(Artificial Pancreas, Closed Loop)

The development of automated insulin delivery has many names – artificial pancreas, hybrid closed loop, bionic pancreas – but all share the same goal: using continuous glucose monitors (CGM) and smart algorithms that automatically adjust insulin delivery via pump. The goal of these products is to reduce or eliminate hypoglycemia, improve time in range, and reduce hyperglycemia – especially overnight.

See below for an overview of the automated insulin delivery field, focused on companies that have products that are already available. We’ve broken our table into two sections:

Predictive low-glucose suspend systems: use continuous glucose monitor (CGM) data to predict when glucose levels will go low, shutting off insulin delivery to avoid hypoglycemia.

Hybrid closed loop: use continuous glucose monitor (CGM) data to increase or decrease basal insulin delivery, helping to keep glucose levels stable. Some systems can also deliver autocorrection boluses.

Do-it-yourself (DIY) automated insulin delivery systems like OpenAPS and Loop are not included here. We acknowledge that our list may be incomplete, as there are likely other startups or academic groups working to build closed-loop technology; this list excludes groups without a commercial path to market.

At the end we’ve included helpful links to our articles about progress on AID systems as well as on specific products.

Updated: August 18, 2020

Table adapted from this paper by Messer et. al.

Currently Commercially Available Products – Predictive Low-Glucose Suspend

Product Name (Countries Available) Medtronic 640G/Enlite Enhanced (UK, Denmark, Australia) Tandem/Dexcom Basal-IQ (US, Canada) How is insulin delivery calculated? Suspends insulin when glucose is predicted to be 20 mg/dL above your low threshold Resumes insulin after 2 hours (or when manually resumed) Suspends insulin when glucose is predicted to be below 80 mg/dL in 30 min or is already ≤70 mg/dL Resumes insulin when glucose values begin rising What can you adjust? User can modify all pump settings and the suspend threshold User can modify all pump settings User cannot modify suspend threshold What if CGM data is lost? System returns to traditional pump therapy System returns to traditional pump therapy What’s important to know about this system? N/A System may start and stop insulin delivery frequently – this will cause frequent alerts What sensor is used? How can data be shared? Sensor: Guardian Sensor 3 Requires 2-4 fingerstick calibrations each day, when glucose is stable (before meals, bedtime, etc.) Maximum 7-day sensor life Blood glucose checks needed for diabetes management decisions Sensor: Dexcom G6 Factory-calibrated sensor 10-day sensor life Sensor value can be used for diabetes management decisions (if value and arrow are present) Use Follow app to remotely follow glucose levels

Currently Commercially Available Products – Hybrid Closed Loop

Product Name (Country Available) Cambridge CamAPS FX (UK) Medtronic 670G (US, Australia, Belgium, Denmark, Finland, Italy, Netherlands, Slovenia, Spain, Sweden, Switzerland, and UK/Ireland) Tandem/Dexcom Control-IQ (US) How is insulin delivery calculated? User enters weight and total daily insulin into algorithm Default glucose target is 5.8 mmol/L (105 mg/dL) Uses total daily insulin over the last 2-6 days to determine algorithm values Hybrid closed loop set point: 120 mg/dL No automated correction doses; manual correction doses based on algorithm User enters weight and total daily insulin to determine algorithm values Hybrid closed loop target range: 112.5-160 mg/dL Automated correction dose (1 per hour – 60% of calculated dose to get to 110 mg/dL) User can give manual doses What can you adjust? User can modify basal rates and hybrid closed loop glucose target User cannot modify urgent low threshold (3.1 mmol/L) User can modify I:C ratios, active insulin time, and temporary target of 150 mg/dL User cannot modify basal rates, insulin sensitivity factor, hybrid closed loop set point User can modify I:C ratios, basal rates, insulin sensitivity factors, hybrid closed loop target range for Exercise and Sleep modes User cannot modify active insulin time or correction target (110 mg/dL) What if something goes wrong? Reverts to open loop if in ‘fail safe’ mode or in ‘attempting’ mode for 30 minutes Reverts to open loop if hyperglycemia continues, max/min delivery thresholds are reached, CGM data is lost, or the sensor isn’t working Reverts to open loop if CGM data is lost for long periods of time What’s important to know about this system? The use of the ‘Block’ feature allows control over app functionality (good for kids) Follow sensor prompts if “BG required” is shown Cannot use temporary basal rates or combo boluses in hybrid closed loop mode Can adjust insulin doses using pump parameters You should not override boluses – could lead to hypoglycemia Cannot use temporary basal rates in hybrid closed loop mode What sensor is used? How can data be shared? Sensor: Dexcom G6 Factory-calibrated sensor 10-day sensor life Sensor value can be used for diabetes management decisions (if value and arrow are present) Use CamAPS FX app to remotely follow glucose levels Sensor: MiniMed Guardian 3 Requires 2-4 fingerstick calibrations each day, when glucose is stable (before meals, bedtime, etc.) Maximum 7-day sensor life Blood glucose checks needed for diabetes management decisions Sensor: Dexcom G6 Factory-calibrated sensor 10-day sensor life Sensor value can be used for diabetes management decisions (if value and arrow are present) Use Follow app to remotely follow glucose levels

Helpful Links

What’s Coming and What’s Delayed in Automated Insulin Delivery? – Updates and delays from Medtronic, Tandem, and Insulet

Automated Insulin Delivery: Six Universal Observations and Understandings – Six universal facts about automated insulin delivery systems, and the things you should keep in mind about this revolutionary technology

Tech on The Horizon: Automated Insulin Delivery Systems Coming In 2020 – 2020 is shaping up to be a huge year in automated insulin delivery. Updates from DiabetesMine Innovation Summit’s first-ever closed loop showcase

Medtronic

MiniMed 780G Receives CE-Mark Approval in Europe – Medtronic’s newest automated insulin delivery system, the MiniMed 780G, has received the CE-Mark, which means it will become available this fall in select European countries

Pivotal Trial for New Closed Loop System Seeks Type 1 Participants – This study, now recruiting 350 participants, will examine the safety of the MiniMed 780G Advanced Hybrid Closed Loop System in people with type 1 diabetes (7+ Years)

The FDA Approves Medtronic’s MiniMed 670G Hybrid Closed Loop System – Coming to US in spring 2017: what it is, what it isn’t, and how to get it

Medtronic MiniMed 670G Trial Results: 44% Reduction in Hypoglycemia, 0.5% A1c Improvement – Highlights from the first study of a commercial automated insulin delivery device. Plus, Medtronic’s latest software updates!

FDA Approves Medtronic MiniMed 670G Hybrid Closed Loop for 7-13 Year Olds – MiniMed 670G becomes the first hybrid closed loop system officially approved for type 1 pediatric use; systems are available now. European approval also received for 7 years and up!

Medtronic MiniMed 670G 2-6-Year-Old Data and Next-Gen Products – When will we see a 670G with Bluetooth and remote monitoring? Also, the upcoming MiniMed 780G with automatic boluses, a seven-day wear infusion set, and better Medtronic CGM

Up Close with Medtronic’s New MiniMed 640G System in Europe – Major updates from Medtronic on the 640G predictive #insulin suspend for type 1 diabetes from ATTD2015

Tandem Control-IQ and Basal-IQ

Tandem’s Control-IQ Cleared for Ages 6-13: Automated Insulin Delivery for Children – In exciting news, Tandem announced expanded clearance for the hybrid closed loop Control-IQ. The system is now available for children ages 6-13

Control-IQ: The Good, the Challenges, and Tips – After a month of her daughter using Control-IQ, Katie Bacon reviews the pros and cons of the algorithm and shares her family’s tips and takeaways

First Impressions of Control-IQ – More time in range and lower stress! In this Trial Watch, Kerri Sparling shares her experience with Tandem's Control-IQ

Tandem’s Control-IQ Cleared in United States – Control-IQ the first AID system with automatic correction boluses and no fingersticks CGM (Dexcom G6); cleared for those ages 14 and older; launch in January 2020

FDA Approves Tandem’s Basal-IQ Predictive Low Glucose Suspend System – New Dexcom G6-compatible Basal-IQ system prevents/reduces hypoglycemia based on CGM; US launch expected in August, including free software update for current users

What’s Coming? AID Systems To Watch For

Insulet

Omnipod Horizon System to Integrate Freestyle Libre 2, G6, and G7 CGMs – Insulet partners with Abbott and Dexcom to develop Omnipod Horizon systems

Omnipod Horizon Hybrid Closed-Loop Pivotal Study Seeking Participants – A clinical trial testing the safety and efficacy of Insulet’s Omnipod Horizon hybrid closed loop system is now fully enrolled. Data will support FDA approval, expected in the second half of 2020

Bigfoot Biomedical & Beta Bionics

What’s Coming from Beta Bionics and Bigfoot? Exciting Next-Gen Automated Insulin Delivery – New product details, pictures, and study timing updates on Beta Bionics’ iLet and Bigfoot’s Loop and Inject systems

Tidepool Loop

How I Loop Series – Read three different people's experiences with Loop, the do-it-yourself (DIY) automated insulin delivery system!

Tidepool will Submit Loop to FDA, the DIY iPhone App for Automated Insulin Delivery – Why it’s a big deal for the closed loop and pump fields, when it might be available, and how Tidepool is working with the FDA and companies to make it happen

Omnipod First Insulin Pump Partner for Tidepool Loop – Tubeless Omnipod will communicate directly with Tidepool Loop app. Insulet’s own Horizon hybrid closed loop expected to launch in second-half of 2020

Diabeloop

Diabeloop’s Automated Insulin Delivery System to Launch in Europe – Diabeloop’s automated insulin delivery system includes the Kaleido insulin pump, an Android controller, and the Dexcom G6 CGM; it is the second hybrid closed loop approved in Europe for adults with type 1 diabetes

Please note, this page is not a comprehensive list of all of the available resources or products available. All links are organized chronologically within their respective sections.