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Type 1 DiabetesNCT05683392

Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

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

The goal of this clinical trial is to assess safety of and explore glycemic outcomes with Control-IQ technology 2.0 in adults, children and preschoolers with type 1 diabetes. Read more about this study

Who is it for?
Ages 2 to 80 years
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
72 participants
Where
4 sitesUnited States
Study dates
1 Feb 2023to 13 Dec 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 2 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Age 2 to ≤ 81 years
  • Diagnosis of type 1 diabetes for at least 1 year, or at least 6 months for age 2-5 years at enrollment
  • Prior Dexcom CGM user, with at least 11 of the prior 14 days of CGM use available for download at the screening visit to confirm eligibility
  • Total Daily Insulin Dose (TDD) at least 2 units/day
  • Weight ≥ 20 lbs
  • HbA1c ≤ 10.5%
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  • For participants <18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia, present with the participant during and after the meal challenges, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study.
  • For participants ≥18 years old, availability of a local contact who has access to the study participant, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study. If the participant lives alone, the local contact must live within 30 minutes and have access to the subject overnight.
  • Investigator has confidence that the participant and/or parent/guardian can successfully operate all study devices and is capable of adhering to the protocol.
  • Willing to use only aspart (novolog) or lispro (humalog) insulin with the study devices, with no use of long-acting basal insulin injections, or inhaled insulin with the study devices.
  • Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one)
  • Willing and able to perform study meal challenges.

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
  • For Female: Currently pregnant or planning to become pregnant during the time period of study participation
  • A negative pregnancy test will be required for all females of child-bearing potential
  • Counseling on appropriate birth control options will be provided to all females of child-bearing potential
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  • Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
  • Hemophilia or any other bleeding disorder
  • Hemoglobinopathy
  • 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 any medications determined by investigator to interfere with study
  • Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
  • Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea
  • 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 (Pediatric Clinic)

    Aurora, Colorado, 80045

  • Barbara Davis Center

    Aurora, Colorado, 80045

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • University of Virginia

    Charlottesville, Virginia, 22903

Other trials in United States

About this study

Official title: Control-IQ 2.0 Feasibility Study #2: Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

The goal of this clinical trial is to assess safety of and explore glycemic outcomes with Control-IQ technology 2.0 in adults, children and preschoolers with type 1 diabetes.

Read the detailed description

This feasibility study is a prospective, randomized, two-period crossover multi-center study of Control-IQ technology 2.0. After a two week run-in period, the automated insulin dosing (AID) system will be evaluated in multiple age groups over 4 weeks of use.

Conditions
Type 1 Diabetes
Being tested
t:slim X2 insulin pump with Control-IQ technology 2.0
Keywords
Control-IQ technology, type 1 diabetes
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 2.0Device

    t:slim X2 insulin pump with Control-IQ technology 2.0, and wearing the Dexcom G6 sensor.

Study groups in NCT05683392
Study groupRoleWhat they receive
Control-IQ 2.0 Lower Range First, then Standard RangeExperimentalAfter a two week run in period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 with a lower range for two weeks, followed by use of t:slim X2 pump with Control-IQ technology 2.0 with a standard range for two weeks.
Receives: Device: t:slim X2 insulin pump with Control-IQ technology 2.0
Control-IQ 2.0 Standard Range First, then Lower RangeExperimentalAfter a two week run in period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 with a standard range for two weeks, followed by use of t:slim X2 pump with Control-IQ technology 2.0 with a lower range for two weeks.
Receives: Device: t:slim X2 insulin pump with Control-IQ technology 2.0

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 hypoglycemic events (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry over a 3-month time period

    Measured: 2 weeks

  2. Number of Diabetic Ketoacidosis (DKA) Events

    Number of diabetic ketoacidosis during study compared with data on DKA events, compared with data on DKA events reported by T1D Exchange clinic registry over a 3-month time period

    Measured: 2 weeks

Secondary outcomes (9)

  1. Percent of Time <54 mg/dL

    CGM percent time <54 mg/dL during each study period.

    Measured: 2 weeks

  2. Percent of Time <70 mg/dL

    CGM percent time <70 mg/dL during each study period.

    Measured: 2 weeks

  3. Percent Time 70-140 mg/dL

    CGM percent time 70-140 mg/dL during each study period.

    Measured: 2 weeks

  4. Percent Time 70-180 mg/dL

    CGM percent time 70-180 mg/dL during each study period.

    Measured: 2 weeks

  5. Percent Time > 180 mg/dL

    CGM percent time >180 mg/dL during each study period.

    Measured: 2 weeks

  6. Percent Time > 250 mg/dL

    CGM percent time >250 mg/dL during each study period.

    Measured: 2 weeks

  7. Mean Glucose

    Mean CGM glucose mg/dL during each study period.

    Measured: 2 weeks

  8. Glucose SD

    Glucose SD mg/dL during each study period.

    Measured: 2 weeks

  9. Glucose Coefficient of Variation

    Glucose Coefficient of Variation (%) during each study period.

    Measured: 2 weeks

Timeline

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

  1. First posted13 Jan 2023
  2. Study start1 Feb 2023
  3. Primary completion13 Dec 2023
  4. Study completion13 Dec 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
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
72 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05683392
Sponsor's protocol ID
TP-0011713
Status last verified
Dec 2024
First submitted
5 Jan 2023
Last updated
20 Dec 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Brown SA, Laffel LM, Akturk HK, Forlenza GP, Shah VN, Wadwa RP, Cobry EC, Isganaitis E, Schoelwer M, Lu VS, Rueda R, Sherer N, Corbett JP, Sasson-Katchalski R, Pinsker JE. Randomized, Crossover Trial of Control-IQ Technology with a Lower Treatment Range and a Modified Meal Bolus Module in Adults, Adolescents, Children, and Preschoolers with Varying Levels of Baseline Glycemic Control. Diabetes Technol Ther. 2025 Mar;27(3):187-193. doi: 10.1089/dia.2024.0501. Epub 2024 Nov 26.

    PubMed 39601043

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 20 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 20 Dec 2024. 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 20 Dec 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: 2 weeks). The study lists 2 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 NCT05683392, 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 20 Dec 2024.

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