By The Biomedical Observer
Managing type 2 diabetes with insulin is a bit like being a short-order cook who's also their own customer, nutritionist, and accountant. Check your blood sugar. Calculate how many carbs you're about to eat. Factor in whether you exercised today. Consider your stress levels. Think about what time it is and what your blood sugar tends to do at this hour. Now give yourself a shot. Repeat this several times a day, every day, forever.
Oh, and if you get the math wrong, you either feel terrible (too high) or pass out (too low). No pressure.
For decades, there's been a better way for people with type 1 diabetes: automated insulin delivery (AID) systems that use a continuous glucose monitor to track blood sugar and an insulin pump that automatically adjusts delivery. It's like cruise control for your pancreas. But type 2 diabetes - which affects roughly ten times as many people - has been largely left out of the automation party.
That's finally changing. And the latest push is to make onboarding so simple that the systems can actually be prescribed and used in primary care, not just specialized diabetes clinics.
Type 2 Diabetes: The Complicated One
Quick refresher: in type 1 diabetes, the immune system destroys insulin-producing beta cells, so you need external insulin from day one. In type 2, the body either doesn't use insulin well or gradually produces less. Many people manage with diet and oral medications for years - but eventually, a significant number need insulin.
The problem? Insulin therapy in type 2 has historically been complicated. Regimens vary - basal only, basal-bolus, premixed - and fear of hypoglycemia keeps many running levels higher than ideal. Add the psychological burden of constant injections and blood sugar checks, and diabetes distress becomes very real.
The Promise of Automation
Automated insulin delivery systems change the game because they do most of the thinking for you.
Here's how they work: A continuous glucose monitor (CGM) checks your blood sugar every few minutes and sends the data to an algorithm. The algorithm predicts where your blood sugar is heading and adjusts insulin delivery from the pump accordingly. Too high? More insulin. Trending low? Reduce or suspend delivery. Repeat every five minutes, 24/7.
For type 1 diabetes, AID systems have been transformative. People report better glucose control, fewer dangerous lows, and improved quality of life. The Omnipod 5, Tandem Control-IQ, and Medtronic 780G are among the systems available in the U.S.
But until recently, none of these were approved for type 2 diabetes. The regulatory pathway, the clinical evidence, and frankly the business model all focused on the type 1 population.
SECURE-T2D: The Trial That Changed Things
The SECURE-T2D trial (NCT05815342) was the first large-scale study of automated insulin delivery in type 2 diabetes - and the results were good enough that Omnipod 5 became the first AID system cleared by the FDA for type 2 in August 2024 (Bergenstal et al., 2025, JAMA Netw Open; DOI: 10.1001/jamanetworkopen.2024.57028).
The numbers:
- 305 adults with type 2 diabetes, using various insulin regimens
- 21 clinical centers across the U.S.
- 24% Black participants, 22% Hispanic - making it one of the most diverse diabetes technology trials ever
- 13 weeks of AID use after a baseline period
The results:
- HbA1c dropped from 8.2% to 7.4% - a 0.8 percentage point reduction overall
- People with worse starting control (HbA1c 9.0% or higher) saw drops of 2.1 percentage points
- Time in range (70-180 mg/dL) increased by 4.8 hours per day
- Time in hypoglycemia didn't increase - meaning the improvement wasn't coming at the cost of dangerous lows
- Total daily insulin actually decreased by an average of 23 units
- Zero cases of diabetic ketoacidosis or hyperosmolar hyperglycemic syndrome
The patient satisfaction scores improved too. The percentage of participants with high diabetes distress dropped significantly. Turns out, not having to obsessively micromanage your blood sugar all day makes life more pleasant. Who knew?
But Here's the Catch: Complexity
AID systems are sophisticated technology. Current onboarding typically involves:
- Extensive training on pump operation
- CGM insertion and calibration education
- Carbohydrate counting instruction
- Algorithm setting configuration
- Multiple clinic visits
This is fine if you're at a specialized diabetes center with certified pump trainers and educators. It's not fine if you're at a busy primary care practice where the providers are managing hypertension, heart disease, and 47 other conditions and don't have hours to spend on pump training.
There are 6 million Americans with insulin-requiring type 2 diabetes. Most of them are not seen at specialized diabetes centers. If AID is going to reach them, the onboarding process needs to be radically simplified.
The Simplified Onboarding Trial (NCT07070830)
This is where the current trial comes in. Insulet - the company behind Omnipod - is conducting a feasibility study called "Feasibility of Simplified Onboarding in Adults With Type 2 Diabetes Using Automated Insulin Delivery."
The goal: figure out whether you can get people started on AID with minimal fuss.
The approach being tested involves the Omnipod M System - a pod (the pump), a controller, and a Dexcom G6 CGM. The trial is evaluating two starting approaches:
- One with a lower initial insulin dose
- One with a higher initial insulin dose
Both are designed to see whether simplified protocols can safely and effectively get patients started without the usual extensive training burden.
The bigger vision - teased in Insulet's public announcements - is something they're calling "Omnipod Fully Closed Loop for Type 2." The goal? An out-of-the-box system that requires zero carb counting, zero manual boluses, and minimal setup. Prescribe it, stick it on, walk away.
That's still aspirational, but this trial is laying the groundwork.
The Primary Care Problem
Most people with type 2 diabetes see their primary care provider for 15 minutes every few months. The provider is juggling hypertension, heart disease, and a dozen other conditions. There's no certified diabetes educator in the building. The nearest endocrinologist has a six-month wait.
In this environment, traditional insulin pump therapy is impossible - too much training, too much follow-up. So people stay on injections with suboptimal control, accumulating complications. If AID could be deployed like a medication - prescribe, give basic instructions, let technology handle the rest - it could reach millions more people.
What Success Would Look Like
Picture this: a primary care provider prescribes an AID system. The patient puts it on with a brief video's guidance. Over weeks, the algorithm learns their patterns. Glucose improves without carb counting or complex dosing. Next HbA1c: 7.2%. No specialist visit required.
The Bottom Line
Your pancreas does a lot more than you realize - until it stops working properly. For 6 million Americans with insulin-requiring type 2 diabetes, the current options are either complicated manual regimens or... complicated manual regimens.
Automated insulin delivery offers a third way: let the robots handle it. The technology exists. The evidence says it works. The remaining challenge is making it simple enough to actually deploy at scale.
That's what these trials are about. And if they succeed, the future of diabetes management might look a lot less like a full-time job and a lot more like something you can mostly forget about while living your life.
Which, honestly, sounds pretty nice.
Disclaimer: This blog post is for informational purposes only and does not constitute medical advice. Diabetes management should be personalized and supervised by qualified healthcare providers. The views expressed are those of the author. Images and graphics are for illustrative purposes only and do not depict actual medical devices, procedures, mechanisms, or research findings from the referenced studies.
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