Control-IQ Observational (CLIO) Post-Approval Study

Tandem Diabetes Care

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: t:slim X2 pump with Control-IQ technology

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04503174

CLIO Study

Details and patient eligibility

About

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).

Full 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 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.

Enrollment: 3,157 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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.

Trial design

3,157 participants in 7 patient groups

Pump Naive

Description:

New to insulin pump use

Treatment:

Device: t:slim X2 pump with Control-IQ technology

6-13 YO

Description:

Subjects between the age of 6-13 years old.

Treatment:

Device: t:slim X2 pump with Control-IQ technology

14-17 YO

Description:

Subjects between the age of 14-17 years old.

Treatment:

Device: t:slim X2 pump with Control-IQ technology

Adults (18+)

Description:

Subjects are 18 years old and older.

Treatment:

Device: t:slim X2 pump with Control-IQ technology

CGM Naive

Description:

Subjects have not used CGM in the 30 days prior to enrollment.

Treatment:

Device: t:slim X2 pump with Control-IQ technology

HbA1c more than or equal to 8.5%

Description:

Subjects have an HbA1c of more than or equal to 8.5% in the 3 months prior to enrollment.

Treatment:

Device: t:slim X2 pump with Control-IQ technology

HbA1c less than or equal to 8.5%

Description:

Subjects have an HbA1c of less than or equal to 8.5% in the 3 months prior to enrollment.

Treatment:

Device: t:slim X2 pump with Control-IQ technology