[CQM-4960] Evaluate whether continuous glucose monitoring (CGM) device data should be included in measure criteria Created: 10/05/21  Updated: 12/20/21  Resolved: 11/04/21

Status: Closed
Project: eCQM Issue Tracker
Component/s: None

Type: Hosp Inpt eCQMs - Hospital Inpatient eCQMs Priority: Moderate
Reporter: Joelencia Leflore Assignee: Joelencia Leflore
Resolution: Answered Votes: 1
Labels: CRP

Solution: We will not move forward with the proposed change during this annual update.
Last Commented Date:

 Description   

Brief Description of Measure:
CMS871/HH-02: Hospital Harm- Severe Hyperglycemia:
This measure assesses the number of inpatient hospital days with a hyperglycemic event (harm) per the total qualifying inpatient hospital days for patients 18 years of age or older at admission.

CMS816/HH-01: Hospital Harm- Severe Hypoglycemia:
The proportion of inpatient hospitalizations for patients 18 years of age or older at admission, who were administered at least one hypoglycemic medication during the encounter, who suffer the harm of a severe hypoglycemic event during the encounter.
Harm (numerator) is defined as a laboratory or point-of-care (POC) test for blood glucose with a result less than 40 mg/dL, where the hypoglycemic medication was given within the 24 hours prior to the start of the low blood glucose event (and administered during the encounter). Only one severe hypoglycemic event is counted per inpatient hospitalization encounter.

Description of Issue:
Glucose lab test results are evaluated in the CMS 816 Hypoglycemia measure's numerator, and in the CMS 871 Hyperglycemia measure's denominator and numerator. ​Currently, the measures use the value set Glucose lab test (OID 2.16.840.1.113762.1.4.1045.134) which includes code concepts of a blood glucose specimen (e.g., 2345-7 Glucose [Mass/volume] in Serum or Plasma) and are not based on the device used, as the criteria is looking to capture just the result.
 
IMPAQ received feedback from pre-rulemaking public comment requesting we consider including in our measures the glucose results from interstitial fluid via a continuous glucose monitoring (CGM) device, and that the guidance on the measures be revised to include this concept.

Proposed Solution:
​IMPAQ seeks to obtain additional information on the use of CGM specimens (interstitial fluid) in the monitoring of glucose levels during inpatient hospitalizations. This feedback will assist in our consideration to include this concept in the measures and to determine if it aligns with measure intent.
Please provide feedback on the following:
 
1) Are results from CGMs consistently used in all hospital settings to monitor the patient's glucose levels?
 
2) What is the workflow/process if CGM results are monitored and recorded, e.g., where and how are the results documented? Are they documented discretely (i.e., as CGM glucose, interstitial glucose fluid, or body fluid)? How frequently are the results recorded, given they are continuous?
 
3) For out of range or critical low/high results, is there an alert and are the clinicians in the hospital notified?
 
4) Does point of care testing still occur on a patient with a CGM device?  If there are differences between the two results, which value is used for clinical decision-making?

Rationale for Change:
​Including glucose values from interstitial fluid will align with those hospitals that have adopted CGM as a tool to monitor glucose levels.

 Comments   
Comment by Jesse Bushman (Inactive) [ 12/16/21 ]

Per a comment from Mathematica, we requested a LOINC for “Glucose levels in interstitial fluid” from LOINC.org and they have created one.  The spreadsheet they sent us with the new code is attached.  I hope this is helpful to you as you consider updates to the guidance on the two referenced quality measures.

 

Comment by Mathematica EC Updates (Inactive) [ 10/21/21 ]

Thank you for commenting, the CRP public comment period has closed for measure developer review.

Comment by eCQM Standards Team [ 10/20/21 ]

Clinical: 1) CGM may be available if the patient had PTA. A small minority of facilities might utilize in select units or settings. (Covid? Hospital in the Home?) but would not be available in all hospitals. 2) Most devices would report to patient cell phone app, but currently problematic for device interoperability to hospital EHR unless facility distribution (future FHIR POC/PHD?). 3) Out of range might alert local reader but not necessarily alert Facility EHR. 4) This would necessitate usage alongside of facility testing which would be favored by clinicians. Data capture to reporting EHR is the challenge but consider adding as an OR'd input for out of range data capture similar to POC fingerstick glucose possibly with confirming lab glucose? /Peter MD 10/11

This question was for implementers regarding what is available. No standards comments. /Floyd 1020

Comment by Jesse Bushman (Inactive) [ 10/20/21 ]

I have attempted, several times, to place the image showing the integration of CGM into EPIC into these comments and have been unable to figure out how to do so.  I will try one more time within this comment.  If it does not come though, please email me directly at jesse.bushman@dexcom.com and I will send that graphic. 

Also, in response to a prior comment, I am placing a link to the webpage that Dexcom has established for app developers where we provide instructions on how to integrate our API into their apps.  https://developer.dexcom.com/  This is, at this time, a possibility for any developer who would like to use our API.

Comment by Alex Liu [ 10/20/21 ]

Currently, CGM data is not incorporated into the EHR for monitoring patient glucose levels in inpatient settings. Many CGM vendors have not published APIs to read the data and incorporate it into the EHR, and some have been resistant to the idea of making any such API available.

We agree with the previous comment that the inclusion of CGM results could be beneficial in quality measurement and should warrant further discussion in the future state when CGM data is available within EHR systems.

Comment by Raechel Pusateri (Inactive) [ 10/19/21 ]

On behalf of the diabetes community, the Diabetes Technology Access Coalition (DTAC) writes to express its support for the inclusion of continuous glucose monitor (CGM) device data in measure criteria for the following new hospital inpatient quality reporting (IQR) measures: (1) CMS871/HH-02: Hospital Harm- Severe Hyperglycemia; and (2) CMS816/HH-01: Hospital Harm- Severe Hypoglycemia.

The current measure descriptions reference a “blood glucose test” for both measures as the tool to determine glycemic levels. Specifically, both descriptors refer to laboratory or point-of-care (POC) tests, including capillary/glucometer tests, but do not reference the use of CGM results as a possible measurement option.

At the beginning of the COVID-19 public health emergency (PHE), the Food and Drug Administration (FDA) issued temporary guidance to help increase the availability and capability of non-invasive remote monitoring devices to facilitate patient monitoring while reducing patient and health care provider contact and exposure to COVID-19. The policy expands the indication of non-invasive patient monitoring technology, including CGM, so they can be used in inpatient hospital settings. Some patients with diabetes also use their existing CGM while admitted to the hospital, which would facilitate data collection through the use of a CGM.

Due to the increased flexibility during the COVID-19 PHE, many hospitals have adopted the use of CGM to monitor glucose levels of inpatients. This change has allowed hospital staff to frequently and effectively monitor patient glucose levels without using personal protective equipment (PPE) or increasing the chances of spreading COVID-19 through direct patient contact. This is especially significant given that patients with diabetes are at increased risk for severe COVID-19, including higher rates of hospitalization and death. 1, 2

Further, the use of CGM in the inpatient setting has demonstrated additional benefits beyond the conservation of PPE and limiting direct patient contact. Although data are limited among the inpatient population, recent investigational studies have demonstrated that use of CGM results in improved glycemic management when compared to POC testing, which is the current inpatient standard. Specifically, these studies show that inpatient use of CGM is more effective in identifying trends toward hypoglycemia and hyperglycemia compared to standard POC glucose testing. 3, 4, 5, 6

Given these initial data, as well as the benefits of reducing PPE use and risk of COVID-19 exposure through direct patient contact, DTAC believes that CGM will ultimately be widely adopted for use in the inpatient setting and should be permitted as one of the means of measuring blood glucose levels for the two new IQR measures. We therefore recommend that Mathematica revise the measure descriptors to include CGM as an option for measuring blood glucose levels.

Thank you for the opportunity to provide these comments. Please feel free to contact Tim Trysla, Executive Director of DTAC at tim.trysla@alston.com should you have any questions or if there are more details we can provide.

 

References:

[1] Zhou F, Yu T, Du R, et al.: Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet 2020;395:1054–1062.

[2] Bode B, Garrett V, Messler J, et al.: Glycemic characteristics and clinical outcomes of COVID-19 patients hospitalized in the United States. J Diabetes Sci Technol 2020;14:813–821.

[3] Gómez AM, Umpierrez GE, Muñoz OM, et al. Continuous Glucose Monitoring Versus Capillary Point-of-Care Testing for Inpatient Glycemic Control in Type 2 Diabetes Patients Hospitalized in the General Ward and Treated With a Basal Bolus Insulin Regimen. J Diabetes Sci Technol. 2015;10(2):325-329.

[4] Davis GM, Galindo RJ, Migdal AL, Umpierrez GE. Diabetes Technology in the Inpatient Setting for Management of Hyperglycemia. Endocrinol Metab Clin North Am. 2020;49(1):79-93.

[5] Singh LG, Satyarengga M, Marcano I, et al. Reducing Inpatient Hypoglycemia in the General Wards Using Real-time Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial. Diabetes Care. 2020;43(11):2736-2743.

[6] Fortmann AL, Spierling Bagsic SR, Talavera L, et al. Glucose as the Fifth Vital Sign: A Randomized Controlled Trial of Continuous Glucose Monitoring in a Non-ICU Hospital Setting. Diabetes Care. 2020;43(11):2873-2877.

Comment by Jesse Bushman (Inactive) [ 10/19/21 ]

Comment by Jesse Bushman (Inactive) [ 10/19/21 ]

Are results from CGMs consistently used in all hospital settings to monitor the patient's glucose levels?

 

Continuous Glucose Monitoring (CGM) Systems are indicated for home use and have not been FDA-cleared or approved for use in hospital settings. Due to the COVID-19 pandemic, the Food and Drug Administration notified Dexcom on April 1, 2020, that it will not object to Dexcom’s provision of CGM systems for the treatment of patients in hospital settings and other healthcare facilities to support COVID-19 healthcare-related efforts during the current pandemic.1 As a result, some hospitals are using CGM in various settings including the emergency department2, intensive care unit (ICU)3,4,5,6,7,8,9,10,11,12, and non-intensive care unit6,7,13,14,15,16,17 for remote glucose monitoring to detect and prevent glycemic excursions, preserve personal protective equipment, and minimize risk of exposure to COVID-19.

 

What is the workflow/process if CGM results are monitored and recorded, e.g., where and how are the results documented? Are they documented discretely (i.e., as CGM glucose, interstitial glucose fluid, or body fluid)? How frequently are the results recorded, given they are continuous?

 ** 

At present, the ambulatory Dexcom G6 product that is being used in the hospital does not integrate with the electronic health record (EHR). Therefore, CGM readings are manually entered into the EHR. The frequency of monitoring and documentation varies across hospital setting and patient acuity level. For example, The Ohio State University established criteria to assess CGM performance against a reference method (e.g., point-of-care (POC) fingerstick). Once validation is established, CGM is used to titrate insulin every hour with POC validation every 6 hours for patients in the ICU on insulin infusion. Once patients are transferred out of the ICU, CGM is used to replace POC, which is typically performed four times a day. If there is a change in the patient’s clinical condition, frequency of glucose monitoring may be adjusted.4,5

 

Values are often recorded in the EHR flowsheet as CGM glucose alongside POC or as a separate CGM-specific row at the time intervals required for glucose documentation, which depends on mode of insulin administration and institution. Additionally, some institutions upload retrospective CGM reports from the Dexcom Clarity software into the EHR.

 

The image below is an example of a flowsheet in EPIC used to document the validation of CGM reading compared to POC reading.12

 

 

For out of range or critical low/high results, is there an alert and are the clinicians in the hospital notified?

 ** 

Yes, Dexcom G6 has one non-customizable alarm and several optional and customizable alerts. The Urgent Low Alarm notifies when CGM glucose is at or below 55 mg/dL. The alarm is non-customizable and always on. The optional alert includes the Urgent Low Soon Alert that notifies when CGM glucose will be at or below 55 mg/dL within 20 minutes. Optional and customizable alerts include the Low Glucose Alert and High Glucose Alert that notifies when CGM glucose is below or above the target glucose threshold, respectively. Optional alerts are also available to notify when CGM glucose is rising or falling rapidly, CGM signal is lost, and CGM readings are not detected.18

 

Alarm and alerts can be viewed and heard from the patient’s display device. If hospitals are using remote monitoring, the alarm and most alerts can be viewed and heard through a central monitoring device such as an iPad at the nurse’s station.

Does POC testing still occur on a patient with a CGM device? If there are differences between the two results, which value is used for clinical decision-making?

 ** 

Some hospitals use the alarm and alerts of CGM to warn of impending hypo- or hyperglycemia, then confirm with POC for clinical decision-making. This CGM use case can assist in identifying hypo- or hyperglycemic events that could otherwise go undetected with POC.15

 

Other hospitals establish validation criteria to assess CGM performance against a reference method such as POC. For example, The Ohio State University uses the following criteria:

 

  • CGM < 20% difference from the reference when the glucose is > 100 mg/dL
  • CGM < 20 mg/dL difference from the reference when the glucose is < 100 mg/dL

 

Validation is established when two consecutive sensor-meter pairs approximately 1-hour apart meet the criteria. If the CGM glucose falls outside these criteria, hospitals use the POC value for clinical decision making and repeat the validation process.4,5

 

References

 

  1. (2021, October 18). Information for Healthcare Providers: Dexcom G6 System in the Hospital. https://www.dexcom.com/hospitalcovid-19.
  2. The Naomi Berrie Diabetes Center. (2021, April 4). Better Care with Less Risk: Dr. Magda Bogun Leads an Effort to Save ICU beds in Covid-19 Pandemic by Using Diabetes Technology. https://www.nbdiabetes.org/news/better-care-less-risk-dr-magda-bogun-leads-effort-save-icu-beds-covid-19-pandemic-using.
  3. Joshi et. al. (2021). Continuous Glucose Monitoring (CGM) in ICU Patients during COVID-19: A Pilot Study. Abstract presented at American Diabetes Association 81st Scientific Sessions, Virtual Conference.
  4. Faulds et. al. (2021). Facilitators and Barriers to Nursing Implementation of Continuous Glucose Monitoring (CGM) in Critically Ill Patients With COVID-19. Endocrine Practice, 27(4), 354-361.

DOI: 10.1016/j.eprac.2021.01.011.

  1. Faulds et. al. (2021). Use of Continuous Glucose Monitor in Critically Ill COVID-19 Patients Requiring Insulin Infusion: An Observational Study. The Journal of Clinical Endocrinology & Metabolism, 106(10), e4007-e4016. DOI: 10.1210/clinem/dgab409.
  2. Longo et. al. (2021). Use and Accuracy of Inpatient CGM During the COVID-19 Pandemic: An Observational Study of General Medicine and ICU Patients. Journal of Diabetes Science and Technology. DOI: 10.1177/19322968211008446.Online ahead of print.
  3. Finn et. al. (2021). Implementation of a Continuous Glucose Monitoring Program at a Safety Net Hospital During Covid 19 Pandemic. Journal of the Endocrine Society, 5(1), A345-A346. DOI: 10.1210/jendso/bvab048.704.
  4. Chow et. al. (2021). Use of Continuous Glucose Monitoring to Assess Parenteral Nutrition–Induced Hyperglycemia in an Adult Patient with Severe COVID-19. Journal of Parenteral and Enteral Nutrition, 45(1), 208–211. DOI: 10.1002/jpen.2032.
  5. Sadhu et. al. (2020). Continuous Glucose Monitoring in Critically Ill Patients With COVID-19: Results of an Emergent Pilot Study. Journal of Diabetes Science and Technology, 14(6), 1065-1073. DOI: 10.1177/1932296820964264.
  6. Agarwal et. al. (2021). Continuous Glucose Monitoring in the Intensive Care Unit During the COVID-19 Pandemic. Diabetes Care, 44, 847–849. DOI.org/10.2337/dc20-2219.
  7. Chow et. al. (2021). Outcomes and Healthcare Provider Perceptions of Real-Time Continuous Glucose Monitoring (rtCGM) in Patients with Diabetes and COVID-19 Admitted to the ICU. Journal of Diabetes Science and Technology, 15(3), 607-614. DOI: 10.1177/1932296820985263.
  8. Davis et. al. (2021). Remote Continuous Glucose Monitoring with a Computerized Insulin Infusion Protocol for Critically Ill Patients in a COVID19 Medical ICU: Proof of Concept. Diabetes Care, 44, 1055–1058. DOI: 10.2337/dc20-2085.
  9. Davis et. al. (2021). Accuracy of Dexcom G6 Continuous Glucose Monitoring in Non–Critically Ill Hospitalized Patients with Diabetes. Diabetes Care, 44, 1–6. DOI: 10.2337/dc20-2856.
  10. Davis et. al. (2021). Comparison of Dexcom G6 Continuous Glucose Monitoring and Point-of-Care Blood Glucose Testing in Hospitalized Patients with Diabetes. Abstract presented at American Diabetes Association 81st Scientific Sessions, Virtual Conference.
  11. Singh et. al. (2020). Reducing Inpatient Hypoglycemia in the General Wards Using RealTime Continuous Glucose Monitoring: The Glucose Telemetry System, a Randomized Clinical Trial. Diabetes Care, 43(11), 2736-2743. DOI: 10.2337/dc20-0840.
  12. Fortmann et. al. (2020). Glucose as the Fifth Vital Sign: A Randomized Controlled Trial of Continuous Glucose Monitoring in a Non-ICU Hospital Setting. Diabetes Care, 43(11), 2873-2877. DOI: 10.2337/dc20-1016.
  13. Reutrakul et. al. (2020). Feasibility of Inpatient Continuous Glucose Monitoring During the COVID-19 Pandemic: Early Experience. Diabetes Care, 43(10), e137-e138. DOI: 10.2337/dc20-1503.
  14. (2020). Dexcom G6 Continuous Glucose Monitoring System User Guide. https://s3-us-west-2.amazonaws.com/dexcompdf/G6-CGM-Users-Guide.pdf.

 

Generated at Sun Aug 31 08:14:40 UTC 2025 using Jira 10.3.8#10030008-sha1:cdaed80cecc964184c5b19b002388d56f96e274e.