A Randomized Trial Evaluating the Efficacy and Safety of Control-IQ Technology in Adults with Type 2 Diabetes Using Basal-Bolus Insulin Therapy (2IQP)

Brief description of study

If you have type 2 diabetes and use short and long acting insulin then we would love to talk to you!

The study is being done to learn if an automated insulin delivery (AID) system can safely control blood sugar in people with type 2 diabetes. We will refer to this as the AID system. The study AID system is made by Tandem Diabetes Care. It is called t:slim X2 with Control-IQ technology. An AID system is sometimes referred to as an artificial pancreas or closed-loop system. The system includes an insulin pump, a continuous glucose monitor (CGM), and a computer program. The CGM measures your sugar level. It sends this information to the pump. A computer program on the pump determines how much insulin should be given. Usually, if your sugar level is going up, the insulin pump will increase the amount of insulin you get. And, if your sugar level is going down, it will decrease the amount of insulin you get.

An earlier version of the study AID system is approved by the Food and Drug Administration (FDA) and Health Canada for use in people with type 1 diabetes. However, the version for this study is not approved by the FDA. For this reason, it is called experimental or investigational, in this study. It is hoped that the results of this study will lead to FDA approval for its use in people with type 2 diabetes to help them manage their condition.

Detailed description of study

You will be asked to be in the study for about 3-4 months. The study includes two parts, described below.

1. You will have a visit to determine if you are eligible to be in the study. If yes, you will start using a continuous glucose monitor (CGM) for about 3 weeks.

2. Then you will start the main part of the study. This will last 3 months. In this part, you will either use the study AID system, or use the study CGM plus continue receiving insulin the same way you usually do.

The most likely risks to you are pain, bruising, redness and temporary discomfort from blood draws, fingersticks, CGM sensor insertions, or infusion set insertions. Although unlikely, it is possible that the system could deliver too much or too little insulin. This could result in low blood sugar or high blood sugar. In rare cases, this could be serious.

The possible benefit is better blood sugar control while you are in the study. You may not benefit from this study. The information gained from the study may help people with type 2 diabetes in the future.

If you do not participate, you may choose to continue your current diabetes treatment or talk to your doctor about other options.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
In person and virtual visits for persons with type 2 diabetes using short and long acting insulin or an insulin pump
Age: Between 18 Years - 99 Years
Gender: All

Inclusion Criteria:

· At least 18 years of age.

· Using short and long-acting insulin therapy via injections or using an insulin pump both

on a stable insulin regimen for at least 3 months.

· Currently resides in the U.S. or Canada with the ability to complete in-person study visits.

· Diagnosis of type 2 diabetes of at least 6 months’ duration.

· On a stable dose of non-insulin glucose-lowering medications or weight-reduction

medications for at least 3 months.

· Willing to participate in meal and exercise challenges if assigned to the intervention group.

Exclusion Criteria:

· Current use of hybrid closed-loop system.

· Current use of systemic glucocorticoids or anticipated use of glucocorticoids during the RCT (topical or inhaled -ie, non-systemic is acceptable).

· Current use of sulfonylurea or meglitinide medications.

· Current use of hydroxyurea.

· Tape allergy or skin condition that will preclude use of the study pump or CGM.

· Pregnant (positive urine hCG), breast feeding, plan to become pregnant during the study

period, or sexually active without use of accepted contraceptive measures.

· Current participation in another diabetes-related interventional clinical trial.

· Travel for more than 7 days at a time during study participation.

Updated on 09 Mar 2024. Study ID: 853482

You have contacted , on

Your message has been sent to the study team at ,

A copy of the message has been sent to your email

What happens next?

You can expect the study team to contact you via email or phone in the next few days.
Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

By sending a message, I agree that my data will be sent to a representative for the selected site and processed in accordance with this website's Privacy Policy (see link in footer).