Evidence and Guidelines TECHNOLOGY 2016 Tina Kader, MD

Transcription

1 Evidence and Guidelines TECHNOLOGY 216 Tina Kader, MD Staff endocrinologist Jewish General Hospital Certified Diabetes Educator Montreal, Quebec

2 AACE/ACE 215 Guidelines Glucose Monitoring: When, How, and In Whom? 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 CGM=continuous glucose monitoring; SMBG=self-monitoring of blood glucose Handelsman Y, et al. Endocrine Practice. 215;21(suppl 1):1-87.

3 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]

4 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

5 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

6 Dr. Kader [Poll #2] How would you rank the adherence of your patients to the recommended frequency of SMBG? A. Poor B. Fair C. Good D. Excellent

7 Daily SMBG is not usually required if: C. DAILY SMBG IS NOT USUALLY REQUIRED if the person with diabetes: Is treated only with lifestyle AND is meeting glycemic targets Has pre-diabetes guidelines.diabetes.ca 1-8-BANTING ( ) diabetes.ca Copyright 213 Canadian Diabetes Association

8 Increased frequency of SMBG may be required: B. INCREASED FREQUENCY OF SMBG MAY BE REQUIRED if the person wit diabetes is: SITUATION SMBG RECOMMENDATION Using drugs known to cause hypoglycemia (e.g. sulfonylureas, meglitinides) Has an occupation that requires strict avoidance of hypoglycemia Not meeting glycemic targets Newly diagnosed with diabetes (< 6 months) Treated with lifestyle and/or oral agents AND is meeting glycemic targets SMBG at times when symptoms of hypoglycemia occur or at times when hypoglycemia has previously occured SMBG as often as is required by employer SMBG 2 times per day, to assist in lifestyle and/or medication changes until such time as glycemic targets are met SMBG 1 time per day (at different times of day) to learn the effects of various meals, exercise and/or medications on blood glucose 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 guidelines.diabetes.ca 1-8-BANTING ( ) diabetes.ca Copyright 213 Canadian Diabetes Association

9 Regular SMBG is required: A. REGULAR SMBG IS REQUIRED if the person with diabetes is: SITUATION Using multiple daily injections of insulin ( 4 times per day) Using an insulin pump Using insulin < 4 times per day guidelines.diabetes.ca 1-8-BANTING ( ) diabetes.ca Copyright 213 Canadian Diabetes Association SMBG RECOMMENDATION SMBG 4 times per day (see page 2 QID [basalbolus/mdi]) SMBG 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 day Hospitalized or acutely ill Starting a new medication known to cause hyperglycemia (e.g. steroids) SMBG individualized and may involve SMBG 2 Experiencing an illness known to cause hyperglycemia times per day (e.g. infection)

10 Monitoring with Meaning 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. 29;3: Polonsky WH, et al. Diabetes Care. 211;34: guidelines.diabetes.ca 1-8-BANTING ( ) diabetes.ca Copyright 213 Canadian Diabetes Association

11 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

12 Causes of glucose variability Kildegaard J, et al: JDST 29, 3(4):

13 Overview of Glucose Monitoring and Assessment Methods A1c SMBG CGM Benefits Reliable estimate of mean BG 3-month average (retrospective) Indicator of complication risk Information on a single point in time Easily measured at home Continuous real-time glucose values Built-in glucose alarms/alerts Limitations Laboratory test Does not capture trends in glycemic variability Misleading in various medical conditions Depends on patient adherence and frequency and timing of measurement Complex interpretation of data Accessibility Cost A1c: glycated hemoglobin; SMBG: self-monitoring blood glucose; CGM: continuous glucose monitoring; AGP: ambulatory glucose profile; BG: blood glucose AGP Comprehensive view of changing glucose patterns over past 14 days Visual summary report of a multitude of glucose measurements Non proprietary Accessibility Cost

14 A1c in Combination with SMBG Glucose (mmol/l) Patient A: A1c 7.% Checks qam (fasting) What if he checked more often? 8 AM 2 PM 8 PM 2 AM 8 AM Patient B: A1c 7.% Checks 4x/d What if he checked more often? 8 AM 2 PM 8 PM 2 AM 8 AM More frequent SMBG gives you a more complete picture

15 Glucose VARIABILITY and Hypoglycemia Increasing glycemic variability is correlated with more frequent episodes of hypoglycemia 1-3 : 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 211, 13: Qu Y et al: Diabetes Technol Ther 212, 14: Catherine Gorst et al; Diabetes Care 215, 1:2337dc

16 How frequently do you recommend obtaining information from CGM in your insulin-treated patients with T2D? A. Rarely B. Sometimes C. Often D. Routinely E. never

17 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

18 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 U/hr Boluses 1U/7g to 1U/11g; ISF = 2.8 to 3.4 Rosuvastatin 1 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 >6 ml/min

19 Mr. Cross CGM Report Basal Maximum Basal2. U/hr Rate Temp Basal TypePercent of Basal Standard (active) 24-Hour Total U TIMEU/hr :.7 3:.65 7:.55 1: : :.35 2:.5 Pattern A 24-Hour Total -- TIMEU/hr ---- Pattern B 24-Hour Total -- TIMEU/hr ---- Data Sources: Paradigm Veo (813483) Bolus Maximum Basal Rate 1. U Dual/Square (Variable) On Blood Glucose Reminder Off Easy (Audio) BolusOff Entry (Step).1 U Bolus WizardOn Unitsg, mmol/l Active Insulin Time (h:mm) 4: Carbohydrate Insuline Concentration-- Insulin Sensitivity Ratio (mmol/l per U) (g/u) TIMERatio TIMESensivity :9. 6:11. :2.8 11:9. 4:3.4 18:7. 12:3.4 18:3. 22:2.8 Missed Bol us Reminder Off StartEnd (h:m (h:mm) m) ---- Blood Glucose Target (mmol/l) TIMELow High : : : Show different settings, e.g., basal rates on exercise or work days, I:C ratios, ISF and pump settings Sensor Sensor On Transmitter ID BG UnitsMmol/L Glucose AlertsOn TIME Low (mmol/l) High (mmol/l) : Alert Repeat Predictive Alert On :3 2: Low High (mins) Rate Alert: Fall Rise (mmol/l/min).2.2 AUC Limit: Low High (mmol/l) Missed Data/Weak Signal (h:mm).3 Graph Timeout (h:mm).2 Auto Calibration Off Calibration Reminder (h:mm) 1: Calibration (Alert) Repeat (h:mm) 1: Utilities Alert Type Vibrate Low Suspend (mmol/l) 3.3 Low Reservoir Warning Insulin Units Amount 2 U

20 INSULIN PUMP 11 3 SETTINGS BASAL RATE CARB RATIO INSULIN SENSITIVITY

21 BASAL RATE 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

22 INSULIN CARB RATIO ONE UNIT FOR? CARBS START IS ONE UNIT FOR 1 GRAMS SOME NEED LESS; IE LEAN ACTIVE 1 UNIT FOR 2 OBESE 1 UNIT FOR 5 SO IF 1/5 IF EATS 4 GRAM ; 4/5 = 8

23 INSULIN SENSITIVITY SLIDING SCALE USUALLY 2 TO 3 IE 1 UNIT WILL DROP SUGAR BY 2 MMOL IF TARGET IS 8; SUGAR IS OVER 2; 4 UNITS EXTRA IS GIVEN

24 Indications for CSII Poor control despite MDI Frequent hypoglycemia Dawn phenomenon Shift work Athletic; work benefit Lifestyle choice or personal preference CSII: continuous subcutaneous insulin infusion; MDI: multiple daily insulin injections Bruttomesso D, et al. Diabetes Metab Res Rev 29;25: Lassmann-Vague V, et al. Diabetes Metab 21;36:79-85.

25 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 29;25: Lassmann-Vague V, et al. Diabetes Metab 21;36:79-85.

26 Mr. Cross CGM Report Glucose (mmol/l) Glucose (mmol/l) 24-Hour Glucose Sensor Overlay Readings & Averages (mmol/l) AM 2 AM 4 AM 6 AM 8 AM 1 AM 12 PM 2 PM 4 PM 6 PM 8 PM 1 PM 12 PM Displays mean glucose Time values of day Glucose Sensor Overlay Bedtime to Wake-Up and Meal Periods Readings & Averages (mmol/l) Bedtime Demonstrates to Breakfast: 6: AM - Wake-up 1: AM post-prandial Lunch: 11: AM - Dinner: 4: PM - 3: PM 1: glucose PM excursions Sensor Interrupt Bedtime: 8: PM - Meals Avg Carbs: Analyzed: 34g 14 Meals Avg Carbs: Analyzed: 26g 8 Meals Avg Carbs: Analyzed: 24g 26 trace ed : AM Wake-up: 5: AM - 9: AM Avg Insulin: 3.1U Avg Carbs/Insulin: 11.2g/U Data Sources: Paradigm Veo (813483) Breakfast Lunch Dinner Avg Insulin: 2.7U Avg Carbs/Insulin: 9.7g/U Avg Insulin: 3.3U Avg Carbs/Insulin: 7.3g/U PC supper glucose is most concerning may require adjustment = Time of meal of I:C ratio 8 PM 9 AM -1: +1: +5: -1: +1: +5: -1: +1: +5: Avera ge

27 Mr. Cross CGM Report Glucos e (mmol/ L) Carbs Insulin (U/hr) (g ) Breakf ast Lunch Dinner Breakf ast Lunch Dinner Breakf ast Lunch Dinner Breakf ast Lunch Dinner Breakf ast Wednesday 1/1 Thursday 1/2 Friday 1/3 Saturday 1/4 Sunday 1/5 Lunch Dinner Glucos e (mmol/ L) Carbs Insulin (U/hr) Glucos e (mmol/ L) Carbs Insulin (U/hr) (g ) (g 9 E.g., October 6 demonstrates over- treatment of 632 Saturday 1/11 Sunday 1/12 Monday 1/13 Tuesday 1/14 ) Monday 1/6 Tuesday 1/7 Wednesday 1/8 Thursday 1/9 Friday 1/1 Useful patient teaching tool Displays basal, bolus, carbs and daily fluctuations hypoglycemia in the evening 12 AM 6 AM 12 PM 6 PM 12 AM 6 AM 12 PM 6 PM 12 AM 6 AM 12 PM 6 PM 12 AM 6 AM 12 PM 6 PM 12 AM 6 AM 12 PM 6 PM 12 AM Sensor trace Interrupted BG reading Off chart Data Sources: Paradigm Veo (813483) Basa ltemp basal Bolu s Suspend Low Suspend Time change Injected insulin (U) Exercis e Other

28 Mr. Cross CGM Report Hypoglycemic Episodes 2 1 Hypoglycemic Episodes, by preceding Event Type - Threshold: 3.9 mmol/l Hyperglycemia Nocturnal Preceding Hypoglycemia Hypoglycemia (11PM-5AM) Basal Rate Increase Bolus Wizard Food Bolus Rapid Falling Sensor Rate of Change Multiple Correction Boluses Most Common Event Types preceding Hypoglycemia Bolus with Corr. Bolus with Falling SensorFalling Sensor Rate of Change Rate of Change Hyperglycemic Episodes 1 5 Hyperglycemic Episodes, by preceding Event Type mmol/l Bolus Wizard Bolus with Rising SensorOvercorrectionBolus Wizard Dawn Food Bolus Rising SensorRate of Change of Override (-) Phenomenon Rate of ChangeWithout BolusHypoglycemia (3AM-7AM) Basal Rate Decrease Most Common Event Types preceding Hyperglycemia Threshold: Delayed Site Change 64 Hyperglycemia 15 Nocturnal 33 Basal Rate Increase Preceding Hypoglycemia Event Type Hypoglycemia Descriptions (11PM-5AM) 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 patient on evening boluses. Basal Rate Increase 44 Consider assessing your patient s basal rate settings, Other Observations including temporary basal rates. No overall issues observed. Data Sources: Paradigm Veo (813483) 69 Bolus Wizard Food 37 Bolus with Rising Bolus Sensor Rate of Change Event Type Descriptions Event Types % Description Bolus Wizard Food Bolus Bolus with Rising Sensor Rate of Change Rising Sensor Rate of Change Without Bolus 17 Rising Sensor Rate of Change Without 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. 37 Consider counseling your patient to modify bolus amounts when sensor glucose values are rising (upward arrow is present). 22 Consider counseling your patient on bolus use with meals and/or correcting rapid glucose excursions. Displays periods of hypoglycemia after hyperglycemia Change in ISF may be required May require carb counseling or revision of I:C ratios

29 Mr. Cross AGP Report er: AGP is a single report with comprehensive view of changing data ove Glucose (mmol/l) 1 Target Range : Lowest glucose readings are between 2:am-8:am Median curve rises after lunch 2: 4: 6: 8: 1: 12: Glucose values are widely spread indicating glucose variability 14: 16: 18: Median curve is moving up and down, indicating glucose variability 2: 22: : Time of day

30 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 CURRENT MEDICATIONS Insulin glargine 4 qhs Insulin aspart 1 U/1 g ac meals; ISF=2 Atorvastatin 2 mg QD Ramipril 1 mg QD LABS A1c 8.8% FPG 12.6 mmol/l LDL-C 2. mmol/l ACR 1.1 mg/mmol egfr 55 ml/min

31 Mr. Smith - SMBG Logbook Pre Breakfast Mon Tues Wed Thur Fri Sat Sun Current insulin regimen: glargine 4 qhs, aspart 1 U/1 g ac meals; ISF=2 Pre Lunch Pre Supper Bed Notes hypo at night hypo at night

32 What would you recommend for Mr. Smith? a. Increase insulin glargine b. Ask Mr. Smith to increase frequency of SMBG for more information c. Initiate CGM for more glucose information d. Obtain an AGP for more glucose information e. Other

33 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

34 Assessing More Frequent Glucose Data Glucose (mmol/l) : 8: 1: 12: 14: 16: 18: 2: 22: : 2: 4: Time of day Continuous Glucose Monitoring (CGM) Continuous real-time glucose values Device measures glucose levels in interstitial fluid Generates a spaghetti view report Glucose (mmol/l) Target Range 4. 4 : 2: 4: 6: 8: 1: 12: Time of day CGM: continuous glucose monitoring; AGP: ambulatory glucose profile 14: 16: 18: 2: 22: : 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

35 Interpretation of Mr. Smith s AGP Glucose (mmol/l) 12 1 Target 9 Range th and 75 th percentiles Median curve rises after meal Wide IQR indicates glucose variability 4: 6: 8: 1: 12: 14: 16: 18: 2: 22: : 2: 4: Time of day 1 th and 9 th percentiles

36 Mr. Smith's AGP Glucose (mmol/l) Target Range Median curve 3 25 th and 1 th and 75 th percentiles 4: 6: 8: 1: 12: 14: 16: 18: 2: 22: : 2: 4: Time of day 9 th percentiles

37 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

38 CGM Devices available in Canada Wired and Wireless Continuous SensorsInstall Transmitter MiniLink Transmitter Implantable Sensors

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41 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