Clinical trial NCT04503174: Control-IQ Observational (CLIO) Post-Approval Study
Official title: Control-IQ Observational (CLIO) Post-Approval Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: Tandem Diabetes Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of California, San Diego
First posted: 2020-08-07
Enrollment: 3157
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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).

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.

Eligibility 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 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.

Primary outcomes:
measure: Incidence Rates of Severe Hypoglycemia (SH)
timeFrame: 12 months
measure: Incidence Rates of Diabetic Ketoacidosis (DKA)
timeFrame: 12 months
measure: Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature
timeFrame: 12 months
Secondary outcomes:
measure: Percent Time in Range 70 - 180 mg/dL
timeFrame: 12 months
measure: Percent Time Greater Than 180 mg/dL
timeFrame: 12 months
measure: Percent Time Greater Than 250 mg/dL
timeFrame: 12 months
measure: Percent Time Less Than 70 mg/dL
timeFrame: 12 months
measure: Percent Time Less Than 54 mg/dL
timeFrame: 12 months
measure: Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score
timeFrame: 12 months
measure: Diabetes Impact and Satisfaction Scale (DIDS), Impact Score
timeFrame: 12 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Tandem Diabetes
state: California
Study officials:
affiliation: Tandem Diabetes Care, Inc.
name: Jordan Pinsker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2024 Jan;26(1):24-32. doi: 10.1089/dia.2023.0341. Epub 2023 Oct 26.