This study is in progress, not accepting new patients

Control-IQ Observational (CLIO) Post-Approval Study

a study on Diabetes Diabetes Type 1

Summary

Eligibility
for people ages 6 years and up (full criteria)
Location
at San Diego, California
Dates
study started
estimated completion

Description

Summary

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).

Details

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.

Keywords

Diabetes Mellitus, Type 1, Type 1 Diabetes Mellitus, Pump Naiive, CGM Naiive

Eligibility

You can join if…

Open to people ages 6 years and up

  • 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).

You CAN'T join if...

  • 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.

Location

  • Tandem Diabetes
    San Diego California 92121 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Tandem Diabetes Care, Inc.
ID
NCT04503174
Study Type
Observational [Patient Registry]
Participants
Expecting 2063 study participants
Last Updated