Join Ongoing Trials Investigating AID Systems for Type 2 Diabetes

While AID systems have been shown to increase time in range in type 1 diabetes, less is known about its benefits for type 2 diabetes. Here’s more on current clinical trials evaluating Control-IQ, MiniMed 780G, and Omnipod 5 AID systems for type 2 diabetes care. 

The benefits of automated insulin delivery (AID) systems – like less time in hyperglycemia and improved time in range – are well-recognized in people with type 1 diabetes. 

Not only do AID systems lessen the hassle of diabetes management, but the benefits extend across most age groups. AID systems have been documented in everyday use and also apply to users of DIY Loop systems. 

Research is beginning to identify the health benefits of AID during sleep and in pregnancy, too. 

However, less is known about how AID systems might affect glucose control in people with type 2 diabetes who use insulin. Studies are currently investigating three major commercial AID systems: 

• Control-IQ launched in January 2020 and was recently cleared for people ages 2 and up. Control-IQ was the first AID system with automatic correction boluses and no fingersticks. As of 2022, Control-IQ users are able to bolus from their smartphone. 

• MiniMed 780G was approved by the FDA in April 2023 for people ages 7 and up. As of 2023, the MiniMed 780G is covered by Medicare for people with type 1 diabetes. 

• Omnipod 5 launched in August 2022 for people ages 2 and up and is the first tubeless AID system. 

Control-IQ (2IQP) 

Clinical Trials Identifier: NCT05785832

Trial Name: A Randomized Trial Evaluating Control-IQ Technology in Adults With Type 2 Diabetes (2IQP)

Diabetes Type: Adults with type 2 diabetes on basal-bolus insulin therapy

Trial Sponsor: Tandem Diabetes Care

The trial aims to enroll 300 adults with type 2 diabetes, who will receive either Control-IQ or standard insulin delivery method plus a Dexcom G6 continuous glucose monitor (CGM) for 13 weeks. Researchers will measure changes in A1C, time in range, and CGM-measured hypoglycemia events. 

You may be eligible to participate if you:

• Are at least 18 years old and have had type 2 diabetes for at least six months 

• Use basal-bolus insulin therapy with at least one injection per day containing rapid-acting insulin or an insulin pump for at least three months, with no major changes to insulin treatment in the last three months (mixed insulin with a rapid component is acceptable)

• If you use other non-insulin glucose-lowering medications (like a GLP-1 receptor agonist or SGLT-2 inhibitor) or weight-reduction medications and your dose has been stable for the past three months 

• Are willing to participate in the study meals and exercise challenges if assigned to the AID group, and have a care partner trained in hypoglycemia treatment guidelines (including glucagon use) present during and immediately after exercise

You are not eligible to participate if you:

• Currently use an AID system 

• Are taking a sulfonylurea

See a full list of inclusion and exclusion criteria and study site locations here. 

MiniMed 780G

Clinical Trials Identifier: NCT05238142

Trial Name: In-Home Study With MiniMed 780G Pump Automated Control in Type 2-Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes

Diabetes Type: Adults with type 2 diabetes on basal-bolus insulin therapy

Trial Sponsor: Medtronic Diabetes

The trial aims to enroll 500 adults with type 2 diabetes, who will receive MiniMed 780G with the Guardian 4 or a disposable CGM sensor. The treatment period will last roughly four months, with researchers focused on measuring changes in A1C and time in range. 

You may be eligible to participate if you:

• Are at least 18 years old and have had type 2 diabetes for at least two years

• Are on basal-bolus insulin treatment, defined as at least two injections per day for at least three months, or insulin pump therapy with stable insulin treatment for the last three months 

• Have an A1C over 10% 

• Are willing to upload data from the study pump, and have Internet access, a computer system, or compatible smartphone for uploading 

• Are willing to take one of the following insulin injections:

  • Humalog (insulin lispro)

  • NovoLog/NovoRapid (insulin aspart)

  • Admelog (insulin lispro)

See a full list of inclusion and exclusion criteria and study site locations here. 

Omnipod 5 (SECURE-T2D)

Clinical Trials Identifier: NCT05815342

Trial Name: Safety and Efficacy of the Omnipod 5 Automated Insulin Delivery System in Adults With Type 2 Diabetes (SECURE-T2D)

Diabetes Type: Adults with type 2 diabetes who use insulin

Trial Sponsor: Insulet

The trial aims to enroll 400 adults with type 2 diabetes. All participants will wear the Omnipod 5 AID system with a Dexcom G6 CGM. The study will last about 15 weeks (3 months) and includes supervised exercise and meal challenges. Researchers will measure changes in A1C and time in range. 

You may be eligible to participate if you:

• Are at least 18 years old and have type 2 diabetes 

• Have been on either basal-bolus, basal only, or premix insulin for at least three months 

• Have an A1C greater than 12%. 

• Have had stable doses of other glucose-lowering or weight-loss medications for the past month 

• Are willing to take one of the following insulin injections:

• Humalog (insulin lispro)

• NovoLog/NovoRapid (insulin aspart)

• Admelog (insulin lispro)

People who have used an AID pump within the three months prior to the study are not eligible.

See a full list of inclusion and exclusion criteria and study site locations here.

Why are these trials important? 

Using diabetes technology increases the chances of achieving A1C goals in type 1 diabetes. 

There has been growing recognition of the benefits of CGM for people with type 2 diabetes on multiple daily injections of insulin. In fact, Medicare expanded CGM coverage for people with type 2 diabetes in March 2023. 

However, there has been little research on the use of AID systems among people with type 2 diabetes. Beyond improving glycemic control, AID systems have the potential to reduce the hassle of diabetes management by automating insulin delivery. 

These three studies will help researchers understand the safety and efficacy of AID systems in type 2 diabetes – and could lead to expanded approvals of this technology in the future. 

Future research may also identify people with type 2 diabetes who could benefit the most from AID systems. According to Dr. Georgia Davis, assistant professor at Emory University’s School of Medicine, AID may be especially helpful for people with type 2 diabetes who are hospitalized or who have end-stage kidney disease. 

Additionally, Davis noted that AID use in type 2 diabetes is associated with lower time above range without raising insulin needs or causing weight gain. 

Learn more about AID systems here: 

• FDA Clears Freestyle Libre 2 and 3 for Use With Automated Insulin Delivery

• New Recommendations on Automated Insulin Delivery

• Diet and Exercise with Automated Insulin Delivery