Hybrid Closed Loop) SmartGuard HCL Technology

57 HOW DOES THE SUSPEND BEFORE LOW FEATURE WORK? NEW SMARTGUARD HCL AUTOMATION IN MANUAL MODE Suspend before low suspends insulin delivery before glucose levels reach a pre-set low, without alerting the user. Suspends insulin delivery when glucose is within 70 mg/dl above the low limit and predicted to reach within 20 mg/dl above the low limit in 30 minutes. Automatically resumes when glucose reaches 20 mg/dl above the low limit and predicted to reach 40 mg/dl above the low limit in 30 minutes and has been suspended for 30 minutes.

58 SUSPEND BEFORE LOW HELPS PREVENT LOWS CLINICAL EVIDENCE & REAL WORLD DATA Suspend before low reduces lows to allow more time in target range.* Clinical evidence and real-world data show 75-97% of lows were avoided using Suspend before low * *Choudhary P, Olsen B, Conget I, Welsh J, Vorrink L, Shin J. Hypoglycemia prevention and user acceptance of an insulin pump system with predictive low glucose management. Diabetes Technol Ther. 2016;18(5): *Medtronic data on field (OUS MiniMed 640G data).

59