evidence and guidelines technology 2016 - mcgill...

Evidence and Guidelines TECHNOLOGY 2016

Tina Kader, MDStaff endocrinologist

Jewish General Hospital

Certified Diabetes Educator

Montreal, Quebec

CGM=continuous glucose monitoring; SMBG=self-monitoring of blood glucoseHandelsman Y, et al. Endocrine Practice. 2015;21(suppl 1):1-87.

A1c measurement• 2 or more times each year in all individuals with diabetes

• 4 or more times each year in individuals not at target

All patients using insulin should perform SMBG• Minimum twice daily• Ideally, before any insulin injection

• More frequent checks after meals or middle of the night may be required for patients with frequent hypoglycemia

Consider CGM for patients with T1D and T2D on basal-bolus therapy• Improve A1c levels• Reduce hypoglycemia

AACE/ACE 2015 GuidelinesGlucose Monitoring: When, How, and In Whom?

Faculty/Presenter Disclosure

Faculty/Presenter: tina kader

Relationships with commercial interests:

Grants/research support: BI; Sanofi

Speaker’s bureau/honoraria:eli lilly sanofi; medtronic; novonordisk;merck

BMS; Astraxeneca;Jansen; Takeda

Consulting fees: eli lilly sanofi; medtronic; novonordisk;merck

Other: [insert company/organization name(s) here]

DIABETES AND TECHNOLOGY

• CANADIAN GUIDELINES FOR CBGM

• HOW ACCURATE ARE OUR CURRENT TOOLS

• CASE PRESENTATION

• WHAT IS AGP; COMING TO YOU SOON

• WHAT TECHNOLOGY IS HERE AND WHAT IS

COMING

[Poll #2]

How would you rank the adherence of your patients to the recommended frequency of SMBG?

A. PoorB. FairC. GoodD. Excellent

Dr. Kader

Is treated only with lifestyle AND is meeting glycemic targets

Has pre-diabetes

C. DAILY SMBG IS NOT USUALLY REQUIRED if the person with

diabetes:

Daily SMBG is not usually required if:

guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association

Increased frequency of SMBG may be

required:


B. INCREASED FREQUENCY OF SMBG MAY BE REQUIRED if the person with

diabetes is: SITUATION SMBG RECOMMENDATION

Using drugs known to cause hypoglycemia (e.g. sulfonylureas, meglitinides)

SMBG at times when symptoms of hypoglycemia occur or at times when hypoglycemia has previously occured

Has an occupation that requires strict avoidance of hypoglycemia

SMBG as often as is required by employer

Not meeting glycemic targetsSMBG ≥ 2 times per day, to assist in lifestyle and/or medication changes until such time as glycemic targets are met

Newly diagnosed with diabetes (< 6 months)SMBG ≥ 1 time per day (at different times of day) to learn the effects of various meals, exercise and/or medications on blood glucose

Treated with lifestyle and/or oral agents AND is meeting glycemic targets

Some people with diabetes might benefit from very infrequent checking (SMBG once or twice per week) to ensure that glycemic targets are being met between A1C tests

Regular SMBG is required:


A. REGULAR SMBG IS REQUIRED if the person with diabetes is:

SITUATION SMBG RECOMMENDATION

Using multiple daily injections of insulin (≥ 4 times per day) SMBG ≥ 4 times per day (see page 2 – QID – [basal-

bolus/MDI])Using an insulin pump

Using insulin < 4 times per daySMBG at least as often as insulin is being given (see page 2 – premixed or basal insulin only)

Pregnant (or planning a pregnancy), whether using insulin or not SMBG individualized and may involve SMBG ≥ 4

times per dayHospitalized or acutely ill

Starting a new medication known to cause hyperglycemia (e.g. steroids) SMBG individualized and may involve SMBG ≥ 2

times per dayExperiencing an illness known to cause hyperglycemia (e.g. infection)

• SMBG accompanied by structured educational program

to facilitate behaviour change results in improved outcomes

• Teach patients

1. How and when to perform SMBG

2. How to record the results

3. Meaning of various BG levels

4. How behaviour and actions affect SMBG results

1.Parkin CG et al. J Diabetes Sci Technol. 2009;3:500-508.

2.Polonsky WH, et al. Diabetes Care. 2011;34:262-267.guidelines.diabetes.ca | 1-800-BANTING (226-8464) | diabetes.caCopyright © 2013 Canadian Diabetes Association

Monitoring with Meaning …







COMING

Kildegaard J, et al: JDST 2009, 3(4):986-991.

Causes of glucose variability

A1c: glycated hemoglobin; SMBG: self-monitoring blood glucose; CGM: continuous glucose monitoring; AGP: ambulatory glucose profile; BG: blood glucose

Benefits Limitations

Overview of Glucose Monitoring and Assessment Methods

A1c

• Reliable estimate of mean BG

• 3-month average (retrospective)

• Indicator of complication risk

• Laboratory test

• Does not capture trends in glycemic variability

• Misleading in various medical conditions

AGP

• Comprehensive view of changing glucose patterns over past 14 days

• Visual summary report of a multitude of glucose measurements

• Non proprietary

• Accessibility

• Cost

SMBG• Information on a single point in time

• Easily measured at home

• Depends on patient adherence and frequency and timing of measurement

CGM• Continuous real-time glucose values

• Built-in glucose alarms/alerts

• Complex interpretation of data

• Accessibility

• Cost

Patient A: A1c 7.0%

8 AM 8 AM8 PM2 PM 2 AM

Checks qAM (fasting)What if he checked more often?

Patient B: A1c 7.0%

8 AM 8 AM8 PM2 PM 2 AM

Checks 4x/dWhat if he checked more often?

More frequent SMBG gives you a more complete picture

6.0

8.0

10.0

Glu

cose

(m

mo

l/L)

6.0

8.0

10.0

A1c in Combination with SMBG

Glucose VARIABILITY and Hypoglycemia

• Increasing glycemic variability is correlated with more

frequent episodes of hypoglycemia1-3:

– Reduced peaks and troughs, should result in a lower likelihood

of patients slipping below their target range.

– Less time below target means less risk of hypoglycemia.

– Reduced glucose variability and flux, will reduce the risk of

HbA1c-independent mortality and morbidity.

1. Monnier L et al: Diabetes Technol Ther 2011, 13:813–818 2. Qu Y et al: Diabetes Technol Ther 2012, 14:1008–1012. 3. Catherine Gorst et al; Diabetes Care 2015, 10:2337dc15-1188

How frequently do you recommend obtaining information from CGM in your insulin-treated patients with T2D?

A. RarelyB. SometimesC. OftenD. RoutinelyE. never







COMING

Mr. Cross – Type 1 diabetes

• Age 48

• Diagnosed at age 6

• Labile glycemia for years

• DKA; seizures

• Multiple admissions

CURRENT MEDICATIONS

• Insulin lispro via CSII (insulin pump)• Basal rates 0.35-0.7 U/hr

• Boluses 1U/7g to 1U/11g; ISF = 2.8 to 3.4

• Rosuvastatin 10 mg QD

• Perindopril 2 mg QD

LABS• A1c 7.2%

• FPG 6.8 mmol/L

• LDL-C 1.8 mmol/L

• ACR 2.5 mg/mmoL

• eGFR >60 ml/min

Data Sources: Paradigm Veo - 554 (813483)

CarbohydrateRatio(g/U)

Insulin Sensitivity(mmol/L per U)

Blood GlucoseTarget(mmol/L)

Mr. Cross – CGM ReportBasal

Maximum BasalRate

2.00 U/hr

Temp Basal TypePercent of Basal

BolusMaximum Basal Rate10.0 U

Dual/Square (Variable) On

Blood Glucose Reminder Off24-Hour

Total12.625 U 24-HourTotal--

24-HourTotal--

PatternA

PatternB

Standard(active)

TIMEU/hr

0:000.700

3:000.650

7:000.550

10:000.475

12:000.525

15:000.350

20:000.500

TIMEU/hr

----

TIMEU/hr

----

TIMERatio

0:009.0

6:0011.0

11:009.0

18:007.0

TIMESensivity

0:002.8

4:003.4

12:003.4

18:003.0

22:002.8

TIMELow High

0:005.5 7.0

6:005.0 6.5

23:005.5 7.0

Easy (Audio) BolusOff

Entry (Step)0.10 U

Bolus WizardOn

Unitsg, mmol/L

Active Insulin Time (h:mm)4:00

Insuline Concentration --

Missed Bolus

ReminderOff

Start(h:mm)

End (h:mm)

----

SensorSensorOn

Transmitter ID2268733

BG UnitsMmol/LGlucose AlertsOn

TIME Low (mmol/L) High (mmol/L)

0:00 4.5 10.5

Alert Repeat 0:30 2:00Predictive Alert On

Low | High (mins) 15 15

Rate Alert: Fall Rise (mmol/L/min) 0.200 0.200

AUC Limit: Low | High (mmol/L) 3.9 10.0

Missed Data/Weak Signal (h:mm)0.30

Graph Timeout (h:mm)0.02

Auto Calibration Off

Calibration Reminder (h:mm)1:00

Calibration (Alert) Repeat (h:mm)1:00

UtilitiesAlert TypeVibrate

Low Suspend (mmol/L)3.3

Low Reservoir Warning Insulin Units

Amount 20 U

• Show different settings, e.g., basal rates on exercise or work days, I:C ratios, ISF and pump settings

• 3 SETTINGS

• BASAL RATE

• CARB RATIO

• INSULIN SENSITIVITY

INSULIN PUMP 101

• CAN CHANGE BASAL RATE EVERY HOUR

• USUALLY 4 A DAY SUFFICE

• USUALLY LOWER AT MIDNIGHT AND HIGHER AFTER 3 AM; DAWN PHENOMENA

• BASAL RATE DURING THE DAY MAY FLUCTUATE

• CAN DECREASE ONE HOUR BEFORE EXERCISE

BASAL RATE

• ONE UNIT FOR ? CARBS

• START IS ONE UNIT FOR 10 GRAMS

• SOME NEED LESS; IE LEAN ACTIVE

• 1 UNIT FOR 20

• OBESE 1 UNIT FOR 5

• SO IF 1/5 IF EATS 40 GRAM ; 40/5 = 8

INSULIN CARB RATIO

• SLIDING SCALE

• USUALLY 2 TO 3

• IE 1 UNIT WILL DROP SUGAR BY 2 MMOL

• IF TARGET IS 8; SUGAR IS 16

• 16-8 OVER 2; 4 UNITS EXTRA IS GIVEN

INSULIN SENSITIVITY

Indications for CSII

• Poor control despite MDI

• Frequent hypoglycemia

• Dawn phenomenon

• Shift work

• Athletic; work benefit

• Lifestyle choice or personal preference

Bruttomesso D, et al. Diabetes Metab Res Rev 2009;25:99-111.

Lassmann-Vague V, et al. Diabetes Metab 2010;36:79-85.

CSII: continuous subcutaneous insulin infusion;

MDI: multiple daily insulin injections

Contraindications or

“Cautions” for CSII

• Lack of motivation

• Psychiatric issues

• Little or no self-monitoring of blood glucose

• Active proliferative retinopathy

• Magnetic fields in environment

• Frequent DKA

CSII: continuous subcutaneous insulin infusion

DKA: diabetic ketoacidosis

Bruttomesso D, et al. Diabetes Metab Res Rev 2009;25:99-111.

Lassmann-Vague V, et al. Diabetes Metab 2010;36:79-85.


Sensor trace

Interrupted

Average

Bedtime toWake-up

Breakfast: 6:00 AM -10:00 AM

Meals Analyzed: 14

Lunch: 11:00 AM -3:00 PM

Meals Analyzed: 8

Dinner: 4:00 PM -10:00 PM

Meals Analyzed: 26Bedtime: 8:00 PM -12:00 AM

Wake-up: 5:00 AM -9:00 AM

Avg Carbs: 34g

Avg Insulin: 3.1U

Avg Carbs/Insulin:11.2g/U

Avg Carbs: 26g

Avg Insulin: 2.7U


Avg Carbs: 24g

Avg Insulin: 3.3U


Glucose Sensor Overlay Bedtime to Wake-Up and Meal Periods – Readings & Averages (mmol/L)

Mr. Cross – CGM Report

Glu

cose

(m

mo

l/L)

15.0

20.0

2.23.9

7.8

10.0

12 AM 2 AM 4 AM 6 AM 8 AM 10 AM 12 PM 2 PM 4 PM 6 PM 8 PM 10 PM 12 PM

Breakfast Lunch Dinner24-Hour Glucose Sensor Overlay – Readings & Averages (mmol/L)

Glu

cose

(m

mo

l/L)

15.0

20.0

2.23.9

7.8

10.0

8 PM 9 AM -1:00 0 +1:00 +5:00 -1:00 0 +1:00 +5:00 -1:00 0 +1:00 +5:00

Time of day

0 = Time of meal

• Displays mean glucose values

• Demonstrates post-prandial glucose excursions

• PC supper glucose is most concerning – may require adjustment of I:C ratio

Sensor trace

BG reading

Basal

Bolus

Suspend

Low Suspend

Time change

Injected insulin (U)

Exercise

Other

Interrupted Off chart

Temp basal

12 AM 6 AM 6 PM 6 AM 6 PM12 PM 12 AM 12 PM 12 AM 6 AM 6 PM 6 AM 6 PM12 PM 12 AM 12 PM 12 AM 6 AM 6 PM12 PM 12 AM

Saturday 10/11 Sunday 10/12 Monday 10/13 Tuesday 10/14

013

15

63

2.2

3.9

7.8

10.0

15.0

20.0

(g)

Insulin(U/hr)

Carbs

Glucose

(mmol/L)

013

15

63

2.2

3.9

7.8

10.0

15.0

20.0

(g)

Insulin(U/hr)

Carbs

Glucose

(mmol/L)

013

15

63

2.2

3.9

7.8

10.0

15.0

20.0

(g)

Insulin(U/hr)

Carbs

Glucose

(mmol/L)

Mr. Cross – CGM ReportBreakf

astLunch Dinner


Breakfast

Lunch Dinner Breakfast



Lunch Dinner

Monday 10/6 Tuesday 10/7 Wednesday 10/8 Thursday 10/9 Friday 10/10

Wednesday 10/1 Thursday 10/2 Friday 10/3 Saturday 10/4 Sunday 10/5

• Useful patient teaching tool

• Displays basal, bolus, carbs and daily fluctuations

• E.g., October 6 demonstrates over- treatment of hypoglycemia in the evening

4.2

3.2


Hypoglycemic Episodes, by preceding Event Type -Threshold: ≤3.9 mmol/L

Hyperglycemic Episodes, by preceding Event Type - Threshold: ≥7.8 mmol/L

Most Common Event Types preceding Hypoglycemia Most Common Event Types preceding Hyperglycemia

Hyp

ogl

ycem

ic

Epis

od

es

8

7

6

5

4

3

2

1

0

Event Type Descriptions

Event Types % Description

Hyperglycemia Preceding Hypoglycemia

78 Consider assessing your patient’s insulin sensitivity factors. Consider counseling your patient on the management of hyperglycemia.

Nocturnal Hypoglycemia (11PM-5AM)

44 Consider assessing overnight basal rates and counseling your patienton evening boluses.

Basal Rate Increase 44 Consider assessing your patient’s basal rate settings, including temporary basal rates.Other Observations

No overall issues observed.

Event Type Descriptions

Event Types % Description

Bolus Wizard Food Bolus

43 Consider assessing the Bolus Wizard settings, counseling your patient on accurate carbohydrate counting, and/or the timing of insulin delivery with respect to carbohydrate intake.

Bolus with Rising Sensor Rate of Change

37 Consider counseling your patient to modify bolus amounts when sensor glucose values are rising (upward arrow is present).

Rising Sensor Rate of Change Without Bolus

22 Consider counseling your patient on bolus use with meals and/or correcting rapid glucose excursions.

Hyp

ergl

yce

mic

Ep

iso

des

40

35

30

25

20

15

10

50

Mr. Cross – CGM Report

HyperglycemiaPreceding

Hypoglycemia

NocturnalHypoglycemia(11PM-5AM)

Basal RateIncrease

Bolus WizardFood Bolus

Rapid FallingSensor Rate of

Change

MultipleCorrection

Boluses

Bolus withFalling Sensor

Rate of Change

Corr. Bolus withFalling Sensor

Rate of Change

Bolus WizardFood Bolus

Bolus withRising Sensor

Rate of Change

Rising SensorRate of ChangeWithout Bolus

Overcorrectionof

Hypoglycemia

Bolus WizardOverride (-)

DawnPhenomenon(3AM-7AM)

Basal RateDecrease

Delayed SiteChange

64 Hyperglycemia Preceding

Hypoglycemia

15 Nocturnal Hypoglycemia(11PM-5AM)

33 Basal Rate Increase 69 Bolus Wizard Food Bolus

37 Bolus with Rising Sensor Rate of Change

17 Rising Sensor Rate of Change Without Bolus

• Displays periods of hypoglycemia after hyperglycemia

• Change in ISF may be required

• May require carb counseling or revision of I:C ratios

Mr. Cross – AGP Report

00:00

2:00 4:00 6:00 8:00 10:00

12:00

14:00

16:00

18:00

20:00

22:00

00:00

15

20

10

Targ

et

Ran

ge

Glu

cose

(m

mo

l/L)

Time of day

10

4.45

0

Reminder: AGP is a single report with comprehensive view of changing data over 14

Glucose values are widely spread indicating glucose

variability

Median curve rises after

lunch

Median curve is moving up and

down, indicating glucose variability

Lowest glucose readings are between

2:00am-8:00am

CURRENT MEDICATIONS

• Insulin glargine 40 qhs

• Insulin aspart 1 U/10 gac meals; ISF=2

• Atorvastatin 20 mg QD

• Ramipril 10 mg QD

LABS• A1c 8.8%

• FPG 12.6 mmol/L

• LDL-C 2.0 mmol/L

• ACR 1.1 mg/mmol

• eGFR 55 ml/min

Mr. Smith – Type 2 Diabetes

• 58 years old

• T2D x 15 yrs

• Poor glycemic control for years

– Neuropathy

– Retinopathy

– Exam normal except for reduced monofilament

• Variable adherence to SMBG

• Aware of carb counting and prandial insulin adjustments

Current insulin regimen: glargine 40 qhs, aspart 1 U/10 g ac meals; ISF=2

Mr. Smith - SMBG Logbook

Pre Breakfast

Pre Lunch Pre Supper Bed Notes

Mon 9.6 6.1hypo at

night

Tues

Wed 3.1 10.2

Thur

Fri 8.8 15.3hypo at

night

Sat

Sun 5.1 7.2

What would you recommend for Mr. Smith?

a. Increase insulin glargineb. Ask Mr. Smith to increase frequency of SMBG for

more informationc. Initiate CGM for more glucose informationd. Obtain an AGP for more glucose informatione. Other







COMING

CGM: continuous glucose monitoring; AGP: ambulatory glucose profile

Ambulatory Glucose Profile (AGP)

• Algorithm developed by the IDC (International Diabetes Centre)

• Single report with statistical summary, visual display and daily views of glucose information

• Analyzes glucose data collected over days/weeks as if they occurred within a single 24-hour period

• Provides a comprehensive view of changing glucose levels/patterns over 14 days

Assessing More Frequent Glucose DataContinuous Glucose Monitoring (CGM)

• Continuous real-time glucose values

• Device measures glucose levels in interstitial fluid

• Generates a “spaghetti view” reportGlu

cose

(m

mo

l/L)

5

10

15

20

25

30

0

Time of day

06:00 08:00 10:00 12:00 14:00 16:00 18:00 20:00 22:00 00:00 02:00 04:00

00:00

02:00

04:00

06:00

08:00

10:00

12:00

14:00

16:00

18:00

20:00

22:00

00:00

15

20

0

Glu

cose

(m

mo

l/L)

10

Time of day

Target Range

4.4

Interpretation of Mr. Smith’s AGP

04:00 06:00 08:00 10:00 12:00 14:00 16:00 18:00 20:00 22:00 00:00 02:00 04:00

0

Glu

cose

(m

mo

l/L)

Time of day

6

12

15

18

21

3 25th and 75th

percentiles

10th and 90th

percentiles

Median curve rises after

meal

Wide IQR indicates glucose

variability

9Target Range

10

4.4

Mr. Smith's AGP

04:00 06:00 08:00 10:00 12:00 14:00 16:00 18:00 20:00 22:00 00:00 02:00 04:00

0

Glu

cose

(m

mo

l/L)

Time of day

6

12

15

18

21Median curve

3 10th and 90th

percentiles

25th and 75th

percentiles

9Target Range

10

4.4

DIABETES AND TECHNOLOGY• CANADIAN GUIDELINES FOR CBGM





COMING

CGM Devices available in CanadaWired and Wireless Continuous

Sensors

MiniLink Transmitter

Implantable Sensors

Install Transmitter

Conclusions

• PUMP USE IS ON THE RISE

• BE AWARE OF BASIC PARAMETERS

• CONTINUOUS TESTING IS COMING

• BE AWARE OF AGP AND HOW TO INTERPRET

• WE WILL SOON BE THE MOST MONITORED

AND PICTURED GENERATION

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