INTERPRETING CGM DATA

Richard M. Bergenstal, MD

Executive Director

International Diabetes Center

Park Nicollet and HealthPartners Institute

Minneapolis, MN

June 22, 2018 2

• I have participated in clinical research, been a member of a

scientific advisory board, or served as a consultant for Abbott

Diabetes Care, Dexcom, Eli Lilly and Company, Hygieia, Johnson &

Johnson, Medtronic, Novo Nordisk, Onduo, Roche, Sanofi, and

United HealthCare.

• I have been a stock shareholder in Merck.

• I am a volunteer for the American Diabetes Association and JDRF.

• My institution receives National Institutes of Health funding for

closed-loop studies.

• My employer, the nonprofit HealthPartners Institute, contracts for

my services, and I receive no personal income from these activities.

DISCLOSURES

June 22, 2018 3

INTERPRETING CGM DATA

Using CGM data to guide:

• Starting and adjusting diabetes medications

• Establishing a therapeutic action plan

• A plan to: TIR and TIHypo

• Use CGM to: A1C and TIHypo

CGM Metrics

AGP:

Patterns

Daily Glucose Views

12 Pages

24 Pages

12 Pages

June 22, 2018 11

June 22, 2018 12

June 22, 2018 13

ONE CASE

• Metrics: definitions and targets

• AGP patterns: 9 steps to agree on a

management plan

– Daily views: refining the management plan

CONTINUOUS GLUCOSE MONITORING—AMBULATORY GLUCOSE PROFILE

CGM—AGP

June 22, 2018 14

June 22, 2018 15<70 >18070-180

June 22, 2018 16

June 22, 2018 17

CGM Metrics

June 22, 2018 18

14

R2

0.84 - 0.86

Optimal Sampling Duration for Continuous Glucose Monitoring

to Determine Long-Term Glycemic Control

Riddlesworth TD, Beck RW, Gal RL, et al. Diabetes Technol Ther. 2018;20:314–316.

June 22, 2018 19

CGM Metrics

June 22, 2018 20

most studies AG is

99–100 mg/dLin normals

Mazze RS, Strock E, Wesley D, et al. Diabetes Technol Ther. 2008;10:149–159.

33 Individuals without diabetes (CGM Normal Study )

Insert Date 21

CGM Metrics

?

June 22, 2018 22

June 22, 2018 23

Estimated A1C

(eA1C)

7.7%

(61 mmol/mol)

June 22, 2018 24

Glucose Management

Indicator (GMI) *

7.7%

(61 mmol/mol)

*GMI proposed to FDA and diabetes community to replace eA1C

June 22, 2018 25

4%

6%

Level 2 hyperglycemia

Level 1 hyperglycemia

Level 1 hypoglycemia

Level 2 hypoglycemia

(Hypoglycemia Alert)

(Immediate Action)

June 22, 2018 26

4%

6%

5%

20%

72%

2%1%

25%

72%

3%

Advanced Technology

670G HCL Data

HCL, hybrid closed-loop.

Bergenstal RM, Garg S, Weinzimer SA, et al. JAMA. 2016;316:1407–1408.

June 22, 2018 27

TIME IN RANGE AND A1C CORRELATION

Measured TIR

A1C 95% CI

40% 8.1% 7.1-9.1%

50% 7.7% 6.7-8.7%

60% 7.3% 6.3-8.3%

70% 6.9% 5.9-7.9%

80% 6.5% 5.5-7.5%

R. Beck, personal communication; secondary analysis of data from Beck RW, Connor CG, Mullen DM, Wesley DM,

Bergenstal RM. Diabetes Care. 2017;40:994–999.

Δ = 0.4%

Δ = 0.4%

Δ = 0.4%

Δ = 0.4%

June 22, 2018 28

Does Time-in-Range Matter? Perspectives From People With

Diabetes in the Success of Current Therapies and the

Drivers of Improved Outcomes

Runge AS, Kennedy L, Brown AS, et al. Clin Diabetes. 2018;36:112–119.

June 22, 2018 29

Glucose Management

Indicator (GMI) *

7.7%

(61 mmol/mol)

*GMI proposed to FDA & Diabetes Community to replace eA1c

*GMI proposed to FDA and diabetes community to replace eA1C

June 22, 2018 30

MEASURES OF GLUCOSE VARIABILITY

StableGlucose Profile

SD < AG/3

Hirsch IB, Amiel SA, Blumer IR, et al. Diabetes Technol Ther. 2012;14:973–983.

Stable Glucose Profile

<36%

Monnier L, Colette C, Wojtusciszyn A, et al. Diabetes Care. 2017;40:832–838.

June 22, 2018 31

Glucose Management

Indicator (GMI) *

7.7%

Daily Glucose Summary

NINE STEPS TO INTERPRETING AN AGP

Carlson AL, Mullen DM, Bergenstal RM. Clinical use of

continuous glucose monitoring in adults with type 2 diabetes.

Diabetes Technol Ther. 2017;19(Suppl. 2):S4–S11.

June 22, 2018 32

Interpreting

an AGP:

Nine Steps Step 1: Check for

adequate data. ✓Glucose Management

Indicator (GMI) *

7.7%

June 22, 2018 33

✓

62 yo. ;T2D for 15 yrs.; No hx. of known CVD; 90 kg; eGFR >60

✓Step 2: Mark up the AGP, noting factors that may

affect the management plan.

Metformin 1,000 mg 1,000mg

Degludec 20 U

Lispro 10 U 8U 12U

W B l D BTx x x x snack

7 11 5 8

June 22, 2018 34

✓

62 yo. ;T2D for 15 yrs.; No hx. of known CVD; 90 kg; eGFR >60

✓ Step 3: Ask the patient “What do you see?” Listen.

Metformin 1,000 mg 1,000mg

Degludec 20 U

Lispro 10 U 8U 12U

W B l D BTx x x x snack

7 11 5 8

4%

6%

5%

20%

72%

2%1%

Corr. Factor

June 22, 2018 35

✓

62 yo. ;T2D for 15 yrs.; No hx. of known CVD; 90 kg; eGFR >60

Step 4: Look for patterns of low glucose levels.

Metformin 1,000 mg 1,000mg

Degludec 20 U

Lispro 10 U 8U 12U

W B l D BTx x x x snack

7 11 5 8

1

June 22, 2018 36

✓

62 yo. ;T2D for 15 yrs.; No hx. of known CVD; 90 kg; eGFR >60

Step 4: Look for patterns of low glucose levels.

Metformin 1,000 mg 1,000mg

Degludec 20 U

Lispro 10 U 8U 12U Corr.Factor

Treat the CLOUD!

16

CF

W B l D BTx x x x snack

7 11 5 8

1 2

June 22, 2018 38

✓

62 yo. ;T2D for 15 yrs.; No hx. of known CVD; 90 kg; eGFR >60

✓

Metformin 1,000 mg 1,000mg

Degludec 20 U

Lispro 10 U 8U 12U Corr.Factor

Treat the CLOUD!

16

CFpre-meal

CF

W B l D BTx x x x snack

7 11 5 8

1 2

Step 4: Look for patterns of low glucose levels.

June 22, 2018 39

✓

62 yo. ;T2D for 15 yrs.; No hx. of known CVD; 90 kg; eGFR >60

✓

Metformin 1,000 mg 1,000mg

Degludec 20 U

Lispro 10 U 8U 12U Corr.Factor

16

CF

Step 5: Look for patterns of high glucose levels.

pre-meal

?13 CF

W B l D BTx x x x snack

7 11 5 8

12

June 22, 2018 40

✓

62 yo. ;T2D for 15 yrs.; No hx. of known CVD; 90 kg; eGFR >60

✓

Metformin 1,000 mg 1,000mg

Degludec 20 U

Lispro 10 U 8U 12U Corr.Factor

16

CFpre-meal

?13

Step 6: Look for areas of wide glucose variability.

CF

GV is about timing or amount

• Timing: insulin and meals, weekday and weekend, snacks, exercise, stress

• Amount: insulin (daily dose or carb counting), insulin:carb ratio, exercise intensity

GV

W B l D BTx x x x snack

7 11 5 8

June 22, 2018 41

✓

62 yo. ;T2D for 15 yrs.; No hx. of known CVD; 90 kg; eGFR >60

✓

Metformin 1,000 mg 1,000mg

Degludec 20 U

Lispro 10 U 8U 12U Corr.Factor

16

CFpre-meal

?13 CF

Step 7: Compare to past AGP and reinforce successful strategies.

4%6%

W B l D BTx x x x snack

7 11 5 8

June 22, 2018 42

✓

62 yo. ;T2D for 15 yrs.; No hx. of known CVD; 90 kg; eGFR >60

✓

Metformin 1,000 mg 1,000mg

Degludec 20 U

Lispro 10 U 8U 12U Corr.Factor

16

CFpre-meal

?13 CF

Step 8: Agree on an action plan with patient.

4%6%

15%

31%

50%

3 %1 %

W B l D BTx x x x snack

7 11 5 8

Action Plan:

1. Get rid lows overnight: long-acting insulin + correction factor

2. Reduce variability: insulin timing, amount of food, consider carb counting

3. As you treat the cloud, remember to look forward 12–18 hours for

secondary effects on glucose

4. As you treat lows first, small or no in TIR initially so schedule repeat

look at 2-week profile soon to address highs (series of 3–4 adjustments)

5. Continue using CGM (real-time or retrospective intermittently)

• If real-time CGM: also teach how to use trend arrows

June 22, 2018 4362 yo. ;T2D for 15 yrs.; No hx. of known CVD; 90 kg; eGFR >60

✓

Metformin 1,000 mg 1,000mg

Degludec 20 U

Lispro 10 U 8U 12U Corr.Factor

16

CFpre-meal

CF

Step 9: Copy the AGP for the patient and the EMR.

W B l D BTx x x x snack

7 11 5 8

June 22, 2018 44

Thank You