Medical Policy: 01.01.30
Original Effective Date: September 2019
Reviewed: September 2020
Revised: September 2020
This policy contains information which is clinical in nature. The policy is not medical advice. The information in this policy is used by Wellmark to make determinations whether medical treatment is covered under the terms of a Wellmark member's health benefit plan. Physicians and other health care providers are responsible for medical advice and treatment. If you have specific health care needs, you should consult an appropriate health care professional. If you would like to request an accessible version of this document, please contact customer service at 800-524-9242.
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This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.
Self-monitoring of blood glucose (SMBG) has replaced urine glucose testing for most patients because urine glucose testing provides only a rough estimate of prevailing blood glucose levels. Urine glucose testing in the home setting consists of semi-quantitative measurements based on single voiding or, less often, by more quantitative blocks collected over 4–24 hours. The rationale for its use is that urinary glucose values reflect mean blood glucose during the period of urine collection. Urine testing is less accurate than blood glucose monitoring and does not provide a complete picture of diabetes. A urine test does not depict the presence of glucose until the blood glucose level is above 180 milligrams per deciliter (mg/dl), making the test useless in monitoring for hyperglycemia. For these reasons, SMBG is the preferred method of monitoring glycemic status on a daily basis.
The 2019 ADA standards of medical care for diabetes state that patients on multiple-dose insulin or insulin pump therapy should perform SMBG prior to meals and snacks, occasionally postprandially, at bedtime, prior to exercise, when they suspect low blood glucose, after treating low blood glucose until they are normoglycemic, and prior to critical tasks such as driving. Any condition leading to deterioration in glycemic control necessitates more frequent monitoring of blood glucose. SMBG results may help to guide self-management for patients using less frequent insulin injections or noninsulin therapies. The need for SMBG may vary with type 2 diabetics on insulin, but before a meal and two hours after a meal are common times. In type 2 diabetics not on insulin, routine SMBG monitoring may be of limited additional clinical benefit. According to the Society of General Internal Medicine’s (2017) Choosing Wisely recommendation, SMBG is an integral part of patient self-management in maintaining safe and target-driven glucose control in type 1 diabetics. However, daily finger glucose testing is not indicated for type 2 diabetics who are not on insulin or medications associated with hypoglycemia.
Measurements obtained with CGM (continuous glucose monitor) systems may differ from those of a SMBG systems. The reasons for such differences are not entirely clear; however, these are at least in part due to compartment measurement differences, the specific system, used and the algorithms implemented in the CGM systems.
Technological solutions for glucose monitoring in patients with diabetes have improved during the last decades, and reliable systems for both SMBG and CGM now exist. However, improvement in a number of areas is still needed, including the need for recalibration, variability in glycemic patterns and lack of standardized software methods for analysis of CGM data, which mean CGM utilization in daily practice is currently limited to a small subgroup of patients. This subgroup includes: There is a lack of randomized controlled trials demonstrating superiority or necessity in management of continuous monitoring, and protocols for patients to monitor the trends in glycemic control are not available. With the existence of performance standards, standards for analysis of CGM data and high-quality training programs for patients (and physicians), usage of CGM systems is possible. Availability of accurate SMBG systems remains a cornerstone in diabetes management.
The first implantable interstitial glucose sensor device recently received FDA approval. Developed by Senseonics, Eversense is a subcutaneous implant that can last for up to 3 months. The device can measure glucose in the interstitial fluid under the skin of the arm by using a polymer that fluoresces in response to the levels of glucose. The data is then sent to a transmitter that displays the glucose levels in real time.
The results of clinical trials are promising, with the accuracy of the device compared to laboratory blood glucose measures demonstrated as being within accepted standards. However, a head-to-head trial with non-implantable CGM devices would allow a better understanding of the potential role of this implantable device in clinical practice. Additionally, there are multiple noninvasive options for glucose monitoring currently available on the market. A better understanding of the benefits and risks of invasive monitoring, including repeated implantations, is needed before the role of implantable CGM devices in clinical care is fully understood and supported. Post-approval study of the Eversense Continuous Glucose Monitor is scheduled to be completed March 2023.
MySentry (Medtronic) is a remote glucose monitor that can be placed at the bedside of a parent or guardian to allow monitoring of glucose information throughout the night. The system consists of a monitor, power source and radio-frequency operated Outpost that transmits information from a Medtronic MiniMed Paradigm REAL-Time Revel insulin pump. The Outpost allows monitoring from 50 feet away or greater. The monitor displays the same information and sounds the same alarms as the pump itself if the alarm silence option is off. The device is not used for making therapy adjustments nor does it control the insulin pump in any way.
The Sleep Sentry is a device that senses nocturnal hypoglycemia on the basis of sweating and lowered skin temperature and does not measure blood glucose directly. The original version was discontinued a number of years ago because of skin sensitivity and the high incidence of false alarms. It has recently been reintroduced with FDA approval.
The Lasette laser blood glucose monitoring device (Cell Robotics), uses a laser instead of a lancet to perforate the skin to obtain a blood sample for glucose measurement. The Lasette is a battery-operated laser unit that is placed on a table. Patients put their finger in the designated area on the unit and start the laser with a push of a button. The laser vaporizes a tiny patch of skin creating a tiny hole, as with a lancet, but without bruising the skin. The Food and Drug Administration (FDA) has cleared the Clinical Lasette for use in drawing capillary blood for screening purposes. In addition to glucose, the Clinical Lasette provides samples for the measurement of cholesterol, electrolytes, lipids, CBC, prothrombin and other tests.
Laser lancets have no proven clinical utility and are used primarily for the individual’s convenience.
Implantable Glucose SensorThe Post-Market Clinical Follow-up (PMCF) registry evaluated the long-term safety and performance of the Eversense CGM system over multiple sensor insertion/removal cycles among adults with type 1 and type 2 diabetes. The primary safety endpoint was the rate of serious adverse events (SAEs) through 4 sensor insertion/removal cycles. Of 3,023 enrolled patients, 280 completed 4 cycles. No related SAEs were reported. The most frequently reported adverse events were sensor location site infection, inability to remove the sensor upon first attempt and adhesive patch location site irritation. One non-serious allergic reaction to lidocaine was reported, which resolved with administration of an antihistamine. The full intended sensor life was achieved by 91% of 90-day sensors and 75% of 180-day sensors. This study is limited by its observational nature. Further studies are needed to evaluate the clinical utility of the Eversense system and the impact on health outcomes (Deiss et al., 2019).
Sanchez et al. (2019) analyzed real-world data from the first U.S. commercial users of the Eversense system. The first 205 patients who reached a 90-day wear period were included in the analysis. Of the 205 patients, 129 had type 1 diabetes, 18 hadtype 2 diabetes and 58 were unreported. •Time in range (≥70-180mg/dL) was 62.3% •>180-250mg/dL was 21.9% •>250mg/dL was 11.6% •<54mg/dL was 1.2% •<70mg/dL was 4.1% Nighttime values were similar. The sensor reinsertion rate was 78.5%. The median transmitter wear time was 83.6%. There were no related serious adverse events. The data showed promising glycemic results, sensor accuracy and safety. Further long-term studies are needed to confirm these results and determine the impact on health outcomes.
In a prospective, single-center, single-arm study, Aronson et al. (2019) evaluated the safety and effectiveness of the Eversense XL implantable CGM system through 180days in a primarily adolescent population with type1 diabetes (n=36). Overall MARD was 9.4%. CGM system agreement through 60, 120 and 180days was 82.9%, 83.6% and 83.4%, respectively. Surveillance error grid analysis showed 98.4% of paired values in clinically acceptable error zones A and B. No insertion/removal or device-related serious adverse events were reported. Study limitations include lack of randomization and control, small patient population and short-term follow-up.PRECISION Study
In the prospective, multicenter PRECISION study, Christiansen et al. (2019) further evaluated the accuracy and safety of Eversense among adults with type 1 or type 2 diabetes (n=35) through 90 days. An updated algorithm was also applied to sensor data from the PRECISE II study to evaluate consistency of accuracy results. The system was shown to be accurate overall with a MARD of 9.6%. Eighty-five percent of CGM values were within 15/15% of reference. All sensors were functional through day 90. No device-or procedure-related SAEs occurred. This study corroborated the favorable accuracy and safety profile observed in PRECISE II. The updated algorithm improved accuracy of measurements in PRECISE II.Study limitations include lack of randomization and control, small patient population and short-term follow-up.
In the prospective, multicenter PRECISE II trial, Christiansen et al. (2018) evaluated the accuracy and safety of the Eversense CGM system in 90 adult participants with type 1 and type 2 diabetes. The updated system included a modified algorithm anda new sensor configuration. The primary efficacy endpoint was the mean absolute relative difference (MARD) between Eversense and reference measurements through 90 days postinsertion for reference glucose values from 40 to 400mg/dL. The primary safety endpoint was the incidence of device-related or sensor insertion/removal procedure-related SAEs through 90 days postinsertion. The system was accurate, with an overall MARD value of 8.8% across the clinically relevant glucose range, with 93% of CGM values within 20% of reference values. The system correctly identified hypoglycemia (<70 mg/dL) 93% of the time and hyperglycemia (>180 mg/dL) 96% of the time.A limited but statistically significant reduction of accuracy occurred in the last month of use. Ninety-one percent of sensors were functional through day 90. One related SAE (1.1%) occurred during the study for removal of a sensor. The authors concluded that the Eversense system provided accurate glucose readings through the intended 90-day sensor life with a favorable safety profile. Study limitations include lack of randomization and short-term follow-up. Long-term surveillance studies are required to ensure that the safety profile remains favorable with multiple sensor placements and removals.
In the PRECISE trial, Kropff et al. (2017) evaluated the accuracy and longevity of the Eversense (Senseonics, Inc.) implantable CGM sensor. Seventy-one participants, aged 18 years and older with type 1 and type 2 diabetes, participated in the 180-day prospective, multicenter pivotal trial. CGM accuracy was assessed during eight in-clinic visits with the MARD for venous reference glucose values >4.2 mmol/L as the primary end point. Secondary end points included Clarke Error Grid Analysis and alarm performance. The primary safety outcome was device-related serious adverse events. The MARD value against reference glucose values >4.2 mmol/L was 11.1%. Clarke Error Grid Analysis showed 99.2% of samples in the clinically acceptable error zones. Eighty-one percent of hypoglycemic events were detected by the CGM system within 30 min. A limited but statistically significant reduction of CGM measurement accuracy occurred in the last month of use, possibly due to long-term degradation of the glucose indicating gel before end of sensor life was reached. No device-related serious adverse events occurred during the study. This study is limited by a lack of randomization and control, small patient population and short-term follow-up. Further studies are needed to assess the safety and efficacy of these devices.
Dehennis et al. (2015) performed a multisite study to assess the accuracy of glucose measurement by the Senseonics CGM system using matched paired measurements to those obtained by laboratory reference analyzer values from venous blood samples. The Senseonics CGM, composed of an implantable sensor, external smart transmitter, and smartphone app, uses a single sensor for continuous display of accurate glucose values for 3 months. Adults ≥18 and ≤65 years of age who had a clinically confirmed diagnosis of type 1 diabetesmellitus or type 2 diabetes and who were receiving insulin injection therapy were eligible to participant in this study. Ten men and 14 women with type 1 diabetes mellitus underwent subcutaneous implantation of sensors in the upper arm. Eight-hour clinic sessions were performed every 14 days (days 1, 15, 30, 45, 60, 75, and 90), during which sensor glucose values were compared against venous blood lab reference measurements using MARDs. The subjects maintained calibration of their CGM system twice daily by entering their SMBG measurement through the smartphone app. Twenty two of the twenty four (92%) sensors reported glucose continuously for 90 days, and the MARD for all 24 sensors was 11.4 ± 2.7% against venous reference glucose values. There was no significant difference in MARD throughout the 90-day study and no serious adverse events were noted. The authors concluded that the study showed successful in-clinic and home use of the Senseonics CGM system over 90 days in subjects with diabetes mellitus. Limitations of this study include non-randomization and small sample size.
The American Diabetes Association (ADA) recommends fingerstick self-monitoring of blood glucose (SMBG) as an integral component of diabetes therapy for type 1 and type 2 diabetics, as well as diabetes that develops during pregnancy (i.e., gestational diabetes). ADA stresses that the patient/caregiver should receive instructions in, and routine follow-up of, SMBG technique and their capability to use the data to adjust therapy. The ADA reports that clinical trials assessing the impact of glycemic control on diabetes complications have included SMBG as part of multifactorial interventions, suggesting that SMBG is a component of effective therapy. SMBG allows patients to evaluate their individual response to therapy and assess whether glycemic targets are being achieved.
The ADA’s 2019 recommendations for home blood glucose testing include:
Features that may be considered when purchasing a home glucose monitor include: analytical ranges; reproducibility of test results; performance reliability; ease of use; size of displays and buttons; safety features; memory and data management capabilities; warnings and alarms; type of batteries needed; and durability.
Findings from studies of SMBG (self-monitoring blood glucose) used in non-insulin-treated T2DM have been inconsistent due to differences in study designs, populations, and interventions used. However, the data available from randomized controlled trials (RCTs) suggest that SMBG is likely to be an effective self-management tool only when results are reviewed and acted upon by healthcare providers and/or people with diabetes to actively modify behavior and/or adjust treatment.
Although further studies are needed to better assess the benefits, optimal use and cost-effectiveness of SMBG, the following recommendations are proposed to guide individuals with non-insulin-treated diabetes and their healthcare providers in the use of SMBG.
The following glucose monitoring therapies have a lack of evidence that they provide an additional benefit over current standard therapies to obtain and monitor blood glucose. They are considered not medically necessary:
To report provider services, use appropriate CPT codes, Alpha Numeric (HCPCS level 2) codes, Revenue codes and / or diagnosis codes.
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