Resources: Automated Insulin Delivery Systems
This list provides, in alphabetical order of the manufacturer or entity, the major AID systems currently approved for use by FDA, submitted to FDA for review, or still in development. All information provided has been obtained from and reviewed for accuracy by the manufacturer or entity. Several other systems and joint efforts between several entities are in development with focus outside of the US currently.
Manufacturer: Beta Bionics (a public benefit company)
Product Name: iLet bionic pancreas (insulin-only).
Description: Pocket-sized, wearable investigational medical device that autonomously controls glucose; integrated with Dexcom G6. For future, a dual chamber AID system that uses both insulin and glucagon. Regarding the liquid-stable glucagon needed in the dual-chamber iLet, Zealand Pharma received FDA approval of Zegalogue (dasiglucagon) in March 2021. 1
FDA status: Investigational device. Not submitted yet. Currently a pivotal trial with insulin-only iLet is ongoing with 440 people with T1D 6 years and older at 17 research sites. Will file for FDA review upon completion of this pivotal trial.
Intended use: TBD by FDA
Data integration/connectivity: TBD
Cost/coverage: Spokesperson stated, “We expect that iLet will fall into existing medical policies and be processed the same way as current integrated systems marketed today.”
Manufacturer: Insulet Corporation
Product Name: Omnipod 5 Automated Insulin Delivery System
Description: Fully on-body AHCL/AID system; Dexcom G6 transmitter communicates directly to a wearable insulin-filled Pod; Personalized Model Predictive Control (MPC) algorithm is built into the Pod; Insulet-provided Controller or personal smartphone is used to start and stop Automated Mode, deliver boluses, view data, and change settings. Customizable glucose target from 110-150 mg/dL in 10 mg/dL increments, adjustable by time of day.
FDA status: Expected FDA approval Q4 2021. Full market release later in 2022.*
FDA Intended use: No information at present.
Unique assets: HypoProtect (for times of decreased insulin needs, such as exercise), waterproof, discreet insulin delivery, Controller or smartphone does not need to be near the Pod for the system to deliver automated basal delivery.
Data integration/connectivity: Dexcom G6 transmitter communicates directly to Pod; Pod communicates wirelessly to the Omnipod 5 App on Controller or smartphone; Dexcom G6 transmitter communicates wirelessly to the Dexcom G6 app; Controller or smartphone controls and monitors Pod operations with Bluetooth wireless technology.
Food coverage: Users will be advised to enter the carbohydrates they are consuming into the SmartBolus calculator. (per email communication with Insulet).
Platform/app: Omnipod 5 App
Cost/coverage: Omnipod 5 will launch at price parity to Omnipod DASH. Insulet plans to expand its “30 days of freedom” free trial period to new Omnipod 5 users. Omnipod 5 will be available exclusively through some pharmacies.
*(Quotes from Closer Look issue 8/6 were acknowledge as correct by Insulet medical information representative.)
Manufacturer: Medtronic Diabetes
Product Name: MiniMedTM 780G
(Referred to by Medtronic as an advanced hybrid closed loop [AHCL] system. Medtronic also refers to MiniMed 670G, MiniMed 770G as hybrid closed loop [HCL] systems.)
Description: AHCL/AID, the SmartGuard™ algorithm automates insulin delivery in a real-time adaptable way with predictive personalized diagnostics.
FDA status: MiniMedTM 780G submitted in April 2021, not yet approved. Received CE mark in Europe in 2020 and is available in other countries globally.
FDA Intended use: No information at present.
Unique assets: Automatically adjusts background insulin with correction boluses every 5 minutes based on integrated CGM (Guardian Sensor 3) results, allows for adjustable target settings (to 100 mg/dL), assists with forgetting to dose for a meals, dosing for a meal late, or underestimating the carbohydrate content of meals.
Data integration/connectivity: CareLink software integrates all data; Smartphone connectivity allows viewing pump and CGM info and device notifications on phone, offer remote access to data to care partners; Bluetooth connectivity will allow for future software updates.
Platform/app: CareLink software
Future: The Personalized Closed Loop (PCL) insulin pump system, will be more advanced than MiniMed 780G was given a fast-track FDA process referred to as the Breakthrough Devices Program. PCL is in feasibility trials now. It will leverage the power of Klue’s (an entity acquired by Medtronic in 2019) 2 gesture technology to ID when food is being consumed coupled with Nutrino, another entity that Medtronic acquired in 2018,3 which improves predictive analytic capabilities around mealtimes to deliver a higher level of personalized precision to dosing intelligence.
Cost/coverage: Pricing and insurance coverage details on MiniMed 780G will not be available until FDA approval is secured.
Manufacturer: Tandem Diabetes Care
Product Name: t:slim X2 with Control-IQ
(t:slim X2 also available alone or with basal-IQ), NextGen product (see Future below).
Description: AHCL/AID; Predicts and helps prevent hypo-and hyperglycemia; uses CGM (Dexcom G6) data to hold glucose in range of 70-180 mg/dL(defined TiR); Auto-correct bolus doses; optional settings for sleep and exercise.
FDA status: Cleared 2019, ages 14+, Cleared ages 6+ 2020.
FDA Intended use: Basal-IQ and Control-IQ cleared by FDA as interoperable automated glycemic controller (iAGC).
Unique assets: Free updatable software uploads for next generation software with prescription; training and online tutorials required.
Data integration/connectivity: Integrated with Dexcom G6 CGM.
Platform/app: Users can utilize t:connect to make their mobile phone a discreet secondary screen from which to access pump data and settings, and for uploading pump data at their clinician visits.
Cost/coverage: t:slim X2 with Control-IQ covered by most healthcare plans under the durable medical equipment (DME) deductible. t:slim X2 is covered by Medicare.
Future: Tandem considers t:sport a next generation device. Submission to FDA is expected late 2021/early 2022 with launch anticipated in Summer, 2022. It will be a discreet tubed pump (micropump) with no screen. It will contain an AID algorithm that will be controlled from the user’s mobile phone.
Entity: Tidepool, a nonprofit organization
Product Name: Tidepool Loop (this is not a standalone AID system)
The goal is to make it interoperable (see Glossary with as many ACE pumps and iCGMs as possible. Announced partners to data include Medtronic, Insulet, and Dexcom.)
Description: Tidepool Loop intends to be delivered as an iOS app that is available in the App Store with a prescription.
FDA status: Tidepool Loop was submitted to FDA as an iAGC and is currently under review.
FDA Intended use: More information expected after FDA review is complete.
Unique assets: Interoperability with other ACE pumps and integrated CGMs. More information expected after FDA review is complete.
Data integration/connectivity: More information expected after FDA review is complete.
Platform/app: Tidepool Loop is being developed as an iOS app.
Cost/coverage: No detail on cost or coverage are available currently.
- FDA approves Zealand Pharma’s Zegalogue for hypoglycemia treatment. https://www.pharmaceutical-business-review.com/news/fda-approves-zealand-pharmas-zegalogue-for-hypoglycemia-treatment/. Accessed August 9, 2021.
- Medtronic Acquires Klue. https://newsroom.medtronic.com/news-releases/news-release-details/medtronic-acquires-klue. Accessed August 9, 2021.
- Medtronic to Acquire Nutrino Health. https://newsroom.medtronic.com/news-releases/news-release-details/medtronic-acquire-nutrino-health. Accessed August 9, 2021.