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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04503174
Recruitment Status : Enrolling by invitation
First Posted : August 7, 2020
Last Update Posted : August 12, 2020
Sponsor:
Collaborator:
University of California, San Diego
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Diabetes Mellitus, Type 1 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.

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 2063 participants
Observational Model: Case-Control
Time Perspective: Other
Target Follow-Up Duration: 1 Year
Official Title: Control-IQ Observational (CLIO) Post-Approval Study
Actual Study Start Date : August 4, 2020
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Pump Naiive
New to insulin pump use
Device: t:slim X2 pump with Control-IQ technology
Real-world use

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

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




Primary Outcome Measures :
  1. Incidence rates of severe hypoglycemia (SH) and diabetic ketoacidosis (DKA) [ Time Frame: 12 months ]
    Overall incidence rate of X events per 100 patient years

  2. Safety of the automatic population of CGM readings into the bolus calculator of the Control-IQ system [ Time Frame: 12 months ]
    Correlating the incidence of AE with the use of the calculator and associated CGM readings.


Secondary Outcome Measures :
  1. Glycemic Outcomes as a measure of efficacy of the Control-IQ system [ Time Frame: 12 months ]
    means/medians as appropriate based on the data extracted

  2. Patient-reported satisfaction with and trust in the Control-IQ system, usability of the system, and sleep quality [ Time Frame: 12 months ]
    means/medians as appropriate based on the data extracted



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04503174


Locations
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United States, California
Tandem Diabetes
San Diego, California, United States, 92121
Sponsors and Collaborators
Tandem Diabetes Care, Inc.
University of California, San Diego
Investigators
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Principal Investigator: Betsy Dokken, NP,PhD Tandem Diabetes Care, Inc.
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Responsible Party: Tandem Diabetes Care, Inc.
ClinicalTrials.gov Identifier: NCT04503174    
Other Study ID Numbers: CLIO Study
First Posted: August 7, 2020    Key Record Dates
Last Update Posted: August 12, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Pediatric Postmarket Surveillance of a Device Product: Yes
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases