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Type 1 DiabetesNCT05422053

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

A study of Type 1 Diabetes, run by Tandem Diabetes Care, Inc. at 4 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
4 sitesUnited States
Study dates
29 Jun 2022to 6 Jan 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Barbara Davis Center

    Aurora, Colorado, 80045

  • Rocky Mountain Diabetes Center

    Idaho Falls, Idaho, 83404

  • International Diabetes Center

    Minneapolis, Minnesota, 55416

  • Diabetes & Endocrine Treatment Specialists

    Sandy City, Utah, 84093

Other trials in United States

About this study

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.

Read the 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.

Conditions
Type 1 Diabetes
Being tested
t:slim X2 insulin pump with Control-IQ technology 1.5
Keywords
Control-IQ, type 1 diabetes, t:slim X2
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • t:slim X2 insulin pump with Control-IQ technology 1.5Device

    t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 CGM.

Study groups in NCT05422053
Study groupRoleWhat they receive
t:slim X2 insulin pump with Control-IQ technologyExperimentalAdults 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.
Receives: Device: t:slim X2 insulin pump with Control-IQ technology 1.5

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Severe Hypoglycemic Events

    Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during the entire study period

    Measured: 3 months

  2. Number of Diabetic Ketoacidosis Events

    Number of diabetic ketoacidosis events during the entire study period

    Measured: 3 months

  3. Unanticipated Adverse Device Effects

    Number of unanticipated adverse device effects during the entire study period

    Measured: 3 months

  4. Other Serious Adverse Events

    Number of serious adverse events during the entire study period

    Measured: 3 months

Secondary outcomes (6)

  1. CGM Time <54 mg/dL Overall

    Percent time CGM glucose <54 mg/dL overall

    Measured: 3 months

  2. CGM Time <54 mg/dL Daytime Only

    Percent time CGM glucose <54 mg/dL daytime only (06:00 - 24:00)

    Measured: 3 months

  3. CGM Time <54 mg/dL Nighttime Only

    Percent time CGM glucose <54 mg/dL nighttime only (00:00 - 06:00)

    Measured: 3 months

  4. CGM Time <70 mg/dL Overall

    Percent time CGM glucose <70 mg/dL overall

    Measured: 3 months

  5. CGM Time <70 mg/dL Daytime Only

    Percent time CGM glucose <70 mg/dL daytime only (06:00 - 24:00)

    Measured: 3 months

  6. CGM Time <70 mg/dL Nighttime Only

    Percent time CGM glucose <70 mg/dL nighttime only (00:00 - 06:00)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2022
  2. Study start29 Jun 2022
  3. Primary completion6 Jan 2023
  4. Study completion6 Jan 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05422053
Sponsor's protocol ID
TP-0009856
Status last verified
Apr 2025
First submitted
13 Jun 2022
Last updated
3 Apr 2025
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Carlson AL, Graham TE, Akturk HK, Liljenquist DR, Bergenstal RM, Sulik B, Shah VN, Sulik M, Zhao P, Briggs P, Sassan-Katchalski R, Pinsker JE. Control-IQ Technology Use in Individuals With High Insulin Requirements: Results From the Multicenter Higher-IQ Trial. J Diabetes Sci Technol. 2024 Nov;18(6):1288-1292. doi: 10.1177/19322968241234072. Epub 2024 Mar 5.

    PubMed 38439656

Questions about this trial

What is this clinical trial studying?

A study of Type 1 Diabetes, run by Tandem Diabetes Care, Inc. at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Severe Hypoglycemic Events (time frame: 3 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05422053, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2025.

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