1-novak-understanding technology...5/16/2018 1 integrating diabetes technology into your practice :...
TRANSCRIPT
5/16/2018
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Integrating Diabetes Technology Into your Practice : Insulin Pump Therapy
Lucia M. Novak, MSN, ANP‐BC, BC‐ADM, CDTC
Director, Riverside Diabetes Center, Riverside Medical Associates
Riverdale, MD
Adjunct Assistant Professor, Uniformed Services University of the Health Sciences
Bethesda, MD
Diosclosures
• Speaker’s Bureau: Novo Nordisk; AstraZeneca; Janssen
• Consultant: Sanofi; CeQur; Intarcia
• Advisory Board: Sanofi; Intarcia
What exactly is an Insulin Pump?
• Not a dumb question!• Not a simple answer!
• Line Pumps• Most of the pumps currently available• Medtronic• Tandem
• Patch Pumps• OmniPod• V‐Go• OneTouch Via (bolus only, not yet)• PAQ (not yet)
• Animas• Accu‐Chek Combo/Spirit• Asante
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Pump Manufacturer
Animas 18%Medtronic 52%
Insulet 17%
Tandem 12%
Other 1%Roche <1%
T1D Exchange data
What Do Insulin Pumps Do?• Delivers insulin
• Continuous basal delivery automatically • Programmed• adjustable
• Bolus doses to address meals or correct elevated blood sugars • directed by the user• calculations are programmed to help the user with the “math”
What DON’T Insulin Pumps Do? –At least not yet!
• Automatically respond to changes in blood glucose without any input from the user
Who Can Have One?• Anyone with Diabetes that requires basal/bolus insulin administration
Who Should Have One?• Anyone with diabetes that requires basal/bolus insulin administration and is doing so (≥ 4 injections; ≥ 4 SMBG)
• motivated to achieve optimal glucose levels
• willing and able to perform required tasks to ensure safe/effective
• actively participating in their diabetes management and with their health care team
• realistic expectations• ~350,000 to 515,000 of people with DM Grunberger, G, et al. (2014). Endocr Pract,20, 463‐489.
Peters, A, et al. (2016). J Clin Endocrinol Metab, 101, 3922‐3937.
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Who Should Order one?
• Providers who possess the necessary knowledge, skills and resources• Only about 2000 physicians currently prescribe pumps
Grunberger, G, et al. (2014). Endocr Pract,20, 463‐489.
Clinical Characteristics of Patients
T1DM
• Neg. c‐pep, a/o pos. Antibodies
• Labile glucose
• Hypoglycemia (severe, unaware)
• Dawn Phenomenon
• Extreme insulin sensitivity
T2DM
• +c‐peptide, but requires MDI
• Erratic lifestyle
• Dawn Phenomenon
• Severe IR
• Microvasc/macrovasccomplications
Grunberger, G, et al. (2014). Endocr Pract,20, 463‐489.
Pros and Cons
Pros
• Attached• Convenience/discreet• Easier Problem Solving
• Fewer lows• Precise insulin dosing• Improved glucose control (hopefully)
• More compatible with life/living
Cons
• Attached• Inconvenience/indiscreet• Site infection/irritation• Inc. risk DKA/hyperglycemia
• Cost!• More work
• Training!
Bottom Line: Patient’s disease, patient’s choice
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One Month of Insulin Doses – at least 4x daily
THIS?
OR THIS?
x10
Unrealistic Realistic
Setting the Right Expectations
The pump will cure my diabetes
I won’t have to check as much
I can eat anything I want
My blood glucose will be perfect
It will be as easy to learn as a meter
I will feel better
I must monitor very frequently
I will have more freedom with my food choices
I will have better control with fewer lows
It will take time to learn and adjust to the pump
Cost Is a SIGNIFICANT Consideration • Average start‐up price can be as much as $7500.
• Disposable infusion supplies will cost a minimum of about $250 per month.
• Cost of insulin
• Blood Glucose monitoring supplies
• CGM supplies
• Insurance coverage varies widely, but is often 80%.
• Annual Deductibles need to be met
• For Medicare INSULIN Prescritions:• MUST INCLUDE ”USE WITH INSULIN PUMP” so that insulin is covered by part B!!!!
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Pump TrainerHalf day for Mechanical Training
Diabetes Educator/Nurse PractitionerTwo hours with CDE/NP
Return in two daysReturn in 1 wk, 1 mo, 2 mo, then every 3 mos
Fax/email BG 1‐2 weekly for 1‐2 months
OngoingReturn to Primary Provider within 3‐6 monthsAnnual return for review & continued education
Why All The Visits ?• Allow the patient to adjust to new therapy• Incorporate into life style and make changes as needed
• Provide basic education, adding information each visit
• Work on improving BG control as well as providing therapy that enhances life style
• Teach higher level skills as patient is ready• Empower patient to own new therapy
• Provide an ongoing relationship with team
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No Team? Still Can Pump!Pick What Works For You
•Refer to sites that have a pump program •Pump Company Trainer and clinical Teams•Pump Clinical Experts•Referrals• Shared visits•Know the pump and the therapy
Pumping Basics
• Type of insulin used• Only fast or rapid‐acting insulin
• Aspart, Lispro, Glulisine most commonly
• Regular U100
• Regular U500
• Must change insertion sites every 3 days maximum – but FAR less needle insertion than MDI!
• Must test BG at least 4x daily or use CGM • Device‐specific for # fingersticks needed
• Lowers risk for hypoglycemia, BUT increases risk for hyperglycemia
Talk the Talk: Pumping Lingo
• TDD= Total Daily Dose (of insulin)• Basal + all bolus doses administered in 24 hours (average for 1 week) x 0.75• 0.23 x weight in lbs (or 0.5 x wt in Kg)
• Basal= approx. 50% of TDD divided over 24 hours• 18 units ÷ 24 hours = 0.75 units/hour
• ICR= Insulin‐to‐carbohydrate ratio• How many carbohydrates 1 unit of insulin will adequately address• 500 ÷ TDD
• 500 ÷ 36 = 1:14 (can round to 15 for ease)• 1:10; 1:15; 1:20; 1:5; 1:3
• ISF= Insulin Sensitivity Factor• How many mg/dL 1 unit of insulin will reduce blood glucose (over a 4‐5 hours)• 1700 ÷ TDD of pump
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Talk the Talk: Pumping Lingo (cont.)
• Blood glucose target• The BG that pump bolus calculator uses to determine bolus doses
• Choose a number rather than a range
• IOB (insulin‐on‐board)• The amount of insulin still working from a previous bolus
• Subtracted from next bolus to prevent insulin STACKING
• Insulin stacking• Administering bolus doses too close together (< 4 to 5 hours apart) and causing overlapping of peaks – LEADS TO HYPOGLYCEMIA
• Incorrectly attempting to correct an elevated BG
Bolus Calculator: Does the Math!
• All of the aforementioned items are determined by patient and HCPand then entered into the pump.
• The patient MUST enter blood glucose
AND
Grams of carbohydrates preparing to eat
• The pump will calculate and suggest a bolus dose
• Pt will either accept the suggested dose or override (take more or less depending on other circumstances (activity, illness, etc.)
Comparing Pumps –Some Things to Consider• Basal increments; number of profiles; temporary settings
• Bolus increments; max bolus dose; duration of delivery; mode of delivery (quick; standard; extended/square; multiwave)
• Size – yes, it matters! Weight
• Communicates with other devices
• Reservoir; priming; rechargeable; backlight; readability; navigation/user‐friendly; touch screen; waterproof; lockout; alarms; CGM compatible or integration; software/reports; wearability
• Customer Service
• Cost/insurance
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Other Considerations
• Supplies to order• Insulin (vials) – consider month of TDD; each vial discarded after 28 days of initial use• Tubing; insertion kits (frequency of site changes every 2 to 3 days)• Test strips specific to compatible meter (if applicable)
• Emergencies:• Insulin Pens AND needles or insulin syringes (to be used with vial)• Glucose tablets; Glucagon kit• Medic Alert ID
• Travel:• Exposure to X‐ray (TSA screening) (“Notice of Medical Device” Letter)
• OmniPod pods and PDAs can safely pass through airport X‐Ray machines• Carry‐on bags! And other storage• Time zone and climate changes• Delays/cancellations
Dexcom: Notice of Medical DeviceNotice of Medical Device
Clinic Name:_______________________
Address:__________________________
__________________________
__________________________
To whom it may concern:
The following patient,___________________________, is using a Dexcom Continuous Glucose Monitoring System that is not removable and needs to remain connected to the patient. This prescribed medical device is comprised of three components:
1. A small sensor that is imbedded underneath the skin that measures glucose levels. 2. A transmitter that is fastened on top of the sensor that sends data wirelessly to a compatible smart
device or a receiver. 3. A display device which can be the Dexcom Receiver or a compatible smart device.
Because the sensor is inserted under the skin, and is connected to the transmitter, neither the sensor nor the transmitter can be removed from the patient.
Sincerely,
__________________________________
Doctor’s Name:_____________________
Title:______________________________
State License Number:________________
www.Dexcom.com/Dexcom‐airport‐and‐travel‐guide‐flying‐Dexcom‐cgm
Tandem: Flying with Your Tandem insulin Pump
www.tandemdiabetes.com/docs/default‐source/general‐guides/ml‐1000524_a_print_info_card_tsa.pdf?afvrsn=9bad3ed7_2
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Medtronic: Airport Information Card (User Guide)
Pumps available in US as of 2014
Grunberger, G, et al. (2014). Endocr Pract,20, 463‐489.
It has only been 4 years! – just sayin!!
Which are still available in US today?
Sensor‐Enhanced Pumps
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• Medtronic MiniMed Paradigm Revel• FDA‐approved for 7‐17 yrs old (pediatric system)* and 18 yrs old + (non‐pediatric system)
• MiniMed 530G• FDA‐approved for 16 yrs old +• Threshold Suspend (TS) feature when sensor is reading low
• Animas Vibe• FDA‐approved for 2 yrs old +• No remote• Company no longer in pump business
• Tandem t:slim G4• FDA‐approved for 2 yrs old +
• Tandem t:flex• Holds 480 units of insulin• Demand low, no longer in production
The NEWER stuff is pretty amazing though!!
MINIMEDTM 630G with ENLIGHT TM Sensor
SMARTGUARDTM TECHNOLOGY:Low Glucose Suspend
(for up to 2 hours)30‐minute PREDICTIVE ALERTS
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t:slim X2TM with Dexcom G5® CGM integration
Only 2 glucose tests daily (calibration). It is only CGM system FDA approved for dosing of insulin.
COMING SOON!!!!Predictive Low Glucose Suspend With Dexcom G5 (and eventually G6)
Control‐IQ Hybrid Closed Loop with Automatic Correction Bolus with Dexcom G6
ALL THAT AND WITHOUT FINGERSTICK TESTING!!!!!
BUT ‐‐ The Future is NOW!
The MiniMed® 670G System
CGM‐GUIDED BASAL INSULIN DELIVERY SYSTEM
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BEFORE USING 670G
Basal rate: 1u/hr x24 hrICR 1:15 CF: 50BG Target: 110 mg/dL
Current A1c: 8.4%
How does the Auto mode feature work?AUTOMATED BASAL INSULIN DELIVERY
Auto Mode:
48 hours before it kicks in (we usually wait 2 weeks in Manual mode)
Warm up period 60‐120 minutes Delivers automated basal insulin doses every 5 minutes
Automated basal target = 120 mg/dL Temporary target of 150 mg/dL can be used
Bolusing & Meals
Must enter blood glucose (BG) readings and/or carbohydrate grams ( 15 minutes before meals)
CURRENT A1c: 7%
Basal rate: MN to 12: 1 u/hr12 to 22: 1.1 u/hr22 to MN: 1 u/hrICR 1:15 CF: 50BG Target: 110 mg/dL
NOW USING 670G:
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One Future Bionic Pancreas:The “iLet” – Coming soon to a Body Near You!!
INSULIN
GLUCAGON
Not Just for Type 1!
A1c Reduction of 1.1% in Insulin Pump Group
9%
8.6%
7.9%
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Lower Total Daily Insulin Dose in PUMP Group
97u
122u
Disposable Patch Pumps for Type 2:
V‐Go
https://www.go‐vgo.com/
https://www.go‐vgo.com/hcp/prescribing‐dosing
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Disposable Patch Pumps for Type 2:
PAQ (not yet available in US)
http://www.cequrcorp.com/cequr‐paq/
http://www.cequrcorp.com/cequr‐paq/
Disposable Patch Pumps for Type 2:
OneTouch Via (not yet available in US)
• Bolus delivery only (must inject basal separately)• 2 unit increments• Reservoir: 200 units rapid acting• 72‐hours wearability
https://www.onetouch.com/about‐us
https://www.jnj.com/media‐center/press‐releases/new‐data‐show‐on‐demand‐mealtime‐insulin‐delivery‐system‐enabled‐more‐than‐fifty‐percent‐of‐patients‐to‐report‐improved‐dose‐compliance
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Potential Pump Candidates
‐54 yr old male with Type 2 x 12 years‐s/p kidney transplant in 2011‐Control poor pre‐transplant but now pt “doing great”‐ Has not been testing but knows sugars are “perfect”
except for occasional AM hypo‐Takes Lantus 36 SQ daily and Amaryl 4 BID‐You continue regimen but ask him to begin testing AC
and HS‐You send for A1c
Case Study 1: JV
A1c: 10.3%
Only preforms SMBG in morning“too busy at work”
Case Study 1: JV
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• 29 y.o female with Type 1 for 15 years
• A1c’s ranging from 7.0‐8.6% over the past two years
• Basal bolus regimen Lantus 12 and Novolog qAC
• Checks her blood sugars qac and qhs as directed
Case Study 2: CZ
• Not interested in pump therapy at this time
• Very frustrated, wants to start trying to conceive
• Despite fingersticks being “good” on log, A1c never at target!
• Discuss checking PP with patient, keeping food log, and suggest Real Time CGMS
Case Study 2: CZ
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A1c today in‐office 7.8%
• 21 yo female college student
• on MDI and CGMS
• A1c= 11.7%
• Prescribed Lantus 12HS and Humalog
• Insulin/Carb Ratio (ICR)= 1/8, and
• Insulin Sensitivity Factor= 1/50
• Target of 120 mg/dL
• Complaining of am hypoglycemia
Case Study 3: E.C.
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Characteristics of Patients Most Often Meeting A1C Goals
more often using insulin pumps
A1c <7.0% vs A1c >9.0%:more frequent self‐monitoring of blood glucose
missing fewer insulin doses
bolusing before meals rather than at the time of or after meal
using meal specific insulin:carbohydrate ratios
T1D Exchange data