Status:
COMPLETED
Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6
Lead Sponsor:
University of Virginia
Collaborating Sponsors:
DexCom, Inc.
Tandem Diabetes Care, Inc.
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
2-6 years
Phase:
NA
Brief Summary
A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition
Detailed Description
This clinical trial aims to demonstrate the safety of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named t:slim X2 with Control-IQ Technology and assess usability in a supervi...
Eligibility Criteria
Inclusion
- Age ≥ 2 and \< 6 years old at the time of consent
- Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months and using insulin at the time of enrollment
- Use of an insulin pump in the past 3 months
- Use of Dexcom G6 for at least 11 out of the last 14 days
- Parent/guardian(s) have familiarity with and use of carbohydrate ratios for meal boluses
- Living with one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff
- At least one parent/guardian is willing to stay with the child during the hotel/house portion of the study on the dates selected by the study team
- Investigator has confidence that the parent/guardian(s) 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 already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study
- Total daily insulin dose (TDD) of at least 5 U/day
- Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
- Child participant and parent/guardian(s) willingness to participate in all training sessions as directed by study staff
- Willingness to discontinue non-Tandem t:slim insulin pumps during the entire study
- Willingness to wear a Dexcom G6 sensor during the entire study
- An understanding and willingness to follow the protocol and sign informed consent
Exclusion
- Hypoglycemia induced seizure or loss of consciousness in the past 3 months
- Diabetes Ketoacidosis in the past 3 months
- Use of diluted insulin
- Concurrent use of any non-insulin glucose-lowering agent
- Hemophilia or any other bleeding disorder
- A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. These conditions may include:
- Acute illness at the time of the enrollment visit (fever of 101 or higher, vomiting, diarrhea)
- Addison's disease
- Diagnosed at less than 1 year of age without positive antibodies
- Decreased renal function
- Cystic fibrosis
- Other chronic conditions, such as an underlying seizure disorder
- Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
- Having a family member(s) employed by Tandem Diabetes Care, 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 :
September 26 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 23 2019
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT04084171
Start Date
September 26 2019
End Date
October 23 2019
Last Update
March 22 2023
Active Locations (3)
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1
Stanford University
Stanford, California, United States, 94304
2
Barbara Davis Center, University of Colorado
Aurora, Colorado, United States, 80045
3
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903