Automated Insulin Delivery Systems

POLICY NUMBER

A.1.01.30

DESCRIPTION

Automated insulin delivery systems, also known as artificial pancreas device systems, link a glucose monitor to an insulin infusion pump that automatically takes action (eg, suspends or adjusts insulin infusion) based on the glucose monitor reading. These devices are proposed to improve glycemic control in patients with insulin-dependent diabetes, in particular, reduction of nocturnal hypoglycemia.

Diabetes and Glycemic Control

Tight glucose control in patients with diabetes has been associated with improved health outcomes. The American Diabetes Association has recommended a glycated hemoglobin level below 7% for most patients. However, hypoglycemia, may place a limit on the ability to achieve tighter glycemic control. Hypoglycemic events in adults range from mild to severe, based on a number of factors including the glucose nadir, the presence of symptoms, and whether the episode can be self-treated or requires help for recovery. Children and adolescents represent a population of individuals with type 1 diabetes who have challenges in controlling hyperglycemia and avoiding hypoglycemia. Hypoglycemia is the most common acute complication of type 1 diabetes.

The table below is a summary of selected clinical outcomes in type 1 diabetes clinical management and research.

Outcome Measures for Type 1 Diabetes

ADA: American Diabetes Association, ISPAD: International Society for Pediatric and Adolescent Diabetes; ULN: upper limit of normal.ªSteering Committee: representatives from American Association of Clinical Endocrinologists (AACE), American Association Diabetes Educators, the American Diabetes Association (ADA), the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, type 1 diabetes Exchange.^bTime in range: has also been adopted by researchers evaluating the precision and effectiveness of emerging glucose monitoring and automated insulin delivery technologies.

Outcome measures for type 2 diabetes have been published, including those used for clinical trials focused on non-surgical treatments addressing hyperglycemia in adults with type 2 diabetes.

Treatment

Type 1 diabetes is caused by the destruction of the pancreatic beta cells which produce insulin, and the necessary mainstay of treatment is insulin injections. Multiple studies have shown that intensive insulin treatment, aimed at tightly controlling blood glucose, reduces the risk of long-term complications of diabetes, such as retinopathy and renal disease. Optimal glycemic control, as assessed by glycated hemoglobin, and avoidance of hyper- and hypoglycemic excursions have been shown to prevent diabetes-related complications. Currently, insulin treatment strategies include either multiple daily insulin injections or continuous subcutaneous insulin infusion with an insulin pump.

Advancements in diabetes technology have significantly improved the management of type 2 diabetes, particularly through the use of continuous glucose monitoring (CGM). CGM has been linked to better glycemic control, despite ongoing challenges for those on insulin therapy to meet their targets. Automated insulin delivery (AID) systems, which have shown benefits in type 1 diabetes, are being explored for type 2 diabetes to address dynamic insulin needs and improve outcomes. AID has the potential to enhance patient satisfaction and ease the complexity of intensive insulin regimens, though clinical data for type 2 diabetes is still limited.

The use of the continuous glucose monitoring component of diabetes self-management is specifically addressed in the Continuous Glucose Monitoring  medical policy.

Restoration of pancreatic function is potentially available through islet cell or allogeneic pancreas transplantation. Medical policies for these interventions are Islet Transplantation and Allogeneic Pancreas Transplant , respectively.

The U.S. Food and Drug Administration (FDA) describes the basic design of an automated insulin delivery (AID) system as a continuous glucose monitoring linked to an insulin pump with the capability to automatically stop, reduce, or increase insulin infusion based on specified thresholds of measured interstitial glucose.

The AID system components are designed to communicate with each other to automate the process of maintaining blood glucose concentrations at or near a specified range or target and to minimize the incidence and severity of hypoglycemic and hyperglycemic events. An AID system control algorithm is embedded in software in an external processor or controller that receives information from the continuous glucose monitoring and performs a series of mathematical calculations. Based on these calculations, the controller sends dosing instructions to the infusion pump.

Different AID system types are currently available for clinical use. Sensor augmented pump therapy with low glucose suspend (suspend on low) may reduce the likelihood or severity of a hypoglycemic event by suspending insulin delivery temporarily when the sensor value reaches (reactive) a predetermined lower threshold of measured interstitial glucose. Low glucose suspension automatically suspends basal insulin delivery for up to two hours in response to sensor-detected hypoglycemia.

A sensor augmented pump therapy with predictive low glucose management (suspend before low) suspends basal insulin infusion with the prediction of hypoglycemia. Basal insulin infusion is suspended when sensor glucose is at or within 70 mg/dL above the patient-set low limit and is predicted to be 20 mg/dL above this low limit in 30 minutes. In the absence of a patient response, the insulin infusion resumes after a maximum suspend period of two hours. In certain circumstances, auto-resumption parameters may be used.

When a sensor value is above or predicted to remain above the threshold, the infusion pump will not take any action based on continuous glucose monitoring readings. Patients using this system still need to monitor their blood glucose concentration, set appropriate basal rates for their insulin pump, and give premeal bolus insulin to control their glucose levels.

A control-to-range system reduces the likelihood or severity of a hypoglycemic or hyperglycemic event by adjusting insulin dosing only if a person's glucose levels reach or approach predetermined higher and lower thresholds. When a patient's glucose concentration is within the specified range, the infusion pump will not take any action based upon continuous glucose monitoring readings. Patients using this system still need to monitor their blood glucose concentration, set appropriate basal rates for their insulin pump, and give premeal bolus insulin to control their glucose levels.

A control-to-target system sets target glucose levels and tries to maintain these levels at all times. This system is fully automated and requires no interaction from the user (except for calibration of the continuous glucose monitoring). There are two subtypes of control-to-target systems: insulin-only and bihormonal (eg, glucagon). There are no systems administering glucagon marketed in the United States.

A hybrid closed-loop system also uses automated insulin delivery with continuous basal insulin delivery adjustments. However, at mealtime, the patient enters the number of carbohydrates they are eating in order for the insulin pump to determine the bolus meal dose of insulin. A hybrid system option with the patient administration of a premeal or partial premeal insulin bolus can be used in either control-to-range or control-to-target systems.

An AID system may also be referred to as a “closed-loop” system. A closed-loop system has AID and continuous glucose sensing and insulin delivery without patient intervention. The systems utilize a control algorithm that autonomously and continually increases and decreases the subcutaneous insulin delivery based on real-time sensor glucose levels.

The table below summarizes the FDA cleared or approved automated insulin delivery systems.

U.S. Food and Drug Administration-Approved Automated Insulin Delivery Systems

CL: closed-loop; HCL: hybrid closed-loop; LGS: low glucose suspend; OZO: Artificial Pancreas Device System, threshold suspend; OZP: Automated Insulin Dosing Device System, Single Hormonal Control; PMA: premarket approval; PLGM: predictive low glucose management.ªMiniMed 530G System consists of the following devices that can be used in combination or individually: MiniMed 530G Insulin Pump, Enlite™ Sensor, Enlite™ Serter, the MiniLink Real-Time System, the Bayer Contour NextLink glucose meter, CareLink® Professional Therapy Management Software for Diabetes, and CareLink® Personal Therapy Management Software for Diabetes (at time of approval).^bMiniMed 630G System with SmartGuard™ consists of the following devices: MiniMed 630G Insulin Pump, Enlite® Sensor, One-Press Serter, Guardian® Link Transmitter System, CareLink® USB, Bayer’s CONTOUR ® NEXT LINK 2.4 Wireless Meter, and Bayer’s CONTOUR® NEXT Test Strips (at time of approval).^cMiniMed 670G System consists of the following devices: MiniMed 670G Pump, the Guardian Link (3) Transmitter, the Guardian Sensor (3), One-Press Serter, and the Contour NEXT Link 2.4 Glucose Meter (at time of approval).^dMiniMed 770G System consists of the following devices: MiniMed 770G Insulin Pump, the Guardian Link (3) Transmitter, the Guardian Sensor (3), One-Press Serter, the Accu-Chek Guide™ Link blood glucose meter, and the Accu-Chek Guide™ Test Strips.^eMiniMed 780G System consists of the following devices: MiniMed 780G Insulin Pump, the Guardian 4 Transmitter, the Guardian 4 Sensor (3), One-Press Serter, the Accu-Chek Guide™ Link blood glucose meter, and the Accu-Chek Guide™ Test Strips.^fBasal-IQ technology was discontinued as of December 2023. The manufacturer (Tandem) continues to maintain service for supply refills and/or technical support.gOmnipod 5 System consists of a tubeless, wearable Pod that adjusts insulin delivery based on CGM readings, controlled via Bluetooth through a handheld device like a smartphone or provided controller. It can function in open loop (Manual Mode) or closed loop (Automated Mode with SmartAdjust™ algorithm enabled), where insulin delivery is managed by the algorithm installed on the Pod. In August 2024, the FDA extended the Omnipod 5 system's approval for adults with type 2 diabetes, following its 2022 clearance for children and adults with type 1 diabetes.hControl-IQ+ technology is intended for use with compatible integrated CGM (iCGM) and ACE pumps to automatically increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose values. It can also deliver correction boluses when the glucose value is predicted to exceed a predefined threshold. In February 2025, the FDA extended the Control-IQ+ technology approval for adults with type 2 diabetes.

The MiniMed 530G System includes a threshold suspend or low glucose suspend feature. The threshold suspend tool temporarily suspends insulin delivery when the sensor glucose level is at or below a preset threshold within the 60 to 90 mg/dL range. When the glucose value reaches this threshold, an alarm sounds. If patients respond to the alarm, they can choose to continue or cancel the insulin suspend feature. If patients fail to respond, the pump automatically suspends action for 2 hours, and then insulin therapy resumes.

The MiniMed® 630G System with SmartGuard™, which is similar to the 530G, includes updates to the system components including waterproofing. The threshold suspend feature can be programmed to temporarily suspend delivery of insulin for up to two hours when the sensor glucose value falls below a predefined threshold value. The MiniMed 630G System with SmartGuard™ is not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a finger stick may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not on the values provided by the MiniMed 630G system. The device is not intended to be used directly for preventing or treating hypoglycemia but to suspend insulin delivery when the user is unable to respond to the SmartGuard™ Suspend on Low alarm to take measures to prevent or treat hypoglycemia themselves.

The MiniMed® 670G System is a hybrid closed-loop insulin delivery system consisting of an insulin pump, a glucose meter, and a transmitter, linked by a proprietary algorithm and the SmartGuard Hybrid closed-loop. The system includes a low glucose suspend feature that suspends insulin delivery; this feature either suspends delivery on low-glucose levels or suspends delivery before low-glucose levels, and has an optional alarm (manual mode). Additionally, the system allows semiautomatic basal insulin-level adjustment (decrease or increase) to preset targets (automatic mode). As a hybrid system, basal insulin levels are automatically adjusted, but the patient needs to administer premeal insulin boluses. The continuous glucose monitoring component of the MiniMed 670G System is not intended to be used directly for making manual insulin therapy adjustments; rather it is to provide an indication of when a glucose measurement should be taken. The MiniMed 670G System was originally approved for marketing in the United States on September 28, 2016 (P160017), and received approval for marketing with a pediatric indication (ages 7 to 13 years) on June 21, 2018 (P160017/S031).

The MiniMed 770G System is an iteration of the MiniMed 670G System. In July 2020, the device was approved for use in children ages 2 to 6 years. In addition to the clinical studies that established the safety and effectiveness of the MiniMed 670G System in users ages 7 years and older, the sponsor performed clinical studies of the 670G System in pediatric subjects ages 2 to 6 years. The FDA concluded that these studies establish a reasonable assurance of the safety and effectiveness of the MiniMed 770G System because the underlying therapy in the 670G system, and the associated Guardian Sensor (3), are identical to that of the 770G System. The FDA subsequently approved the MiniMed 780G System in May 2023.

On June 21, 2018, the FDA approved the t:slim X2 Insulin Pump with Basal-IQ Technology (PMA P180008) for individuals who are 6 years of age and older. This system was discontinued as of December 2023. The manufacturer (Tandem) will continue to maintain service for supply refills and/or technical support.

In December 2019, the FDA approved the t:slim X2 Insulin Pump with Control-IQ Technology through the De Novo process. The device uses the same pump hardware as the insulin pump component of the systems approved in t:slim X2 Insulin Pump with Basal-IQ Technology (P180008) and P140015. A custom disposable cartridge is motor-driven to deliver patient programmed basal rates and boluses through an infusion set into subcutaneous tissue.

In January 2022, the FDA approved the Omnipod 5 system for individuals who are 6 years of age and older with type 1 diabetes. The system uses SmartAdjust™ technology for use with compatible integrated CGMs and ACE pumps to automatically increase, decrease, and pause delivery of insulin based on current and predicted glucose values. In August 2022, the FDA expand the age indication to individuals who are 2 years and older with type 1 diabetes.

In May 2023, the FDA approved the first closed-loop system (iLet Bionic Pancreas) through the 510(k) premarket clearance pathway.

In August 2024, the FDA extended approval of the Omnipod 5 system for use by individuals who are 18 years of age and older with type 2 diabetes.

In February 2025, the FDA extended approval of the t:slim X2 Insulin Pump with Control-IQ+ technology for use by individuals who are 18 years of age and older for type 2 diabetes.

Related medical policies –

• Continuous Glucose Monitoring

• Islet Transplantation

• Allogeneic Pancreas Transplant

POLICY

Use of a U.S. Food and Drug Administration cleared or approved automated insulin delivery system with a low-glucose suspend feature may be considered medically necessary in individuals with type 1 diabetes who meet all of the following criteria:

• Age 6 years and older AND

  • Glycated hemoglobin level between 5.8% and 10.0%;

  • Used insulin pump therapy for more than 6 months;

  • At least 2 documented nocturnal hypoglycemic events in a 2-week period.

Use of a U.S. Food and Drug Administration cleared or approved automated insulin delivery system designated as a hybrid closed-loop insulin delivery system (with low glucose suspend and suspend before low features) may be considered medically necessary in individuals with type 1 diabetes who meet all of the following criteria:

• Over age 6 years AND

  • Glycated hemoglobin level between 5.8% and 10.0%;

  • Used insulin pump therapy for more than 6 months;

  • At least 2 documented nocturnal hypoglycemic events in a 2-week period.OR 

• Age 2 to 6 years AND

  • Clinical diagnosis of type 1 diabetes for 3 months or more;

  • Used insulin pump therapy for more than 3 months;

  • Glycated hemoglobin level <10.0%;

  • Minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.

Use of a U.S. Food and Drug Administration cleared or approved automated insulin delivery system designated as a closed-loop insulin delivery system may be considered medically necessary in individuals with type 1 diabetes who meet all of the following criteria:

• Age 6 years and older AND

  • Clinical diagnosis of type 1 diabetes for 12 months or more;

  • Using insulin for at least 12 months;

  • Diabetes managed using the same regimen (either pump or multiple daily injections, with or without continuous glucose monitoring) for 3 months or longer.

Use of a U.S Food and Drug Administration cleared or approved automated insulin delivery system designated as a hybrid closed-loop insulin delivery system (with low glucose suspend and suspend before low features) may be considered medically necessary in individuals with type 2 diabetes who meet all the following criteria (see Policy Guidelines):

• Age 18 years and older AND

  • Diagnosed with type 2 diabetes for at least 12 months;

  • On multiple daily injections (insulin administration ≥3x/day or use of insulin infusion pump) for at least 3 months;

  • Glycated hemoglobin level ≥7% or experience significant hypoglycemia.

Use of an automated insulin delivery system is investigational for individuals who do not meet the above criteria.

Use of an automated insulin delivery system not cleared or approved by the Food and Drug Administration is investigational.

POLICY EXCEPTIONS

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

POLICY GUIDELINES

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Diabetes mellitus (DM) encompasses various distinct types, all of which are characterized by abnormal carbohydrate metabolism manifesting as hyperglycemia and may require insulin therapy. The current body of evidence supporting the use of automated insulin delivery (AID) systems for each type of DM is variable, and the initiation of additional clinical trials is unlikely. Individuals with DM should understand the technology, be motivated to use the device correctly and consistently, adhere to a comprehensive treatment plan supervised by a qualified provider, and be capable of recognizing alerts and alarms from the device.

The U.S. Food and Drug Administration (FDA) has approved two hybrid closed-loop insulin delivery systems for type 2 diabetes management: the Omnipod 5 AID system (Insulet Corporation) and t:slim X2 insulin pump equipped with Control-IQ+ technology (Tandem Diabetes Care).

• The Omnipod 5 AID system was approved following a pivotal clinical trial by Pasquel and colleagues in 2025 (SECURE-T2D; NCT05815342). Trial participants aged 18 to 75 years, who had been on a stable insulin regimen for at least three months prior to screening (as per the above policy criteria), were selected. Additionally, they could be on other antihyperglycemic and weight loss drugs, provided there were no dose changes for at least 4 weeks before the trial commenced. However, those who experienced more than one severe hypoglycemic event or episode of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome within 6 months before screening were excluded.

• The t:slim X2 insulin pump equipped with Control-IQ+ technology was approved following a pivotal randomized controlled trial by Kudva and colleagues in 2025 (2IQP; NCT05785832). Trial participants were aged 19 to 87 years and had type 2 diabetes for at least 6 months, according to clinical history and available laboratory data. All participants were receiving multiple daily injections of insulin with at least one injection containing rapid-acting insulin per day or were using an insulin pump for at least 3 months before enrollment. Mixed insulin use with a rapid-acting component was allowed. Concurrent treatment with noninsulin glucose-lowering medications or weight-reduction medications was permitted, provided the dose had been stable for the previous 3 months; during the trial, these medications were continued in both treatment groups.

This policy does not address use of automated insulin delivery systems in pregnancy.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting. 

POLICY HISTORY

04/09/2015: Approved by Medical Policy Advisory Committee.

08/18/2015: Medical policy revised to add ICD-10 codes.

12/18/2015: Policy description updated regarding devices. Policy statements unchanged.

05/31/2016: Policy number A.1.01.30 added.

09/30/2016: Code Reference section updated to add the following new ICD-10 diagnosis codes: E10.3211 - E10.3219, E10.3291 - E10.3299, E10.3311 - E10.3319, E10.3391 - E10.3399, E10.3411 - E10.3419, E10.3491 - E10.3499, E10.3511 - E10.3519, E10.3521 - E10.3529, E10.3531 - E10.3539, E10.3541 - E10.3549, E10.3551 - E10.3559, E10.3591 - E10.3599, and E10.37X1 - E10.37X9.

11/30/2016: Policy description updated regarding devices. Policy statements unchanged.

12/13/2017: Policy description updated regarding hypoglycemia and devices. Medically necessary policy statement updated to change "hemoglobin value" to "hemoglobin level." Policy statement revised to state that the use of hybrid closed loop insulin delivery system as an artificial pancreas device system is considered investigational. Code Reference section updated to removed deleted ICD-10 diagnosis codes E10.321, E10.329, E10.331, E10.339, E10.341, E10.349, E10.351, and E10.359.

01/12/2018: Policy statement regarding the use of a hybrid closed loop insulin delivery system updated to include the Food and Drug Administration-approved device for age 14 and older as investigational.

11/15/2019: Policy description extensively revised. Added information regarding outcome measures for type 1 diabetes and devices. First medically necessary statement updated to change the age criterion from "Age 16 and older" to "Age 14 and older." Added medically necessary statement that the use of a U.S. FDA-approved automated insulin delivery system designated as a hybrid closed-loop insulin delivery system may be considered medically necessary in patients with type 1 diabetes who meet the listed criteria. The use of an automated insulin delivery system is investigational for individuals who do not meet the criteria. Use of an automated insulin delivery system not approved by the FDA is investigational. Policy Guidelines updated to remove information regarding a hypoglycemic episode.

01/13/2020: Policy reviewed; no changes.

05/14/2020: Policy description updated regarding devices. Policy statements unchanged.

03/21/2022: Policy description updated regarding devices. First medically necessary statement updated to change age criteria from "Age 14 and older" to "Age 6 years and older." Second medically necessary statement regarding the hybrid closed-loop insulin delivery system updated to change the age criteria from "Age 7 and older" to "Over age 6 years," and to add criteria for ages 2 to 6. Policy Guidelines updated to change "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity."

08/08/2022: Policy description updated regarding devices. Policy statements updated to change "patients" to "individuals."

03/15/2024: Policy description updated regarding devices. Added policy statement that the use of a FDA cleared or approved automated insulin delivery system (artificial pancreas device system) designated as a closed-loop insulin delivery system may be considered medically necessary in individuals with type 1 diabetes who meet all of the specified criteria. Code Reference section updated to add HCPCS codes A4226 and E0787.

08/05/2024: Policy reviewed. First medically necessary statement updated with minor change to maintain consistency with policy statements.

05/15/2025: Policy description updated regarding advancements in diabetes technology and devices. Added policy statement that the use of an FDA-approved hybrid closed-loop insulin delivery system may be considered medically necessary in individuals with type 2 diabetes meeting the listed criteria. Policy Guidelines updated regarding clinical trial information. Code Reference section updated to add ICD-10 diagnosis codes E11.00 - E11.9.

08/29/2025: Policy title changed from "Artificial Pancreas Device Systems" to "Automated Insulin Delivery Systems." Policy description updated regarding devices. Revised medically necessary criteria regarding individuals with type 2 diabetes. Policy Guidelines updated regarding diabetes mellitus and devices for type 2 diabetes management.

SOURCE(S)

Blue Cross and Blue Shield Association Policy # 1.01.30

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY medically necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

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