The diabetes technology ecosystem is the network of glucose sensors, insulin delivery devices, dosing algorithms, apps, and data platforms that share data to manage diabetes. Since 2018, the FDA has regulated its core components as interoperable components: integrated CGMs (iCGMs), alternate controller-enabled (ACE) insulin pumps, and interoperable automated glycemic controllers (iAGCs). That model now underpins every major automated insulin delivery (AID) system in the US and determines where a new device or software product can fit.
In late 2015, Nathaniel Heintzman, PhD, described a digital ecosystem in which a person with diabetes could get dosing strategies and predicted glucose responses for a meal on a smart device (Journal of Diabetes Science and Technology, 2016). Much of the hardware for that vision now exists, and the devices increasingly work together. This guide maps the ecosystem as it stands in 2026, explains the FDA component model behind it, and shows where device makers and software companies can still add value.
What is the diabetes technology ecosystem?
A technology ecosystem is a set of products that exchange data so each one works better than it would alone. In diabetes care, the ecosystem began with the collection and interpretation of glucose data. It now also takes in insulin doses, meals, activity, and other behavioral and environmental signals.
The ecosystem has six layers:
Layer | What it does | Examples |
|---|---|---|
Glucose sensing | Measures glucose continuously or on demand | CGMs, connected blood glucose meters |
Insulin delivery | Delivers basal and bolus insulin | Tubed and patch pumps, connected pens |
Dosing algorithms | Calculate and command insulin doses | AID algorithms, bolus advisors |
Mobile apps | Display data, take user input, control devices | Pump controller apps, CGM apps |
Data platforms | Store, analyze, and share data with care teams | Cloud platforms, clinic dashboards, EHR integrations |
Ancillary wearables | Add context such as activity and heart rate | Smartwatches, fitness trackers |
The layers matter because value increasingly comes from how they connect. A pump on its own delivers insulin. A pump that takes readings from a CGM and receives commands from an algorithm becomes an AID system that adjusts insulin automatically throughout the day.
FDA’s interoperable component model: iCGM, ACE pump, and iAGC
FDA built the ecosystem’s regulatory backbone between 2018 and 2019 through three De Novo authorizations. Each one created a Class II classification with special controls, which lets later devices of the same type reach the market through a 510(k).
Component | Regulation and product code | What it is | First authorization |
|---|---|---|---|
iCGM | 21 CFR 862.1355, QBJ | A CGM that can reliably send glucose data to other connected devices, including AID systems | Dexcom G6, De Novo DEN170088, March 27, 2018 |
ACE pump | 21 CFR 880.5730, QFG | An insulin pump that can take dosing commands from a separate, compatible controller | Tandem t:slim X2, De Novo DEN180058, February 14, 2019 |
iAGC | 21 CFR 862.1356, QJI | Software that automatically calculates insulin doses from glucose and other inputs and commands a connected pump | Tandem Control-IQ, De Novo DEN190034, December 13, 2019 |
Before this model, an AID system was typically approved as a single, closed system. Now a sensor, a pump, and an algorithm can each be cleared on their own and combined with compatible partners. That is why one company’s algorithm can run on another company’s pump, using a third company’s sensor.
One detail matters for anyone building a sensor. FDA has cleared some iCGMs that are not for use with AID systems. Abbott’s original FreeStyle Libre 2 and Libre 3 sensors were cleared under a separate iCGM product code that excludes AID use. Modified sensors cleared for AID use in March 2023 led to the FreeStyle Libre 2 Plus and 3 Plus sensors that now connect to AID systems. For a deeper look at sensor technology, see our guide to continuous glucose monitoring technology.
Who builds on the model: US AID systems in 2026
Every major US AID system now pairs a pump with a separately cleared dosing algorithm, and Abbott sensors are now integrated or announced for all five systems below.
AID system | Company | ACE pump | iAGC (algorithm) | Recent sensor integration |
|---|---|---|---|---|
Omnipod 5 | Insulet | Omnipod 5 Pod (cleared January 2022) | SmartAdjust technology | FreeStyle Libre 2 Plus, November 2024 |
Control-IQ+ | Tandem Diabetes Care | t:slim X2 and Tandem Mobi | Control-IQ+ | FreeStyle Libre 3 Plus with t:slim X2, October 2025 |
iLet Bionic Pancreas | Beta Bionics | iLet ACE Pump (cleared May 2023) | iLet Dosing Decision Software | FreeStyle Libre 3 Plus, October 2024 |
twiist | Sequel Med Tech | twiist (cleared March 2024) | Tidepool Loop | FreeStyle Libre 3 Plus, announced March 2025 |
MiniMed 780G | MiniMed (Medtronic) | MiniMed 780G pump, cleared as an ACE pump in September 2025 | SmartGuard, cleared as an iAGC in September 2025 | Instinct sensor made by Abbott, US launch December 2025 |
Algorithms are also reaching the market on their own. Tidepool Loop, cleared as an iAGC in January 2023, is the algorithm inside twiist. Diabeloop’s DBLG2 algorithm received 510(k) clearance as an iAGC in January 2026.
The business side has shifted too. Beta Bionics went public on Nasdaq in January 2025, and Medtronic’s diabetes business went public as MiniMed in March 2026. For device makers, the pattern is clear: sensors, pumps, and algorithms now compete and partner as separate products.
What changed since 2023
In early 2023, the big questions were whether the MiniMed 780G would reach the US, when Tandem’s smaller pumps would launch, and whether connected pens would catch on. Here is what actually happened, newest first.
Date | Event |
|---|---|
August 2026 | Tandem submits a 510(k) for a tubeless version of Tandem Mobi |
March 2026 | Medtronic’s diabetes business prices its IPO as MiniMed (Nasdaq: MMED) |
February 2026 | MiniMed 780G with the Instinct sensor cleared for insulin-requiring type 2 diabetes |
January 2026 | Diabeloop’s DBLG2 algorithm cleared as an iAGC |
December 2025 | MiniMed 780G with the Instinct sensor made by Abbott launches in the US |
October 2025 | t:slim X2 with FreeStyle Libre 3 Plus becomes available in the US |
September 2025 | SmartGuard cleared as an iAGC and the 780G pump as an ACE pump; 780G approved for adults with insulin-requiring type 2 diabetes |
April 2025 | FDA approves the Simplera Sync sensor for the MiniMed 780G; Dexcom G7 15 Day cleared |
February 2025 | Tandem’s Control-IQ+ cleared for adults with type 2 diabetes |
January 2025 | Beta Bionics begins trading on Nasdaq |
November 2024 | Embecta discontinues its insulin patch pump program; Omnipod 5 adds FreeStyle Libre 2 Plus in the US |
October 2024 | iLet Bionic Pancreas launches with FreeStyle Libre 3 Plus |
September 2024 | Eversense 365 cleared as an iCGM; Embecta’s patch pump receives 510(k) clearance |
August 2024 | Omnipod 5 cleared for adults with type 2 diabetes; Abbott and Medtronic announce a global CGM partnership |
May 2024 | CamDiab’s CamAPS FX app receives FDA 510(k) clearance |
March 2024 | Sequel’s twiist AID system, using the Tidepool Loop algorithm, receives 510(k) clearance |
September 2023 | Abbott completes its acquisition of Bigfoot Biomedical |
August 2023 | Novo Nordisk completes the purchase of a controlling stake in Biocorp, maker of the Mallya pen sensor |
July 2023 | Tandem Mobi cleared |
May 2023 | iLet ACE Pump and iLet Dosing Decision Software cleared; Embecta and Tidepool announce a type 2 AID partnership |
April 2023 | MiniMed 780G approved; Omnipod GO, a basal-only pump for type 2 diabetes, cleared |
March 2023 | Modified FreeStyle Libre 2 and 3 sensors cleared as iCGMs for use with AID systems |
January 2023 | Tidepool Loop cleared as an iAGC; Tandem completes its acquisition of AMF Medical, developer of the Sigi patch pump |
Three trends stand out. Interoperability became the default, with Abbott sensors integrated or announced for every major US AID system. Type 2 diabetes moved from an afterthought to a labeled indication. And the market rewarded companies that partnered, while some standalone efforts, such as Embecta’s patch pump, did not reach launch.
Type 2 diabetes: the ecosystem’s next frontier
About 90% to 95% of Americans with diabetes have type 2, according to the CDC. Yet AID systems were built and labeled for type 1 diabetes first. That gap is closing quickly.
Insulin pumps for type 2 diabetes fall into three groups:
- Basal-only pumps deliver a steady stream of rapid-acting insulin in place of long-acting injections. Insulet’s Omnipod GO, cleared in April 2023, is one example.
- Basal-bolus pumps add mealtime doses. Many pumps carry a general indication for people who need insulin, though they were mostly used in type 1 diabetes.
- AID systems adjust insulin automatically. Omnipod 5 (August 2024), Tandem’s Control-IQ+ (February 2025), and the MiniMed 780G (September 2025) now carry indications for adults with type 2 diabetes.
The Embecta story shows how fast this segment moved. In May 2023, Embecta and Tidepool announced a partnership to build an AID system designed for type 2 diabetes, around a patch pump that held FDA Breakthrough Device designation. The pump received 510(k) clearance in September 2024. Two months later, Embecta discontinued the program. By then, established AID makers were expanding their own labels to cover type 2 diabetes.
For device makers, the lesson is that type 2 is now a competitive market, not an open one. New entrants will need a clear advantage, such as a simpler workflow, lower cost, or support for people who use oral medications or injections rather than a pump.
Where the gaps are: opportunities for device and software makers
The hardware is in place. The remaining gaps are mostly about software: turning more signals into better decisions, for more people, with less effort.
Unmet need | What exists today | What is still missing |
|---|---|---|
Missed doses | Connected pen add-ons, such as Lilly’s Tempo Smart Button (FDA-cleared September 2022) and Biocorp’s Mallya (510(k) cleared December 2022) | Missed-dose detection that works across pens, pumps, and oral medications, ideally inferred from CGM patterns |
Infusion site problems | Pumps alarm on occlusions | Earlier detection of poor absorption and failing sites, before glucose rises |
Changing insulin needs | AID adjusts automatically for pump users | Software that flags when therapy needs adjusting for people on injections or oral medications, between clinic visits |
Meal dosing | Carbohydrate counting and bolus calculators | Meal estimation linked directly to dosing decisions |
Too many data streams | Separate apps for each device | One view of pump, CGM, pen, and wearable data, for users and for clinicians inside the EHR |
Complication risk | Glucose-focused tracking | Integration of blood pressure, heart rate, and other signals to flag early signs of complications |
Context the algorithm cannot see | Activity data in consumer apps | Algorithms that use activity, sleep, menstrual cycle, location, and weather to anticipate glucose changes |
Emergencies | Consumer fall detection, such as Apple Watch Fall Detection, which calls emergency services after a hard fall followed by about a minute of stillness | Alerts that combine severe low glucose with fall or inactivity signals and notify caregivers or emergency services |
Most of these ideas cross into regulated territory. Software that analyzes glucose data to alert users or recommend doses is likely a device function, so plan the regulatory path before you design the feature. Our guide to diabetes management app development explains where FDA draws those lines, and our white paper on interoperable SaMD for diabetes goes deeper on building connected solutions.
What it takes to build for an interoperable ecosystem
Building a product that plugs into this ecosystem is different from building a standalone device. These steps keep the interoperability work from becoming a late surprise.
- Choose your role. Decide whether you are building an iCGM, an ACE pump, an iAGC, or an app or platform that sits outside those classifications. The role sets your regulatory path and your partners.
- Read the special controls early. The requirements in 21 CFR 862.1355, 880.5730, and 862.1356 shape design inputs, testing, and labeling. Treat them as requirements from day one. See our guide to SaMD regulatory pathways.
- Plan partner integrations. Each connection to another company’s device needs interface specifications, an agreement, and testing with that device. See diabetes tech interoperability explained.
- Design a modular architecture. Separate device communication, algorithms, and user interface so you can add partners without rebuilding. See component architecture for SaMD.
- Build security in. A connected diabetes device is likely a cyber device under section 524B of the FD&C Act, which requires a vulnerability management plan and a software bill of materials. See medical device cybersecurity.
- Test usability across the system. Users switch between your app, your partner’s device, and their own routines, so apply usability engineering across the entire workflow.
- Plan the data layer. Decide how data reaches clinicians, cloud platforms, and EHRs, and who owns each connection.
- Map future indications. Type 2 indications reached the market as label expansions of existing systems, so plan the clinical evidence for each population early.
Frequently asked questions
What is the diabetes technology ecosystem?
It is the network of glucose sensors, insulin pumps and pens, dosing algorithms, apps, and data platforms that share data to manage diabetes. In the US, the FDA regulates the core parts as interoperable components, allowing products from different companies to work together in automated insulin delivery systems.
What is an iCGM?
An integrated continuous glucose monitoring system (iCGM) is a CGM that the FDA has classified under 21 CFR 862.1355, allowing it to reliably send glucose data to other connected devices. The Dexcom G6 was the first, authorized in March 2018. Some iCGMs are cleared for use with AID systems, and some are not.
What is an ACE pump?
An alternate controller-enabled (ACE) pump is an insulin pump that can accept dosing commands from a separate, compatible controller, such as an algorithm or app from another company. FDA created the category under 21 CFR 880.5730 with the Tandem t:slim X2 in February 2019.
What is an iAGC?
An interoperable automated glycemic controller (iAGC) is software that automatically calculates insulin doses from glucose and other inputs and sends commands to a connected pump. FDA created the category under 21 CFR 862.1356 with Tandem’s Control-IQ in December 2019. Tidepool Loop and Diabeloop’s DBLG2 are later examples.
Which AID systems are indicated for type 2 diabetes in the US?
Omnipod 5 was cleared for adults with type 2 diabetes in August 2024 and Tandem’s Control-IQ+ in February 2025. The MiniMed 780G was approved for adults with insulin-requiring type 2 diabetes in September 2025. Omnipod GO, cleared in April 2023, is a basal-only pump for type 2 diabetes, not an AID system.
Build for the ecosystem with Sequenex
The diabetes technology ecosystem now rewards products that connect. Whether you are building a sensor, a pump, an algorithm, or the app and cloud platform that tie them together, interoperability has to be designed in from the start.
Sequenex designs, develops, and sustains purpose-built software for diabetes and connected devices, with a focus on interoperability. See our biosensor and CGM software development services, or contact us to discuss your project.
