Evidence
Lower A1c and Reduce Hospital/ED Use in Members with Insulin-Treated Type 2 Diabetes via Real-Time Continuous Glucose Monitoring
September 16, 2021Clinical Outcomes Economic Outcomes Infographic
Optimize Outcomes in Insulin-Treated T1 and T2D via Evidence-Based Coverage Criteria with Real-Time Continuous Glucose Monitoring
September 16, 2021Clinical Outcomes Coverage and Benefit Design Economic Outcomes Infographic
Association Between Real-Time Continuous Glucose Monitor Use and Diabetes-Related Medical Costs for Patients with Type 2 Diabetes
September 2, 2021Clinical Outcomes Economic Outcomes Article / PublicationLearn MoreReal-World Studies Support Use of Continuous Glucose Monitoring in Type 1 and Type 2 Diabetes Independently of Treatment Regimen
September 2, 2021Clinical Outcomes Article / PublicationLearn MoreReal-Time Continuous Glucose Monitor (RTCGM) Use Associated with Decreased Diabetes Medical Costs for Patients with Type 2 Diabetes (T2D)
August 9, 2021Economic Outcomes Article / Publication
Source: Digital Technology and Therapeutics
Key Takeaway: A retrospective analysis of administrative claims data from the Optum Research Database showed rtCGM use was associated with diabetes-related medical cost reductions in patients with T2D. Increased access to rtCGM for patients with T2D may help to reduce diabetes-related cost of care.
Diabetes-related Medical Care Costs Decreased $424 PPPM After Initiating rtCGM Treatment
*PPPM = per patient per month
Learn MoreJune 23, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Key Takeaways: Continuous Glucose Monitoring improved outcomes more than intermittent testing of blood glucose in 41,753 patients with insulin-treated diabetes.
“Our real-world study found that in patients with insulin-treated diabetes, initiating a continuous glucose monitor substantially improved blood glucose control and cut the rate of emergency room visits for hypoglycemia in half.”1
Andrew J. Karter, PhD, Senior Research Scientist at Kaiser Permanente Division of Research
1Shaffer R. Real-time CGM lowers HbA1c, reduces ED visits in insulin-treated diabetes. Endocrine Today. June 2021. https://www.healio.com/news/endocrinology/20210607/realtime-cgm-lowers-hba1c-reduces-ed-visits-in-insulintreated-diabetes. Accessed June 24, 2021.
Learn MoreJune 22, 2021Clinical Outcomes Coverage and Benefit Design Article / Publication
Source: The Journal of the American Medical Association
Authors: Monica E. Peek, MD, MPH, MS; Celeste C. Thomas, MD, MS
“…the studies by Karter et al. and Martens et al. provide additional evidence that patients with type 2 diabetes benefit from the use of CGM in terms of improved HbA1c level, time spent in the target blood glucose range, and reduced hypoglycemic episodes…”
“…institutional changes that promote its use in primary care will go a long way to improving diabetes control and reducing complications, particularly among the populations most in need. The time has come to broaden access to CGM for patients with type 2 diabetes.”
Learn MoreEffect of Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Treated with Basal Insulin: A Randomized Clinical Trial
June 21, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Learn MoreJune 9, 2021Clinical Outcomes Article / Publication
Source: The Lancet – June 2021
Key Takeaways:
The ALERTT1 trial is the first 6-month, multicenter, prospective, randomized controlled trial comparing rtCGM with isCGM in 254 adults with type 1 diabetes, who previously used isCGM. Mean HbA1c was 7·4% (58 mmol/mol) and a minority of the study population was hypoglycemia unaware (44 [17%] people) or had a history of severe hypoglycemia (29 [11%]). Most (205 [81%]) were treated with multiple daily injections. Findings showed that in an unselected group of people with type 1 diabetes, 6-month use of rtCGM with alert functionality improved time in range (70–180 mg/dL [3.9–10.0 mmol/L]), while HbA1c, time in clinically significant hypoglycemia (< 54 mg/dL [3.0 mmol/L), and hyperglycemia (180 mg/dL [10.0 mmol/L]) were reduced. Additionally, more people on rtCGM achieved glycemic targets as defined by international consensus guidelines, and had less frequently severe hypoglycemia. Moreover, rtCGM users experienced less hypoglycemia worry and higher treatment satisfaction at the end of study.
Percentage of Participants Achieving Consensus Targets
Learn MoreWhat’s Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring
June 2, 2021Coverage and Benefit Design Guidelines / Policy
Source: Diabetes Technology & Therapeutics
Key Takeaway: Current CMS eligibility criteria for CGM coverage is limited and inconsistent relative to current scientific evidence. To expand access to all individuals who would benefit from CGM, it is recommended that CMS modify its eligibility requirements to include all Medicare beneficiaries who meet any one of the first four criteria below, and who also meet the fifth criterion:
Criterion Supporting Evidence 1. Diagnosed with T1D. CGM use confers:
Significant reductions in
• HbA1c
• severe hypoglycemia events
• %TBR
• diabetes-related hospitalizations Significant improvements in
• %TIR
• treatment satisfaction with less diabetes distress
2. Diagnosed with T2D and treated with any insulin regimen. CGM use confers:
Significant reductions in
• HbA1c
• %TBR
• diabetes-related hospitalizations
Significant increases in %TIR 3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: Level 2 (moderate) hypoglycemia, characterized by glucose levels ≤54 mg/dL; Level 3 (severe) hypoglycemia, characterized by physical/mental dysfunction requiring third-party assistance; or nocturnal hypoglycemia CGM use confers:
Significant reductions in
• diabetes-related hospitalizations, including severe hypoglycemia events
• hypoglycemia fear and Increased patient confidence in avoiding/treating hypoglycemia, thereby supporting treatment adherence
4. Advanced CKD at risk for hypoglycemia. CGM use facilitates:
• More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia
• Effective monitoring and managing of glycemic levels in nondiabetes patients with ESRD undergoing dialysis 5. In-person or telemedicine consultation with the prescribing health care provider before CGM initiation and every 6 months thereafter while continuing CGM therapy. (Coverage for telemedicine consults should be available for all patients regardless of geographic location.) Use of telemedicine consults:
Significantly reduces
• the incidence of severe hypoglycemia events
• diabetes-related distress Significantly improves medication adherence
• Effectively addresses the obstacles caused by the COVID-19 pandemic
• Are more effective for patients who are residents of cities and using the websites as their
intervention method
Use of downloaded CGM data into standardized reports:
• Supports patient education
• Enhances patient engagement in their self-management
Click here to view CGM Payer Insights Sheet with key findings.
Learn More
Sign Up To Stay Current On The Latest Coverage
Updates, Recent News, And Resources
Lower A1c and Reduce Hospital/ED Use in Members with Insulin-Treated Type 2 Diabetes via Real-Time Continuous Glucose Monitoring
Optimize Outcomes in Insulin-Treated T1 and T2D via Evidence-Based Coverage Criteria with Real-Time Continuous Glucose Monitoring
September 16, 2021Clinical Outcomes Coverage and Benefit Design Economic Outcomes Infographic
Learn MoreAssociation Between Real-Time Continuous Glucose Monitor Use and Diabetes-Related Medical Costs for Patients with Type 2 Diabetes
September 2, 2021Clinical Outcomes Economic Outcomes Article / PublicationLearn MoreReal-World Studies Support Use of Continuous Glucose Monitoring in Type 1 and Type 2 Diabetes Independently of Treatment Regimen
September 2, 2021Clinical Outcomes Article / PublicationLearn MoreReal-Time Continuous Glucose Monitor (RTCGM) Use Associated with Decreased Diabetes Medical Costs for Patients with Type 2 Diabetes (T2D)
August 9, 2021Economic Outcomes Article / Publication
Source: Digital Technology and Therapeutics
Key Takeaway: A retrospective analysis of administrative claims data from the Optum Research Database showed rtCGM use was associated with diabetes-related medical cost reductions in patients with T2D. Increased access to rtCGM for patients with T2D may help to reduce diabetes-related cost of care.
Diabetes-related Medical Care Costs Decreased $424 PPPM After Initiating rtCGM Treatment
*PPPM = per patient per month
Learn MoreJune 23, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Key Takeaways: Continuous Glucose Monitoring improved outcomes more than intermittent testing of blood glucose in 41,753 patients with insulin-treated diabetes.
“Our real-world study found that in patients with insulin-treated diabetes, initiating a continuous glucose monitor substantially improved blood glucose control and cut the rate of emergency room visits for hypoglycemia in half.”1
Andrew J. Karter, PhD, Senior Research Scientist at Kaiser Permanente Division of Research
1Shaffer R. Real-time CGM lowers HbA1c, reduces ED visits in insulin-treated diabetes. Endocrine Today. June 2021. https://www.healio.com/news/endocrinology/20210607/realtime-cgm-lowers-hba1c-reduces-ed-visits-in-insulintreated-diabetes. Accessed June 24, 2021.
Learn MoreJune 22, 2021Clinical Outcomes Coverage and Benefit Design Article / Publication
Source: The Journal of the American Medical Association
Authors: Monica E. Peek, MD, MPH, MS; Celeste C. Thomas, MD, MS
“…the studies by Karter et al. and Martens et al. provide additional evidence that patients with type 2 diabetes benefit from the use of CGM in terms of improved HbA1c level, time spent in the target blood glucose range, and reduced hypoglycemic episodes…”
“…institutional changes that promote its use in primary care will go a long way to improving diabetes control and reducing complications, particularly among the populations most in need. The time has come to broaden access to CGM for patients with type 2 diabetes.”
Learn MoreEffect of Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Treated with Basal Insulin: A Randomized Clinical Trial
June 21, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Learn MoreJune 9, 2021Clinical Outcomes Article / Publication
Source: The Lancet – June 2021
Key Takeaways:
The ALERTT1 trial is the first 6-month, multicenter, prospective, randomized controlled trial comparing rtCGM with isCGM in 254 adults with type 1 diabetes, who previously used isCGM. Mean HbA1c was 7·4% (58 mmol/mol) and a minority of the study population was hypoglycemia unaware (44 [17%] people) or had a history of severe hypoglycemia (29 [11%]). Most (205 [81%]) were treated with multiple daily injections. Findings showed that in an unselected group of people with type 1 diabetes, 6-month use of rtCGM with alert functionality improved time in range (70–180 mg/dL [3.9–10.0 mmol/L]), while HbA1c, time in clinically significant hypoglycemia (< 54 mg/dL [3.0 mmol/L), and hyperglycemia (180 mg/dL [10.0 mmol/L]) were reduced. Additionally, more people on rtCGM achieved glycemic targets as defined by international consensus guidelines, and had less frequently severe hypoglycemia. Moreover, rtCGM users experienced less hypoglycemia worry and higher treatment satisfaction at the end of study.
Percentage of Participants Achieving Consensus Targets
Learn MoreWhat’s Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring
June 2, 2021Coverage and Benefit Design Guidelines / Policy
Source: Diabetes Technology & Therapeutics
Key Takeaway: Current CMS eligibility criteria for CGM coverage is limited and inconsistent relative to current scientific evidence. To expand access to all individuals who would benefit from CGM, it is recommended that CMS modify its eligibility requirements to include all Medicare beneficiaries who meet any one of the first four criteria below, and who also meet the fifth criterion:
Criterion Supporting Evidence 1. Diagnosed with T1D. CGM use confers:
Significant reductions in
• HbA1c
• severe hypoglycemia events
• %TBR
• diabetes-related hospitalizations Significant improvements in
• %TIR
• treatment satisfaction with less diabetes distress
2. Diagnosed with T2D and treated with any insulin regimen. CGM use confers:
Significant reductions in
• HbA1c
• %TBR
• diabetes-related hospitalizations
Significant increases in %TIR 3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: Level 2 (moderate) hypoglycemia, characterized by glucose levels ≤54 mg/dL; Level 3 (severe) hypoglycemia, characterized by physical/mental dysfunction requiring third-party assistance; or nocturnal hypoglycemia CGM use confers:
Significant reductions in
• diabetes-related hospitalizations, including severe hypoglycemia events
• hypoglycemia fear and Increased patient confidence in avoiding/treating hypoglycemia, thereby supporting treatment adherence
4. Advanced CKD at risk for hypoglycemia. CGM use facilitates:
• More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia
• Effective monitoring and managing of glycemic levels in nondiabetes patients with ESRD undergoing dialysis 5. In-person or telemedicine consultation with the prescribing health care provider before CGM initiation and every 6 months thereafter while continuing CGM therapy. (Coverage for telemedicine consults should be available for all patients regardless of geographic location.) Use of telemedicine consults:
Significantly reduces
• the incidence of severe hypoglycemia events
• diabetes-related distress Significantly improves medication adherence
• Effectively addresses the obstacles caused by the COVID-19 pandemic
• Are more effective for patients who are residents of cities and using the websites as their
intervention method
Use of downloaded CGM data into standardized reports:
• Supports patient education
• Enhances patient engagement in their self-management
Click here to view CGM Payer Insights Sheet with key findings.
Learn More
Sign Up To Stay Current On The Latest Coverage
Updates, Recent News, And Resources
Optimize Outcomes in Insulin-Treated T1 and T2D via Evidence-Based Coverage Criteria with Real-Time Continuous Glucose Monitoring
Association Between Real-Time Continuous Glucose Monitor Use and Diabetes-Related Medical Costs for Patients with Type 2 Diabetes
September 2, 2021Clinical Outcomes Economic Outcomes Article / PublicationLearn MoreReal-World Studies Support Use of Continuous Glucose Monitoring in Type 1 and Type 2 Diabetes Independently of Treatment Regimen
September 2, 2021Clinical Outcomes Article / PublicationLearn MoreReal-Time Continuous Glucose Monitor (RTCGM) Use Associated with Decreased Diabetes Medical Costs for Patients with Type 2 Diabetes (T2D)
August 9, 2021Economic Outcomes Article / Publication
Source: Digital Technology and Therapeutics
Key Takeaway: A retrospective analysis of administrative claims data from the Optum Research Database showed rtCGM use was associated with diabetes-related medical cost reductions in patients with T2D. Increased access to rtCGM for patients with T2D may help to reduce diabetes-related cost of care.
Diabetes-related Medical Care Costs Decreased $424 PPPM After Initiating rtCGM Treatment
*PPPM = per patient per month
Learn MoreJune 23, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Key Takeaways: Continuous Glucose Monitoring improved outcomes more than intermittent testing of blood glucose in 41,753 patients with insulin-treated diabetes.
“Our real-world study found that in patients with insulin-treated diabetes, initiating a continuous glucose monitor substantially improved blood glucose control and cut the rate of emergency room visits for hypoglycemia in half.”1
Andrew J. Karter, PhD, Senior Research Scientist at Kaiser Permanente Division of Research
1Shaffer R. Real-time CGM lowers HbA1c, reduces ED visits in insulin-treated diabetes. Endocrine Today. June 2021. https://www.healio.com/news/endocrinology/20210607/realtime-cgm-lowers-hba1c-reduces-ed-visits-in-insulintreated-diabetes. Accessed June 24, 2021.
Learn MoreJune 22, 2021Clinical Outcomes Coverage and Benefit Design Article / Publication
Source: The Journal of the American Medical Association
Authors: Monica E. Peek, MD, MPH, MS; Celeste C. Thomas, MD, MS
“…the studies by Karter et al. and Martens et al. provide additional evidence that patients with type 2 diabetes benefit from the use of CGM in terms of improved HbA1c level, time spent in the target blood glucose range, and reduced hypoglycemic episodes…”
“…institutional changes that promote its use in primary care will go a long way to improving diabetes control and reducing complications, particularly among the populations most in need. The time has come to broaden access to CGM for patients with type 2 diabetes.”
Learn MoreEffect of Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Treated with Basal Insulin: A Randomized Clinical Trial
June 21, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Learn MoreJune 9, 2021Clinical Outcomes Article / Publication
Source: The Lancet – June 2021
Key Takeaways:
The ALERTT1 trial is the first 6-month, multicenter, prospective, randomized controlled trial comparing rtCGM with isCGM in 254 adults with type 1 diabetes, who previously used isCGM. Mean HbA1c was 7·4% (58 mmol/mol) and a minority of the study population was hypoglycemia unaware (44 [17%] people) or had a history of severe hypoglycemia (29 [11%]). Most (205 [81%]) were treated with multiple daily injections. Findings showed that in an unselected group of people with type 1 diabetes, 6-month use of rtCGM with alert functionality improved time in range (70–180 mg/dL [3.9–10.0 mmol/L]), while HbA1c, time in clinically significant hypoglycemia (< 54 mg/dL [3.0 mmol/L), and hyperglycemia (180 mg/dL [10.0 mmol/L]) were reduced. Additionally, more people on rtCGM achieved glycemic targets as defined by international consensus guidelines, and had less frequently severe hypoglycemia. Moreover, rtCGM users experienced less hypoglycemia worry and higher treatment satisfaction at the end of study.
Percentage of Participants Achieving Consensus Targets
Learn MoreWhat’s Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring
June 2, 2021Coverage and Benefit Design Guidelines / Policy
Source: Diabetes Technology & Therapeutics
Key Takeaway: Current CMS eligibility criteria for CGM coverage is limited and inconsistent relative to current scientific evidence. To expand access to all individuals who would benefit from CGM, it is recommended that CMS modify its eligibility requirements to include all Medicare beneficiaries who meet any one of the first four criteria below, and who also meet the fifth criterion:
Criterion Supporting Evidence 1. Diagnosed with T1D. CGM use confers:
Significant reductions in
• HbA1c
• severe hypoglycemia events
• %TBR
• diabetes-related hospitalizations Significant improvements in
• %TIR
• treatment satisfaction with less diabetes distress
2. Diagnosed with T2D and treated with any insulin regimen. CGM use confers:
Significant reductions in
• HbA1c
• %TBR
• diabetes-related hospitalizations
Significant increases in %TIR 3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: Level 2 (moderate) hypoglycemia, characterized by glucose levels ≤54 mg/dL; Level 3 (severe) hypoglycemia, characterized by physical/mental dysfunction requiring third-party assistance; or nocturnal hypoglycemia CGM use confers:
Significant reductions in
• diabetes-related hospitalizations, including severe hypoglycemia events
• hypoglycemia fear and Increased patient confidence in avoiding/treating hypoglycemia, thereby supporting treatment adherence
4. Advanced CKD at risk for hypoglycemia. CGM use facilitates:
• More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia
• Effective monitoring and managing of glycemic levels in nondiabetes patients with ESRD undergoing dialysis 5. In-person or telemedicine consultation with the prescribing health care provider before CGM initiation and every 6 months thereafter while continuing CGM therapy. (Coverage for telemedicine consults should be available for all patients regardless of geographic location.) Use of telemedicine consults:
Significantly reduces
• the incidence of severe hypoglycemia events
• diabetes-related distress Significantly improves medication adherence
• Effectively addresses the obstacles caused by the COVID-19 pandemic
• Are more effective for patients who are residents of cities and using the websites as their
intervention method
Use of downloaded CGM data into standardized reports:
• Supports patient education
• Enhances patient engagement in their self-management
Click here to view CGM Payer Insights Sheet with key findings.
Learn More
Sign Up To Stay Current On The Latest Coverage
Updates, Recent News, And Resources
Association Between Real-Time Continuous Glucose Monitor Use and Diabetes-Related Medical Costs for Patients with Type 2 Diabetes
Real-World Studies Support Use of Continuous Glucose Monitoring in Type 1 and Type 2 Diabetes Independently of Treatment Regimen
September 2, 2021Clinical Outcomes Article / PublicationLearn MoreReal-Time Continuous Glucose Monitor (RTCGM) Use Associated with Decreased Diabetes Medical Costs for Patients with Type 2 Diabetes (T2D)
August 9, 2021Economic Outcomes Article / Publication
Source: Digital Technology and Therapeutics
Key Takeaway: A retrospective analysis of administrative claims data from the Optum Research Database showed rtCGM use was associated with diabetes-related medical cost reductions in patients with T2D. Increased access to rtCGM for patients with T2D may help to reduce diabetes-related cost of care.
Diabetes-related Medical Care Costs Decreased $424 PPPM After Initiating rtCGM Treatment
*PPPM = per patient per month
Learn MoreJune 23, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Key Takeaways: Continuous Glucose Monitoring improved outcomes more than intermittent testing of blood glucose in 41,753 patients with insulin-treated diabetes.
“Our real-world study found that in patients with insulin-treated diabetes, initiating a continuous glucose monitor substantially improved blood glucose control and cut the rate of emergency room visits for hypoglycemia in half.”1
Andrew J. Karter, PhD, Senior Research Scientist at Kaiser Permanente Division of Research
1Shaffer R. Real-time CGM lowers HbA1c, reduces ED visits in insulin-treated diabetes. Endocrine Today. June 2021. https://www.healio.com/news/endocrinology/20210607/realtime-cgm-lowers-hba1c-reduces-ed-visits-in-insulintreated-diabetes. Accessed June 24, 2021.
Learn MoreJune 22, 2021Clinical Outcomes Coverage and Benefit Design Article / Publication
Source: The Journal of the American Medical Association
Authors: Monica E. Peek, MD, MPH, MS; Celeste C. Thomas, MD, MS
“…the studies by Karter et al. and Martens et al. provide additional evidence that patients with type 2 diabetes benefit from the use of CGM in terms of improved HbA1c level, time spent in the target blood glucose range, and reduced hypoglycemic episodes…”
“…institutional changes that promote its use in primary care will go a long way to improving diabetes control and reducing complications, particularly among the populations most in need. The time has come to broaden access to CGM for patients with type 2 diabetes.”
Learn MoreEffect of Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Treated with Basal Insulin: A Randomized Clinical Trial
June 21, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Learn MoreJune 9, 2021Clinical Outcomes Article / Publication
Source: The Lancet – June 2021
Key Takeaways:
The ALERTT1 trial is the first 6-month, multicenter, prospective, randomized controlled trial comparing rtCGM with isCGM in 254 adults with type 1 diabetes, who previously used isCGM. Mean HbA1c was 7·4% (58 mmol/mol) and a minority of the study population was hypoglycemia unaware (44 [17%] people) or had a history of severe hypoglycemia (29 [11%]). Most (205 [81%]) were treated with multiple daily injections. Findings showed that in an unselected group of people with type 1 diabetes, 6-month use of rtCGM with alert functionality improved time in range (70–180 mg/dL [3.9–10.0 mmol/L]), while HbA1c, time in clinically significant hypoglycemia (< 54 mg/dL [3.0 mmol/L), and hyperglycemia (180 mg/dL [10.0 mmol/L]) were reduced. Additionally, more people on rtCGM achieved glycemic targets as defined by international consensus guidelines, and had less frequently severe hypoglycemia. Moreover, rtCGM users experienced less hypoglycemia worry and higher treatment satisfaction at the end of study.
Percentage of Participants Achieving Consensus Targets
Learn MoreWhat’s Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring
June 2, 2021Coverage and Benefit Design Guidelines / Policy
Source: Diabetes Technology & Therapeutics
Key Takeaway: Current CMS eligibility criteria for CGM coverage is limited and inconsistent relative to current scientific evidence. To expand access to all individuals who would benefit from CGM, it is recommended that CMS modify its eligibility requirements to include all Medicare beneficiaries who meet any one of the first four criteria below, and who also meet the fifth criterion:
Criterion Supporting Evidence 1. Diagnosed with T1D. CGM use confers:
Significant reductions in
• HbA1c
• severe hypoglycemia events
• %TBR
• diabetes-related hospitalizations Significant improvements in
• %TIR
• treatment satisfaction with less diabetes distress
2. Diagnosed with T2D and treated with any insulin regimen. CGM use confers:
Significant reductions in
• HbA1c
• %TBR
• diabetes-related hospitalizations
Significant increases in %TIR 3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: Level 2 (moderate) hypoglycemia, characterized by glucose levels ≤54 mg/dL; Level 3 (severe) hypoglycemia, characterized by physical/mental dysfunction requiring third-party assistance; or nocturnal hypoglycemia CGM use confers:
Significant reductions in
• diabetes-related hospitalizations, including severe hypoglycemia events
• hypoglycemia fear and Increased patient confidence in avoiding/treating hypoglycemia, thereby supporting treatment adherence
4. Advanced CKD at risk for hypoglycemia. CGM use facilitates:
• More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia
• Effective monitoring and managing of glycemic levels in nondiabetes patients with ESRD undergoing dialysis 5. In-person or telemedicine consultation with the prescribing health care provider before CGM initiation and every 6 months thereafter while continuing CGM therapy. (Coverage for telemedicine consults should be available for all patients regardless of geographic location.) Use of telemedicine consults:
Significantly reduces
• the incidence of severe hypoglycemia events
• diabetes-related distress Significantly improves medication adherence
• Effectively addresses the obstacles caused by the COVID-19 pandemic
• Are more effective for patients who are residents of cities and using the websites as their
intervention method
Use of downloaded CGM data into standardized reports:
• Supports patient education
• Enhances patient engagement in their self-management
Click here to view CGM Payer Insights Sheet with key findings.
Learn More
Sign Up To Stay Current On The Latest Coverage
Updates, Recent News, And Resources
Real-World Studies Support Use of Continuous Glucose Monitoring in Type 1 and Type 2 Diabetes Independently of Treatment Regimen
Real-Time Continuous Glucose Monitor (RTCGM) Use Associated with Decreased Diabetes Medical Costs for Patients with Type 2 Diabetes (T2D)
August 9, 2021Economic Outcomes Article / Publication
Source: Digital Technology and Therapeutics
Key Takeaway: A retrospective analysis of administrative claims data from the Optum Research Database showed rtCGM use was associated with diabetes-related medical cost reductions in patients with T2D. Increased access to rtCGM for patients with T2D may help to reduce diabetes-related cost of care.
Diabetes-related Medical Care Costs Decreased $424 PPPM After Initiating rtCGM Treatment
*PPPM = per patient per month
Learn MoreJune 23, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Key Takeaways: Continuous Glucose Monitoring improved outcomes more than intermittent testing of blood glucose in 41,753 patients with insulin-treated diabetes.
“Our real-world study found that in patients with insulin-treated diabetes, initiating a continuous glucose monitor substantially improved blood glucose control and cut the rate of emergency room visits for hypoglycemia in half.”1
Andrew J. Karter, PhD, Senior Research Scientist at Kaiser Permanente Division of Research
1Shaffer R. Real-time CGM lowers HbA1c, reduces ED visits in insulin-treated diabetes. Endocrine Today. June 2021. https://www.healio.com/news/endocrinology/20210607/realtime-cgm-lowers-hba1c-reduces-ed-visits-in-insulintreated-diabetes. Accessed June 24, 2021.
Learn MoreJune 22, 2021Clinical Outcomes Coverage and Benefit Design Article / Publication
Source: The Journal of the American Medical Association
Authors: Monica E. Peek, MD, MPH, MS; Celeste C. Thomas, MD, MS
“…the studies by Karter et al. and Martens et al. provide additional evidence that patients with type 2 diabetes benefit from the use of CGM in terms of improved HbA1c level, time spent in the target blood glucose range, and reduced hypoglycemic episodes…”
“…institutional changes that promote its use in primary care will go a long way to improving diabetes control and reducing complications, particularly among the populations most in need. The time has come to broaden access to CGM for patients with type 2 diabetes.”
Learn MoreEffect of Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Treated with Basal Insulin: A Randomized Clinical Trial
June 21, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Learn MoreJune 9, 2021Clinical Outcomes Article / Publication
Source: The Lancet – June 2021
Key Takeaways:
The ALERTT1 trial is the first 6-month, multicenter, prospective, randomized controlled trial comparing rtCGM with isCGM in 254 adults with type 1 diabetes, who previously used isCGM. Mean HbA1c was 7·4% (58 mmol/mol) and a minority of the study population was hypoglycemia unaware (44 [17%] people) or had a history of severe hypoglycemia (29 [11%]). Most (205 [81%]) were treated with multiple daily injections. Findings showed that in an unselected group of people with type 1 diabetes, 6-month use of rtCGM with alert functionality improved time in range (70–180 mg/dL [3.9–10.0 mmol/L]), while HbA1c, time in clinically significant hypoglycemia (< 54 mg/dL [3.0 mmol/L), and hyperglycemia (180 mg/dL [10.0 mmol/L]) were reduced. Additionally, more people on rtCGM achieved glycemic targets as defined by international consensus guidelines, and had less frequently severe hypoglycemia. Moreover, rtCGM users experienced less hypoglycemia worry and higher treatment satisfaction at the end of study.
Percentage of Participants Achieving Consensus Targets
Learn MoreWhat’s Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring
June 2, 2021Coverage and Benefit Design Guidelines / Policy
Source: Diabetes Technology & Therapeutics
Key Takeaway: Current CMS eligibility criteria for CGM coverage is limited and inconsistent relative to current scientific evidence. To expand access to all individuals who would benefit from CGM, it is recommended that CMS modify its eligibility requirements to include all Medicare beneficiaries who meet any one of the first four criteria below, and who also meet the fifth criterion:
Criterion Supporting Evidence 1. Diagnosed with T1D. CGM use confers:
Significant reductions in
• HbA1c
• severe hypoglycemia events
• %TBR
• diabetes-related hospitalizations Significant improvements in
• %TIR
• treatment satisfaction with less diabetes distress
2. Diagnosed with T2D and treated with any insulin regimen. CGM use confers:
Significant reductions in
• HbA1c
• %TBR
• diabetes-related hospitalizations
Significant increases in %TIR 3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: Level 2 (moderate) hypoglycemia, characterized by glucose levels ≤54 mg/dL; Level 3 (severe) hypoglycemia, characterized by physical/mental dysfunction requiring third-party assistance; or nocturnal hypoglycemia CGM use confers:
Significant reductions in
• diabetes-related hospitalizations, including severe hypoglycemia events
• hypoglycemia fear and Increased patient confidence in avoiding/treating hypoglycemia, thereby supporting treatment adherence
4. Advanced CKD at risk for hypoglycemia. CGM use facilitates:
• More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia
• Effective monitoring and managing of glycemic levels in nondiabetes patients with ESRD undergoing dialysis 5. In-person or telemedicine consultation with the prescribing health care provider before CGM initiation and every 6 months thereafter while continuing CGM therapy. (Coverage for telemedicine consults should be available for all patients regardless of geographic location.) Use of telemedicine consults:
Significantly reduces
• the incidence of severe hypoglycemia events
• diabetes-related distress Significantly improves medication adherence
• Effectively addresses the obstacles caused by the COVID-19 pandemic
• Are more effective for patients who are residents of cities and using the websites as their
intervention method
Use of downloaded CGM data into standardized reports:
• Supports patient education
• Enhances patient engagement in their self-management
Click here to view CGM Payer Insights Sheet with key findings.
Learn More
Sign Up To Stay Current On The Latest Coverage
Updates, Recent News, And Resources
Real-Time Continuous Glucose Monitor (RTCGM) Use Associated with Decreased Diabetes Medical Costs for Patients with Type 2 Diabetes (T2D)
Source: Digital Technology and Therapeutics
Key Takeaway: A retrospective analysis of administrative claims data from the Optum Research Database showed rtCGM use was associated with diabetes-related medical cost reductions in patients with T2D. Increased access to rtCGM for patients with T2D may help to reduce diabetes-related cost of care.
Diabetes-related Medical Care Costs Decreased $424 PPPM After Initiating rtCGM Treatment
*PPPM = per patient per month
Learn MoreJune 23, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Key Takeaways: Continuous Glucose Monitoring improved outcomes more than intermittent testing of blood glucose in 41,753 patients with insulin-treated diabetes.
“Our real-world study found that in patients with insulin-treated diabetes, initiating a continuous glucose monitor substantially improved blood glucose control and cut the rate of emergency room visits for hypoglycemia in half.”1
Andrew J. Karter, PhD, Senior Research Scientist at Kaiser Permanente Division of Research
1Shaffer R. Real-time CGM lowers HbA1c, reduces ED visits in insulin-treated diabetes. Endocrine Today. June 2021. https://www.healio.com/news/endocrinology/20210607/realtime-cgm-lowers-hba1c-reduces-ed-visits-in-insulintreated-diabetes. Accessed June 24, 2021.
Learn MoreJune 22, 2021Clinical Outcomes Coverage and Benefit Design Article / Publication
Source: The Journal of the American Medical Association
Authors: Monica E. Peek, MD, MPH, MS; Celeste C. Thomas, MD, MS
“…the studies by Karter et al. and Martens et al. provide additional evidence that patients with type 2 diabetes benefit from the use of CGM in terms of improved HbA1c level, time spent in the target blood glucose range, and reduced hypoglycemic episodes…”
“…institutional changes that promote its use in primary care will go a long way to improving diabetes control and reducing complications, particularly among the populations most in need. The time has come to broaden access to CGM for patients with type 2 diabetes.”
Learn MoreEffect of Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Treated with Basal Insulin: A Randomized Clinical Trial
June 21, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Learn MoreJune 9, 2021Clinical Outcomes Article / Publication
Source: The Lancet – June 2021
Key Takeaways:
The ALERTT1 trial is the first 6-month, multicenter, prospective, randomized controlled trial comparing rtCGM with isCGM in 254 adults with type 1 diabetes, who previously used isCGM. Mean HbA1c was 7·4% (58 mmol/mol) and a minority of the study population was hypoglycemia unaware (44 [17%] people) or had a history of severe hypoglycemia (29 [11%]). Most (205 [81%]) were treated with multiple daily injections. Findings showed that in an unselected group of people with type 1 diabetes, 6-month use of rtCGM with alert functionality improved time in range (70–180 mg/dL [3.9–10.0 mmol/L]), while HbA1c, time in clinically significant hypoglycemia (< 54 mg/dL [3.0 mmol/L), and hyperglycemia (180 mg/dL [10.0 mmol/L]) were reduced. Additionally, more people on rtCGM achieved glycemic targets as defined by international consensus guidelines, and had less frequently severe hypoglycemia. Moreover, rtCGM users experienced less hypoglycemia worry and higher treatment satisfaction at the end of study.
Percentage of Participants Achieving Consensus Targets
Learn MoreWhat’s Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring
June 2, 2021Coverage and Benefit Design Guidelines / Policy
Source: Diabetes Technology & Therapeutics
Key Takeaway: Current CMS eligibility criteria for CGM coverage is limited and inconsistent relative to current scientific evidence. To expand access to all individuals who would benefit from CGM, it is recommended that CMS modify its eligibility requirements to include all Medicare beneficiaries who meet any one of the first four criteria below, and who also meet the fifth criterion:
Criterion Supporting Evidence 1. Diagnosed with T1D. CGM use confers:
Significant reductions in
• HbA1c
• severe hypoglycemia events
• %TBR
• diabetes-related hospitalizations Significant improvements in
• %TIR
• treatment satisfaction with less diabetes distress
2. Diagnosed with T2D and treated with any insulin regimen. CGM use confers:
Significant reductions in
• HbA1c
• %TBR
• diabetes-related hospitalizations
Significant increases in %TIR 3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: Level 2 (moderate) hypoglycemia, characterized by glucose levels ≤54 mg/dL; Level 3 (severe) hypoglycemia, characterized by physical/mental dysfunction requiring third-party assistance; or nocturnal hypoglycemia CGM use confers:
Significant reductions in
• diabetes-related hospitalizations, including severe hypoglycemia events
• hypoglycemia fear and Increased patient confidence in avoiding/treating hypoglycemia, thereby supporting treatment adherence
4. Advanced CKD at risk for hypoglycemia. CGM use facilitates:
• More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia
• Effective monitoring and managing of glycemic levels in nondiabetes patients with ESRD undergoing dialysis 5. In-person or telemedicine consultation with the prescribing health care provider before CGM initiation and every 6 months thereafter while continuing CGM therapy. (Coverage for telemedicine consults should be available for all patients regardless of geographic location.) Use of telemedicine consults:
Significantly reduces
• the incidence of severe hypoglycemia events
• diabetes-related distress Significantly improves medication adherence
• Effectively addresses the obstacles caused by the COVID-19 pandemic
• Are more effective for patients who are residents of cities and using the websites as their
intervention method
Use of downloaded CGM data into standardized reports:
• Supports patient education
• Enhances patient engagement in their self-management
Click here to view CGM Payer Insights Sheet with key findings.
Learn More
Sign Up To Stay Current On The Latest Coverage
Updates, Recent News, And Resources
Source: The Journal of the American Medical Association
Key Takeaways: Continuous Glucose Monitoring improved outcomes more than intermittent testing of blood glucose in 41,753 patients with insulin-treated diabetes.
“Our real-world study found that in patients with insulin-treated diabetes, initiating a continuous glucose monitor substantially improved blood glucose control and cut the rate of emergency room visits for hypoglycemia in half.”1
Andrew J. Karter, PhD, Senior Research Scientist at Kaiser Permanente Division of Research
1Shaffer R. Real-time CGM lowers HbA1c, reduces ED visits in insulin-treated diabetes. Endocrine Today. June 2021. https://www.healio.com/news/endocrinology/20210607/realtime-cgm-lowers-hba1c-reduces-ed-visits-in-insulintreated-diabetes. Accessed June 24, 2021.
Learn MoreJune 22, 2021Clinical Outcomes Coverage and Benefit Design Article / Publication
Source: The Journal of the American Medical Association
Authors: Monica E. Peek, MD, MPH, MS; Celeste C. Thomas, MD, MS
“…the studies by Karter et al. and Martens et al. provide additional evidence that patients with type 2 diabetes benefit from the use of CGM in terms of improved HbA1c level, time spent in the target blood glucose range, and reduced hypoglycemic episodes…”
“…institutional changes that promote its use in primary care will go a long way to improving diabetes control and reducing complications, particularly among the populations most in need. The time has come to broaden access to CGM for patients with type 2 diabetes.”
Learn MoreEffect of Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Treated with Basal Insulin: A Randomized Clinical Trial
June 21, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Learn MoreJune 9, 2021Clinical Outcomes Article / Publication
Source: The Lancet – June 2021
Key Takeaways:
The ALERTT1 trial is the first 6-month, multicenter, prospective, randomized controlled trial comparing rtCGM with isCGM in 254 adults with type 1 diabetes, who previously used isCGM. Mean HbA1c was 7·4% (58 mmol/mol) and a minority of the study population was hypoglycemia unaware (44 [17%] people) or had a history of severe hypoglycemia (29 [11%]). Most (205 [81%]) were treated with multiple daily injections. Findings showed that in an unselected group of people with type 1 diabetes, 6-month use of rtCGM with alert functionality improved time in range (70–180 mg/dL [3.9–10.0 mmol/L]), while HbA1c, time in clinically significant hypoglycemia (< 54 mg/dL [3.0 mmol/L), and hyperglycemia (180 mg/dL [10.0 mmol/L]) were reduced. Additionally, more people on rtCGM achieved glycemic targets as defined by international consensus guidelines, and had less frequently severe hypoglycemia. Moreover, rtCGM users experienced less hypoglycemia worry and higher treatment satisfaction at the end of study.
Percentage of Participants Achieving Consensus Targets
Learn MoreWhat’s Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring
June 2, 2021Coverage and Benefit Design Guidelines / Policy
Source: Diabetes Technology & Therapeutics
Key Takeaway: Current CMS eligibility criteria for CGM coverage is limited and inconsistent relative to current scientific evidence. To expand access to all individuals who would benefit from CGM, it is recommended that CMS modify its eligibility requirements to include all Medicare beneficiaries who meet any one of the first four criteria below, and who also meet the fifth criterion:
Criterion Supporting Evidence 1. Diagnosed with T1D. CGM use confers:
Significant reductions in
• HbA1c
• severe hypoglycemia events
• %TBR
• diabetes-related hospitalizations Significant improvements in
• %TIR
• treatment satisfaction with less diabetes distress
2. Diagnosed with T2D and treated with any insulin regimen. CGM use confers:
Significant reductions in
• HbA1c
• %TBR
• diabetes-related hospitalizations
Significant increases in %TIR 3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: Level 2 (moderate) hypoglycemia, characterized by glucose levels ≤54 mg/dL; Level 3 (severe) hypoglycemia, characterized by physical/mental dysfunction requiring third-party assistance; or nocturnal hypoglycemia CGM use confers:
Significant reductions in
• diabetes-related hospitalizations, including severe hypoglycemia events
• hypoglycemia fear and Increased patient confidence in avoiding/treating hypoglycemia, thereby supporting treatment adherence
4. Advanced CKD at risk for hypoglycemia. CGM use facilitates:
• More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia
• Effective monitoring and managing of glycemic levels in nondiabetes patients with ESRD undergoing dialysis 5. In-person or telemedicine consultation with the prescribing health care provider before CGM initiation and every 6 months thereafter while continuing CGM therapy. (Coverage for telemedicine consults should be available for all patients regardless of geographic location.) Use of telemedicine consults:
Significantly reduces
• the incidence of severe hypoglycemia events
• diabetes-related distress Significantly improves medication adherence
• Effectively addresses the obstacles caused by the COVID-19 pandemic
• Are more effective for patients who are residents of cities and using the websites as their
intervention method
Use of downloaded CGM data into standardized reports:
• Supports patient education
• Enhances patient engagement in their self-management
Click here to view CGM Payer Insights Sheet with key findings.
Learn More
Sign Up To Stay Current On The Latest Coverage
Updates, Recent News, And Resources
Source: The Journal of the American Medical Association
Authors: Monica E. Peek, MD, MPH, MS; Celeste C. Thomas, MD, MS
“…the studies by Karter et al. and Martens et al. provide additional evidence that patients with type 2 diabetes benefit from the use of CGM in terms of improved HbA1c level, time spent in the target blood glucose range, and reduced hypoglycemic episodes…”
“…institutional changes that promote its use in primary care will go a long way to improving diabetes control and reducing complications, particularly among the populations most in need. The time has come to broaden access to CGM for patients with type 2 diabetes.”
Learn More
Effect of Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Treated with Basal Insulin: A Randomized Clinical Trial
June 21, 2021Clinical Outcomes Article / Publication
Source: The Journal of the American Medical Association
Learn MoreJune 9, 2021Clinical Outcomes Article / Publication
Source: The Lancet – June 2021
Key Takeaways:
The ALERTT1 trial is the first 6-month, multicenter, prospective, randomized controlled trial comparing rtCGM with isCGM in 254 adults with type 1 diabetes, who previously used isCGM. Mean HbA1c was 7·4% (58 mmol/mol) and a minority of the study population was hypoglycemia unaware (44 [17%] people) or had a history of severe hypoglycemia (29 [11%]). Most (205 [81%]) were treated with multiple daily injections. Findings showed that in an unselected group of people with type 1 diabetes, 6-month use of rtCGM with alert functionality improved time in range (70–180 mg/dL [3.9–10.0 mmol/L]), while HbA1c, time in clinically significant hypoglycemia (< 54 mg/dL [3.0 mmol/L), and hyperglycemia (180 mg/dL [10.0 mmol/L]) were reduced. Additionally, more people on rtCGM achieved glycemic targets as defined by international consensus guidelines, and had less frequently severe hypoglycemia. Moreover, rtCGM users experienced less hypoglycemia worry and higher treatment satisfaction at the end of study.
Percentage of Participants Achieving Consensus Targets
Learn MoreWhat’s Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring
June 2, 2021Coverage and Benefit Design Guidelines / Policy
Source: Diabetes Technology & Therapeutics
Key Takeaway: Current CMS eligibility criteria for CGM coverage is limited and inconsistent relative to current scientific evidence. To expand access to all individuals who would benefit from CGM, it is recommended that CMS modify its eligibility requirements to include all Medicare beneficiaries who meet any one of the first four criteria below, and who also meet the fifth criterion:
Criterion Supporting Evidence 1. Diagnosed with T1D. CGM use confers:
Significant reductions in
• HbA1c
• severe hypoglycemia events
• %TBR
• diabetes-related hospitalizations Significant improvements in
• %TIR
• treatment satisfaction with less diabetes distress
2. Diagnosed with T2D and treated with any insulin regimen. CGM use confers:
Significant reductions in
• HbA1c
• %TBR
• diabetes-related hospitalizations
Significant increases in %TIR 3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: Level 2 (moderate) hypoglycemia, characterized by glucose levels ≤54 mg/dL; Level 3 (severe) hypoglycemia, characterized by physical/mental dysfunction requiring third-party assistance; or nocturnal hypoglycemia CGM use confers:
Significant reductions in
• diabetes-related hospitalizations, including severe hypoglycemia events
• hypoglycemia fear and Increased patient confidence in avoiding/treating hypoglycemia, thereby supporting treatment adherence
4. Advanced CKD at risk for hypoglycemia. CGM use facilitates:
• More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia
• Effective monitoring and managing of glycemic levels in nondiabetes patients with ESRD undergoing dialysis 5. In-person or telemedicine consultation with the prescribing health care provider before CGM initiation and every 6 months thereafter while continuing CGM therapy. (Coverage for telemedicine consults should be available for all patients regardless of geographic location.) Use of telemedicine consults:
Significantly reduces
• the incidence of severe hypoglycemia events
• diabetes-related distress Significantly improves medication adherence
• Effectively addresses the obstacles caused by the COVID-19 pandemic
• Are more effective for patients who are residents of cities and using the websites as their
intervention method
Use of downloaded CGM data into standardized reports:
• Supports patient education
• Enhances patient engagement in their self-management
Click here to view CGM Payer Insights Sheet with key findings.
Learn More
Sign Up To Stay Current On The Latest Coverage
Updates, Recent News, And Resources
Effect of Continuous Glucose Monitoring on Glycemic Control in Patients with Type 2 Diabetes Treated with Basal Insulin: A Randomized Clinical Trial
Source: The Journal of the American Medical Association
June 9, 2021Clinical Outcomes Article / Publication
Source: The Lancet – June 2021
Key Takeaways:
The ALERTT1 trial is the first 6-month, multicenter, prospective, randomized controlled trial comparing rtCGM with isCGM in 254 adults with type 1 diabetes, who previously used isCGM. Mean HbA1c was 7·4% (58 mmol/mol) and a minority of the study population was hypoglycemia unaware (44 [17%] people) or had a history of severe hypoglycemia (29 [11%]). Most (205 [81%]) were treated with multiple daily injections. Findings showed that in an unselected group of people with type 1 diabetes, 6-month use of rtCGM with alert functionality improved time in range (70–180 mg/dL [3.9–10.0 mmol/L]), while HbA1c, time in clinically significant hypoglycemia (< 54 mg/dL [3.0 mmol/L), and hyperglycemia (180 mg/dL [10.0 mmol/L]) were reduced. Additionally, more people on rtCGM achieved glycemic targets as defined by international consensus guidelines, and had less frequently severe hypoglycemia. Moreover, rtCGM users experienced less hypoglycemia worry and higher treatment satisfaction at the end of study.
Percentage of Participants Achieving Consensus Targets
Learn MoreWhat’s Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring
June 2, 2021Coverage and Benefit Design Guidelines / Policy
Source: Diabetes Technology & Therapeutics
Key Takeaway: Current CMS eligibility criteria for CGM coverage is limited and inconsistent relative to current scientific evidence. To expand access to all individuals who would benefit from CGM, it is recommended that CMS modify its eligibility requirements to include all Medicare beneficiaries who meet any one of the first four criteria below, and who also meet the fifth criterion:
Criterion Supporting Evidence 1. Diagnosed with T1D. CGM use confers:
Significant reductions in
• HbA1c
• severe hypoglycemia events
• %TBR
• diabetes-related hospitalizations Significant improvements in
• %TIR
• treatment satisfaction with less diabetes distress
2. Diagnosed with T2D and treated with any insulin regimen. CGM use confers:
Significant reductions in
• HbA1c
• %TBR
• diabetes-related hospitalizations
Significant increases in %TIR 3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: Level 2 (moderate) hypoglycemia, characterized by glucose levels ≤54 mg/dL; Level 3 (severe) hypoglycemia, characterized by physical/mental dysfunction requiring third-party assistance; or nocturnal hypoglycemia CGM use confers:
Significant reductions in
• diabetes-related hospitalizations, including severe hypoglycemia events
• hypoglycemia fear and Increased patient confidence in avoiding/treating hypoglycemia, thereby supporting treatment adherence
4. Advanced CKD at risk for hypoglycemia. CGM use facilitates:
• More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia
• Effective monitoring and managing of glycemic levels in nondiabetes patients with ESRD undergoing dialysis 5. In-person or telemedicine consultation with the prescribing health care provider before CGM initiation and every 6 months thereafter while continuing CGM therapy. (Coverage for telemedicine consults should be available for all patients regardless of geographic location.) Use of telemedicine consults:
Significantly reduces
• the incidence of severe hypoglycemia events
• diabetes-related distress Significantly improves medication adherence
• Effectively addresses the obstacles caused by the COVID-19 pandemic
• Are more effective for patients who are residents of cities and using the websites as their
intervention method
Use of downloaded CGM data into standardized reports:
• Supports patient education
• Enhances patient engagement in their self-management
Click here to view CGM Payer Insights Sheet with key findings.
Learn More
Source: The Lancet – June 2021
Key Takeaways:
The ALERTT1 trial is the first 6-month, multicenter, prospective, randomized controlled trial comparing rtCGM with isCGM in 254 adults with type 1 diabetes, who previously used isCGM. Mean HbA1c was 7·4% (58 mmol/mol) and a minority of the study population was hypoglycemia unaware (44 [17%] people) or had a history of severe hypoglycemia (29 [11%]). Most (205 [81%]) were treated with multiple daily injections. Findings showed that in an unselected group of people with type 1 diabetes, 6-month use of rtCGM with alert functionality improved time in range (70–180 mg/dL [3.9–10.0 mmol/L]), while HbA1c, time in clinically significant hypoglycemia (< 54 mg/dL [3.0 mmol/L), and hyperglycemia (180 mg/dL [10.0 mmol/L]) were reduced. Additionally, more people on rtCGM achieved glycemic targets as defined by international consensus guidelines, and had less frequently severe hypoglycemia. Moreover, rtCGM users experienced less hypoglycemia worry and higher treatment satisfaction at the end of study.
Percentage of Participants Achieving Consensus Targets
What’s Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring
June 2, 2021Coverage and Benefit Design Guidelines / Policy
Source: Diabetes Technology & Therapeutics
Key Takeaway: Current CMS eligibility criteria for CGM coverage is limited and inconsistent relative to current scientific evidence. To expand access to all individuals who would benefit from CGM, it is recommended that CMS modify its eligibility requirements to include all Medicare beneficiaries who meet any one of the first four criteria below, and who also meet the fifth criterion:
Criterion Supporting Evidence 1. Diagnosed with T1D. CGM use confers:
Significant reductions in
• HbA1c
• severe hypoglycemia events
• %TBR
• diabetes-related hospitalizations Significant improvements in
• %TIR
• treatment satisfaction with less diabetes distress
2. Diagnosed with T2D and treated with any insulin regimen. CGM use confers:
Significant reductions in
• HbA1c
• %TBR
• diabetes-related hospitalizations
Significant increases in %TIR 3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: Level 2 (moderate) hypoglycemia, characterized by glucose levels ≤54 mg/dL; Level 3 (severe) hypoglycemia, characterized by physical/mental dysfunction requiring third-party assistance; or nocturnal hypoglycemia CGM use confers:
Significant reductions in
• diabetes-related hospitalizations, including severe hypoglycemia events
• hypoglycemia fear and Increased patient confidence in avoiding/treating hypoglycemia, thereby supporting treatment adherence
4. Advanced CKD at risk for hypoglycemia. CGM use facilitates:
• More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia
• Effective monitoring and managing of glycemic levels in nondiabetes patients with ESRD undergoing dialysis 5. In-person or telemedicine consultation with the prescribing health care provider before CGM initiation and every 6 months thereafter while continuing CGM therapy. (Coverage for telemedicine consults should be available for all patients regardless of geographic location.) Use of telemedicine consults:
Significantly reduces
• the incidence of severe hypoglycemia events
• diabetes-related distress Significantly improves medication adherence
• Effectively addresses the obstacles caused by the COVID-19 pandemic
• Are more effective for patients who are residents of cities and using the websites as their
intervention method
Use of downloaded CGM data into standardized reports:
• Supports patient education
• Enhances patient engagement in their self-management
Click here to view CGM Payer Insights Sheet with key findings.
Learn More
What’s Wrong with This Picture? A Critical Review of Current Centers for Medicare & Medicaid Services Coverage Criteria for Continuous Glucose Monitoring
Source: Diabetes Technology & Therapeutics
Key Takeaway: Current CMS eligibility criteria for CGM coverage is limited and inconsistent relative to current scientific evidence. To expand access to all individuals who would benefit from CGM, it is recommended that CMS modify its eligibility requirements to include all Medicare beneficiaries who meet any one of the first four criteria below, and who also meet the fifth criterion:
| Criterion | Supporting Evidence |
| 1. Diagnosed with T1D. | CGM use confers: Significant reductions in • HbA1c • severe hypoglycemia events • %TBR • diabetes-related hospitalizations Significant improvements in |
| 2. Diagnosed with T2D and treated with any insulin regimen. | CGM use confers: Significant reductions in • HbA1c • %TBR • diabetes-related hospitalizations Significant increases in %TIR |
| 3. Diagnosed with T2D and documented problematic hypoglycemia regardless of diabetes therapy. This would include a history of at least one of the following conditions: Level 2 (moderate) hypoglycemia, characterized by glucose levels ≤54 mg/dL; Level 3 (severe) hypoglycemia, characterized by physical/mental dysfunction requiring third-party assistance; or nocturnal hypoglycemia | CGM use confers: Significant reductions in • diabetes-related hospitalizations, including severe hypoglycemia events • hypoglycemia fear and Increased patient confidence in avoiding/treating hypoglycemia, thereby supporting treatment adherence |
| 4. Advanced CKD at risk for hypoglycemia. | CGM use facilitates: • More frequent treatment changes and improved glycemic control without increased risk of hypoglycemia • Effective monitoring and managing of glycemic levels in nondiabetes patients with ESRD undergoing dialysis |
| 5. In-person or telemedicine consultation with the prescribing health care provider before CGM initiation and every 6 months thereafter while continuing CGM therapy. (Coverage for telemedicine consults should be available for all patients regardless of geographic location.) | Use of telemedicine consults: Significantly reduces • the incidence of severe hypoglycemia events • diabetes-related distress Significantly improves medication adherence Use of downloaded CGM data into standardized reports: |
Click here to view CGM Payer Insights Sheet with key findings.
Learn More