Control-IQ Observational (CLIO) Post-Approval Study
Last updated on July 2021Recruitment
- Recruitment Status
- Enrolling by invitation
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Diabetes Mellitus - Type 1
- Design
- Observational Model: Case-ControlTime Perspective: Other
Participation Requirements
- Age
- Between 6 years and 125 years
- Gender
- Both males and females
Description
Post-approval study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system), by assessing the rate of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) during the first 12 months of use. Secondary endpoints...
Post-approval study designed to collect primarily safety data on the US FDA-cleared product, t:slim X2 insulin pump with Control-IQ technology (Control-IQ system), by assessing the rate of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) during the first 12 months of use. Secondary endpoints assessing the effectiveness of this product in real-world use by assessing the impact on patients' glycemic outcomes and user experience will also be collected. The Control-IQ system will be used as intended and in accordance with FDA-approved labeling.
Tracking Information
- NCT #
- NCT04503174
- Collaborators
- University of California, San Diego
- Investigators
- Principal Investigator: Betsy Dokken, NP,PhD Tandem Diabetes Care, Inc.
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