Automated Insulin Delivery (AID) Integration

Automated Insulin Delivery (AID) Integration

An automated insulin delivery (AID) system joins a continuous glucose monitor (CGM) to an insulin pump through software that adjusts insulin from the sensor's readings. Test strips aren't part of that loop. Yet when we read the labeling for five US systems, every one still expected its user to have a blood glucose meter, and Insulet's guide for the Omnipod 5 lists ketone test strips by name [1][2][3][4][5]. Medicare's rules then decide whether those strips arrive bundled with CGM supplies or get billed on their own. What each system does when its sensor stops is in Closed-Loop Control Algorithms (Artificial Pancreas), and meter pairing and calibration are in Integration of BGM/CGM into Automated Insulin Delivery (AID).

What the labeling says to keep, system by system

These are labeling statements as of October 2026, taken from each system's user guide or FDA record. They describe what the documents say. How and when to use any of these supplies is a decision for your care team.

Omnipod 5

Insulet's user guide, dated April 2026, tells users to keep an emergency kit with them at all times, both for diabetes emergencies and in case the system stops working [1]. On that list: a blood glucose meter with its test strips, plus ketone test strips and a lancing device with lancets [1]. Ketones are acidic by-products of the body breaking down fat for energy. The guide defines diabetic ketoacidosis (DKA) as a serious condition in which very high glucose and a severe lack of insulin push the body to burn fat, releasing ketones into the blood and urine [1]. It notes that DKA symptoms look a lot like the flu, and its sick-day section adds that ketones can be present during illness even when glucose is in range [1].

Tandem t:slim X2 with Control-IQ+

Tandem's guide is less specific. It says the emergency kit should hold, at the very least, an insulin syringe and vial or a prefilled pen, and it leaves the rest of the list to a conversation with your healthcare provider [2]. The first item in its examples is "BG testing supplies": a meter, strips, control solution, lancets and meter batteries [2]. Ketone strips aren't among those examples.

MiniMed 780G

FDA's summary for the 780G with the Simplera Sync sensor states that insulin pump therapy is not recommended for people unwilling or unable to perform blood glucose meter readings [3]. FDA also explained the restriction. Insulin pump use is known to carry an increased risk of DKA, and people who don't use the system as intended could harm themselves, so the 780G is prescription-only and contraindicated for anyone unwilling or unable to do fingerstick readings [3].

iLet Bionic Pancreas

The iLet writes the meter into its indications. FDA cleared the software to accept blood glucose values typed in from a meter and keep dosing for a limited time when CGM input is temporarily unavailable, and the labeling says not to use it if you're unable or unwilling to test with a meter at those times [4].

twiist AID System

Sequel Med Tech's twiist guide, revision 1.18 from July 2026, says the system isn't intended for anyone unable or unwilling to test blood glucose as their healthcare provider recommends [5]. It's also the most explicit about timing. Fingerstick values are entered when no CGM has been added, during CGM warm-up, during signal loss, or when the user wants a bolus without recent CGM data [5]. Several of its high-glucose CGM messages suggest considering a ketone check. Its backup-supplies warning says an extended delay in insulin delivery may cause high glucose or DKA [5]. For the implanted Eversense 365 sensor, the guide says to monitor glucose with a meter during warm-up and until a second calibration succeeds [5].

Why ketone supplies keep appearing

The ADA ties ketone risk to the pump itself. The American Diabetes Association's 2026 Standards of Care say infusion-set problems such as dislodgement and occlusion put people at risk for ketosis and DKA, and that these must be recognized and managed early [6]. The same section says people using CGM devices must also have access to blood glucose monitoring at all times [6].

Here's what surprised us: FDA had to set up a new device category before it could authorize a sensor that reads ketones alongside glucose. In August 2026 it granted De Novo classification, the route for devices with no existing match, to Abbott's Libre Duo 10 Day [7]. The order covers people age 2 and older and describes real-time monitoring of glucose and ketone (beta-hydroxybutyrate) levels [7]. The new category, the integrated continuous glucose ketone monitoring system, is designed to send data to connected devices, automated insulin dosing systems included [7]. In its announcement, Abbott said it planned a US launch later in 2026 and expected the sensor to work with the iLet and twiist systems by the end of that year, and with Insulet and Tandem devices in 2027 [8]. Whether that changes what AID labeling asks people to keep on hand is still an open question.

How Medicare covers strips for CGM users

Medicare draws its line at one word: adjunctive. Its Glucose Monitors coverage determination, LCD L33822, defines a non-adjunctive CGM as one that can be used for treatment decisions without a stand-alone meter to confirm results, and an adjunctive CGM as one whose readings must first be verified with a meter [9]. For billing, non-adjunctive CGMs replace a standard home meter and its supplies. Claims for a meter and strips billed on top of a non-adjunctive CGM and its supply allowance are denied [9].

The strips don't vanish, though. The companion policy article, A52464 (revision effective February 18, 2025), says the non-adjunctive supply allowance also includes a home meter and related supplies, "if necessary," naming test strips, lancets, a lancing device, calibration solution and batteries [10]. Supplies billed separately are denied as unbundling [10]. Put plainly, Medicare pays for those strips inside the CGM supply allowance rather than as their own claim.

Adjunctive CGMs work the other way. Their supply allowance excludes the meter and testing supplies, which may be billed separately [10]. The policy article says no stand-alone adjunctive CGM on the US market meets Medicare's definition of durable medical equipment, though adjunctive CGMs built into an insulin pump may [10]. When strips are billed on their own, the LCD covers up to 300 every 3 months for someone treated with insulin, with more allowed when its documentation criteria are met [9]. Which category a given CGM falls into is settled by a coding review: CGMs billed under either CGM code must be reviewed by Medicare's coding contractor and appear on its product classification list [9].

Two gaps are worth knowing. Neither L33822 nor A52464 mentions ketone test strips, so these documents don't say how Medicare treats them [9][10]. And private insurers and Medicaid plans write their own rules; we read only Medicare's. How many strips and ketone strips to keep on hand is a question to settle with your care team.