Diabetes Technology: What Primary Care Providers Need to ...
Transcript of Diabetes Technology: What Primary Care Providers Need to ...
Diabetes Technology:What Primary Care Providers Need to Know
Malek Mushref, MD, Piedmont Athens Endocrinology
Adjunct clinical assistant professor at UGA/AU partnership
Disclosures:
• No financial disclosure
• Several slides are obtained from AACE slides library
Background:
Kesavadev et al. Diabetes Ther. 2020 Jun;11(6):1251-1269. doi: 10.1007/s13300-020-00831-z.
Outlines:
Discuss the use continuous glucose monitors (CGM)• Rational for use
• Indications
• Practical approach
What is new in diabetes care?• Insulin pumps
• Smart pens
A1C & Diabetes management
A1C, glycated hemoglobin; CKD, chronic kidney disease.
1. Garber AJ, et al. Endocr Pract. 2019;25:69-90. 2. ADA/EASD. Diabetes Care. 2019;42:S61-S70. 3. Diabetes Canada Clinical Practice GuidelinesExpert Committee. Can J Diabetes. 2018;42:S1-S325. 4. Davies MJ, et al. Diabetologia. 2018;61:2461-2498. 5. NICE guideline. Updated May 2017. https://www.nice.org.uk/guidance/ng28.
Organization Recommended A1C Target
American Association of Clinical Endocrinologists1
≤6.5% Based on safety and affordability; individualize where appropriate
American Diabetes Association/ European Association for the Study of Diabetes2
≤7% Most nonpregnant adults with adequate life expectancy; individualize based on patient characteristics and preferences and risk of adverse events
Diabetes Canada3
≤6.5% Adults with low hypoglycemia risk, to reduce CKD and retinopathy risk≤7% Most adults7.1%-8.5% Elderly (+/- dementia), functionally dependent, at high risk for hypoglycemia, and/or with limited life expectancy
Latin American Diabetes Association4
≤6.5% Young, no complications, at low risk for hypoglycemia<7% Individualize treatment
National Institute for Health and Care Excellence5
6.5% If managed by lifestyle + diet +/- single drug7.0% If on a drug associated with hypoglycemiaConsider less stringent target if patient has lower life expectancy, high hypoglycemia risk, and/or significant comorbidities
https://diatribe.org/time-range
Looking Beyond A1C:
This Photo is licensed under CC BY-NC
A1C
SMBG
Time in Range
Glucose variability
A1C
Continuous Glucose Monitoring (CGM)
• A small sensor is placed under the skin, to measure the interstitial glucose levels in intervals of 5 to 15 minutes1
• CGM can inform patients of impending glucose excursions using glucose trend arrows and influence treatment decisions2
Figure: Cengiz and Tamborlane. Diabetes Technol Ther. 2009. Jun;11 (Suppl 1)
1. Bergenstal et al. Diabetes Care. 2018 Nov;41(11):2275-2280.
2. Ajjan et al. Adv Ther. 2019 Mar;36(3):579-596.
Continuous Glucose Monitoring
• 3 types of CGM systems:• Real-time CGM
• Provides continuous data on sensor glucose values, trends and alarms to the CGM receiver or smartphone
• Intermittent scanned CGM (Flash)• Glucose data and trend information are available after scanning the CGM sensor
with the receiver or smartphone
• Newer versions have real-time optional alarms
• Professional CGM• A blinded CGM sensor is placed on the patient and worn for two weeks to obtain
data on glucose values and trends
• No real-time glucose data or alarms, only retrospective review of sensor glucosedata
No user calibration required
No user calibration required
Only implantable CGM
Indications for CGM Therapy
1. Danne et al. Diabetes Care 2017; 40:1631-1640.
2. ADA. Diabetes Care. 2019 Jan;42(Suppl 1):S71-S80.
3. Handelsman et al. Endocr Pract. 2015 Apr;21 Suppl 1:1-87.
International Consensus:1
• All patients with T1D
• T2D treated with intensive insulin
therapy, not meeting glycemic goals
• Those with problematic
hypoglycemia
American Diabetes Association:2
• T1D not meeting glycemic goals
(consider in T2D)
• Hypoglycemia/unawareness
• Sensor-augmented pump therapy
• Consider in pregnancy
AACE:3
• T1D with hypoglycemia/unawareness
or not meeting glycemic goals
• T2D on intensive insulin therapy, high
risk for hypoglycemia, or
unappreciated hyperglycemia
Why using a CGM?
• FDA approved for treatment decision (non-adjunctive use)
• Allow patients to achieve glycemic target while avoiding acute complications of hypoglycemia and hyperglycemia
• Provides retrospective assessment for clinicians to make better treatment decisions
Am J Med Sci 2019;358(5):332–339
Meta-analysis of CGM trials in T1D and T2D
Change in Hemoglobin A1C Time in Target Glucose Range
Maiorino et al. Diabetes Care. 2020;43:1146–1156.
CGM lower time in hypoglycemia and CV
Curr Diab Rep (2019) 19: 50
Curr Diab Rep (2019) 19: 50
Mean absolute relative difference (MARD) is the mean of the absolute difference expressed as a percentage of a reference glucose concentration over many samples
Trend Arrows
Add context to a static measurement
A shift from point in time to anticipating future glucose
J Endocr Soc. 2017 Nov 20;1(12):1445-1460.
Trend Arrows
J Endocr Soc. 2017 Nov 20;1(12):1445-1460.
Trend Arrows
J Endocr Soc. 2017 Nov 20;1(12):1445-1460.
Trend Arrows
J Endocr Soc. 2017 Nov 20;1(12):1445-1460.
Curr Diab Rep (2019) 19: 50
Q1
You start a patient with type 1 diabetes on a real time continuous glucose monitor (rtCGM). He comes back for a follow up visit with concerns about the accuracy of his CGM. His CGM’s readings occasionally are different from his regular glucometer, and he decided to stop using his CGM for this reason.
What do you tell the patient?
a) Change the CGM’s sensor when there a difference
b) There is 5-15 minutes lag between the CGM and regular glucometer (CGM always behind) and the lag is longer during rapid change in glucose
c) Change the regular glucometer
Q1
You start a patient with type 1 diabetes on a real time continuous glucose monitor (rtCGM). He comes back for a follow up visit with concerns about the accuracy of his CGM. His CGM’s readings occasionally are different from his regular glucometer, and he decided to stop using his CGM for this reason.
What do you tell the patient?
a) Change the CGM’s sensor when there a difference
b) There is 5-15 minutes lag between the CGM and regular glucometer (CGM always behind) and the lag is longer during rapid change in glucose
c) Change the regular glucometer
Key features of current personal CGM devices
1. Kravarusic J, Aleppo G. Endocrinol Metab Clin North Am. 2020 Mar;49(1):37-55.
1. Kravarusic J, Aleppo G. Endocrinol Metab Clin North Am. 2020 Mar;49(1):37-55.
Key features of current personal CGM devices
is-CGM = intermittent scanned CGM
NA = not availablert-CGM = real time CGM
CGM metrics
• February 2019, the Advanced Technologies & Treatments for Diabetes (ATTD) Congress convened an international panel of individuals with diabetes and clinicians and researchers with expertise in CGM
Diabetes Care 2019;42:1593–1603
CGM metrics
Diabetes Care 2019;42:1593–1603
Curr Diab Rep (2019) 19: 50
Diabetes Care 2019;42:1593–1603
CGM/A1C correlation
Vigersky RA, McMahon C. Diabetes Technol Ther 2019;21: 81–85
Diabetes Technology & Therapeutics 2017;19(Suppl 2):S4–S11.
Ambulatory Glucose Report
More Green Less Red
MGLR
Flat Narrow In Range
FNIR
Step by Step
Diabetes Technology & Therapeutics 2017;19(Suppl 2):S4–S11.
Step by Step
Diabetes Technology & Therapeutics 2017;19(Suppl 2):S4–S11.
Step by Step
Diabetes Technology & Therapeutics 2017;19(Suppl 2):S4–S11.
Q2:
39-year-old male
T2DM
100 kg
A1C 11.5%
Glargine 90 units
Lispro 5 units with meals
Glipizide 5 mg daily
Metformin 1000 mg BID
Q2:
What would you do next:a) Increase basal and bolusb) Increase glipizide dose to 10 mg dailyc) Add empagliflozin 25 mg dailyd) Decrease basal, increase bolus and
add GLP-1RA
Q2:
What would you do next:a) Increase basal and bolusb) Increase glipizide dose to 10 mg dailyc) Add empagliflozin 25 mg dailyd) Decrease basal, increase bolus and
add GLP-1RA
Glargine 30 units BID
Lispro 10 units +2:50>150 AC
Ozempic 0.5 mg weekly
Metformin 1000 mg BID
Q2:
39-year-old male
T2DM
100 kg
A1C 11.5%
Glargine 30 units BID
Lispro 10 units +2:50>150 AC
Ozempic 0.5 mg weekly
Metformin 1000 mg BID
Future of CGM:
Smaller devices, longer duration of use, easier to access
Using AI and pattern recognition, CGM may recommend a specific class of diabetes medication
Inpatient and nursing home use of CGM (one monitoring unit like telemetry units..)
More Accurate and Smaller?
Smart Pens
This Photo is licensed under CC BY-SA-NC
Medtronic InPen
Report example
Continuous subcutaneous insulin infusion (CSII)
This Photo is licensed under CC BY-NC-ND
Current Status
What’s in the pipeline?
• Built-in correction bolus capability
• An adjustable target glucose level down to 100 mg/dl (an improvement over the 670G’s fixed 120 mg/dl)
• Bluetooth connectivity allows for mobile app use, wireless data uploads, and future software updates
• Reduced alarms and simplified operation
• Increased time in closed-loop (“Auto Mode”)
4 9
Tubeless Automated Insulin Delivery System+ Wearable, tubeless, insulin-filled Pod communicates directly
with Dexcom G6 sensor (continuous glucose monitor)
+ Algorithm is built into the Pod – automated insulin delivery
can continue without the handheld controller nearby
+ Omnipod 5 App is used to start and stop Automated Mode,
deliver boluses, view data, and change settings
+ Customizable glucose targets, adjustable by time of day
+ HypoProtect feature for times of elevated hypoglycemic risk,
such as exercise
Omnipod 5 App
Pod + Algorithm Continuous Glucose Monitor
See Brown, Forlenza, et al. Diabetes Care. 2021. and
Forlenza et al. DTT. 2021; 23(6) 410-424. for a detailed
description of the system and algorithm
Investigational Device. Limited by Federal (or United States) law to investigational use.
Carlson A et al;. Glycemic Management over 6 Months with the Omnipod® 5 Automated Insulin Delivery System. Presented at
Virtual American Diabetes Association Meeting, 2021
Feature names, descriptions and user interface are for the investigational
Omnipod 5 System and are subject to change with commercial
availability.
Resources:• Danne T, Nimri R, Battelino T, Bergenstal RM, Close KL, DeVries JH, Garg S, Heinemann L, Hirsch I, Amiel SA, Beck R, Bosi E, Buckingham
B, Cobelli C, Dassau E, Doyle FJ 3rd, Heller S, Hovorka R, Jia W, Jones T, Kordonouri O, Kovatchev B, Kowalski A, Laffel L, Maahs D, Murphy HR, Nørgaard K, Parkin CG, Renard E, Saboo B, Scharf M, Tamborlane WV, Weinzimer SA, Phillip M. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care. 2017 Dec;40(12):1631-1640. doi: 10.2337/dc17-1600. PMID: 29162583; PMCID: PMC6467165.
• Aleppo G, Laffel LM, Ahmann AJ, Hirsch IB, Kruger DF, Peters A, Weinstock RS, Harris DR. A Practical Approach to Using Trend Arrows on the Dexcom G5 CGM System for the Management of Adults With Diabetes. J Endocr Soc. 2017 Nov 20;1(12):1445-1460. doi: 10.1210/js.2017-00388. PMID: 29344577; PMCID: PMC5760210.
• Kravarusic J, Aleppo G. Diabetes Technology Use in Adults with Type 1 and Type 2 Diabetes. Endocrinol Metab Clin North Am. 2020 Mar;49(1):37-55. doi: 10.1016/j.ecl.2019.10.006. Epub 2019 Dec 10. PMID: 31980120.
• American Association of Clinical Endocrinology Clinical Practice Guideline: The Use of Advanced Technology in the Management of Persons With Diabetes Mellitus. Endocrine Practice 27 (2021) 505e537.
• Martin CT, Criego AB, Carlson AL, Bergenstal RM. Advanced Technology in the Management of Diabetes: Which Comes First-Continuous Glucose Monitor or Insulin Pump? Curr Diab Rep. 2019 Jun 27;19(8):50. doi: 10.1007/s11892-019-1177-7. PMID: 31250124; PMCID: PMC6597598.