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Type 2 Diabetes Treated With Insulin2IQPNCT05785832

A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes

A study testing Standard Therapy plus continuous glucose monitoring (CGM) in people with Type 2 Diabetes Treated With Insulin, run by Tandem Diabetes Care, Inc. at 21 sites in 2 countries.

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 randomized controlled trial (RCT) to assess the safety and efficacy of use of Control-IQ+ technology in adults with type 2 diabetes using basal-bolus insulin therapy. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Treated With Insulin
What is being tested?
Standard Therapy plus continuous glucose monitoring (CGM)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
319 participants
Where
21 sitesin 2 countries
Study dates
1 Jun 2023to 24 Sep 2024
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 old at time of screening.
  • Currently resides in the U.S. or Canada with the ability to complete in-person study visits at one of the participating clinical sites.
  • Clinical diagnosis, based on investigator assessment, of type 2 diabetes of at least 6 months duration at time of screening.
  • Using basal-bolus insulin therapy with at least one injection containing rapid-acting insulin per day or an insulin pump for at least 3 months prior to enrollment, with no major modification to insulin regime in the last 3 months (mixed insulin with a rapid component is acceptable).
  • If using noninsulin glucose-lowering medications (such as GLP-1 receptor agonist, SGLT2 inhibitor, or other) or weight-reduction medications, dose has been stable for the 3 months prior to screening; and participant is willing to not change the dose unless required for safety purposes.
  • Participant willing to not initiate use of any new glucose-lowering medications during the trial.
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  • Willing to use an approved insulin while using the study pump if assigned to the AID group.
  • Willing to not use concentrated insulin above U-100 or inhaled insulin while using the study pump.
  • Willing to participate in the study meal and exercise challenges if assigned to the AID group, and have a care partner, trained in hypoglycemia treatment guidelines, to include glucagon use, present during and immediately after the exercise challenges.
  • Has the ability to read and understand written English.
  • Investigator believes that the participant has the cognitive capacity to provide informed consent.
  • Investigator believes that the participant can successfully and safely operate all study devices and is capable of adhering to the protocol and completing the study.
  • No medical, psychiatric, or other conditions, or medications being taken that in the investigator's judgement would be a safety concern for participation in the study. This includes considering the potential impact of medical conditions known to be present including cardiovascular, liver, kidney disease, thyroid disease, adrenal disease, malignancies, vision difficulties, active proliferative retinopathy, and other medical conditions; psychiatric conditions including eating disorders; drug or alcohol abuse.
  • Participants capable of becoming pregnant must meet one of the following criteria:
  • has a negative urine pregnancy test and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the trial from screening until last follow-up visit. The following contraceptive measures are considered adequate:
  • Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
  • Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
  • Placement of an intrauterine device or intrauterine hormone-releasing system.
  • Bilateral tubal occlusion.
  • Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository).
  • Has a vasectomized or sterile partner (where partner is sole partner of subject) and where vasectomy has been confirmed by medical assessment.
  • Exercises true sexual abstinence. Sexual abstinence is defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
  • or
  • Participant is of non-childbearing potential due to menopause with at least one year since last menses or a medical condition confirmed by the investigator.

Who cannot join

  • Current use of hybrid closed-loop system.
  • Current use of systemic glucocorticoids or anticipated use of glucocorticoids during the RCT (topical or inhaled -ie, non-systemic is acceptable).
  • Current use of sulfonylurea or meglitinide medications.
  • Current use of hydroxyurea.
  • Tape allergy or skin condition that will preclude use of the study pump or CGM.
  • Presence of a hemoglobinopathy or other condition that is expected to affect the measurement of HbA1c.
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  • Pregnant (positive urine hCG), breast feeding, plan to become pregnant in the next 2 months, or sexually active without use of contraception.
  • Current participation in another diabetes-related interventional clinical trial.
  • Anticipated change of residency or travel for more than 7 days at a time during the study that may, per investigator judgment, interfere with the completion of study visits, contacts, or procedures.
  • Immediate family member (spouse, biological or legal guardian, child, sibling, parent) who is an investigative site personnel directly affiliated with this study or who is an employee of Tandem Diabetes Care, Inc.

Trial locations and contacts

21 sites in 2 countries.

21 sites in 2 countries

United States19 sites

  • Emory University School of Medicine

    Atlanta, Georgia, 30303

  • Texas Diabetes and Endocrinology, P.A.

    Austin, Texas, 78731

  • Baltimore VA Medical Center

    Baltimore, Maryland, 21201

  • Boston Medical Center Corporation

    Boston, Massachusetts, 02118

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Northwestern University

    Chicago, Illinois, 60611

  • UHH Cleveland Medical Center

    Cleveland, Ohio, 44106

  • University of Texas Southwestern

    Dallas, Texas, 75013

  • Henry Ford Health System

    Detroit, Michigan, 48202

  • Rocky Mountain Clinical Research

    Idaho Falls, Idaho, 83404

  • Icahn School of Medicine at Mt. Sinai

    New York, New York, 10029

  • Hoag Memorial Hospital Presbyterian

    Newport Beach, California, 92663

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Diabetes & Endocrine Treatment Specialists

    Sandy City, Utah, 84093

  • University of Washington

    Seattle, Washington, 98109

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

Other trials in United States

Canada2 sites

  • Lawson Health Research Institute

    London, Ontario, N6A 4V2

  • McGill University

    Montreal, Quebec, H4A 3J1

Other trials in Canada

About this study

Official title: A Randomized Trial Evaluating the Efficacy and Safety of Control-IQ+ Technology in Adults With Type 2 Diabetes Using Basal-Bolus Insulin Therapy (2IQP)

A randomized controlled trial (RCT) to assess the safety and efficacy of use of Control-IQ+ technology in adults with type 2 diabetes using basal-bolus insulin therapy.

Read the detailed description

A randomized controlled trial (RCT) will evaluate 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ+ technology in adults with type 2 diabetes age 18 and older using basal-bolus insulin therapy compared with continuation of pre-study insulin delivery plus continuous glucose monitoring (CGM). At least 300 participants will complete the trial at up to 25 clinical sites, across the United States and Canada.

Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the intervention group using the t:slim X2 insulin pump with Control-IQ+ technology or to continue their pretrial insulin-delivery method for 13 weeks. Both arms used the Dexcom G6 CGM.

The primary outcome is change in hemoglobin A1c (HbA1c) compared between the intervention and control group. The secondary endpoints will be tested for superiority, with a hierarchical testing approach. Additional outcomes are exploratory.

Being tested
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM, Standard Therapy plus continuous glucose monitoring (CGM)
Keywords
Control-IQ+ technology, type 2 diabetes, automated insulin dosing, automated insulin delivery
Medical subject headings
Diabetes Mellitus, Type 2

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 and Dexcom G6 CGMDevice

    The t:slim X2 insulin pump with Control-IQ+ technology, used with the Dexcom G6 CGM.

  • Standard Therapy plus continuous glucose monitoring (CGM)Device

    Standard therapy is continuation of pre-study basal-bolus insulin delivery method, plus use of Dexcom G6 CGM.

Study groups in NCT05785832
Study groupRoleWhat they receive
Intervention groupExperimentalt:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
Receives: Device: t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM
Control groupActive comparatorContinuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Receives: Device: Standard Therapy plus continuous glucose monitoring (CGM)

What is being measured

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

  1. HbA1c

    Change in HbA1c (%) from baseline between the intervention and control groups

    Measured: 13 weeks

Secondary outcomes (9)

  1. Time in Range 70-180 mg/dL

    Change in CGM percent time 70-180 mg/dL from baseline, compared between the intervention and control groups

    Measured: 13 weeks

  2. Mean Glucose

    Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups

    Measured: 13 weeks

  3. Time >180 mg/dL

    Change in CGM percent time >180 mg/dL from baseline, compared between the intervention and control groups

    Measured: 13 weeks

  4. Time >250 mg/dL

    Change in CGM percent time >250 mg/dL from baseline, compared between the intervention and control groups

    Measured: 13 weeks

  5. Prolonged Hyperglycemia Events Per Week

    Change in number of prolonged hyperglycemia events (>90 minutes >300 mg/dL within a 120-minute period) per week from baseline, compared between the intervention and control groups

    Measured: 13 weeks

  6. Time <70 mg/dL

    Change in CGM percent time <70 mg/dL from baseline, compared between the intervention and control groups

    Measured: 13 weeks

  7. Time <54 mg/dL

    Change in CGM percent time <54 mg/dL from baseline, compared between the intervention and control groups

    Measured: 13 weeks

  8. CGM-measured Hypoglycemia Events Per Week

    Change in number of CGM-measured hypoglycemia events per week (15 or more consecutive minutes <54 mg/dL) from baseline, compared between the intervention and control groups

    Measured: 13 weeks

  9. Coefficient of Variation

    Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups

    Measured: 13 weeks

Timeline

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

  1. First posted27 Mar 2023
  2. Study start1 Jun 2023
  3. Primary completion24 Sep 2024
  4. Study completion24 Sep 2024

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
Parallel groups
Masking
None (open label)
Enrolment
319 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05785832
Sponsor's protocol ID
TP-0013437
Acronym
2IQP
Status last verified
May 2026
First submitted
14 Mar 2023
Last updated
22 May 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Kudva YC, Raghinaru D, Lum JW, Graham TE, Liljenquist D, Spanakis EK, Pasquel FJ, Ahmann A, Ahn DT, Aleppo G, Blevins T, Kruger D, Brown SA, Levy CJ, Weinstock RS, Steenkamp DW, Spaic T, Hirsch IB, Broyles F, Rickels MR, Tsoukas MA, Raskin P, Hatipoglu B, Desjardins D, Terry AN, Singh LG, Davis GM, Schmid C, Kravarusic J, Coyne K, Casaubon L, Espinosa V, Jones JK, Estrada K, Afreen S, Levister C, O'Malley G, Liu SL, Marks S, Peleckis AJ, Pasqua MR, Tardio V, Kurek C, Luker RD, Churchill J, Tajrishi FZ, Dean A, Dennis B, Fronczyk E, Perez J, Mukhashen S, Dhillon J, Ipek A, Bzdick S, Atakov Castillo A, Driscoll M, Averkiou X, Dalton-Bakes CV, Moore A, Jordan LF, Lesniak A, Pinsker JE, Sasson-Katchalski R, Campos T, Spanbauer C, Kanapka L, Kollman C, Beck RW; 2IQP Study Group. A Randomized Trial of Automated Insulin Delivery in Type 2 Diabetes. N Engl J Med. 2025 May 8;392(18):1801-1812. doi: 10.1056/NEJMoa2415948. Epub 2025 Mar 19.

    PubMed 40105270

  • Hirsch IB, Kudva YC, Ahn DT, Blevins T, Rickels MR, Raghinaru D, Lum JW, Kollman C, Pinsker JE, Beck RW; 2IQP Study Group*. Adults With Type 2 Diabetes Benefit From Automated Insulin Delivery Irrespective of C-Peptide Level. Diabetes Care. 2025 Dec 1;48(12):2061-2066. doi: 10.2337/dc25-1125.

    PubMed 40953318

  • Graham TE, Raghinaru D, Afreen S, Ahmann A, Haidar A, Raskin P, Tsoukas MA, Lum JW, Sasson-Katchalski R, Pinsker JE, Beck RW; 2IQP Study Group*. Additive Benefits of Control-IQ+ AID to GLP-1 Receptor Agonist Use in Adults With Type 2 Diabetes. Diabetes Care. 2025 Dec 1;48(12):2154-2159. doi: 10.2337/dc25-1753.

    PubMed 41264828

  • Levy CJ, Kanapka L, Brown SA, Marks S, Spaic T, Steenkamp DW, Lu VS, Zhao P, Lum JW, Beck RW, Pinsker JE; 2IQP Study Group. Simplified Meal Bolus Strategies with Control-IQ+ Automated Insulin Delivery Are Safe and Effective in Adults with Type 2 Diabetes. Diabetes Technol Ther. 2026 May;28(5):501-508. doi: 10.1177/15209156251395035. Epub 2025 Nov 14.

    PubMed 41264341

  • Singh LG, Lum JW, Kanapka L, Pinsker JE, Beck RW; 2IQP Study Group. Consistent Benefit of Control-IQ+ Automated Insulin Delivery Across a Range of Characteristics of Adults with Type 2 Diabetes. Diabetes Technol Ther. 2026 Aug;28(8):792-807. doi: 10.1177/15209156261416920. Epub 2026 Jan 23.

    PubMed 41574573

  • Beck RW, Hirsch IB, Raghinaru D, Lum JW, Pinsker JE, Kudva YC; 2IQP Study Group*. Automated Insulin Delivery Is Beneficial in Adults With Insulin-Treated Type 2 Diabetes With and Without GAD65 Antibodies. Diabetes Care. 2026 Feb 1;49(2):e18-e20. doi: 10.2337/dc25-2059. No abstract available.

    PubMed 41348329

  • Al Rawashdh N, Patel BV, Wang SM, Zur RM, Anaya P, Kahn EB, Pinsker JE, Sasson-Katchalski R, Trahan AC, Messer LH, Assadi K, Kudva YC, Beck RW. Cost-Effectiveness of Control-IQ+ Technology in Insulin-Treated Patients With Type 2 Diabetes in the United States. Diabetes Obes Metab. 2026 Jul;28(7):6280-6290. doi: 10.1111/dom.70759. Epub 2026 May 5.

    PubMed 42086278

Questions about this trial

What is this clinical trial studying?

A study testing Standard Therapy plus continuous glucose monitoring (CGM) in people with Type 2 Diabetes Treated With Insulin, run by Tandem Diabetes Care, Inc. at 21 sites in 2 countries.

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 24 inclusion and 10 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 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 21 sites in United States, Canada. 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 3 Jun 2025). 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?

HbA1c (time frame: 13 weeks). 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 NCT05785832, which also lists 7 linked publications.

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 22 May 2026.

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