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.