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March 11, 2021
CGM Use Beyond
Type 1 Diabetes?
Aaron Neinstein, MD
Associate Professor, UCSF
Director of Clinical Informatics
UCSF Center for Digital Health Innovation
Disclosures
Research Support
 Cisco Systems, Inc
 Commonwealth Fund
Writing
 WebMD/Medscape
Advisor (Uncompensated)
 Tidepool
 OPEN (Outcomes of Patients with Novel,
DIY Artificial Pancreas Technology)
Consultant or Advisor (Compensated)
 Steady Health
 Medtronic Diabetes
 Intuity Medical
 Eli Lilly
 Roche
 Nokia Growth Partners
 Grand Rounds
Presentation Title
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Presentation Title
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Let’s start with a prediction: By 2025, everyone with
diabetes will be tracking their blood sugar with devices
called continuous glucose monitors, and it will be
common for many people without diabetes to dabble in
tracking, too.
CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein
8
Why are we seeing this?
What is evidence-based?
What is fact?
What is hype?
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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T1D Exchange: US CGM Use Over Time
Foster NC et al. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018. Diabetes
Technology & Therapeutics. 2019 Feb.
Industry
Estimates
50%
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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T1D Exchange: Mean A1c by Use of Tech (2016-2018)
CGM use associated with larger impact on A1c than Insulin Pumps
Foster NC et al. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018.
Diabetes Technology & Therapeutics. 2019 Feb.
Pump +
CGM
MDI +
CGM
Pump
Only
MDI
Only
Age <13 Age 13-26 Age >26
Pump +
CGM
MDI +
CGM
Pump
Only
MDI
Only
Pump +
CGM
MDI +
CGM
Pump
Only
MDI
Only
CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein
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“From this review, we conclude that when diabetes duration is over one year,
the overall effect of self-monitoring of blood glucose on glycemic control
in patients with type 2 diabetes who are not using insulin is small up to six
months after initiation and subsides after 12 months. Furthermore, based on
a best-evidence synthesis, there is no evidence that SMBG affects patient
satisfaction, general well-being or general health-related quality of life.”
Jan 18, 2012
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein
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Fifteen-day glucose traces of two subjects with identical A1c
of 8.0% but different degrees of glycemic variability.
Boris Kovatchev, and Claudio Cobelli Dia Care 2016;39:502-510
A1c has many limitations: Glycemic Variability
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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… and SMBG is not as accurate as people often think
2016 FDA Guidance on Home BG Meter Accuracy
 95% of BG meter values must be within 15% of true lab value
 99% of BG meter values must be within 20% of true lab value
 Therefore, if lab-measured glucose is 100 mg/dl:
- BG meter has to be within 15 mg/dl (85-115 mg/dl) 95% of time
- BG meter has to be within 20 mg/dl (80-120 mg/dl) 99% of time
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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2016 FDA Guidance on Home BG Meter Accuracy
 95% of BG meter values must be within 15% of true lab value
 99% of BG meter values must be within 20% of true lab value
 Therefore, if lab-measured glucose is 100 mg/dl:
- BG meter has to be within 15 mg/dl (85-115 mg/dl) 95% of time
- BG meter has to be within 20 mg/dl (80-120 mg/dl) 99% of time
https://www.diabetestechnology.org/surveillance.shtml
CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein
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CGM is not the same as it was in 1999
 Bulky
 Painful insertion
 Expensive
 Poor accuracy
 Multiple calibrations
 <3 day wear
 Data trapped
 Slimmer
 Easier to insert
 Improving reimbursement
 Improved accuracy
 No calibrations
 10+ day wear
 Data liquidity
1999 2021
CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein
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… and major trends will drive increased interest in use
1. Accuracy, size, cost, & availability
2. Cloud data upload
3. Analytic software & digital coaching tools
4. Telehealth
5. Shift toward value-based care (sort of)
… and don’t forget: People really don’t like doing fingersticks!
21 CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
Rapid Rise in Telehealth Rates During COVID19
UCSF – Endocrinology Visits
22 CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
Rapid Rise in Telehealth Rates During COVID19
UCSF – Endocrinology Visits
Endocrinology remains one of the top users of telehealth in the US
CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein
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Summary: Context for CGM Use Beyond T1D
 Diabetes rates continue to grow globally
 Direct US healthcare spend on diabetes is $237B
 Lifestyle & behavior change are cornerstones of diabetes prevention & treatment
 Neither SMBG nor A1c are effective tools to enable lifestyle & behavior change
 CGM has gotten cheaper, easier, more accessible
 Telehealth is here to stay
25
Ok…
What are the data?
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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DIAMOND Study Group (2017) – 158 adults with T2D using multiple daily insulin injections
Results at 24
weeks
CGM Group Control
(Blinded CGM)
Group
P values
Mean A1c 7.5% 7.9% 0.005
Fingersticks 2.9/day 3.8/day <0.001
Time per day <70
mg/dL
4 minutes 12 minutes
QoL metrics No difference
Beck, R. W. et al. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving
Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med 167, 365–374 (2017).
CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein
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Park C and Le Q. The effectiveness of continuous glucose monitoring in patients with type 2 diabetes: a systematic review of literature and meta-analysis. DTT. 2018.
Meta-Analysis of CGM in People with Type 2 Diabetes (1 of 2)
 1384 patients
 65.5% insulin users
 4902 patients
 69.1% insulin users
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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Meta-Analysis of CGM in People with Type 2 Diabetes (2 of 2)
Ida et al. Utility of Real-Time and Retrospective Continuous Glucose Monitoring in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials.
J Diabetes Res 2019, 1–10 (2019).
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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Miller et al; 84-LB; Diabetes 2020 Jun; 69 (Supplement 1)
Reduction in A1c after CGM initiation – retrospective, observational
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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CGM in T2D on rapid-acting insulin - retrospective, observational
Bergenstal et al; 69-OR; Diabetes 2020 Jun; 69 (Supplement 1)
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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Miller et al; 85-LB; Diabetes 2020 Jun; 69 (Supplement 1)
CGM in T2D on no rapid-acting insulin - retrospective, observational
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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Feb 2018 to Dec
2018
• Mean Follow-Up:
4.2 months
• 191 participants
had telemedicine
visit with Endo
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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CGM + Shared
Medical Appointments
Simonyan, A. R. et al. Continuous Glucose Monitoring
Shared Medical Appointments Improve Diabetes
Self‐Efficacy and Hemoglobin A1C. J Am Coll Clin Pharm
(2021) doi:10.1002/jac5.1409.
• 171 participants – 69% T2D
• Baseline A1c average 8.64%
• Baseline Meds: 76% basal insulin, 63%
bolus; 2% on no medications
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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CGM + Shared Medical Appointments
 Significant improvements in
diabetes self-efficacy scores
 0.83% A1c reduction
(p <0.001) in people with T2D
Simonyan, A. R. et al. Continuous Glucose Monitoring Shared Medical Appointments Improve Diabetes Self‐Efficacy and
Hemoglobin A1C. J Am Coll Clin Pharm (2021) doi:10.1002/jac5.1409.
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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Case: 70 yo man with T2D on Metformin
 No microvascular complications, diabetes diagnosis approx.
2-3 years ago
 Coronary artery disease, multiple stents
 A1c 7.3% on 500mg Metformin BID
 A1c 6.5% on 1000mg Metformin BID and decreased dessert
 Never does fingersticks
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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Case: 70 yo man with T2D on Metformin
A1c 6.5% - 7.3%
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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Case: 70 yo man with T2D on Metformin
A1c 6.5% - 7.3%
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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Case: 70 yo man with T2D on Metformin
CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein
39
Case: 70 yo man with T2D on Metformin
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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Case: 70 yo man with T2D on Metformin
Pre and Post Meal BGs Miss Spike
81
99
114
131
129
112
100
41
Is it cost-effective?
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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Cost Effectiveness Estimates: T2D not on prandial insulin
Fonda et al (2016)
 0.10 yr life expectancy gain
 0.07 quality-adjusted life expectancy gain
 Estimated cost of $9,319 per life year gained
 Estimated cost of $13,030 per QALY gained
43
What about people
without diabetes?
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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Glucotypes – Hall et al
57 healthy participants without diabetes
Hall H et al. Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol. 2018 Jul
CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein
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Glucotypes – Hall et al
Clinical metabolic phenotypes created based on CGM data
Hall H et al. Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol. 2018 Jul
 All 3 glucotype patterns observed within traditional categories
 Severe glucose variability present in 25% of “normoglycemic”
 Is it possible that increased glucose variability might represent an
earlier (or different) method of determining risk?
 What is the predictive value of a CGM “severe glucotype”?
CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein
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Many Questions Remain
 Which population segments? Basal insulin. Non-insulin medications.
No medications. Pre-diabetes. No known pathology. Athletic
performance.
 Cost effectiveness in each population?
 What’s the right “dose”? Duration? Frequency?
 What care model is needed? CGM alone? CGM accompanied by
coaching? What intensity of coaching?

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Continuous Glucose Monitoring and Its Use Beyond Type 1 Diabetes

  • 1. March 11, 2021 CGM Use Beyond Type 1 Diabetes? Aaron Neinstein, MD Associate Professor, UCSF Director of Clinical Informatics UCSF Center for Digital Health Innovation
  • 2. Disclosures Research Support  Cisco Systems, Inc  Commonwealth Fund Writing  WebMD/Medscape Advisor (Uncompensated)  Tidepool  OPEN (Outcomes of Patients with Novel, DIY Artificial Pancreas Technology) Consultant or Advisor (Compensated)  Steady Health  Medtronic Diabetes  Intuity Medical  Eli Lilly  Roche  Nokia Growth Partners  Grand Rounds
  • 5. 5
  • 6. 6
  • 7. Presentation Title 7 Let’s start with a prediction: By 2025, everyone with diabetes will be tracking their blood sugar with devices called continuous glucose monitors, and it will be common for many people without diabetes to dabble in tracking, too. CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein
  • 8. 8 Why are we seeing this? What is evidence-based? What is fact? What is hype?
  • 9. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 9 T1D Exchange: US CGM Use Over Time Foster NC et al. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018. Diabetes Technology & Therapeutics. 2019 Feb. Industry Estimates 50%
  • 10. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 10 T1D Exchange: Mean A1c by Use of Tech (2016-2018) CGM use associated with larger impact on A1c than Insulin Pumps Foster NC et al. State of Type 1 Diabetes Management and Outcomes from the T1D Exchange in 2016-2018. Diabetes Technology & Therapeutics. 2019 Feb. Pump + CGM MDI + CGM Pump Only MDI Only Age <13 Age 13-26 Age >26 Pump + CGM MDI + CGM Pump Only MDI Only Pump + CGM MDI + CGM Pump Only MDI Only
  • 11. CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein 11 “From this review, we conclude that when diabetes duration is over one year, the overall effect of self-monitoring of blood glucose on glycemic control in patients with type 2 diabetes who are not using insulin is small up to six months after initiation and subsides after 12 months. Furthermore, based on a best-evidence synthesis, there is no evidence that SMBG affects patient satisfaction, general well-being or general health-related quality of life.” Jan 18, 2012
  • 12. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 12
  • 13. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 13
  • 14. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 14
  • 15. CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein 15
  • 16. Fifteen-day glucose traces of two subjects with identical A1c of 8.0% but different degrees of glycemic variability. Boris Kovatchev, and Claudio Cobelli Dia Care 2016;39:502-510 A1c has many limitations: Glycemic Variability CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 16
  • 17. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 17 … and SMBG is not as accurate as people often think 2016 FDA Guidance on Home BG Meter Accuracy  95% of BG meter values must be within 15% of true lab value  99% of BG meter values must be within 20% of true lab value  Therefore, if lab-measured glucose is 100 mg/dl: - BG meter has to be within 15 mg/dl (85-115 mg/dl) 95% of time - BG meter has to be within 20 mg/dl (80-120 mg/dl) 99% of time
  • 18. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 18 2016 FDA Guidance on Home BG Meter Accuracy  95% of BG meter values must be within 15% of true lab value  99% of BG meter values must be within 20% of true lab value  Therefore, if lab-measured glucose is 100 mg/dl: - BG meter has to be within 15 mg/dl (85-115 mg/dl) 95% of time - BG meter has to be within 20 mg/dl (80-120 mg/dl) 99% of time https://www.diabetestechnology.org/surveillance.shtml
  • 19. CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein 19 CGM is not the same as it was in 1999  Bulky  Painful insertion  Expensive  Poor accuracy  Multiple calibrations  <3 day wear  Data trapped  Slimmer  Easier to insert  Improving reimbursement  Improved accuracy  No calibrations  10+ day wear  Data liquidity 1999 2021
  • 20. CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein 20 … and major trends will drive increased interest in use 1. Accuracy, size, cost, & availability 2. Cloud data upload 3. Analytic software & digital coaching tools 4. Telehealth 5. Shift toward value-based care (sort of) … and don’t forget: People really don’t like doing fingersticks!
  • 21. 21 CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein Rapid Rise in Telehealth Rates During COVID19 UCSF – Endocrinology Visits
  • 22. 22 CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein Rapid Rise in Telehealth Rates During COVID19 UCSF – Endocrinology Visits
  • 23. Endocrinology remains one of the top users of telehealth in the US
  • 24. CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein 24 Summary: Context for CGM Use Beyond T1D  Diabetes rates continue to grow globally  Direct US healthcare spend on diabetes is $237B  Lifestyle & behavior change are cornerstones of diabetes prevention & treatment  Neither SMBG nor A1c are effective tools to enable lifestyle & behavior change  CGM has gotten cheaper, easier, more accessible  Telehealth is here to stay
  • 26. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 26 DIAMOND Study Group (2017) – 158 adults with T2D using multiple daily insulin injections Results at 24 weeks CGM Group Control (Blinded CGM) Group P values Mean A1c 7.5% 7.9% 0.005 Fingersticks 2.9/day 3.8/day <0.001 Time per day <70 mg/dL 4 minutes 12 minutes QoL metrics No difference Beck, R. W. et al. Continuous Glucose Monitoring Versus Usual Care in Patients With Type 2 Diabetes Receiving Multiple Daily Insulin Injections: A Randomized Trial. Ann Intern Med 167, 365–374 (2017).
  • 27. CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein 27 Park C and Le Q. The effectiveness of continuous glucose monitoring in patients with type 2 diabetes: a systematic review of literature and meta-analysis. DTT. 2018. Meta-Analysis of CGM in People with Type 2 Diabetes (1 of 2)  1384 patients  65.5% insulin users  4902 patients  69.1% insulin users
  • 28. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 28 Meta-Analysis of CGM in People with Type 2 Diabetes (2 of 2) Ida et al. Utility of Real-Time and Retrospective Continuous Glucose Monitoring in Patients with Type 2 Diabetes Mellitus: A Meta-Analysis of Randomized Controlled Trials. J Diabetes Res 2019, 1–10 (2019).
  • 29. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 29 Miller et al; 84-LB; Diabetes 2020 Jun; 69 (Supplement 1) Reduction in A1c after CGM initiation – retrospective, observational
  • 30. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 30 CGM in T2D on rapid-acting insulin - retrospective, observational Bergenstal et al; 69-OR; Diabetes 2020 Jun; 69 (Supplement 1)
  • 31. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 31 Miller et al; 85-LB; Diabetes 2020 Jun; 69 (Supplement 1) CGM in T2D on no rapid-acting insulin - retrospective, observational
  • 32. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 32 Feb 2018 to Dec 2018 • Mean Follow-Up: 4.2 months • 191 participants had telemedicine visit with Endo
  • 33. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 33 CGM + Shared Medical Appointments Simonyan, A. R. et al. Continuous Glucose Monitoring Shared Medical Appointments Improve Diabetes Self‐Efficacy and Hemoglobin A1C. J Am Coll Clin Pharm (2021) doi:10.1002/jac5.1409. • 171 participants – 69% T2D • Baseline A1c average 8.64% • Baseline Meds: 76% basal insulin, 63% bolus; 2% on no medications
  • 34. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 34 CGM + Shared Medical Appointments  Significant improvements in diabetes self-efficacy scores  0.83% A1c reduction (p <0.001) in people with T2D Simonyan, A. R. et al. Continuous Glucose Monitoring Shared Medical Appointments Improve Diabetes Self‐Efficacy and Hemoglobin A1C. J Am Coll Clin Pharm (2021) doi:10.1002/jac5.1409.
  • 35. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 35 Case: 70 yo man with T2D on Metformin  No microvascular complications, diabetes diagnosis approx. 2-3 years ago  Coronary artery disease, multiple stents  A1c 7.3% on 500mg Metformin BID  A1c 6.5% on 1000mg Metformin BID and decreased dessert  Never does fingersticks
  • 36. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 36 Case: 70 yo man with T2D on Metformin A1c 6.5% - 7.3%
  • 37. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 37 Case: 70 yo man with T2D on Metformin A1c 6.5% - 7.3%
  • 38. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 38 Case: 70 yo man with T2D on Metformin
  • 39. CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein 39 Case: 70 yo man with T2D on Metformin
  • 40. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 40 Case: 70 yo man with T2D on Metformin Pre and Post Meal BGs Miss Spike 81 99 114 131 129 112 100
  • 42. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 42 Cost Effectiveness Estimates: T2D not on prandial insulin Fonda et al (2016)  0.10 yr life expectancy gain  0.07 quality-adjusted life expectancy gain  Estimated cost of $9,319 per life year gained  Estimated cost of $13,030 per QALY gained
  • 44. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 44 Glucotypes – Hall et al 57 healthy participants without diabetes Hall H et al. Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol. 2018 Jul
  • 45. CGM Use Beyond Type 1 Diabetes | Mar 11 2021 | @aaronneinstein 45 Glucotypes – Hall et al Clinical metabolic phenotypes created based on CGM data Hall H et al. Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol. 2018 Jul  All 3 glucotype patterns observed within traditional categories  Severe glucose variability present in 25% of “normoglycemic”  Is it possible that increased glucose variability might represent an earlier (or different) method of determining risk?  What is the predictive value of a CGM “severe glucotype”?
  • 46. CGM Use Beyond Type 1 Diabetes | Mar 11, 2021 | @aaronneinstein 46 Many Questions Remain  Which population segments? Basal insulin. Non-insulin medications. No medications. Pre-diabetes. No known pathology. Athletic performance.  Cost effectiveness in each population?  What’s the right “dose”? Duration? Frequency?  What care model is needed? CGM alone? CGM accompanied by coaching? What intensity of coaching?

Editor's Notes

  1. Many of you have seen marketing like this recently More and more companies, backed by huge VC money, advertising that they will provide you with a CGM along with insights into what the data mean about your health Some of them seem to be targeting general wellness, some prediabetes
  2. And some focused on promising that they will improve your peak athletic performance And of course….
  3. And of course….
  4. When Apple gets involved in anything, it tends to turn heads and move markets Rumors are that the next Apple Watch will have glucose monitoring in it
  5. What does this all mean? Why is this happening? As Endocrinologists, what should we be thinking about this? What should we be thinking about CGM
  6. Whatever your insulin delivery method, use of CGM is associated with greater impact on A1c.
  7. Let’s talk about BG monitoring in non-insulin users and what the data show This literature is pretty well-known at this point
  8. But, applying those evidence to the modern world would be like saying that this is not effective as a web browser
  9. We might call them both “phones,” but they are categorically different technologies When you take an analog device and make it digital, you give it new properties and capabilities It collects data and can report those data. It is collecting a way higher frequency and quantity of data. It can connect to the cloud and the software can add features over time without buying a new device You can network it with other tools. You can write apps for the data that are created on the device.
  10. Also, physiology is fluid – one data point in time is not the same as understanding where things are going Fingersticks are painful!
  11. The first iPhone was mostly just a phone. But then what happens with digital tools is apps get developed. The App Store changed everything. Digitizing data means you can do analytics – you can learn about individual people’s patterns, habits, behaviors – leverage AI A world of applications, analytics, coaching all becomes possible with digital, connected data And remember, that neither A1c or SMBG are so perfect either….
  12. Fifteen-day glucose traces of two subjects who had identical HbA1c of 8.0% but different degrees of GV. High GV in subject 1 was reflected by numerous episodes of both hypo- and hyperglycemia (A), whereas low GV in subject 2 resulted in no such episodes (B).
  13. We often like to think of SMBG as “perfect,” but it’s not
  14. High costs and uncertainty over efficacy and necessity have kept CGM from widespread use in people with T2D. However, the newest CGM models, the Abbott Freestyle Libre and Dexcom G6, have begun to overcome many of these technical barriers to use of CGM systems. The sensors are inserted painlessly, are small enough to fit easily under clothing, can remain in place for 10 to 14 days, and are FDA approved as sufficiently accurate to use in lieu of fingersticks to make insulin-dosing decisions. Overcoming another significant barrier to use, data can now be seamlessly and continuously uploaded wirelessly to the cloud via a user’s smartphone. Perhaps most importantly, Abbott has introduced a new, lower-pricing category with Libre, at around $75 to $150 each month for sensors (2 sensors that last 14 days each), translating to $900 to $1800 per year compared with what is typically $3000 to $5000 per year for traditional CGM. A CGM recording BG every 5 minutes will record 105,120 BG readings per year compared with between just 1000 to 2000 in a person doing frequent SMBG Ability of CGM systems to provide real-time biofeedback. With real-time data now seamlessly available on a user’s mobile device and the internet, easily visible trends and trajectories can help a person understand their own glycemic response in a more meaningful way. Patients can observe which foods and exercises affect them the most. Iterative exposure to this immediate biofeedback allows patients to learn about their own bodies and physiologic responses. DISPOSABLE
  15. In 2019, estimates put more than 30 million Americans living with T2D and 84 million with prediabetes, and both numbers are rising. Direct US healthcare spending on diabetes, both type 1 diabetes (T1D) and T2D, is currently estimated at $237 billion, with 1 in 4 US healthcare dollars going toward the care of people with diabetes.1  The critical importance of early glycemic control to prevent acute complications and halt disease progression to prevent chronic complications only intensifies as these costs, including the rising costs of insulin, increase.
  16. 79 subjects per group; mean age 60 years; mean A1c 8.5% At 24 weeks… This was done with Dexcom – might come out even better with Libre
  17. The pooled sample size of all included studies that used RT-CGM and P-CGM was 1384, of which 574 patients received the intervention and 810 patients were in the control. The mean age was 56.8 years, and 65.2% of subjects were males. Patients on insulin therapy with or without other hypoglycemic agents were 65.5%. The pooled sample size of RCTs only was 426 patients with 213 patients who received CGM and 213 patients for the control. The mean age was 58.5 years, and 49.4% of subjects were males. Patients on insulin therapy with or without other hypoglycemic agents were 62.0%. For FGM, the pooled sample size of all included studies was 4902, of which 2488 patients received the intervention and 2414 patients were in the control. The mean age was 57.3 years, and 61.4% of subjects were males. Patients on insulin therapy with or without other hypoglycemic agents were 69.1%.
  18. Abstract from 2020 ADA Evaluates change in HbA1c from baseline to 6mo and baseline to 12mo after starting a FreeStyle Libre system for T2D patients on long-acting insulin and non-insulin (including GLP-1) therapy. A retrospective, observational analysis was performed by linking data from the LibreView® data management platform, DRG (a commercial medical and pharmacy claims database), and Quest lab HbA1c. Index was the first date of data in LibreView (Nov 2017-Sept 2019). Medication and diagnosis were from DRG. HbA1c tests were from Quest. Baseline A1c must be ≥ 6.5% within 6mo prior to index. HbA1c tests closest to +180 days (+150-210) used for 6mo; closest to +360 days (+330-390) used for 12mo. The 6mo T2D cohort (n=774) reduced HbA1c by -0.8%. The 12mo T2D cohort (n=207) reduced HbA1c by -0.6%. The greatest reduction in HbA1c was seen in the T2D non-insulin group at 6mo (-0.9%, n=497) and 12mo (-0.7% n=120). All groups saw clinically significant reduction in HbA1c (Table). Reduction in HbA1c post-FreeStyle Libre use supports the real-world effectiveness of the system in T2D patients using long-acting insulin or non-insulin therapies.
  19. IBM MarketScan™ Commercial Claims and Medicare Supplemental databases Retrospective, observational analysis. MarketScan contains insurance billing claims for inpatient, outpatient, and pharmacy expenses. Cohort requirements included: de novo FreeStyle Libre system purchase in 2017 Q4-2018 Q2, diagnosis of T2D, ≥18 years old, fast- or short-acting insulin, and ≥6-months pre-CGM observation time. Primary outcome was acute diabetes events (ADE): hospitalization with hyper-/hypoglycemia as the primary diagnosis or outpatient emergency associated with a code of hyper-/hypoglycemia. Secondary outcome was all-cause hospitalizations. Compared event rates 6-months pre-/post-CGM. The cohort (n=1,244, age 53.6±9.7 years, 53.8% male) experienced a reduction in ADE from 0.158 to 0.077 events/patient-year (HR: 0.49 [0.34 0.69]; P:<0.001). Hospitalizations also reduced from 0.345 to 0.247 events/patient-year (HR: 0.72 [0.58 0.88]; P:0.002). After FreeStyle Libre system purchase, T2D patients had lower rates of ADE and all-cause hospitalizations
  20. Clinical outcomes after a FreeStyle Libre® system purchase in people with type 2 diabetes (T2D) not using bolus insulin. IBM MarketScan™ Commercial Claims and Medicare Supplemental databases were used MarketScan contains insurance billing claims for inpatient, outpatient, and pharmacy. Cohort requirements included: de novo CGM, FreeStyle Libre system purchase 2017 Q4-2018 Q4, T2D diagnosis, ≥18 years old, no fast-/short-acting insulin, ≥6-months pre-index observation time. Primary outcome was acute diabetes events (ADE): hospitalization with hyper-/hypoglycemia as primary diagnosis or outpatient emergency with same codes. Secondary outcome was all-cause hospitalization. Compared event rates 6-months pre-/post-index. The cohort (n= 7,167, age 53.3±9.5 years, 51.5% male, avg. post-index follow-up 155 days) Saw a reduction in ADE from 0.071 to 0.052 events/pt-yr (HR: 0.70 [0.57 0.85]; P:<0.001). Hospitalizations reduced from 0.180 to 0.161 events/pt-yr (HR: 0.87 [0.78 0.98]; P: 0.025). After FreeStyle Libre system purchase, T2D patients not on bolus insulin had lower rates of ADE and all-cause hospitalization.
  21. Onduo data Virtual diabetes clinic: mobile app, personal coaching from CDE and coaches, connected devices Live video consultations available with endocrinologists Care team management platform Communication tool between team, clinicians, participants VDC app enables glucose data mgmt and conversation among care team Care team uses Athena Health EHR
  22. Cleveland Clinic program Shared medical appointments Visit 1 – insert CGM, discuss plans Visit 2 – Download report, interpret, self-efficacy, med adjustment
  23. A reminder of what this can look like in real life anecdote Story
  24. Looks pretty good, right? You could have chosen to either leave things alone and be happy with A1c of 6.5%, or you might have added a second medication, maybe a GLP1 or SGLT2i
  25. Every single morning, there is a BG spike up over 200 mg/dl The rest of the day is not so bad
  26. The patient immediately identifies the culprit – his daily glass of orange juice and banana On his own, he realizes he needs to change his breakfast
  27. He was never doing SMBG, only q3 months A1c A1c was missing all of this important detail Even if he had agreed to do SMBG, he STILL would have missed this detail – his pre and post breakfast BGs would have looked quite good Only with the full CGM tracing detail do you see the problem
  28. RT-CGM for people with T2D not on prandial insulin vs SMBG/fingerstick only
  29. 57 healthy participants recruited without diabetes 5 of them ended up on screening tests with A1c and OGTT to actually have type 2 diabetes CGM monitoring in normal real-world environment Clinical metabolic phenotypes created based on CGM data Then, fed standardized meals to view responses
  30. Clinical metabolic phenotypes created based on CGM data Categorized each person based on amount of time spent in each glycemic class
  31. Costs will come down – hopefully Access should increase Will CGM be over the counter?