updates in diabetes millerowen centeno -...
TRANSCRIPT
10/1/2016
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Updates in Diabetes :New Medications and Devices
Stacy Centeno, MSN, APN, CDE;Edward‐Elmhurst Health
Colleen Miller‐Owen, MSN, APN, CDE;Northwestern Medicine Regional Medical Group
Disclosures
• Stacy Centeno is a speaker for Roche.
• Colleen Miller‐Owen is a speaker for Dexcom, Eisai, Inc., Roche, and Valeritas.
↓DPP4
DPP4
↑ DPP4
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SGLT2 Inhibitors:Invokana, Farxiga, Jardiance
How it works: Allows the kidneys to flush out excess glucose in the urine and lower the glucose in the blood
Pros and Cons of SGLT2 ClassPros
• Once a day tablet
• Enhanced effect of a naturally occurring mechanism in the body.
• Free with copay card to those who have commercial insurance
• No restrictions of use with other meds or insulin
• Weight loss component
• Mild decrease of blood pressure.
• Data showing CV protection and potential long term renal protection.
• Effective and cost effective way to lower glucose and weight
Cons• Contraindications with renal
impairment• Higher risk of mycotic and UTI
infections. • Lab monitoring of CMP and possibly
U/A after initiation and periodically.• Has been associated with acute renal
disease. • Some reported cases of DKA with this
medication• Some correlation shown in increased
lower extremity amputations and osteopathic issues.
• Can cause polyuria • Important that patient hydrates when
on this. • Newer drug class
GLP‐1 Byetta, Victoza, Bydureon, Tanzeum,
Trulicity
Works in 4 ways:
1. Helps the pancreas to make insulin
2. Slows down food leaving the stomach
3. Reduces how much glucose liver makes
4. Reduces appetite and can aid in weight loss
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Pros and Cons of GLP1 Class
Pros • Can aid in weight loss• Enhanced effect of a naturally
occurring mechanism. • Can lower HgbA1C as much as 1.5% • Can lower insulin requirements • New data showing CV benefits of
this drug class • Easy to administer most are weekly
some are daily• New combined basal and GLP1
classes in 1 injection currently before the FDA with release anticipated in 2016
Cons Injection
AE: can cause GI side effects
Black box warning: Medullary thyroid cancer and Multiple Endocrine Neoplasia Syndrome Type 2
Not recommended if history of pancreatitis
Often not covered if on mealtime insulin
Costly/Copay cards
Patients can be leery because of negative commercials
Ways to deliver insulin
• Insulin Pen
• Vial/Syringe
• Insulin Delivery Device
• Inhaled
• Insulin Pump
• IV
Physiology of Insulin and Blood Glucose
Breakfast Lunch Dinner
Basal blood glucoseBlood
Glucose
Basal insulin
Insulin Secretion
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Classes of InsulinType Onset Peak Duration
Rapid
Humalog(Lispro)/U200
Novolog (Aspart)Apidra (Glulisine)Afrezza (Inhaled)
15 min10‐20 min10‐15 min12‐15 min
30‐90 minutes60‐180 minutes30‐90 minutes50‐60 minutes
< 5 hours3‐5 hours< 3 hours2.5‐3 hours
Regular (R)Humulin RNovolin RHumulin R U‐500
30‐60 min30 min30‐45 min
2‐3 hours21/2‐5 hours2‐4 hours
4‐6 hours8 hours8‐24 hours
NPHHumulin NNovolin N
2‐4 hours90 min
4‐10 hours4‐12 hours
14‐18 hoursUp to 24 hours
Pre‐MixedHumalog 75/25Humulin 70/30Novolin 70/30Humulin 50/50
15 min15‐30 min30 min15‐30 min
1‐6.5 hours2‐12 hours2‐12 hours1‐4 hours
18‐26 hours18‐24 hoursUp to 24 hours18‐24 hours
Peak less BasalLantus (Glargine)Levemir (Determir)Toujeo (Glargine)Tresiba ((Degludec)
1‐4 hours1‐4 hours1‐6 hours1‐6 hours30‐90 minutes
MinimalMinimalMinimalNoneNone
24 hoursUp to 24 hours24‐36 hoursUp to 36 hoursSteady state after 3‐4 days
www.Sithtech.net
Concentrated InsulinHow does it work? When do you use it?
U‐100 U‐200 U‐500
U‐100
Most Common
Vial or Pen
Basal, Bolus, Mixed
100 units/ML
1 Vial =1000 units/10 ML
1 Pen has 300 units Usually
Dosing varies by pen
60‐80 units/dose
1 Box= 5 pens
U‐200
Pen form only
1 Pen = 600 units
2 pens per box
Dose interchangeable with
U100 Qwikpen
Twice as concentrated
Less volume
Example: Current dose
20 units ; new dose remains 20 units
Dosing varies by pen 80‐160 units/dose
U‐500
Vial = 20ML Pen=3ML
1 vial = 10,000 units
1 Pen = 1500 units ‐ 2 per box
Can give 2‐4 times daily
5 times stronger than U‐100
Replaces basal and bolus insulin
Less Volume and more concentrated for patients on high doses of insulin
Indicated for patients on 1u/kg/day or 200 units/day
Example: Current dose 30 units now 6 units with vial
Pen does conversion automatically
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What is so special about the new concentrated insulin’s?
• Dosing is the same but patient receives less volume
• Important to preserve subcutaneous sites
• Better absorption• Overall more cost
effective (pens last longer, copay cards)
• Often simplifies regimen to that only take 1 injection of basal instead of 2
Site Selection
• Subcutaneous= fatty area just below the skin• Site of choice because little blood flow to fatty
tissue, and medicine absorbed more slowly• Do not use area if skin burned, hardened,
inflamed, or swollen• Each injection should be given about 1 inch
apart• Fastest absorption from abdomen, slower
arms, even slower legs, and slowest buttocks• Lipodystrophy: scarring of fat
Happens when inject too many times into same siteWhy is it a problem:
Decreases insulin absorption May increase glucose variability Insensitive to pain
•How to avoid: Appropriate site rotation Perform regular inspection Change needle with each injection
Blanco, M. Hernandez, M.T., Strauss, K.W.,& Amaya, M. Prevalence and risk factors of lipohypertrophy in insulin‐injecting patients with diabetes. Diabetes Metab.2013 39 (5) 445‐453. doi.org/10.1016/i.diabet.2013.05.006.Frid,A., Hirsch, L., Gaspar, R., Hicks, D., Kruegel, G., Liersch, J., Letondeur, C., Sauvanet, J.P., Tubiana‐Rufi, N., Strauss, K. New injection recommendations for patients with diabetes. Diabetes & Metabolism. 2010, Supplement 2: S3‐18. DOI: 10.1016/S1262‐3636(10)70002‐1
Teaching about length and reuse
The 4, 5, and 6 mm needles may be used by any age including adult patient and obese ‐No medical reason for pen needles > 8 mm in adults. ‐Begin Initial therapy with shorter lengths.
Used needle magnified 370 times Used needle magnified 2000 times
•Significant tip damage after only one injection •Most reused needles showed tip damage after only puncturing human skin (not even rubber stopper) •Tip of reused needle can weaken: break off and get imbedded under the skin •Reused needle doesn't inject as easily or cleanly as new one & may cause pain, bleeding, and bruising. •Correlation between needle reuse and lipohypertrophy exists
Frid,A., Hirsch, L., Gaspar, R., Hicks, D., Kruegel, G., Liersch, J., Letondeur, C., Sauvanet, J.P., Tubiana‐Rufi, N., Strauss, K. New injection recommendations for patients with diabetes. Diabetes & Metabolism. 2010, Supplement 2: S3‐18. DOI: 10.1016/S1262‐3636(10)70002‐1.Blanco, M. Hernandez, M.T., Strauss, K.W.,& Amaya, M. Prevalence and risk factors of lipohypertrophy in insulin‐injecting patients with diabetes. Diabetes Metab.2013 39 (5) 445‐453. doi.org/10.1016/i.diabet.2013.05.006
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Bolus Calculator Meter
• Programmable blood glucose meter
– Insulin to Carb Ratio
• For food intake
– Insulin Sensitivity Factor
• For blood sugar correction
Background
• Multiple daily injections (MDI) using insulin to carb ratio (ICR) and insulin sensitivity factor– Can improve glycemic control– Give greater flexibility
• Requires manual calculations of bolus doses– Time consuming– Potential for math errors
• Bolus Calculator Meter can be programmed with the ICR and ISF
Advantages of Meter
• Improvement in control without adding another type of medication
• More precise dosing and flexibility of carbohydrate intake compared to:
– Set insulin doses
– Sliding Scale
– Potential for error with manual calculation
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Advantages of Meter
• Randomized control studies showed– > 0.5% reduction in A1C
– Improvement in treatment satisfaction
– < 2% blood sugars less than 50mg/dl
• Retrospective Review of patients– 29 adult patients
– 1.3% decrease in A1C
– 0.67% decrease in BMI for Type 2
– Reduction in severe hypoglycemia
Advantages of Meter
• Advanced Features– Download reports/logbook
• Web based portal
– Insulin action time• Individualized to patient’s insulin absorption
• Prevent stacking of insulin
– Health Settings can adjust bolus based on:• Stress
• Exercise
• Illness
Disadvantages of Meter
• Need more training than traditional meter
• Insurance coverage can be a concern
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Conclusion
• Bolus Calculator Meter should be considered for patients:– Wanting improved glycemic
control
– Increased carbohydrate intake
flexibility
– Not interested/ready for insulin pump
Subcutaneous Insulin Delivery Device
• Disposable insulin delivery device
• Gives continuous insulin and bolus dosing
– Continuous basal insulin
• 0.83 units/hour
• 1.25 units/hour
• 1.67 units/hour
– Bolus doses
• Up to 36 units/24 hours
• 2 unit increments
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Most Patients on Insulin Therapy Not at A1C Goal
• 80% of patients have A1C > 7%– 50% of medications not taken as prescribed
• 57% of MDI Patients admit to missing doses– 20% miss regularly
– Small study showed 1 or more missed meal bolus increases A1C by 0.8%
• Increased basal doses does not improve control– Greater than 30 units basal or >0.5units/kg
• No improvement in A1C
• Increased risk of hypoglycemia
Subcutaneous Insulin Delivery Device
Advantages
– More physiologic insulin delivery
• Basal
• Meal time bolus
– Discrete and Easy to use
• Fill, Attach, Use
• Less injections
– Decreased insulin dose
• 13‐33% reduction in dose
– Medicare covered
Disadvantages
– Limited basal rates
– Limited total daily dose
– Adhesive issues: site irritation
– Bolus dosing in 2 unit increments only
– Insurance coverage
Subcutaneous Insulin Delivery Device
• Starting Doses
– Weight based
• Under 220 pounds– 20 unit device
– 4 units (2 clicks) at meal and titrate up to 36 units
– If max out doses, increase device size
• Over 220 pounds
– 30 unit device
– 6 units (3 clicks) at meals and titrate up
– If max out doses, increase device size
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Continuous Glucose Monitor
• Device reads glucose every 5 minutes
• Stand alone or integrated with pump
• Professional and personal
Continuous Glucose Monitor• What does a finger stick of 110 mg/dl mean
– At target?
– Okay to exercise?
– Safe to
go to sleep?
Continuous Glucose Monitor
• Why doesn’t log book always reflect A1C?
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Continuous Glucose Monitor
Advantages
– Decreased number of finger sticks
– Blood sugar trends between readings
– High/Low Alarms
– Directional Alarms
– See effect of exercise and other factors influencing blood sugar readings
– Billable Service 99250 and 99251
Disadvantages
– Accuracy
– Cost/Insurance Coverage
– Another infusion site
– Another device
– Need to calibrate
– Need to still test blood sugars
Professional Continuous Glucose Monitor
• Placed in office for patient to wear for 3‐7 days
• Review downloads to make therapy changes
Professional Continuous Glucose Monitor
• Advantages
– See trends/patterns not seen with usual self monitoring of blood glucose
– Make more meaningful treatment adjustments
– If not blinded, learning tool for patient as can see cause/effect
– May increase patient engagement in care and interest in home use
– Billable service 99250 and 99251
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Professional Continuous Glucose Monitor
• Disadvantages
– Limited time frame
– Only able to do 2‐4
times a year
– Additional
appointments for
patient
Continuous Glucose Monitor and Insulin Pump Combinations
Medtronic Pump/Sensor
– Threshold Suspend
Dexcom G4
– Animas Vibe
– Tslim/G4
Continuous Glucose Monitor/Pump Combinations
Advantages
– Medtronic Suspend feature
– Trend screen on pump
– Convenience
Disadvantages
– Not automatic delivery
– Another infusion site
– May not have latest continuous glucose monitor system
– Need to carry additional device to share data
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Stand Alone Continuous Glucose Monitor
• Advantages
– Not limited to specific pump
– Not required to use an insulin pump
– Latest technology
– Share data with others
Stand Alone Continuous Glucose Monitor
• Disadvantages
Additional Device to carry
• Can go directly to I‐phone
Questions
• Stacy Centeno
• Colleen Miller‐Owen
– Colleen.Miller‐[email protected]
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References
• American Diabetes Association. Standards of medical care in diabetes—2016. Diabetes Care. 2016;39(Supplement 1), S4,5,52‐59. • American Medical Association. From the medical letter on drugs and therapeutics. An inhaled insulin: Afrezza. JAMA.2015; 313(21): 2176‐2177.• Blanco, M. Hernandez, M.T., Strauss, K.W.,& Amaya, M. Prevalence and risk factors of lipohypertrophy in insulin‐injecting patients with diabetes.
Diabetes Metab.2013 39 (5) 445‐453. doi.org/10.1016/i.diabet.2013.05.006.• Frid,A., Hirsch, L., Gaspar, R., Hicks, D., Kruegel, G., Liersch, J., Letondeur, C., Sauvanet, J.P., Tubiana‐Rufi, N., Strauss, K. New injection
recommendations for patients with diabetes. Diabetes & Metabolism. 2010, Supplement 2: S3‐18. DOI: 10.1016/S1262‐3636(10)70002‐1.• http://www.ndei.org/ADA‐diabetes‐management‐guidelines‐in‐patient‐glycemia‐targets‐critically‐ill.aspx• "Insulin Lispro (Rx)‐ Humalog, Humalog Kwikpen." Medscape.com. 1 July 2015. Web. 1 July 2015. <http://reference.medscape.com/drug/humalog‐
insulin‐lispro‐999005>. • Brown, M.T. & Bussell, J.K. (2011) Medication Adherence: WHO Cares? Mayo Clinic Proceedings, 86 (4):304‐314• Cavan, D.A., Ziegler, R., Cranston, I., Barnard, K, Ryder, J., …Wagner, R.S. (2014). Use of an insulin bolus advisor facilitates earlier and more frequent
changes in insulin therapy parameters in sub optimally controlled patients with diabetes treated with multiple daily injection therapy: Results of the ABACUS trial. Journal of Diabetes Technology Therapies, 16(5): 310‐316, doi: 10.1089/dia.2013.0280.
• Jaser, S.S. & Datye, K.A. Frequency of missed insulin boluses in type 1 diabetes and its impact on diabetes control. Diabetes Technology and Therapeutics. 18 (6): 341‐342.
• Rosenstock,J. & Ferrannini, E. Euglycemic diabetic ketoacidosis: A predictable detectable, and preventable safety concern with SGLT2 iinhibitors. Diabetes Care, 38(9):1638‐1642. DOI:10.2337/dc15‐1380.
• Schwartz, F.,& Marling, C. (2013). Use of automated bolus calculators for diabetes management. U.S. Endocrinology, 9 (2): 124‐127. doi: 10.17925/USE.2013.09.02.124.
• Siminerio,L.,Kulkarni,K., Meece,J.,Williams, A., Cyprus,M.,Haas,L., Pearson,T., Rodbard,H., Lavernia,F. Strategies for insulin injection therapy in diabetes self‐management. AADE. 2011.
• Sussman, A., Taylor, E., Patel, M., Ward, J.L., Aiva, S., Lawrence, A. & Ng, R. (2012). Performance of a glucose meter with a built–in automated bolus calculator versus manual bolus calculation in insulin‐using subjects. Journal of Diabetes Science and Technology. 6(2):339‐344
• Taylor,S.U‐500 concentrated regular insulin: Practical application in the outpatient setting. The Nurse Practitioner.2012; 37(9):47‐52.• Trujillo, J.M., Nuffer,W. & Ellis, S.. GLP‐1 receptor agonists: a review of head‐to‐head clinical studies. Therapeutic Advancesi Endocrinology and
Metabolism. 2015 June 6(3):135.• Wallia,A. &Molitch,M.E. Insulin Therapy for Type 2 Diabetes Mellitus. JAMA. 2014;311(22):2315‐2325 doi:10.1001/jama.2014.5951.
• Ziegler, R., Cavan, D., Cranston, I., Barnard, K., Ryder, J., Vogel, C., … Wagner, R. (2013). Use of an insulin bolus advisor improves glycemic control in multiple daily insulin injections (MDI) therapy patients with suboptimal glycemic control. Diabetes Care. Nov; 36(11): 3613‐3619. Doi:10.2337/dc13‐0251,
• Zinman,B.,Fulcher,G.,Rao,P.V., Thomas,N., Endahl,L.A., Johansen,T., Lindh,R., Lewin.A., Rosenstock,J., Pinget,M.,& Mathieu,C. Insulin degludec, an ultra‐long‐acting basal insulin, one a day or three times a week versus insulin glargine once a day in patients with type 2 diabetes: A 16‐week, randomized, open‐label, phase 2 trial. The Lancet. 2011; 377:924‐31. DOI:10.1016/S0140‐6736(10)62305‐7.