Phase
Condition
Diabetes Mellitus Types I And Ii
Diabetes Mellitus, Type 1
Diabetes And Hypertension
Treatment
Control-IQ Technology v1.5
Clinical Study ID
Ages 2-5 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Self-reported type 1 diabetes who have been prescribed the Control-IQ 1.5 system inthe t:slim X2 or Mobi insulin pump
Age 2 to <6 years at time of screening
Using an insulin approved for use in the pump
Using an iCGM sensor approved for use with the pump
Agreement to use Control-IQ technology 1.5, and to continue use for at least 12consecutive months after study enrollment.
Agree to provide HbA1c result, obtained within the 6-month period prior toenrollment.
Ability for parent/guardian to respond to alerts and alarms, and to provide basicdiabetes self-management.
Reside full-time in the United States.
Willingness to download the t:connect Mobile application to their smartphone andkeep it active throughout the study if using a Tandem t:slim X2 pump. Participantswho are unable to use the t:connect mobile application must be willing to manuallyupload their insulin pump data to Tandem Source every three months and at thecompletion of the study.
Participant's parent/guardian has read, understood and agreed to participate in thestudy, and has electronically signed the Informed Consent Form (ICF).
Exclusion
Exclusion Criteria:
Use of any glucose-lowering therapy other than insulin.
A medical or other condition, or medications being taken that in the investigator'sjudgement would be a safety concern for participation in the study.
Study Design
Study Description
Connect with a study center
Tandem Diabetes Care
San Diego, California 92130
United StatesSite Not Available
Tandem Diabetes Care
San Diego 5391811, California 5332921 92130
United StatesSite Not Available

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