Saturday, November 12, 2016

8:30am-5:00pm

Atlanta Marriott Marquis

265 Peachtree Center Ave NE,

Atlanta, GA 30303

Disclosures to ParticipantsRequirements for Successful Completion:For successful completion, participants are required to be in attendance in the full activity, complete and submit the program evaluation at the conclusion of the educational event.

Conflicts Of Interest and Financial Relationships Disclosures Planners: LaShonda Hulbert, MPH - None

Lisa Graham, RN, BSN, CDE – NoneSarah Piper, MPH, CDE – NoneCaSonya Green, MA, CHES, CDE – NoneGerald Griffin, RPh – NoneJessica Knopf, MSW – NoneGlenda Summerville, DNP, BC-ADM, CDE, FNP-C – NonePresenters: Sarah Piper, MPH, CDE – NoneGlenda Summerville, DNP, BC-ADM, CDE, FNP-C – NoneDarin Olson, MD, PhD – NoneMonica W. Parker, MD – NoneWhitney Wharton, PhD – NoneMichael Crooks, PharmD – NoneYiling Cheng, MD, PhD – NoneBetsy Rodriguez, MSN, DE – NoneCarl Goolsby, MD – NoneFritz Jean-Pierre, MD, FACS, FASMBS – Speakers Bureau – Ofirmev,

PaciraPatricia Tatro, LCSW, MSW, MSM – NoneMichelle Bravo, RD, CDE – Employee, Stock – DexcomFadi Nahab, MD - None

Disclosures to Participants

Disclosure of Relevant Financial Relationships and Mechanism to Identify and Resolve Conflicts of Interest: Undertaking review of the educational activity by a content reviewer to evaluate for potential bias, balance in presentation, evidence-based content or other indicators of integrity, and absence of bias, AND monitoring the educational activity to evaluate for commercial bias in the presentation AND reviewing participant feedback to evaluate for commercial bias in the activity.

Sponsorship / Commercial Support: None

Non-Endorsement Of Products:Approval status does not imply endorsement by AADE, ANCC, ACPE or CDR of

any commercial products displayed in conjunction with this educational activity.

Off-Label Use:Participants will be notified by speakers to any product used for a purpose other

than that for which it was approved by the Food and Drug Administration.

Activity-Type : Knowledge-based

This continuing nursing education activity was approved by The American

Association of Diabetes Educators, an accredited approver by the American

Nurses Credentialing Center’s Commission on Accreditation. This program

2016-054 is awarded 6.0 contact hours of continuing education credit.

The AADE is also accredited by the California Board of Registered Nursing

(CEP#10977).

The American Association of Diabetes Educators is accredited by

the Accreditation Council for Pharmacy Education as a provider of

continuing pharmacy education. This program provides 6.0 contact

hours (.60 CEU’s) of continuing education credit.

ACPE Universal Activity Number: 0069-0000-16-255-L01-P; 0069-0000-16-

256-L01-P; 0069-0000-16-257-L01-P; 0069-0000-16-258-L01-P; 0069-0000-16-

259-L01-P; 0069-0000-16-260-L01-P; 0069-0000-16-261-L01-P;

0069-0000-16-263-L01-P; 0069-0000-16-264-L01-P; 0069-0000-16-265-L01-P

Effective Date: November 12, 2016 to November 12, 2017

Sponsored by The Diabetes Association of Atlanta, a designated provider of

continuing education contact hours (CECH) in health education by the National

Commission for Health Education Credentialing, Inc. This program is designated

for Certified Health Education Specialists (CHES) and/or Master Certified Health

Education Specialists (MCHES) to receive up to __6___ total Category I continue

education contact hours.

Continuous Glucose Monitoring

Effectiveness and Efficiency with Real

Time Continuous Glucose Monitoring

Michelle Bravo, RD, CDE

November 12, 2016

What Are the Glycemic Goals?

ADA AACE ISPAD

HbA1c <7% < 6.5% < 7.5%

Fasting

Glucose mg/dl

80-120 < 110

Pre-meal

Glucose mg/dl

90-130

Post-meal

Glucose mg/dl

100-180 < 140

Bedtime

Glucose mg/dl

100-140 100-140

1. ADA. Diabetes Care. 2010;33(suppl 1):S11-S61.

2. AACE Diabetes Mellitus Clinical Practice Guidelines Task Force. Endocr Pract. 2007;13(suppl 17):3-68.

Patient with Diabetes – Daily “Guestimating”

Simple Carbs

Blood

Glucose

Levels

Fast

Gastroparesis

constipation

insomnia

exposure to cold

menstruation

illness

medication

emotion

stress

time change

caffeine

smoking

French Meal

Fatty Meal

Complex

Carbs

Slow Very

Slow

Still there the

next day

See French

Meal

Exercise

Rapid

DigestionBrain function2% of body mass, 25% of glucose

consumption

Variable Sustained

What’s the Difference Between Your

Blood Glucose Meter and Your CGM?

•Am I 120 mg/dL going up or down?

•How fast is my glucose changing?

Questions: Answers:

•I am 120 mg/dL going

down.

•My glucose is going down

fast at a rate 2-3 mg/dL/min.

Real-Time Continuous Glucose Monitoring (CGM) Systems

DexCom G5 Mobile & G4™

PLATINUM with Share

Medtronic: Minimed 530G &

630G System with Enlite

Sensor

*Medtronic Guardian® REAL-Time also available.

Sensor

Longest indicated sensor life2

Smallest insertion needle3

Water resistant

2 calibrations per day (q 12 hr)

Transmitter

Simple wireless platform

No recharging required

20-foot transmission range

Built in BLE for direct

transmission of CGM data to

receiver and mobile device+

System Receiver

Alternative device to view data

Slim modern profile with colors

Customizable alerts

The Dexcom G5 Mobile CGM SystemFDA Approved for adults and children as young as 2 years old

Dexcom's G5 Mobile CGM system consists of 3 parts1*

*1 Dexcom G5 Mobile CGM System User Guide, 2015. 2. Medtronic Summary of Safety and Efficacy Data, 2013. 3. DiabetesHealth.com, Product

Reference Guide, 2010; Caliper measurements: Dexcom 0.018, Medtronic 0.028, measurements are in 1/1000th inches, May 2011.

+For a listing of compatible devices, visit www.dexcom.com/compatibility

Always Know with Dexcom G5 Mobile

Dexcom G5 Mobile Sharing and

Following

Dexcom G4 PLATINUM with Share

Medtronic 530G with Enlite

Sensor augmented pump

FDA approved for 16 years

and older

6 day sensor wear

6 foot transmission range

3-4 times per day calibration

recommended for optimal

accuracy

Medtronic 630G with Enlite

Sensor augmented pump

SMARTGUARDTM TECHNOLOGY

PREDICTIVE ALERTS

CONTOUR®NEXT LINK 2.4

METER6

FDA approved for 16 years and

older

6 day sensor wear

6 foot transmission range

3-4 times per day calibration

recommended for optimal accuracy

Medtronic SMARTGUARDTM Technology

Clinical Practice Guidelines and

Consensus Statements

Professional Society Statements on CGMThe Endocrine Society CGM Clinical Practice Guidelines 2011, “Recommend personal

use CGM for children, adolescents and adults with T1DM who have an A1c above 7.0% OR

less than 7.0% who are willing to use them on a nearly daily basis. CGM has been shown to

assist in lowering or maintaining target A1c levels while limiting hypoglycemia.”

American Association of Clinical Endocrinologists /American College of

Endocrinology Consensus Statement CGM 2015, “CGM is recommended in all patients

with type 1 diabetes and should be offered to all type 2 diabetes on multiple insulin

injections, basal insulin, or sulfonylureas. “CGM should also be used in all patients who are

at risk of hypoglycemia and/or have hypoglycemia unawareness.”

American Diabetes Association Standards of Medical Care in Diabetes 2014, “When

used properly, RT-CGM in conjunction with intensive insulin regimens is a useful tool to

lower HbA1c in selected adults with type 1 diabetes (T1DM). RT-CGM is beneficial for

those with hypoglycemia unawareness and/or frequent hypoglycemic events.”

International Society of Pediatrics and Adolescent Diabetes Clinical Practice

Consensus Guidelines 2014, “The youngest children (< 6 yrs.) are at increased risk for

adverse neurologic outcomes from severe hypoglycemia, and because they are unable to

self-identify hypoglycemia, caution in achieving lower targets for younger children is

appropriate. CGM can identify times of increased risk for hypoglycemia presenting a much

more sophisticated approach to SMBG.”

American Diabetes Association Position Statement on T1DM Throughout the Life

Span 2014, “Based on clinical studies and expert opinion, the HbA1c goal for children was

changed from < 8.5% to <7.5%. According to ADA, RT-CGM is particularly useful in those

patients with hypoglycemia unawareness and/or frequent episodes of hypoglycemia and

can reduce glycemic excursions in children.”

The Value of CGM

Time Spent Outside Target Range Could Be

Reduced Based on CGM Information

0

70

140

210

280

350

2 4 6 8 10 12 14 16 18 20 22 24

Time (Hours)

Glu

co

se (

mg

/dL

)

0

Fingerstick 4.2 hours after

passing 210 mg/dL

Above 210 mg/dL

for 4.8 hours

Above 140 mg/dL

for 13.5 hours

Target Range

Meter

Sensor

Data on file; DexCom.

Trends Up or Down Indicate Different Clinical Situations

LBL010705 Rev 03

CGM Supports Patients in Proactive vs

Reactive Self-Management

Warns of impending hypoglycemia and/or hyperglycemia

– Alerts and alarms help patient “stay between the lines”

Helps detect nocturnal events

Provides immediate feedback on how changes in diet, exercise, and insulin affect glucose levels

May help avoid overinsulinization and weight gain by alerting of impending high and low glucose values

Supports pattern management

– Tracking and trending provides a series of multiple sequential glucose readings over time that can aid in diabetes self-management decisions

Empowers patients to optimize control and allow for a more meaningful conversation with their HCP.

CGM Download Software Reports

DexCom, Data on File. DexCom DM®2 Software, 2008.

Portrait Report‒ One page summary

Glucose trends

– Shows sensor and FS data

Modal day

– Overlays multiple days of glucose tracings one on top of the other

Hourly statistics

– Graphs and statistics

Glucose distribution

– Charts based on times of the day

Daily statistics

– Daily charts

What NOT to Expect From CGM

Replacement for glucose meter

– CGM IS an adjunctive therapy to the meter

– Dosing decisions should be on the blood glucose value from your meter, but the trend information of the CGM

Device to put on and “forget” about

System that replaces or is a substitute for already existing diabetes management tools

Bailey TS, et al. Diabetes Technol Ther. 2007;9(3):203-210.

Accuracy and Performance

CGM Accuracy Comparisons

Dexcom G4 PLATINUM User’s Guide, 2014.

Damiano, ER et al. Journal of Diabetes Science and Technology. On-line, April 21, 2014.

Kropff J, et al. Diabetes Technology and Therapeutics. 2014. 16(1): A34-35.

Accuracy and Treatment Experience with

Dexcom G4 PLAT vs. Enlite

Dexcom G4 PLAT Medtronic Enlite

Mean ARD (%) 13.9% 17.8%

Hypo Mean ARD (%) 20% 34.7%

Mean ARD Days 1-3

Days 4-6

15%

13.6%

19.4%

15.9%

“Patients rated treatment experience to be more positive with the

Dexcom G4 in 12 out of 13 user-related questions, including

interpretation of the user screen, feelings of safety using the system,

ease of use, pain or discomfort, problems with sensor contact,

system calibration, disturbances from alarms, and willingness to use

the system in daily life.”

Conclusion: Accuracy and Treatment Experience

with Dexcom G4 PLAT vs. Enlite

“Hence, our findings indicate that the Dexcom G4 is

more optimal when dosing insulin, when taking other

treatment actions, and in avoiding hypoglycemia. The

results also indicate that the Dexcom G4 may make it

possible for more patients to wear a CGM device for a

longer period of time. These findings should be

considered by treatment providers when recommending

suitable CGM systems and evaluating ongoing

therapies.”

CGM: Clinical Indications

1. Glycemic variability

2. Hypoglycemia

3. Hypoglycemia unawareness

4. Gastroparesis

5. Preconception/Pregnancy

6. Behavior modification

7. Insulin-requiring DM

Hirsch IB, et al. Diabetes Technol Ther. 2008;10(4):232-246.

Reduction in Hemoglobin A1c

JDRF RT-CGM Randomized

Controlled Trial

Subjects

n = 322

3 cohorts by age: 8-14, 14-24, > 25 yrs old

A1c 7.0% - 10.0%

CSII (79.5%) or MDI (20.5%)

SMBG mean 6.4 tests per day

Treatment Groups

Real-time CGM + SMBG group Abbott, DexCom or Medtronic RT Sensors

SMBG control groupNew Engl J Med 2008: 359: 1464-1476

JDRF Study: Near Daily Use of CGM Associated With Significant Decrease in A1c

“The use of continuous monitoring averaged 6.0 days per week for 83% of patients 25 years

of age or older, 30% for those 15 to 24 years of age, and 50% for those 8 to 12 years of age.”

Baseline to 26 weeks: mean difference of -0.53% (CI -0.71 to -0.35; P<.001) in

patients 25 years or older

Near daily use of CGM associated with similar benefit in A1c in all age groups

Hypoglycemia did not increase, even in the adult group with lower A1c

JDRF Continuous Glucose Monitoring Study Group. N Engl J Med. 2008;359(14):1464-1476.

Cohort Starting with A1c 7.0-10.0%

Changes in A1c in >25 yr olds

*Error bars stand for 95% CI. New Engl J Med 2008: 359: 1464-1476

Difference: -0.53%

p-value <0.001

A1c Change in ≥7.0% A1c Cohort

with CGM Use ≥ 6 days/week at Month 12

-0.5 -0.5

-1.0

-0.5

-0.7

-0.8

-1.2

-1

-0.8

-0.6

-0.4

-0.2

0

0-26wks

0-52wks

Age > 25 Age 15-24 Age 8-14

N=34 N=6 N=15

Ch

an

ge i

n A

1c

(%

)

Diabetes Care 2009; 32:2047-2049

Time Spent in Hypoglycemia Reduced by CGM vs.

SMBG

122 adults and children T1D

HbA1c <7.5% at recruitment

CSII or MDI

Randomised to SMBG or RT-CGM for 26 weeks

Time spent in hypo reduced on CGM

HbA1c

Time in hypoglycaemia

SMBG

CGM

SMBG

CGM

Battelino et al Diabetes Care 2011; 34: 795-800

The SWITCH Study

Group

Jan 2008 – July 2010

Diabetologia 2012;55:3155-3162.

Diabetologia 2012;55:3155-3162.

SWITCH Study: A1c with/without

Sensor Use7 European Centers

COMISAIR STUDY: Comparison of different treatment

modalities of Type 1 diabetes including Sensor Augmented Insulin

Regimes (SAIR)

COMISAIR STUDY

COMISAIR STUDY

COMISAIR STUDY RESULTS

CGM and Type 2 Diabetes

CGM and Intermittent Use of Real Time

CGM with Type 2 Diabetes

Study population:

– Type 2 diabetes with an

A1C of > 7.0%.

– N=50 real-time CGM

group; N=50

SMBG/control group.

– No subjects were on

meal-time/prandial

insulin.

Vigersky RA, Ehrhardt NM, Chellappa M, Walker S, Fonda SJ. Diabetes Late-Breaking Abstract 0026-LB ADA, 2011.

7

51

9

33

0

10

20

30

40

50

60

%

Lifestyle Orals Orals+Byetta Orals+Basal

InsulinTherapy

Mean A1c Change From Baseline (RT-CGM vs.

SMBG) With Type 2 Diabetes Patients

Vigersky RA, Ehrhardt NM, Chellappa M, Walker S, Fonda SJ. Diabetes Late-Breaking Abstract 0026-LB ADA, 2011.

Summary: Multiple Studies Have Demonstrated the Clinical Benefit of CGM

Reduction in A1c levels without increased hypoglycemia1,2,5,6

Significant decrease in A1c in patients aged 25 or older2

Reduced glucose variability3-4

Increased time in target range1,2,4

Reduced hypo-2-4,7 and hyperglycemic excursions2,3,4

Consistent accuracy over 7 days of use1,5

Significantly greater decrease in A1c related to frequency of use2,6,7

A1c reduction with BOTH MDI and CSII patients1,2,5,6

CGM helps improve A1c and glycemic control from both high and low A1c

patients1,2,6,7

1. Garg S, et al. Diabetes Care. 2006;29(12):2644-2649.

2. JDRF Continuous Glucose Monitoring Study Group.

N Engl J Med. 2008;359(14):1464-1476.

3. Garg S, et al. Diabetes Care. 2006;29(1):44-50.

4..Garg S, et al. Diabetes Care. 2007;30(12):3023-3025.

5. Bailey TS, et al. Diabetes Technol Ther. 2007;9(3):203-210.

6. Deiss D, et al. Diabetes Care. 2006;29(12):2730-2732.

7. Hirsch IB, et al. Diabetes Technol Ther. 2008;10(5):377-383.

Questions??