Control-IQ Observational (CLIO) Post-Approval Study (CLIO)

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).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: t:slim X2 pump with Control-IQ technology

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.

• Study Type: Observational
• Enrollment (Actual): 3157

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States, 92121
      • Tandem Diabetes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All subjects who start therapy with the Control-IQ System once the study is approved to start, that meet the indications for use and the study eligibility criteria.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

7

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
6-13 YO; Subjects between the age of 6-13 years old.	Device: t:slim X2 pump with Control-IQ technology; Real-world use
14-17 YO; Subjects between the age of 14-17 years old.	Device: t:slim X2 pump with Control-IQ technology; Real-world use
Adults (18+); Subjects are 18 years old and older.	Device: t:slim X2 pump with Control-IQ technology; Real-world use
HbA1c more than or equal to 8.5%; Subjects have an HbA1c of more than or equal to 8.5% in the 3 months prior to enrollment.	Device: t:slim X2 pump with Control-IQ technology; Real-world use
HbA1c less than or equal to 8.5%; Subjects have an HbA1c of less than or equal to 8.5% in the 3 months prior to enrollment.	Device: t:slim X2 pump with Control-IQ technology; Real-world use
Pump Naive; New to insulin pump use	Device: t:slim X2 pump with Control-IQ technology; Real-world use
CGM Naive; Subjects have not used CGM in the 30 days prior to enrollment.	Device: t:slim X2 pump with Control-IQ technology; Real-world use

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence Rates of Severe Hypoglycemia (SH)	Overall incidence rate of events per 100 patient years	12 months
Incidence Rates of Diabetic Ketoacidosis (DKA)	Overall incidence rate of events per 100 patient years	12 months
Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature	Percent of boluses using the auto population feature resulting in at least one reading less than 70 mg/dL than those not using the feature, in every pre-bolus glucose range examined.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Time in Range 70 - 180 mg/dL	CGM measured percent time in range 70 - 180 mg/dL during 12 months of Control-IQ use	12 months
Percent Time Greater Than 180 mg/dL	CGM measured percent time greater than 180 mg/dL during 12 months of Control-IQ use	12 months
Percent Time Greater Than 250 mg/dL	CGM measured percent time greater than 250 mg/dL during 12 months of Control-IQ use	12 months
Percent Time Less Than 70 mg/dL	CGM measured percent time less than 70 mg/dL during 12 months of Control-IQ use	12 months
Percent Time Less Than 54 mg/dL	CGM measured percent time less than 54 mg/dL during 12 months of Control-IQ use	12 months
Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score	DIDS satisfaction score after 12 months of Control-IQ use. Score range from 0-10 with higher scores indicating better outcome.	12 months
Diabetes Impact and Satisfaction Scale (DIDS), Impact Score	DIDS impact score after 12 months of Control-IQ use. Score range from 0 -10 with lower scores indicating better outcome.	12 months

Collaborators and Investigators

• Sponsor: Tandem Diabetes Care, Inc.
• Collaborators: University of California, San Diego
• Investigators: Principal Investigator: Jordan Pinsker, MD, Tandem Diabetes Care, Inc.

Publications and helpful links

General Publications

• Graham R, Mueller L, Manning M, Habif S, Messer LH, Pinsker JE, Aronoff-Spencer E. Real-World Use of Control-IQ Technology is Associated with a Lower Rate of Severe Hypoglycemia and Diabetic Ketoacidosis Than Historical Data: Results of the Control-IQ Observational (CLIO) Prospective Study. Diabetes Technol Ther. 2023 Oct 26. doi: 10.1089/dia.2023.0341. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 4, 2020
• Primary Completion (Actual): June 2, 2023
• Study Completion (Actual): June 26, 2023

Study Registration Dates

• First Submitted: August 3, 2020
• First Submitted That Met QC Criteria: August 3, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): December 8, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CLIO Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes