Status:
COMPLETED
Control-IQ Observational (CLIO) Post-Approval Study
Lead Sponsor:
Tandem Diabetes Care, Inc.
Collaborating Sponsors:
University of California, San Diego
Conditions:
Diabetes Mellitus, Type 1
Eligibility:
All Genders
6+ years
Brief Summary
Post-approval 522 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).
Detailed 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 hypo...
Eligibility Criteria
Inclusion
- Patients with self-reported type 1 diabetes who have been prescribed the Control-IQ system.
- At least 6 years of age
- Using Humalog or Novolog insulin
- For females, not pregnant or planning pregnancy in the next 12 months.
- Agreement to use the t:slim X2 with Control-IQ technology, and to continue use for at least 12 consecutive months after study enrollment.
- Agree to provide HbA1c result, obtained within the 6-month period prior to enrollment.
- Ability to respond to alerts and alarms, and to provide basic diabetes self-management.
- Patients who reside full-time in the United States.
- Willingness to download the t:connect Mobile application to their Smartphone and keep it active throughout the study. Patients unable to use t:connect Mobile application must be willing to manually upload their insulin pump data to t:connect every three months and at the completion of the study.
- Subject has read, understood and agreed to participate in the study, and has electronically signed the Informed Consent Form (ICF).
Exclusion
- Self-reported type 2 diabetes
- \< 6 years of age
- Use of any glucose-lowering therapy other than Humalog or Novolog insulin
- Inability to respond to alerts and alarms, or to provide basic diabetes self-management.
- Pregnancy
- Subjects who have not signed the ICF.
Key Trial Info
Start Date :
August 4 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 26 2023
Estimated Enrollment :
3157 Patients enrolled
Trial Details
Trial ID
NCT04503174
Start Date
August 4 2020
End Date
June 26 2023
Last Update
December 8 2023
Active Locations (1)
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1
Tandem Diabetes
San Diego, California, United States, 92121