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  • Bruce W. Bode, MD, FACE

    Atlanta Diabetes Associates

    Atlanta, Georgia

    Technology Update in Diabetes Pumps, Sensors, and Progress Toward Closed Loop Systems

  • Disclosures

    � Research and Grant Support to Employer: Abbott, Biodel, DexCom, Halozyme, Lilly, MannKind, Medtronic, Novo Nordisk, Sanofi, Valeritas

    � Consultant: Abbott, Halozyme, Medtronic, Novo Nordisk, Sanofi, Valeritas

    � Speaker’s Bureau: DexCom, Lilly, Medtronic, Novo Nordisk, Sanofi, Valeritas

  • 1

    3

    5

    7

    9

    11

    13

    15

    6 7 8 9 10 11 12

    Eye disease

    Kidney disease

    Nerve damage

    HbA1c

    Relative Risk of

    Complications

    Skyler, J: Endo Met Cl N Am, vol 25, 2, p.243- 254, June 1996 Adapted from DCCT Research Group: NEJM 1993;329:977-986 Minshall M, et al. Clin Ther. 2005;27:940–950.

    DCCT Results HbA1c and Relative Risk of Diabetic Complications

    6.5*

    Average US HbA1c Range

    7.8-8.6%

    AACE recommendation is

    6.5%

  • DCCT Research Group, 1993

    Trade-off between: Reducing Long-term Complications & Minimizing Hypoglycemia

    Patients used:

    • Regular insulin/ Intensive therapy via injections or insulin

    pump

    • Self monitoring blood glucose (SMBG)

    DCCT Results P

    rogression of R etinopathy

    (per 100 patient years)

    10

    8

    6

    4

    2

    0R at

    e of

    S ev

    er e

    H yp

    og ly

    ce m

    ia (p

    er 1

    00 p

    at ie

    nt -y

    ea rs

    )

    0

    20

    40

    60

    80

    100

    120

    Percentage of A1C Level

    Published 1993

  • Risk of Death Over a Range of Average A1c

    Riddle et al. Diabetes Care 2010

    Average A1c %

    Adjusted log (HR) by Treatment Strategy Relative to standard at A1c of 6%

    Standard strategy

    6 8 97

    Steady increase of risk from 6 to 9% A1c with intensive strategy

    Excess risk with intensive strategy vs standard occurred above A1c 7%

    Intensive strategy 1

    0

    –1

    HR = hazard ratio

  • Hypoglycemia and Cardiovascular Events

    � Tachycardia and high blood pressure

    � Myocardial ischemia

    – Silent ischemia, angina, infarction � Cardiac arrhythmias

    – Transiently prolonged corrected QT interval,

    – Increased QT dispersion � Sudden death

    Wright RJ, Frier BM, Diabetes Metab Res Rev 2008; 24: 353–363.

  • Mean Glucose & In-Hospital Mortality in 16,871 Patients with AMI

    (Reference: Mean BG 100-110 mg/dl)

    Kosiborod M et al. Circulation 2008:117:1018

  • 2005 Blinded CGM Study

    � 101 people with diabetes were placed on a blinded CGM and were told to do 10 finger stick blood tests a day; they averaged 9 tests per day

    - < 30% of day was 90-130 mg/dL

    - 30% of the day was >180 mg/dL

    - two hours a day was

  • Status of Diabetes Care: Therapy Advances Needed

    The Type 1 Exchange, n=25,000 subjects, 67 sites2

    Not at Goal Excess Hypoglycemia

    The average type-1 patient has: • Two symptomatic hypoglycemic events per week1

    • One or more episodes of severe, temporally disabling hypoglycemia per year • Nocturnal hypoglycemia occurs ~ 8.5% of nights2

  • Indications for Basal Bolus Therapy (MDI or Insulin Pump)

    � All Type 1 DM patients

    � All Type 2 DM patients not at goal (>6.5 to 7%)

    � All Hospital patients not at goal (>140 mg/dL)

    � All Pregnancy patients not at goal (Fasting >90 mg/dL; 1 hr PC >120 mg/dL)

  • 4:00 16:00 20:00 24:00 4:00

    Breakfast Lunch Dinner

    8:0012:008:00

    Time

    Glargine or

    Detemir

    RAI RAI RAI

    Pl as

    m a

    in su

    lin Basal/Bolus Treatment Program with Rapid-acting and Long-acting Analogs

    RAI: Rapid Acting Insulin (Aspart, Glulisine, Lispro)

  • Initiating SC Basal Bolus

     Starting total dose (TDD) = 0.5 x wgt. in kg Wt. is 100 kg; 0.5 x 100 = 50 units

     Basal dose (basal analog) = 50% of TDD at HS 0.5 x 50 = 25 units at HS

     Bolus doses (rapid analog) = 50% of TDD 0.5 x 50 = 25 divided by 3 = ~8 units pc (tid)

     Correction bolus = (BG - 100)/ CF, where CF = 1700/total daily dose; CF = 30

  • The pump delivers basal and bolus insulin precisely and can be easily customized as needed to meet individual requirements.

    0

    1.0

    2.0

    3.0

    4.0

    5.0

    6.0

    12am 4am 8am 12pm 4pm 8pm 12am

    Bolus insulin delivery

    Basal insulin delivery

    Basal programmed to help prevent dawn phenomenon

    Dual Wave™ Bolus for brunch

    Temporary basal during walking to help prevent hypoglycemia

    Dinner bolus

    Basal reduced to help prevent

    nocturnal hypoglycemia

    U ni

    ts o

    f i ns

    ul in

    Insulin Pump Therapy

  • Photograph reproduced with permission of manufacturer.

    Current Durable Insulin Pumps

  • – Durable light aluminum case

    – Shatter-resistant glass

    – Rechargeable battery

    Touch Screen Insulin Delivery System

  • Combo system • Offers an easy, quick* & discreet way to manage

    insulin pump therapy

    • “smart meter”

    Intelligent communication in both directions using Bluetooth® technology

  • Snap Pump with Insulin Cartridge

  • Snap Pump with Prefilled Insulin Cartridges � Uses prefilled 300 unit insulin cartridges that take seconds to drop in.

    � Automatically fills your tubing (autoprime) – saving you time.

    � Is 25% lighter than the leading pump.†

    � Never needs to have the battery changed or charged. Dispose post 300 units is used

    � Never requires an insulin reservoir to be filled

  • Infusion Sets

    • Subcutaneous indwelling catheters • Teflon cannula or steel needle • Must be changed every 2-3 days • pump and tubing may be disconnected without removing insertion

    site

  • Crimped soft canulae

  • Pump infusion sets: perpendicular vs oblique

    Perpendicular (Sof-set™, Quick-set™, Ultraflex™)

    - Easier insertion

    - Prone to kink

    Oblique (Silouette™, Tender™, Comfort™)

    - More difficult insertion

    - Less kinking

  • Patch Pump platform Just two simple parts

    �Fully integrated two-part design

    • Built-in FreeStyle® BG meter that automatically incorporates BG levels into suggested bolus calculations and history records

    • Integrated infusion set, insulin reservoir, automated inserter, and batteries

    �Automated processes • Cannula insertion

    • Priming

    � Intuitive user interface • Full text navigation

    • Set-up wizard

    • Easy to teach, easy to learn

    � Waterproof Pod 22

  • Simple Patch Pump for Type 2 DM

    23

    – Continuous preset basal insulin rate (20, 30 or 40 units/24 hrs)

    – On-demand mealtime insulin via 2 unit clicks (Max 18 clicks/36 units)

    – Uses only RAI – Easy to fill, apply, use, and

    remove every 24 hours – No electronics, batteries, infusion sets,

    or programming – Fully disposable

  • Metabolic Advantages with CSII

    � Improved glycemic control

    � Better pharmacokinetic delivery of insulin

    – Less hypoglycemia than NPH based therapy

    – Less insulin required

    � Improved quality of life

  • Current Pump Therapy Indications � Need to normalize blood glucose (BG)

    –A1C > 6.5% or 7%

    –Glycemic excursions

    � Hypoglycemia or Hypoglycemia unawareness

    � Need for a flexible insulin regimen

    Medicare requires: Fasting C-peptide to be ≤110% lower limit of normal or ≤200% lower limit of normal if CrCl ≤50 ml/min with concurrent FPG ≤225 mg/dL; or Beta Cell autoantibody positive (+ICA or +GAD antibodies)

  • US Pump Usage: Patients Using Insulin Pumps

    Industry estimates

  • Insulin Therapy Segmentation (US) – 2008

    T2 Conventional 3,080,160(69%)

    T1 Conventional 368,160 (48%)

    T1 MDI 398,840 (52%)

    T1 Pump Therapy 361,000

    T2 Pump Therapy 37,000

    T2 MDI 1,383,840 (31%)

    4.5 Million Type 2 (T2) >5.6 Million = 1.2 Million Type 1 (T1)

    >31% Penetration in Type 1

  • � Monitoring – A1C = 8.3 - (0.21 x BG per day)

    CSII Factors Affecting A1C

    Bode et al. Diabetes 1999;48 Suppl 1:264

    Bode et al. Diabetes Care 2002;25 439

  • Correlation between HbA1c levels and number of SMBG measurements

    6.00 6.25 6.50 6.75 7.00 7.25 7.50 7.75

    8.50

    8.00 8.25

    H bA

    1c (%

    )

    ≤1 2 3 4 5 6 7 8 9 10 10 Number of BG measurements per day

    Mean  0.95 CI n = 12,