Control-IQ Observational (CLIO) Post-Approval Study

Control-IQ Observational (CLIO) Post-Approval Study

Sponsors

Lead Sponsor: Tandem Diabetes Care, Inc.

Collaborator: University of California, San Diego

Source Tandem Diabetes Care, Inc.
Brief 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).

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 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.

Overall Status Enrolling by invitation
Start Date August 4, 2020
Completion Date December 31, 2021
Primary Completion Date September 30, 2021
Study Type Observational [Patient Registry]
Primary Outcome
Measure Time Frame
Incidence rates of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) 12 months
Safety of the automatic population of CGM readings into the bolus calculator of the Control-IQ system 12 months
Secondary Outcome
Measure Time Frame
Glycemic Outcomes as a measure of efficacy of the Control-IQ system 12 months
Patient-reported satisfaction with and trust in the Control-IQ system, usability of the system, and sleep quality 12 months
Enrollment 2063
Condition
Intervention

Intervention Type: Device

Intervention Name: t:slim X2 pump with Control-IQ technology

Description: Real-world use

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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 3-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.

Gender: All

Minimum Age: 6 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Betsy Dokken, NP,PhD Principal Investigator Tandem Diabetes Care, Inc.
Location
Facility: Tandem Diabetes
Location Countries

United States

Verification Date

August 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Pump Naiive

Description: New to insulin pump use

Label: 6-13 YO

Description: Subjects between the age of 6-13 years old.

Label: 14-17 YO

Description: Subjects between the age of 14-17 years old.

Label: Adults (18+)

Description: Subjects are 18 years old and older.

Label: CGM Naiive

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

Label: 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.

Label: 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.

Acronym CLIO
Patient Data No
Study Design Info

Observational Model: Case-Control

Time Perspective: Other

Source: ClinicalTrials.gov