Control-IQ Technology for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
The trial aims to gather safety data on Control-IQ technology v1.5 for young children with type 1 diabetes. Participants will use this technology, which manages insulin levels, for 12 months in a real-world setting. It is designed for children who have type 1 diabetes, already use the Control-IQ system with an insulin pump, and live in the United States. This study is crucial for understanding how well this technology functions for young children in their everyday lives. As an unphased trial, it offers participants a unique opportunity to contribute to research that could enhance diabetes management for young children.
Do I have to stop taking my current medications for the trial?
The trial requires that participants only use insulin as their glucose-lowering therapy. If you are taking other glucose-lowering medications, you would need to stop them to participate.
What is the safety track record for Control-IQ Technology v1.5?
Research has shown that Control-IQ technology is generally easy to use and safe. In earlier studies, researchers examined key safety issues such as severe low blood sugar and ketoacidosis, a serious condition that occurs when blood sugar is too high and insulin is insufficient. The results indicated these issues were rare with Control-IQ 1.5.
The FDA has already approved Control-IQ for managing diabetes, confirming its safety for various groups. It is important to keep the pump away from extreme temperatures, as this can affect the insulin.
Overall, evidence suggests Control-IQ technology is safe when used correctly and monitored. Always follow healthcare provider advice when using new technology.12345Why are researchers excited about this trial?
Control-IQ Technology v1.5 is unique because it represents an advanced algorithm designed to manage insulin delivery for people with diabetes. Unlike traditional insulin pumps, which require manual adjustments, Control-IQ technology automates and optimizes insulin dosing based on real-time glucose monitoring. This smart system aims to maintain glucose levels within a target range more effectively, reducing the risk of both high and low blood sugar episodes. Researchers are excited about this technology because it promises to improve quality of life and provide more freedom for individuals managing diabetes.
What evidence suggests that Control-IQ Technology v1.5 is effective for children with type 1 diabetes?
Research shows that Control-IQ Technology helps people with diabetes manage their blood sugar more effectively. In one study, users maintained their blood sugar in the healthy range more often, increasing from 63.6% to 73.6% over a year, indicating more stable blood sugar levels. Other findings indicate that Control-IQ reduces high blood sugar episodes and increases user satisfaction with the device. This trial will evaluate the real-world use of Control-IQ Technology v1.5 over 12 months, and these results suggest it might also be effective for young children with type 1 diabetes.678910
Who Is on the Research Team?
Jordan Pinsker, MD
Principal Investigator
Chief Medical Officer, Tandem Diabetes Care
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants use Control-IQ technology v1.5 in a real-world setting
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Control-IQ Technology v1.5
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Real-world use of Control-IQ technology v1.5 for 12 months.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Tandem Diabetes Care, Inc.
Lead Sponsor
University of California, San Diego
Collaborator
Citations
One Year Real-World Use of the Control-IQ Advanced ...
At baseline, median percent time in range (70–180 mg/dL) was 63.6 (IQR: 49.9%–75.6%) and increased to 73.6% (IQR: 64.4%–81.8%) for the 12 months of Control-IQ ...
Control-IQ Technology Improves Time Above Range for ...
Control-IQ technology showed significant glycemic improvements, increased device satisfaction, and clinically valuable improvements in hyperglycemia and time ...
Control-IQ Technology Use in Individuals With High Insulin ...
Control-IQ 1.5 allows wider weight/TDI input, removes 3 unit/h basal clipping, and supports temporary basal rates and extended boluses.
4.
diabetesjournals.org
diabetesjournals.org/clinical/article/42/1/116/153543/Beneficial-Effects-of-Control-IQ-Automated-InsulinBeneficial Effects of Control-IQ Automated Insulin Delivery in ...
Thirty adults with type 2 diabetes using the Control-IQ system showed substantial glycemic improvement with no increase in hypoglycemia.
Assessing the Impact of Control-IQ Technology
The study team will compare patient reported outcomes, measures of glycemic control, and measures of insulin pump management pre and 16 weeks post-initiation of ...
t:slim X2 Insulin Pump with Control-IQ Technology
AVOID exposure of your pump to temperatures below 40°F (5°C) or above 99°F (37°C). Insulin can freeze at low temperatures or degrade at high temperatures.
den190034 summary - accessdata.fda.gov
Control-IQ is a software device for diabetes that controls insulin delivery based on CGM and user input, predicting glucose levels to adjust insulin.
PS230005 Control-IQ 1.5 Post-Approval Study
This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ ...
PS230005 Control-IQ 1.5 Post-Approval Study
This 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ ...
A 510(k) Number K232382 B Applicant Tand
The key safety outcomes were severe hypoglycemia and ketoacidosis. In this phase the standard care group switched over to use of Control-IQ 1.5. The data used ...
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