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

NCT05785832 | Completed Results DMC FDA Device

• 1 other identifier: TP-0013437
• Study Type: interventional
• Target: 319
• Locations: 2 countries
• Sites: 21

Brief 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.

Conditions

Type 2 Diabetes Treated With Insulin

Keywords

Control-IQ+ technology; type 2 diabetes; automated insulin dosing; automated insulin delivery

Outcome Measures

Primary Outcomes (1)

• HbA1c

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

  13 weeks

Secondary Outcomes (9)

• Time in Range 70-180 mg/dL

  13 weeks

• Mean Glucose

  13 weeks

• Time >180 mg/dL

  13 weeks

• Time >250 mg/dL

  13 weeks

• Prolonged Hyperglycemia Events Per Week

  13 weeks

Other Outcomes (34)

• HbA1c <7.0%

  13 weeks

• HbA1c <7.0% in Participants With Baseline HbA1c >7.5%

  13 weeks

• HbA1c <7.5%

  13 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.

Device: t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM

Control group

ACTIVE COMPARATOR

Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.

Device: Standard Therapy plus continuous glucose monitoring (CGM)

Interventions

t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM DEVICE

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

Intervention group

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.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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:

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead
• Jaeb Center for Health Research: collaborator

Study Sites (21)

Hoag Memorial Hospital Presbyterian

Newport Beach, California, 92663, United States

Location

Emory University School of Medicine

Atlanta, Georgia, 30303, United States

Location

Rocky Mountain Clinical Research

Idaho Falls, Idaho, 83404, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

Boston Medical Center Corporation

Boston, Massachusetts, 02118, United States

Location

Henry Ford Health System

Detroit, Michigan, 48202, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

SUNY Upstate Medical University

Syracuse, New York, 13210, United States

Location

UHH Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Texas Diabetes and Endocrinology, P.A.

Austin, Texas, 78731, United States

Location

University of Texas Southwestern

Dallas, Texas, 75013, United States

Location

Diabetes & Endocrine Treatment Specialists

Sandy City, Utah, 84093, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

University of Washington

Seattle, Washington, 98109, United States

Location

Lawson Health Research Institute

London, Ontario, N6A 4V2, Canada

Location

McGill University

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (6)

• 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.

  PMID: 40105270 RESULT

• 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.

  PMID: 40953318 RESULT

• 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.

  PMID: 41264828 RESULT

• 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. 2025 Nov 14. doi: 10.1177/15209156251395035. Online ahead of print.

  PMID: 41264341 RESULT

• 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 Jan 23:15209156261416920. doi: 10.1177/15209156261416920. Online ahead of print.

  PMID: 41574573 RESULT

• 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.

  PMID: 41348329 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Continuous Glucose Monitoring

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Results Point of Contact

• Title: Sr. Supervisor of Clinical Operations
• Organization: Tandem Diabetes Care

clinicalaffairs@tandemdiabetes.com

18583666900

Study Officials

• Jordan Pinsker, MD

  Tandem Diabetes Care

  STUDY DIRECTOR

• Yogish Kudva, MBBS

  Mayo Clinic

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2023
• First Posted: March 27, 2023
• Study Start: June 1, 2023
• Primary Completion: September 24, 2024
• Study Completion: September 24, 2024
• Last Updated: February 19, 2026
• Results First Posted: June 3, 2025

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (19); CA (2)