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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Treated With Insulin
• Intervention / Treatment: Device: Standard Therapy plus continuous glucose monitoring (CGM); Device: t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM

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.

• Study Type: Interventional
• Enrollment (Actual): 319
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • London, Ontario, Canada, N6A 4V2
      • Lawson Health Research Institute
  • Quebec
    • Montreal, Quebec, Canada, H4A 3J1
      • McGIll University
• United States
  • California
    • Newport Beach, California, United States, 92663
      • Hoag Memorial Hospital Presbyterian
  • Georgia
    • Atlanta, Georgia, United States, 30303
      • Emory University School Of Medicine
  • Idaho
    • Idaho Falls, Idaho, United States, 83404
      • Rocky Mountain Clinical Research
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center Corporation
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mt. Sinai
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • UHH Cleveland Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Texas
    • Austin, Texas, United States, 78731
      • Texas Diabetes and Endocrinology, P.A.
    • Dallas, Texas, United States, 75013
      • University of Texas Southwestern
  • Utah
    • Sandy City, Utah, United States, 84093
      • Diabetes & Endocrine Treatment Specialists
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia
  • Washington
    • Renton, Washington, United States, 98057
      • Rainier Clinical Research Center
    • Seattle, Washington, United States, 98109
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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:

  1. 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:

     1. Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal).
     2. Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable).
     3. Placement of an intrauterine device or intrauterine hormone-releasing system.
     4. Bilateral tubal occlusion.
     5. Barrier methods of contraception (condom or occlusive cap with spermicidal foam/gel/film/cream/suppository).
     6. Has a vasectomized or sterile partner (where partner is sole partner of subject) and where vasectomy has been confirmed by medical assessment.
     7. 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

  2. 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; 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; The t:slim X2 insulin pump with Control-IQ+ technology, used with the Dexcom G6 CGM.
Active Comparator: Control group; 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); Standard therapy is continuation of pre-study basal-bolus insulin delivery method, plus use of Dexcom G6 CGM.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Change in HbA1c (%) from baseline between the intervention and control groups	13 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time >180 mg/dL	Change in CGM percent time >180 mg/dL from baseline, compared between the intervention and control groups	13 weeks
Time >250 mg/dL	Change in CGM percent time >250 mg/dL from baseline, compared between the intervention and control groups	13 weeks
Time <70 mg/dL	Change in CGM percent time <70 mg/dL from baseline, compared between the intervention and control groups	13 weeks
Time <54 mg/dL	Change in CGM percent time <54 mg/dL from baseline, compared between the intervention and control groups	13 weeks
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	13 weeks
Mean Glucose	Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups	13 weeks
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	13 weeks
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	13 weeks
Coefficient of Variation	Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups	13 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c <7.0%	Number of participants with HbA1c <7.0% at 13 weeks, compared between the intervention and control groups	13 weeks
HbA1c <7.5%	Number of participants with HbA1c <7.5% at 13 weeks, compared between the intervention and control groups	13 weeks
Time >300 mg/dL	Change in CGM percent time >300 mg/dL from baseline, compared between the intervention and control groups	13 weeks
Time <70 mg/dL <4%	Number of participants with CGM time <70 mg/dL <4%, compared between the intervention and control groups	13 weeks
Time <54 mg/dL <1%	Number of participants with CGM time <54 mg/dL <1%, compared between the intervention and control groups	13 weeks
Total Insulin	Total daily insulin delivery (units), compared between the intervention and control groups	13 weeks
Weight	Change in weight (kg) from baseline, compared between the intervention and control groups	13 weeks
HbA1c <7.0% in Participants With Baseline HbA1c >7.5%	Number of participants with HbA1c <7.0% at 13 weeks, in participants with baseline HbA1c >7.5%, compared between the intervention and control groups	13 weeks
HbA1c Improvement From Baseline to 13 Weeks >0.5%	Number of participants with HbA1c improvement from baseline to 13 weeks >0.5%, compared between the intervention and control groups	13 weeks
HbA1c Improvement From Baseline to 13 Weeks >1.0%	Number of participants with HbA1c improvement from baseline to 13 weeks >1.0%, compared between the intervention and control groups	13 weeks
HbA1c Relative Improvement From Baseline to 13 Weeks >10%	Number of participants with HbA1c relative improvement from baseline to 13 weeks >10%, compared between the intervention and control groups	13 weeks
HbA1c Improvement From Baseline to 13 Weeks >1.0% or HbA1c <7.0% at 13 Weeks	Number of participants with HbA1c improvement from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks, compared between the intervention and control groups	13 weeks
Time in Range 70-140 mg/dL	Change in CGM percent time 70-140 mg/dL from baseline, compared between the intervention and control groups	13 weeks
Area Over the Curve (70 mg/dL)	CGM area over the curve (70 mg/dL), compared between the intervention and control groups	13 weeks
Low Blood Glucose Index	Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia, compared between the intervention and control groups. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 < LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 < LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI > 5.0 is associated with high risk of hypoglycemia.	13 weeks
Area Under the Curve (180 mg/dL)	CGM area under the curve (180 mg/dL), compared between the intervention and control groups	13 weeks
High Blood Glucose Index	High Blood Glucose Index (HBGI) by CGM, compared between the intervention and control groups., as a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI < 4.5 is associated with lower risk of hyperglycemia, 4.5 < HBGI < 9 is associated with a moderate risk of hyperglycemia and HBGI > 9 is associated with high risk of hyperglycemia.	13 weeks
Time in Range 70-180 mg/dL >70%	Number of participants who achieved time in range 70-180 mg/dL >70%, compared between the intervention and control groups	13 weeks
Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5%	Number of participants with time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5%, compared between the intervention and control groups	13 weeks
Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10%	Number of participants with time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10%, compared between the intervention and control groups	13 weeks
Time in Range 70-180 mg/dL >70% and Time <54 mg/dL <1%	Number of participants with time in range 70-180 mg/dL >70% and time <54 mg/dL <1%, compared between the intervention and control groups	13 weeks
Basal Insulin	Percentage of insulin delivered as basal, compared between the intervention and control groups	13 weeks
Blood Pressure - Systolic	Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups	13 weeks
Blood Pressure - Diastolic	Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups	13 weeks
Lipid Levels - HDL	Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups	13 weeks
Lipid Levels - LDL	Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups	13 weeks
Triglycerides	Change in triglycerides (mg/dL), compared between the intervention and control groups	13 weeks
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)	Patient-reported outcome (PRO) measures from the Type 2 Diabetes Distress Assessment System (Core and Source) questionnaire, compared between the intervention and control groups. The T2-DDAS includes a Core measure that precisely characterizes the intensity of the emotional DD experience, and a set of Sources measures that identifies the key contributors or specific sources of distress. The seven Sources are: management demands, healthcare provider, hypoglycemia, long-term health, interpersonal issues, shame/stigma and healthcare access. Scoring for each question is on a scale of 1-5, with higher scores indicating more problems/distress. Scores are reported individually per domain area at baseline and 13 weeks.	13 weeks
DAWN Impact of Diabetes Profile (DIDP)	Patient-reported outcome (PRO) measures from DAWN Impact of Diabetes Profile (DIDP) questionnaire, compared between the intervention and control groups. The DIDP provides a brief assessment of the perceived impact of diabetes on six key dimensions of life. Participants rate the impact of diabetes on each domain on a 7-point scale, with 1 being a very positive impact and 7 being a very negative impact. A converted percentage (0-100%) scale scores are reported. Lower scale scores indicate greater positive impact and higher scale scores indicate greater negative impact across global life dimensions.	13 weeks
Diabetes Impact and Satisfaction (DIDS) Scale	Patient-reported outcome (PRO) measures from Diabetes Impact and Satisfaction (DIDS) Scale questionnaire, compared between the intervention and control groups. For the DIDS satisfaction score, scores range from 0-10 with higher scores indicating better outcome. For the DIDS impact score, scores range from 0-10 with lower scores indicating better outcome.	13 weeks
PROMIS Sleep-Related Impairment Questionnaire	Patient-reported outcome (PRO) measures from PROMIS Sleep-Related Impairment questionnaire, compared between the intervention and control groups. The PROMIS Sleep-Related Impairment Questionnaire utilizes a T-score metric for scoring, with a mean of 50 and a standard deviation of 10. Higher T-scores indicate greater sleep-related impairment. The questionnaire uses a 5-point Likert scale (1=never to 5=always) for each item, and the responses are summed to calculate a total raw score. This raw score is then converted to a T-score using a lookup table provided in the scoring manual.	13 weeks
System Usability Scale (SUS)	Patient-reported outcome (PRO) measures from System Usability Scale (SUS) questionnaire, compared between the intervention and control groups. 10 items rated on 5-point Likert scale (1=Strongly Disagree, 5=Strongly Agree). Total score is on a 100 point scale (0 - 100), with higher scores indicating greater usability.	13 weeks
Hypoglycemia Fear Survey II	Patient-reported outcome (PRO) measures from Hypoglycemia Fear Survey II Behavior and Worry Scores, compared between the intervention and control groups. The HFS-II consists of 33 items, which are organized into two subscales: HFS-B (Behavior): A 15 item subscale that focuses on behaviors to avoid hypoglycemia, and HFS-W (Worry): a 18 item subscale that focuses on worries about hypoglycemia and its consequences. The HFS-II subscale scores range from 0-60 and 0-72 for the HFS-B and HFS-W, respectively. Higher scores indicate higher fear of hypoglycemia.	13 weeks
EQ5D-5L	Patient-reported outcome (PRO) measures from EQ5D-5L questionnaire, compared between the intervention and control groups, showing EQ-Index Scores. The EQ5D utility index consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories, from which a single EQ-5D index score can be calculated ranging from 0 (worst imaginable health) to 1 (best imaginable health) on which participants have to indicate their current health.	13 weeks

Collaborators and Investigators

• Sponsor: Tandem Diabetes Care, Inc.
• Collaborators: Jaeb Center for Health Research
• Investigators: Study Director: Jordan Pinsker, MD, Tandem Diabetes Care; Study Chair: Yogish Kudva, MBBS, Mayo Clinic

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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 May 5. doi: 10.1111/dom.70759. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2023
• Primary Completion (Actual): September 24, 2024
• Study Completion (Actual): September 24, 2024

Study Registration Dates

• First Submitted: March 14, 2023
• First Submitted That Met QC Criteria: March 14, 2023
• First Posted (Actual): March 27, 2023

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: type 2 diabetes; automated insulin delivery; automated insulin dosing; Control-IQ+ technology
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Investigative Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Blood Chemical Analysis; Clinical Chemistry Tests; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Continuous Glucose Monitoring
• Other Study ID Numbers: TP-0013437

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