Control-IQ Observational (CLIO) Post-Approval Study

Diabetes Mellitus, Type 1 Clinical Trial

— CLIO  

Official title:

Control-IQ Observational (CLIO) Post-Approval Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04503174
• Other study ID #: CLIO Study
• Status: Completed
• Start date: August 4, 2020
• Est. completion date: June 26, 2023

Study information

• Verified date: December 2023
• Source: Tandem Diabetes Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3157
• Est. completion date: June 26, 2023
• Est. primary completion date: June 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1

Intervention

Device:
• t:slim X2 pump with Control-IQ technology
Real-world use

Locations

Country	Name	City	State
United States	Tandem Diabetes	San Diego	California

Sponsors (2)

Lead Sponsor	Collaborator
Tandem Diabetes Care, Inc.	University of California, San Diego

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 Obs — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence Rates of Severe Hypoglycemia (SH)	Overall incidence rate of events per 100 patient years	12 months
Primary	Incidence Rates of Diabetic Ketoacidosis (DKA)	Overall incidence rate of events per 100 patient years	12 months
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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