Automated Insulin Delivery for Type 1 Diabetes

Age: < 65
Sex: Any
Trial Phase: Academic
Sponsor: Stanford University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how automated insulin delivery (AID) systems can help manage Type 1 diabetes in children. The researchers aim to determine if early use of these systems can improve blood sugar control and simplify life for patients. Participants will use a Tandem Automated Insulin Delivery System, which includes an insulin pump, and will share their experiences through surveys. This trial is ideal for those diagnosed with Type 1 diabetes in the last two weeks who plan to receive care at Stanford Children's Pediatric Diabetes Clinic. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could simplify diabetes management for children.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this automated insulin delivery system is safe for use in managing Type 1 diabetes?

Research has shown that the Tandem Automated Insulin Delivery System is safe for people with type 1 diabetes. One study found that the Tandem t:slim X2 insulin pump, a component of this system, is safe for young children, suggesting it is likely safe for other age groups as well. Another review found that the Tandem Mobi system enhances users' quality of life and is well-received. Overall, this system predicts blood sugar levels and automatically adjusts insulin delivery, simplifying and improving the safety of diabetes management.12345

Why are researchers excited about this trial?

Researchers are excited about the Tandem Automated Insulin Delivery System for Type 1 Diabetes because it offers a more personalized approach to managing blood sugar levels. Unlike traditional insulin pumps, this system automatically adjusts insulin delivery based on real-time glucose readings, potentially reducing the burden of constant monitoring. This hands-free feature could lead to improved blood sugar control and a better quality of life for users. Additionally, the ability for users to choose between devices like the Tandem Mobi or Tandem X2 provides flexibility to match individual needs and preferences.

What evidence suggests that the Tandem Automated Insulin Delivery System is effective for Type 1 diabetes?

Research has shown that the Tandem Automated Insulin Delivery System, which includes the Tandem Mobi and t:slim X2 pumps, effectively manages type 1 diabetes. In this trial, participants will choose either the Tandem Mobi or Tandem X2 pump to begin early pump usage. Studies have found that these devices control blood sugar by predicting glucose levels 30 minutes in advance and automatically adjusting insulin delivery. Users have reported spending more time with their blood sugar in a healthy range and experiencing lower hemoglobin A1c levels, which measure average blood sugar over time. The system also maintains low rates of hypoglycemia (very low blood sugar) from the first day of use. Overall, the Tandem system simplifies and enhances diabetes management.12567

Who Is on the Research Team?

DM

David Maahs, MD, PhD

Principal Investigator

Stanford University

Are You a Good Fit for This Trial?

This trial is for children and teens who have been diagnosed with type 1 diabetes in the past two weeks and plan to receive care at Stanford Children's Pediatric Diabetes Clinic.

Inclusion Criteria

I was diagnosed with type 1 diabetes in the last 2 weeks.
* intent to follow at Stanford Children's Pediatric Diabetes Clinic for clinical care

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants initiate early use of an automated insulin delivery system using either Tandem Mobi or Tandem X2 for approximately 2 months

8 weeks
Regular visits for device monitoring and insulin dose adjustments

Follow-up

Participants are monitored for sustained use of the AID system and glycemic outcomes

1 year
Periodic follow-up visits to assess long-term use and outcomes

What Are the Treatments Tested in This Trial?

Interventions

  • Tandem Automated Insulin Delivery System

Trial Overview

The study is testing an automated insulin delivery (AID) system called the Tandem AID System, which automatically adjusts insulin levels. The goal is to see how well early use of this technology helps manage blood sugar in newly diagnosed patients.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Tandem Insulin PumpExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials
2,527
Recruited
17,430,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Citations

An overview of the t:slim X2 and Mobi insulin pumps ... - PMC

This review will cover Tandem Control IQ AID technology and the Tandem t:slim X2 and Tandem Mobi insulin pumps including their physical features and function, ...

Clinical Evidence | Tandem Diabetes Care

2024 - Patient reported outcomes (PROs) and user experiences of young children with type 1 diabetes using t:slim X2 insulin pump with Control-IQ technology.

Tandem Mobi Automated Insulin Delivery System

The Tandem Mobi system is powered by Control‑IQ+ technology, which uses CGM sensor* values to predict glucose levels 30 minutes ahead and automatically adjust ...

Tandem Diabetes Care Announces NEJM Publication of ...

Results published in NEJM demonstrate significant improvements in time in range and hemoglobin A1c (A1C) in people with type 2 diabetes when using Control-IQ+ ...

Tandem Mobi - Insulin Pumps l t:slim X2 Control

Tandem Mobi is an automated insulin pump with a hybrid closed-loop system. Predicts 30 minutes ahead and can decrease, stop or increase insulin delivery.

Safety and Psychological Outcomes of Tandem t:Slim X2 ...

Finally, evidence from the literature shows that this system is safe and effective in improving psychological personal outcomes. Even if further ...

Tandem Mobi Improves Quality of Life for People Living With ...

The survey found that 86 percent of participants were satisfied or very satisfied with Tandem Mobi regardless of prior therapy and agreed that Tandem Mobi ...