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

December 6, 2023 updated by: Tandem Diabetes Care, Inc.
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3157

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence Rates of Severe Hypoglycemia (SH)
Time Frame: 12 months
Overall incidence rate of events per 100 patient years
12 months
Incidence Rates of Diabetic Ketoacidosis (DKA)
Time Frame: 12 months
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
Time Frame: 12 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percent Time in Range 70 - 180 mg/dL
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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
Time Frame: 12 months
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tandem Diabetes Care, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, San Diego

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jordan Pinsker, MD, Tandem Diabetes Care, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 4, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 2, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 26, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 3, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 3, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 7, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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