To Normoglycemia & Beyond: Updates in Diabetes Therapy - Utah Academy of Family ...

 
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To Normoglycemia & Beyond: Updates in Diabetes Therapy - Utah Academy of Family ...
To Normoglycemia & Beyond:
 Updates in Diabetes Therapy
Hanna Raber, PharmD, BCPS, BCACP              Elizabeth Bald, PharmD, BCACP
             Assistant Professor (Clinical)   Assistant Professor (Clinical)
   University of Utah College of Pharmacy     University of Utah College of Pharmacy

                                                         Utah Academy of Family Physicians
To Normoglycemia & Beyond: Updates in Diabetes Therapy - Utah Academy of Family ...
OBJECTIVES

• Compare & contrast the benefits of SGLT2 inhibitors & GLP-1 agonists
  as add-on therapies for the treatment of type 2 diabetes mellitus
  (T2DM)
• Review available higher concentration insulin products & determine
  which patients may benefit from use of higher concentration insulin
• Identify patients with T2DM that would benefit from personal
  continuous glucose monitoring (P-CGM) & those that are most likely to
  be eligible for insurance coverage of P-CGM
• Utilize P-CGM data to make treatment modifications for patients
  with T2DM

                                              Utah Academy of Family Physicians
To Normoglycemia & Beyond: Updates in Diabetes Therapy - Utah Academy of Family ...
Presentation Overview

 Clinical Updates          CGM Overview
• SGLT2 Inhibitors       • Patient Identification
• GLP-1 Agonists         • Data Interpretation
• Concentrated Insulin

                               Utah Academy of Family Physicians
To Normoglycemia & Beyond: Updates in Diabetes Therapy - Utah Academy of Family ...
DM Clinical Updates

             Utah Academy of Family Physicians
To Normoglycemia & Beyond: Updates in Diabetes Therapy - Utah Academy of Family ...
MEET RL

CC: RL is a 56-year-old male who presents to clinic for a follow-up appointment to discuss
type 2 diabetes management. RL was recently diagnosed 3 months ago and started on
Metformin (titrated to max dose).

Current DM Medications            Vitals:                          Labs
• Metformin 1g BID                • BP: 132/88mmHg                 • HbA1c
                                  • HR: 72 bpm                        • 4/11/21: 7.8%
Past Medical History              • RR: 16 rpm                        • 1/13/20: 8.5%
• T2DM                            • Temp: 98ºF                     • SCr
• HTN                             • BMI: 36                           • 0.9
• HLD
• CAD
• GAD
                                                             Utah Academy of Family Physicians
To Normoglycemia & Beyond: Updates in Diabetes Therapy - Utah Academy of Family ...
T2DM THERAPY OVERVIEW

                     Step 1                                                            Metformin + Comprehensive Lifestyle

                     Step 2                                                         ASCVD                                                      GLP-1 RA* or SGLT2I*

                                                                                         CKD                                                          SGLT2I*

                                                                                        HF**                                                          SGLT2I*
 *Choose an agent with proven benefit in this population
 **Particularly HFrEF (LVEF
To Normoglycemia & Beyond: Updates in Diabetes Therapy - Utah Academy of Family ...
T2DM THERAPY OVERVIEW

          Step 2                                                        Hypoglycemia                                                           DPP-4, GLP-1 RA, SGLT2I,
                                                                                                                                                        TZD

                                                                                   Weight                                                            GLP-RA, SGLTI

                                                                                        Cost                                                             SU, TZD

                                                                                                                                                 Utah Academy of Family Physicians
American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care.
To Normoglycemia & Beyond: Updates in Diabetes Therapy - Utah Academy of Family ...
SGLT2 Inhibitors &
  GLP-1 Agonists

             Utah Academy of Family Physicians
To Normoglycemia & Beyond: Updates in Diabetes Therapy - Utah Academy of Family ...
SGLT2 INHIBITORS

                                         Sodium-Glucose Co-Transporter 2 (SGLT2) Inhibitors
                  MOA: inhibits transporter in proximal renal tubules which reduces reabsorption of
                  filtered glucose & increases urinary excretion

                  Generic:                                              Brand:                                   Starting Dose:                     Max Dose:

                  Canagliflozin                                         Invokana                                 100mg daily                        300mg daily

                  Dapagliflozin                                         Farxiga                                  5mg daily                          10mg daily

                  Empagliflozin                                         Jardiance                                10mg daily                         25mg daily

                  Ertugliflozin                                         Steglatro                                5mg daily                          15mg daily

                                                                                                                                               Utah Academy of Family Physicians
Lexicomp Online Database
American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care.
To Normoglycemia & Beyond: Updates in Diabetes Therapy - Utah Academy of Family ...
SGLT2 INHIBITORS: CLINICAL CONSIDERATIONS

              Efficacy:                                                                                                          Safety:
              • A1c lowering:                                                                                                    • Genital yeast infection/UTI
                        • 0.5-1%                                                                                                           • Rare: Fournier’s gangrene
              • Weight loss:                                                                                                     • Increased urination,
                        • ~2kg                                                                                                     dizziness, hypotension
              • CV Benefit:
                        • Empagliflozin, Canagliflozin,
                                                                                                                                 • Hypoglycemia (rare)
                          (Dapagliflozin)                                                                                                  • Rare: DKA
              • HF Benefit:                                                                                                      • Increased LDL cholesterol
                        • Dapagliflozin, Empagliflozin                                                                           • Bone fractures/amputations
              • Renal Benefit:
                        • Canagliflozin, Dapagliflozin
                                                                                                                                                  Utah Academy of Family Physicians
American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care.
GLP-1 AGONISTS

                                                           Glucagon-Like,Peptide-1 (GLP-1) Agonists
                  MOA: increases insulin secretion in response to elevated blood glucose, decreases
                  glucagon secretion
                  Generic:                                               Brand:                                     Starting Dose:                    Max Dose:

                  Liraglutide                                            Victoza                                    0.6mg SQ daily                    1.8mg SQ daily

                  Lixisenatide                                           Adlyxin                                    10mcg SQ daily                    20mcg SQ daily

                  Exenatide                                              Byetta                                     5mcg SQ twice daily               10mcg SQ twice daily
                  Exenatide XR                                           Bydureon                                   2mg SQ weekly                     2mg SQ weekly
                  Dulaglutide                                            Trulicity                                  0.75mg weekly                     4.5mg weekly

                  Semaglutide                                            Ozempic                                    0.25mg SQ weekly                  1mg SQ weekly
                                                                         Rybelsus                                   3mg PO daily                      14mg PO daily
                                                                                                                                               Utah Academy of Family Physicians
Lexicomp Online Database
American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care.
GLP-1 AGONISTS: CLINICAL CONSIDERATIONS

          Efficacy:                                                                                                     Safety:
          • A1c lowering:                                                                                               • GI side effects (~8-20%)
                    • 0.5-1%                                                                                                      • Nausea, vomiting, diarrhea
          • Weight loss:                                                                                                • Injection site reactions
                    • ~1.6kg – ~5.5kg                                                                                             • Up to 23% w/ Bydureon
                      (Semaglutide)
                                                                                                                        • Hypoglycemia (rare)
          • CV/Renal Benefit:
                                                                                                                        • Thyroid C-cell tumors
                    • Liraglutide, Semaglutide,
                      Dulaglutide
                                                                                                                          (rodents)
                                                                                                                        • Pancreatitis/Gallbladder
                                                                                                                          disease

                                                                                                                                               Utah Academy of Family Physicians
American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care.
MEDICATION ACCESS

                           Patient
Uninsured                 Assistance
                          Programs
Commercial
 Insurance              Manufacturer
                        Discount Cards
 Medicaid

                         Low Income
 Medicare                  Subsidy
                        Utah Academy of Family Physicians
MEET RL

CC: RL is a 56-year-old male who presents to clinic for a follow-up appointment to discuss
type 2 diabetes management. RL was recently diagnosed 3 months ago and started on
Metformin (titrated to max dose).
 Current DM Medications              Vitals:                           Labs
 • Metformin 1g BID                  • BP: 132/88mmHg                  • HbA1c
                                     • HR: 72 bpm                          • 4/11/21: 7.8%
 Past Medical History                • RR: 16 rpm                          • 1/13/20: 8.5%
 • T2DM                              • Temp: 98ºF                      • SCr
 • HTN                               • BMI: 36                             • 0.9
 • HLD
 • CAD              Options include:
 • GAD              • Initiating GLP-1 (Semaglutide 0.25mg weekly x 4 weeks)
                   • Initiating SGLT2 Inhibitor (Empagliflozin 10mg or Canagliflozin 100mg)
                                                                Utah Academy of Family Physicians
Concentrated Insulin

              Utah Academy of Family Physicians
INITIATING INSULIN IN T2DM

                                                                                              “In patients with T2DM, a GLP-1 is preferred
                Step 1
                                                                                                        to insulin when possible”

                Step 2                                                                                                                  Add basal insulin

                Step 3                                                                                             Add prandial insulin once daily

                Step 4                                                                                             Add additional prandial insulin

                Step 5                                                                                              Consider concentrated insulin

                                                                                                                                                Utah Academy of Family Physicians
American Diabetes Association. 9. Pharmacologic Approaches to Glycemic Treatment: Standards of Medical Care in Diabetes-2021. Diabetes Care.
MEET SR

CC: SR is a 52-year-old female who presents to clinic for a follow-up appointment to
discuss type 2 diabetes management.

Current DM Regimen                       Labs                       SMBG
• Metformin 1g BID                       • HbA1c                    • Fasting BG
• Semaglutide (Ozempic) 1mg once weekly     • 4/11/21: 8.9%            • 135-185 mg/dL
• Empagliflozin (Jardiance) 25mg daily      • 1/13/20: 9.1%         • Post Prandial BG
• Insulin Glargine (Lantus) U-100 Pen 80                               • >200 mg/dL
  units daily at bedtime
• Insulin Lispro (Humalog) U-100 Pen 26
  units three times daily with meals

                                                            Utah Academy of Family Physicians
CONCENTRATED INSULIN OVERVIEW
                                                          PRODUCTS

                                                            WHO?
                 • Patients who require higher insulin doses due to insulin
                   resistance
                 • Patients who require multiple injections/dose
                 • Patients who require frequent pen changes
                                                           WHY?

                 • Less volume= less pain
                 • Less injections= better adherence?
                 • Less pens= less cost?
Diabetes Research and Clinical Practice 2019; 148: 93-101
                                                                   Utah Academy of Family Physicians
Diabetes Obes Metab 2014; 16(10):971-6.
Images obtained from: https://www.humulin.com/what-is-humulin
CONCENTRATED INSULIN PRODUCTS
                                   Bolus Insulin                       Basal Insulin            Basal/Bolus Hybrid

    Generic                   Lispro       Lispro-aabc U-      Glargine          Degludec         Regular U-500
                              U-200              200            U-300             U-200
    Brand                   Humalog          Lyumjev           Toujeo             Tresiba       Humulin R 500u/mL
                            200u/mL          200u/mL          300u/mL            200u/mL
    Onset                  15-30 mins       15-17 mins      Up to 360 mins      30-90 mins           30 mins

    Peak                    0.5-2.5 hrs      2-2.9 hrs           N/A              12 hrs             1-3 hrs
                                                                                 (minimal)

    Duration                 3-6.5 hrs       4.6-7.3 hrs       >24 hrs             42 hrs          Up to 24 hrs
    Preparation               KwikPen          KwikPen       SoloStar Pen      FlexTouch Pen      Vial & KwikPen
                           (60 units per    (60 units per    (80 units per     (160 units per     (300 units per
                             injection)       injection)       injection)         injection)         injection)
                                                            Max SoloStar
                                                            Pen (160 units
                                                             per injection
                                                                                   Utah Academy of Family Physicians
Lexicomp Online Database
BOLUS CONCENTRATED INSULIN

                                                              ü INTERCHANGEABLE W/ U-100
            Humalog
             U-200                                               ü CONVERT UNIT-PER-UNIT
                                                         ü SAME MAXIMUM DOSE/INJECTION, 60 UNITS

                                                         ü “ULTRA-FAST ACTING”
            Lyumjev
                                             ü CONVERT UNIT-PER-UNIT FROM OTHER BOLUS INSULIN
             U-200
                                                 ü CAN INJECT UP TO 20 MINS POST MEALS

                                                                                     Utah Academy of Family Physicians
Humalog Kwikpen U-200 [Package Insert]. Eli Lilly and Company; 2019
Lyumjev [Package Insert]. Eli Lilly and Company; 2020
BASAL CONCENTRATED INSULIN

                                          ü IF CONVERTING TO TOUJEO, CONVERT UNIT-PER-UNIT,
               Toujeo
               U-300
                                         ü IF CONVERTING FROM TOUJEO, ADMINISTER 80% OF DOSE
                                          ü ADJUST DOSE IN 2-UNIT INCREMENTS (MAX SOLOSTAR)

                                                   ü
                                              AVAILABLE IN U-100 AND U-200 CONCENTRATIONS
              Tresiba
                                                     ü CONVERT UNIT-PER-UNIT
              U-200
                                        ü CONSIDER FOR PATIENTS W/ HX OR RISK OF HYPOGLYCEMIA

Toujeo [Package Insert]. Sanofi-Aventis; 2015
                                                                         Utah Academy of Family Physicians
Tresiba [Package Insert]. Novo Nordisk A/S; 2015
JAMA 2017;318(1):45-56
U-500 INSULIN

                                                                 ü
                                                            CONSIDER FOR PATIENT WITH INSULIN TDD> 200
                                                       ü UNUSUAL KINETICS! REPLACES BASAL + BOLUS INSULIN
                                                          ü DOSED BID OR TID 30 MINUTES BEFORE MEALS

                                                                                    Utah Academy of Family Physicians
Humulin R U-500 [Package Insert]. Eli Lilly and Company: 2019.
Images obtained from: https://www.humulin.com/what-is-humulin
MEET SR

CC: SR is a 52-year-old female who presents to clinic for a follow-up appointment to
discuss type 2 diabetes management.

 Current DM Regimen                       Labs                      SMBG
 • Metformin 1g BID                       • HbA1c                   • Fasting BG
 • Semaglutide (Ozempic) 1mg once weekly     • 4/11/21: 8.9%           • 135-185 mg/dL
 • Empagliflozin (Jardiance) 25mg daily      • 1/13/20: 9.1%        • Post Prandial BG
 • Insulin Glargine (Lantus) U-100 Pen 80                              • >200 mg/dL
   units daily at bedtime
 • Insulin Lispro (Humalog) U-100 Pen 26
   units three times daily with meals

ü Switch Lantus 80 units daily to Toujeo 80 units daily or Tresiba 80 units daily
ü Max for Humalog U-100 is 60 units/injection       Utah Academy of Family Physicians
CGM Device Overview

             Utah Academy of Family Physicians
DEVICE COMPARISON

                                                  Personal CGM                                                                                            Professional CGM
                              CGM owned by user that is worn                                                                          CGM owned by clinic that is worn
                               long-term & used to make real                                                           VS          vs  short-term & used for pattern
                                  time treatment decisions                                                                                      identification

                                               Real-Time CGM                                                                              Intermittently Scanned CGM
                                                                                                                                      measures glucose continuously
                                  measures & displays glucose                                                          VS          vs but only displays values when
                                     values continuously
                                                                                                                                      swiped by reader/smartphone

                                             Therapeutic CGM                                                                                       Non-Therapeutic CGM
                               approved by the FDA to replace
                                 SMBG and make diabetes                                                                 VS vs                     approved by the FDA as an
                                                                                                                                                       adjunct to SMBG
                                    treatment decisions

                                                                                                                                                                 Utah Academy of Family Physicians
American Diabetes Association. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S85-S99. doi: 10.2337/dc21-S007. PMID: 33298418.
Longo R, Sperling S. Personal Versus Professional Continuous Glucose Monitoring: When to Use Which on Whom. Diabetes Spectr. 2019;32(3):183-193. doi:10.2337/ds18-009
Therapeutic Continuous Glucose Monitors. Medicare.gov. https://www.medicare.gov/coverage/therapeutic-continuous-glucose-monitors-cgms. Accessed April; 8, 2021.
DEVICE COMPARISON

                                                          Freestyle Libre: 14-day therapeutic intermittently scanned
                                                          CGM system consisting of a sensor/ transmitter worn on the
                                                              back of the arm & a handheld reader or phone app

                                                           Freestyle Libre 2: 14-day therapeutic intermittently scanned
                                                            CGM system consisting of a sensor/ transmitter worn on the
                                                                       back of the arm & a handheld reader

                                                                Dexcom G6: 10-day therapeutic real-time CGM system
                                                               consisting of a sensor/transmitter worn on the abdomen
                                                                         and a handheld reader or phone app

                                                                                                                                                                   Utah Academy of Family Physicians
Scalzo PL, Brock KA, Isaacs D. Personal Continuous Glucose Monitoring Implementation Playbook. 2020 Association of Diabetes Care & Education Specialists. Accessed April 8, 2021.
DEVICE COMPARISON

                                        FDA                              Sensor                           Warmup                                                              Display        Interfering
                                                                                                                                              Alarms
                                      Approval                          Duration                           Time                                                               Options        Substances

   Freestyle                                                                                                                                                                reader or        vitamin C &
                                        age 18+                            14 days                           1 hour                              none
 Libre 14 day                                                                                                                                                              smartphone        salicylic acid

     Freestyle                            age 4+                           14 days                           1 hour                         real-time                               reader    vitamin C
      Libre 2

      Dexcom                                                                                                                                                                reader or        hydroxyurea
                                          age 2+                           10 days                          2 hours                         real-time
       G6®                                                                                                                                                                 smartphone          & APAP

                                                                                                                                                                   Utah Academy of Family Physicians
Scalzo PL, Brock KA, Isaacs D. Personal Continuous Glucose Monitoring Implementation Playbook. 2020 Association of Diabetes Care & Education Specialists. Accessed April 8, 2021.
DEVICE COMPARISON

                                                                                                      LIBRE 14 DAY
                                                                                                       FREESTYLE
                                                                                                                     Reader: $83 for 1 reader
                                                                                                                     Sensor: $126.36 for 2 (28 day supply)

                                                                                                      FREESTYLE
                                                                                                                     Reader: $83 for 1 reader

                                                                                                       LIBRE 2
                                                                                                                     Sensor: $126.36 for 2 (28 day supply)

                                                                                                                     Reader: $425 for 1 reader

                                                                                                      DEXCOM
                                                                                                                     Sensor: $129.17 for 3 (30 day supply)

                                                                                                        G6
                                                                                                                     Transmitter: $272.50 for 1 (90 day supply)

                                                                                                                                  Utah Academy of Family Physicians
Get a Sensor. Diabetes Wise. https://diabeteswise.org/how-to-get-a-sensor. Accessed April 15, 2021.
Patient Identification
& Insurance Coverage

               Utah Academy of Family Physicians
MEET HS

CC: HS is a 69-year-old female who presents to clinic for T2DM follow-up.

Current DM Regimen                    SMBG
• Metformin XR 2000 mg daily          • Fasting: ~120 mg/dL
• Lantus 60 units every morning       • Dinner 2-hour Postprandial: 150-180 mg/dL
• Humalog
   • 10-15 units with brunch
   • 20-30 units with dinner          Insurance                  HbA1c
   • 15-30 units at bedtime           • Medicare                 • 1/20/2021: 6.1%

                                                            Utah Academy of Family Physicians
PATIENT IDENTIFICATION

                        2019 Association of
                         Diabetes Care &                                       • diabetes care & education specialist can help identify those
                       Education Specialists                                     who would benefit from professional or personal CGM
                          Practice Paper

                                          • CGM in conjunction with multiple daily injections &
                   2021 American Diabetes   continuous subcutaneous insulin infusion & other forms of
                    Association Standards   insulin therapy is a useful tool to lower &/or maintain A1C
                     of Care in Diabetes    levels &/or reduce hypoglycemia in adults & youth with
                                            diabetes

                                                                               • T1DM: real-time CGM recommended for adults who are
                     2016 Endocrine Society                                      willing & able to use device on a nearly daily basis
                     Guideline on Diabetes
                          Technology                                           • T2DM: short-term, intermittent, real-time CGM recommended
                                                                                 for adults not on prandial insulin who have A1c ≥ 7%
                                                                                                                                                                    Utah Academy of Family Physicians
American Diabetes Association. 7. Diabetes Technology: Standards of Medical Care in Diabetes-2021. Diabetes Care. 2021 Jan;44(Suppl 1):S85-S99. doi: 10.2337/dc21-S007. PMID: 33298418.
Isaacs D, Cox C, Schwab K, et al. Technology Integration: The Role of the Diabetes Care and Education Specialist in Practice. Diabetes Educ. 2020;46(4):323-334. doi:10.1177/0145721720935123
Peters AL, Ahmann AJ, Battelino T, et al. Diabetes Technology-Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline. J Clin Endocrinol Metab. 2016;101(11):3922-3937.
doi:10.1210/jc.2016-2534
PATIENT IDENTIFICATION

                    2020 American
                 Association of Clinical • CGM preferred over SMBG
                  Endocrinologists &     • P-CGM should be considered for patients on intensive insulin
                  American College of      therapy, those with history of hypoglycemia unawareness, or
                Endocrinology Executive    those with recurrent hypoglycemia
                       Summary

                     2017 International                            • T1DM: CGM recommended for all adults with type 1 diabetes
                    Consensus on Use of
                    Continuous Glucose                             • T2DM: CGM recommended for patients treated with intensive
                        Monitoring                                   insulin therapy who are not achieving glucose targets

                                                                                                                                          Utah Academy of Family Physicians
Danne T, Nimri R, Battelino T, et al. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017;40(12):1631-1640. doi:10.2337/dc17-1600
Garber AJ, Handelsman Y, Grunberger G, et al. CONSENSUS STATEMENT BY THE AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND AMERICAN COLLEGE OF ENDOCRINOLOGY ON THE COMPREHENSIVE TYPE 2 DIABETES MANAGEMENT ALGORITHM -
2020 EXECUTIVE SUMMARY. Endocr Pract. 2020;26(1):107-139. doi:10.4158/CS-2019-0472
PATIENT IDENTIFICATION

                                         CANDIDATE SELECTION CHARACTERISTICS

                                • Taking multiple daily insulin injections
                                • Using an insulin pump
                                • Frequent hypoglycemia
                                • Hypoglycemia unawareness
                                • High degree of glycemic variability
                                • Not achieving glucose targets

                                                                                                                                                                   Utah Academy of Family Physicians
Scalzo PL, Brock KA, Isaacs D. Personal Continuous Glucose Monitoring Implementation Playbook. 2020 Association of Diabetes Care & Education Specialists. Accessed April 8, 2021.
INSURANCE COVERAGE

                             MEDICAID                                     MEDICARE           COMMERCIAL
                       varies by state;
                                                                          covered for
                         covered for
                                                                        certain patients      varies by plan
                       certain patients
                                                                         with T1DM &
                        with T1DM &
                                                                             T2DM
                        T2DM in Utah

Abbott Laboratories. FreeStyle Libre System.
                                                                                           Utah Academy of Family Physicians
Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring (CGM) System.
Centers for Medicare and Medicaid Services. Ruling No.: [CMS-1682-R].
INSURANCE COVERAGE

                                                                        UTAH MEDICAID CRITERIA

                                                                                                   Utah Academy of Family Physicians
https://medicaid.utah.gov/pharmacy/priorauthorization/pdf/Continuous%20Glucose%20Monitor.pdf
INSURANCE COVERAGE

               MEDICARE PART B CRITERIA

        • diagnosis of type 1 or type 2 diabetes
        • ≥ 4 daily blood glucose checks
        • ≥ 3 daily injections of insulin or a
          continuous insulin infusion pump
        • insulin regimen requiring frequent
          adjustments made possible by CGM
        • in-person visit with treating provider
          in past 6 months

                                                                                      Utah Academy of Family Physicians
Centers for Medicare and Medicaid Services. Ruling No.: [CMS-1682-R].
Image obtained from https://provider.myfreestyle.com/
INSURANCE COVERAGE

 [Patient Name] checks blood glucose 4 times
per day, uses ≥3 insulin injections per day, and
has a treatment regimen that requires frequent
 adjustments based on glucose readings. They
are indicated for a personal continuous glucose
     monitoring system in order to prevent
         diabetes-related complications.

                                 Utah Academy of Family Physicians
INSURANCE COVERAGE

                                                         PRODUCT          QUANTITY       REFILL
                    DEXCOM G6

                                              Dexcom G6 Receiver             1        once a year

                                           Dexcom G6 Transmitter             1       every 90 days

                                                Dexcom G6 Sensor             3       every 30 days

                                                         PRODUCT          QUANTITY       REFILL
                 FRESTYLE

                                        FreeStyle Libre Reader OR
                   LBRE

                                                                             1        once a year
                                         FreeStyle Libre 2 Reader
                                        FreeStyle Libre Sensor OR
                                                                             2       every 28 days
                                         FreeStyle Libre 2 Sensor

                                                                                     Utah Academy of Family Physicians
Abbott Laboratories. FreeStyle Libre System.
Dexcom, Inc. Dexcom G6 Continuous Glucose Monitoring (CGM) System.
MEET HS

  CANDIDATE SELECTION CHARACTERISTICS                     MEDICARE PART B CRITERIA

                                                 • diagnosis of type 1 or type 2 diabetes
• taking multiple daily insulin injections
                                                 • ≥ 4 daily blood glucose checks
• using an insulin pump
                                                 • ≥ 3 daily injections of insulin or a
• frequent hypoglycemia?                           continuous insulin infusion pump
• hypoglycemia unawareness                       • insulin regimen requiring frequent
• high degree of glycemic variability              adjustments made possible by CGM

• not achieving glucose targets                  • in-person visit with treating provider
                                                   in past 6 months

          Patient would be eligible for personal CGM
            if she increases SMBG to 4 times daily                Utah Academy of Family Physicians
Data Interpretation

              Utah Academy of Family Physicians
DATA INTERPRETATION
                                                                          • Key metrics, ambulatory glucose profile (AGP), day-by-day graph
                        Download Data                                     • Start with global overview & describe what key metrics mean
                                                                          • Ask what person learned & what is going well

                                                                         • Identify times below range, % time in hypoglycemia, # of
                           Assess Safety                                   hypoglycemic events
                                                                         • Interactive discussion about possible causes & solutions

                                                                         • Focus on the positive – identify days or times when time in
                          Time in Range                                    range is highest
                                                                         • Interactive discussion about how to replicate what is working
                                                                           well
                                                                         • Identify times above range, % time in hyperglycemia, # of
                      Areas to Improve                                     hyperglycemic events
                                                                         • Interactive discussion: possible causes, solutions, events

                              Action Plan                                 • Develop collaboratively with patient

                                                                                                                                                                   Utah Academy of Family Physicians
Scalzo PL, Brock KA, Isaacs D. Personal Continuous Glucose Monitoring Implementation Playbook. 2020 Association of Diabetes Care & Education Specialists. Accessed April 8, 2021.
DATA INTERPRETATION
                                     LIBREVIEW                                                                                                              DEXCOM CLARITY

                                                                                                            KEY METRICS

                                                                                                           AMBULATORY
                                                                                                             GLUCOSE
                                                                                                             PROFILE

                                                                                                            DAY-BY-DAY
                                                                                                              GRAPH

                                                                                                                                                             Utah Academy of Family Physicians
Images obtained from LibreView and Dexcom Clarity
Scalzo PL, Brock KA, Isaacs D. Personal Continuous Glucose Monitoring Implementation Playbook. 2020 Association of Diabetes Care & Education Specialists.
DATA INTERPRETATION

                                                                                                                                                                    14+ days recommended
                                                                                                                                                                    ≥70% recommended

                                                                                                                                                                    estimate of current A1c
                                                                                                                                                                    ≤36% recommended

                                                                                                                                                                   Utah Academy of Family Physicians
Images obtained from LibreView
Scalzo PL, Brock KA, Isaacs D. Personal Continuous Glucose Monitoring Implementation Playbook. 2020 Association of Diabetes Care & Education Specialists. Accessed April 8, 2021.
DATA INTERPRETATION

                 10% ↑ time in range = 0.5-0.8% ↓ HbA1c
                                                                                                                                                                  Utah Academy of Family Physicians
Battelino T, Danne T, Bergenstal RM, et al. Clinical Targets for Continuous Glucose Monitoring Data Interpretation: Recommendations From the International Consensus on Time in Range. Diabetes Care. 2019;42(8):1593-1603. doi:10.2337/dci19-0028
Scalzo PL, Brock KA, Isaacs D. Personal Continuous Glucose Monitoring Implementation Playbook. 2020 Association of Diabetes Care & Education Specialists. Accessed April 8, 2021.
MEET CT

CC: CT is a 62-year-old male who presents to clinic for a follow-up appointment to discuss
type 1 diabetes management.

PMH                       Current Regimen                            Labs
• BPH                     • Insulin glargine U-300 (Toujeo) 35       • HbA1c
• Hypertension              units daily at bedtime                      • 3/11/21: 8.1%
• Major depression        • Insulin lispro (Humalog) three times        • 12/3/20: 8.1%
• Seborrheic dermatitis     daily with meals 5 units plus 3 units       • 8/14/20: 7.8%
• T1DM                      for every 50 mg/dL >150 mg/dL

                                                            Utah Academy of Family Physicians
Download Data
                                              too                                 too
                                              high                                high
                                                                    wide
                                                                  variability

                                 below goal          too                        too
                                 of ≥70%             low                        low

                                                                  above goal of
Assess Safety

                                    Possible Causes of Hypoglycemia
                                 • Frequently administers a dose of Humalog before
                                   bedtime to correct high readings
                                 • Rarely feels any symptoms when glucose is low
                                   and typically corrects with 1 glucose tablet
                                 • Increased physical activity due to helping
                                   daughter move
                                                    Utah Academy of Family Physicians
Images obtained from LibreView
Time in Range

                                 Factors that Contributed to Best Glucose Day
                                     • Did not drink any soda
                                     • Remembered to administer all Humalog doses
                                       with meals

                                                      Utah Academy of Family Physicians
Images obtained from LibreView
Areas to Improve

                                   Possible Causes of Hyperglycemia
                                 • Typically drinks three 16 oz bottles of regular soda
                                   daily
                                 • Frequently forgets to take Humalog

                                                       Utah Academy of Family Physicians
Images obtained from LibreView
Action Plan

    • Stop giving Humalog at bedtime
    • Provide education about signs/symptoms of hypoglycemia
      and the rule of 15
    • Consider switching to Freestyle Libre 2 CGM as the patient
      may benefit from the predictive low alarms
    • Set goal to switch to diet soda
    • Increase adherence to Humalog mealtime dosing
    • Follow up in 2-3 weeks
                                              Utah Academy of Family Physicians
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                                                                                                                                                                   Utah Academy of Family Physicians
Scalzo PL, Brock KA, Isaacs D. Personal Continuous Glucose Monitoring Implementation Playbook. 2020 Association of Diabetes Care & Education Specialists. Accessed April 8, 2021.
KEY POINTS
• Consider adding a GLP-1 agonist or SGLT2 inhibitor to metformin for
  patients with T2DM and comorbid ASCVD.
• Consider adding a SGLT2 inhibitor to metformin for patients with T2DM
  and comorbid kidney dysfunction or HF.
• Utilize concentrated insulin for patients who would benefit from less
  insulin volume or reduced injections per day.
• Patients who are using intensive insulin regimens, have frequent
  hypoglycemia or hypoglycemia unawareness, have a high degree of
  glycemia variability, and/or who are not achieving glucose targets may
  benefit from personal CGM.
• The DATAA Method is recommended for evaluating CGM data.
• The time in range metric better captures glucose variability than HbA1c.

                                                  Utah Academy of Family Physicians
QUESTIONS

 Hanna Raber | hanna.raber@pharm.utah.edu

Elizabeth Bald | elizabeth.bald@pharm.utah.edu

                             Utah Academy of Family Physicians
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