Phase
Condition
Diabetes Mellitus, Type 1
Diabetes Mellitus Types I And Ii
Diabetes And Hypertension
Treatment
CLC + BAM
CLC + ABC
Clinical Study ID
Ages 18-70 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Age ≥18.0 and ≤70 years old at time of consent
Clinical diagnosis, based on investigator assessment, of type 1 diabetes for atleast one year
Currently using an insulin pump for at least six months
Currently using insulin for at least six months
Currently using the t:slim X2 insulin pump for at least two months
Currently using or anticipated to be using the t:slim X2 insulin pump withControl-IQ technology at randomization (Visit 3).
Using or willing to use insulin parameters such as carbohydrate ratio and correctionfactors consistently on their pump in order to dose insulin for meals or corrections
Access to internet and willingness to upload data during the study as needed
Willing to use an app on a smart phone during the study.
For females, not currently known to be pregnant or breastfeeding
If female, sexually active, and of childbearing potential, must agree to use a formof contraception to prevent pregnancy while a participant in the study. A negativeserum or urine pregnancy test will be required for all females of childbearingpotential. Participants who become pregnant will be discontinued from the study.Also, participants who during the study develop and express the intention to becomepregnant within the timespan of the study will be discontinued.
Willingness to use only insulin analogs approved for use in the t:slim X2 pump suchas lispro (Humalog) or as part (Novolog) and not use ultra-rapid acting insulinanalogs (e.g., FiAsp) during the study
Total daily insulin dose (TDD) at least 10 units per day
Willingness not to start any new non-insulin glucose-lowering agent during thecourse of the trial (including metformin (biguanides), GLP-1 receptor agonists,pramlintide, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas)
An understanding and willingness to follow the protocol and signed informed consent
Exclusion
Exclusion Criteria:
Concurrent use of any non-insulin glucose-lowering agent other than metformin orGLP-1 receptor agonists following screening (including pramlintide, DPP-4inhibitors, SGLT-2 inhibitors, sulfonylureas)
A condition, which in the opinion of the investigator or designee, would put theparticipant at risk or interfere with the completion of the protocol.
History of diabetic ketoacidosis (DKA) in the 12 months prior to enrollment
Severe hypoglycemia resulting in seizure or loss of consciousness in the 12 monthsprior to enrollment
Currently being treated for a seizure disorder
Hemophilia or any other bleeding disorder
Planned surgery during study duration
Participation in another pharmaceutical or device trial at the time of enrollment orduring the study
Having a direct supervisor at place of employment who is also directly involved inconducting the clinical trial (e.g., study investigator, coordinator, etc.); orhaving a first-degree relative who is directly involved in conducting the clinicaltrial.
Study Design
Study Description
Connect with a study center
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia 22903
United StatesSite Not Available

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