Control-IQ Technology for High Insulin Users With Type 1 Diabetes (Higher-IQ)

April 1, 2025 updated by: Tandem Diabetes Care, Inc.
A prospective, single-arm study of 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ technology in individuals with type 1 diabetes who will plan to use at least one basal rate > 3 units/hr.

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

The objectives of the study are to assess safety and explore glycemic outcomes with use of an automated insulin dosing (AID) system (t:slim X2 insulin pump with Control-IQ technology v1.5) in adults with type 1 diabetes who will plan to use at least one basal rate > 3 units/hr. Up to 60 participants may be recruited.

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.
Interventional

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.
34

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

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
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
    • Utah
      • Sandy, Utah, United States, 84093
        • Diabetes & Endocrine Treatment Specialists

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥ 18 years
  • Diagnosis of type 1 diabetes for at least 1 year
  • Currently using an insulin pump (of any brand) for at least 3 months, and will plan to use at least one basal rate above 3 units/hr with the study pump
  • HbA1c < 10.5%
  • Weight ≤ 200 kg
  • Residing full-time in the United States, with no anticipated travel outside the United States during the period of study participation.
  • Participant has agreed to participate in the study; and has read, understood and signed the informed consent form (ICF); and has agreed to follow all study procedures, including suspending use of any personal CGM for the duration of the clinical trial once the study CGM is in use.
  • Willing to use only aspart (novolog) or lispro (humalog) insulin with the study pump, with no use of concentrated insulin above U-100, long-acting basal insulin injections, or inhaled insulin with the study pump.
  • Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one)
  • Willing and able to perform the study exercise and meal challenges.
  • Have a care partner, trained in hypoglycemia and hyperglycemia treatment guidelines, present during the challenges and until the next day.
  • Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including ability to respond to alerts and alarms, and to provide basic diabetes self-management.

Exclusion Criteria:

  • More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
  • More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
  • Inpatient psychiatric treatment in the past 6 months
  • History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study.
  • For Female: Currently pregnant or planning to become pregnant during the time period of study participation
  • Use of sulfonylureas, meglitinides or other medications specifically listed in protocol or determined by investigator to interfere with the study
  • Unstable dose of SGLT-2 inhibitor, GLP-1 receptor agonist, or DPP-4 inhibitor as listed in the protocol, or starting a new non-insulin glucose lowering or weight loss agent during the trial
  • Hemophilia or any other bleeding disorder
  • History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
  • History of allergic reaction to Humalog or Novolog
  • Use of glucocorticoids or other medications determined by investigator to interfere with study
  • Abnormal screening electrocardiogram consistent with increased risk during study exercise activities, such as arrhythmia, ischemia, or prolonged QTc interval. Investigator will review all electrocardiograms
  • Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
  • History of adrenal insufficiency
  • History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
  • History of gastroparesis
  • A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
  • Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
  • Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

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

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
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.
Experimental: t:slim X2 insulin pump with Control-IQ technology
Adults with type 1 diabetes will use the t:slim X2 insulin pump with Control-IQ technology 1.5 for 3-months of outpatient use. Meal and exercise challenges will be performed.
Device: t:slim X2 insulin pump with Control-IQ technology 1.5
t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.

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
Number of Severe Hypoglycemic Events
Time Frame: 3 months
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during the entire study period
3 months
Number of Diabetic Ketoacidosis Events
Time Frame: 3 months
Number of diabetic ketoacidosis events during the entire study period
3 months
Unanticipated Adverse Device Effects
Time Frame: 3 months
Number of unanticipated adverse device effects during the entire study period
3 months
Other Serious Adverse Events
Time Frame: 3 months
Number of serious adverse events during the entire study period
3 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
CGM Time <54 mg/dL Overall
Time Frame: 3 months
Percent time CGM glucose <54 mg/dL overall
3 months
CGM Time <54 mg/dL Daytime Only
Time Frame: 3 months
Percent time CGM glucose <54 mg/dL daytime only (06:00 - 24:00)
3 months
CGM Time <54 mg/dL Nighttime Only
Time Frame: 3 months
Percent time CGM glucose <54 mg/dL nighttime only (00:00 - 06:00)
3 months
CGM Time <70 mg/dL Overall
Time Frame: 3 months
Percent time CGM glucose <70 mg/dL overall
3 months
CGM Time <70 mg/dL Daytime Only
Time Frame: 3 months
Percent time CGM glucose <70 mg/dL daytime only (06:00 - 24:00)
3 months
CGM Time <70 mg/dL Nighttime Only
Time Frame: 3 months
Percent time CGM glucose <70 mg/dL nighttime only (00:00 - 06:00)
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Hemoglobin A1c
Time Frame: 3 months
Change in Hemoglobin A1c from baseline
3 months
CGM Time in Range 70-180 mg/dL Overall
Time Frame: 3 months
Percent time CGM glucose in range 70-180 mg/dl overall
3 months
CGM Time in Range 70-180 mg/dL Daytime Only
Time Frame: 3 months
Percent time CGM glucose in range 70-180 mg/dl daytime only (06:00 - 24:00)
3 months
CGM Time in Range 70-180 mg/dL Nighttime Only
Time Frame: 3 months
Percent time CGM glucose in range 70-180 mg/dl nighttime only (00:00 - 06:00)
3 months
CGM Time >180 mg/dL Overall
Time Frame: 3 months
Percent time CGM glucose> 180 mg/dL overall
3 months
CGM Time >180 mg/dL Daytime Only
Time Frame: 3 months
Percent time CGM glucose> 180 mg/dL daytime only (06:00 - 24:00)
3 months
CGM Time >180 mg/dL Nighttime Only
Time Frame: 3 months
Percent time CGM glucose> 180 mg/dL nighttime only (00:00 - 06:00)
3 months
CGM Time >250 mg/dL Overall
Time Frame: 3 months
Percent time CGM glucose >250 mg/dL overall
3 months
CGM Time >250 mg/dL Daytime Only
Time Frame: 3 months
Percent time CGM glucose >250 mg/dL daytime only (06:00 - 24:00)
3 months
CGM Time >250 mg/dL Nighttime Only
Time Frame: 3 months
Percent time CGM glucose >250 mg/dL nighttime only (00:00 - 06:00)
3 months
CGM Time in Range 70-140 mg/dL Overall
Time Frame: 3 months
Percent time CGM glucose in range 70-140 mg/dl overall
3 months
CGM Time in Range 70-140 mg/dL Daytime Only
Time Frame: 3 months
Percent time CGM glucose in range 70-140 mg/dl daytime only (06:00 - 24:00)
3 months
CGM Time in Range 70-140 mg/dL Nighttime Only
Time Frame: 3 months
Percent time CGM glucose in range 70-140 mg/dl nighttime only (00:00 - 06:00)
3 months
CGM Mean Glucose mg/dL Overall
Time Frame: 3 months
CGM-measured mean glucose (mg/dL) overall
3 months
CGM Mean Glucose mg/dL Daytime Only
Time Frame: 3 months
CGM-measured mean glucose (mg/dL) daytime only (06:00 - 24:00)
3 months
CGM Mean Glucose mg/dL Nighttime Only
Time Frame: 3 months
CGM-measured mean glucose (mg/dL) nighttime only (00:00 - 06:00)
3 months
Coefficient of Variation Overall
Time Frame: 3 months
CGM measured glucose variability measured with the coefficient of variation overall
3 months
Coefficient of Variation Daytime Only
Time Frame: 3 months
CGM measured glucose variability measured with the coefficient of variation daytime only (06:00 - 24:00)
3 months
Coefficient of Variation Nighttime Only
Time Frame: 3 months
CGM measured glucose variability measured with the coefficient of variation nighttime only (00:00 - 06:00)
3 months
Standard Deviation of Glucose, Overall
Time Frame: 3 months
CGM measured standard deviation of glucose (mg/dL) overall
3 months
Standard Deviation of Glucose, Daytime
Time Frame: 3 months
CGM measured standard deviation of glucose (mg/dL), daytime only (06:00 - 24:00)
3 months
Standard Deviation of Glucose, Nighttime Only
Time Frame: 3 months
CGM measured standard deviation of glucose (mg/dL), nighttime only (00:00 - 06:00)
3 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.

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.
  • Study Director: Jordan Pinsker, MD, Tandem Diabetes Care

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.
June 29, 2022

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.
January 6, 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.
January 6, 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).
June 13, 2022

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.
June 13, 2022

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.
June 16, 2022

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.
April 3, 2025

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.
April 1, 2025

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.
April 1, 2025

More Information

Terms related to this study

Keywords

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.
  • TP-0009856

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings