Automated Insulin Delivery for Type 1 Diabetes
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?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants initiate early use of an automated insulin delivery system using either Tandem Mobi or Tandem X2 for approximately 2 months
Follow-up
Participants are monitored for sustained use of the AID system and glycemic 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
Participants will choose an automated Insulin Device either Tandem Mobi or Tandem X2. The participants will use the device to initiate early pump usage. Participants will use pump for approximately 2 Months, but may vary slightly upon individual insurances. The dose of insulin will vary between patient to patient based on food intake. Participants will complete surveys regarding their perspectives and experiences with the study intervention.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator
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 ...
4.
investor.tandemdiabetes.com
investor.tandemdiabetes.com/news-releases/news-release-details/tandem-diabetes-care-announces-nejm-publication-positive-pivotalTandem 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+ ...
5.
adces.org
adces.org/education/danatech/insulin-pumps/find-and-compare-insulin-pumps/product-detail/tandem-mobiTandem 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 ...
7.
investor.tandemdiabetes.com
investor.tandemdiabetes.com/news-releases/news-release-details/tandem-mobi-improves-quality-life-people-living-type-1-diabetesTandem 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 ...
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