Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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

Key facts

Study ID

NCT04084171

Run by

University of Virginia

People needed

12

Starts

2019-09-26

Expected to finish

2019-10-23

Last updated by the study team

2023-03-22

Who can join

Age: 2 and older, up to 6. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Stanford University — Stanford, California, United States
• Barbara Davis Center, University of Colorado — Aurora, Colorado, United States
• University of Virginia Center for Diabetes Technology — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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