Status:
COMPLETED
The Pediatric Artificial Pancreas Automated Initialization Trial
Lead Sponsor:
Marc Breton
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Jaeb Center for Health Research
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
2-5 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) with perio...
Detailed Description
In this single-arm pilot study of an AI Advisor-driven closed loop system initiation and parameter adaptation in youth age 2 to \<6 years old, participants will use the Tandem t:slim X2 with Control-I...
Eligibility Criteria
Inclusion
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 1 month
- Familiarity and use of a carbohydrate ratio for meal boluses
- Age ≥2 and \<6 years old
- Using a Dexcom CGM at the time of enrollment, with use on at least 21 out of the prior 28 days
- Living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff
- Parent/guardian has a phone that can run the Tandem t:connect Mobile App (typically Android 10 or above or iPhone Operating System (iOS) 15 or above)
- Willingness to use the t:connect Mobile App as needed during the study and ensure connectivity for a data upload at least once per day
- Investigator has confidence that the parent can successfully operate all study devices and is capable of adhering to the protocol
- Willingness to switch to lispro (Humalog) or aspart (Novolog) if not using already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study for participants using a study162 provided Tandem pump during the study
- Total daily insulin dose (TDD) at least 5 Units/day
- Body weight at least 20 pounds (lbs)
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
- Participant and parent(s)/guardian(s) willingness to participate in all training sessions as directed by study staff
- Parent/guardian proficient in reading and writing English
- Live in the United States, with no plans to move outside the United States during the study period
Exclusion
- Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
- Hemophilia or any other bleeding disorder
- History of \>1 severe hypoglycemic event with seizure or loss of consciousness in the last 3 months
- History of \>1 diabetic ketoacidosis (DKA) event in the last 6 months not related to illness, infusion set failure, or initial diagnosis
- History of chronic renal disease or currently on hemodialysis
- History of adrenal insufficiency
- Hypothyroidism that is not adequately treated in the opinion of the investigator
- Use of oral or injectable steroids within the last 8 weeks
- Known, ongoing adhesive intolerance
- Plans to receive blood transfusions or erythropoietin injections during the course of the study
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study
- Having immediate family members employed by Tandem Diabetes Care, Inc. or Dexcom, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Key Trial Info
Start Date :
November 10 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 17 2024
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT06017089
Start Date
November 10 2023
End Date
June 17 2024
Last Update
September 15 2025
Active Locations (3)
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1
Stanford University
Stanford, California, United States, 94305
2
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States, 80045
3
University of Virginia
Charlottesville, Virginia, United States, 22903