Clinical trial NCT05785832: A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Treated With Insulin
Keywords: Control-IQ+ technology
type 2 diabetes
automated insulin dosing
automated insulin delivery
Lead sponsor: Tandem Diabetes Care, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Jaeb Center for Health Research
First posted: 2023-03-27
Enrollment: 319
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: HbA1c
timeFrame: 13 weeks
Secondary outcomes:
measure: Time in Range 70-180 mg/dL
timeFrame: 13 weeks
measure: Mean Glucose
timeFrame: 13 weeks
measure: Time >180 mg/dL
timeFrame: 13 weeks
measure: Time >250 mg/dL
timeFrame: 13 weeks
measure: Prolonged Hyperglycemia Events Per Week
timeFrame: 13 weeks
measure: Time <70 mg/dL
timeFrame: 13 weeks
measure: Time <54 mg/dL
timeFrame: 13 weeks
measure: CGM-measured Hypoglycemia Events Per Week
timeFrame: 13 weeks
measure: Coefficient of Variation
timeFrame: 13 weeks
Other outcomes:
measure: HbA1c <7.0%
timeFrame: 13 weeks
measure: HbA1c <7.0% in Participants With Baseline HbA1c >7.5%
timeFrame: 13 weeks
measure: HbA1c <7.5%
timeFrame: 13 weeks
measure: HbA1c Improvement From Baseline to 13 Weeks >0.5%
timeFrame: 13 weeks
measure: HbA1c Improvement From Baseline to 13 Weeks >1.0%
timeFrame: 13 weeks
measure: HbA1c Relative Improvement From Baseline to 13 Weeks >10%
timeFrame: 13 weeks
measure: HbA1c Improvement From Baseline to 13 Weeks >1.0% or HbA1c <7.0% at 13 Weeks
timeFrame: 13 weeks
measure: Time in Range 70-140 mg/dL
timeFrame: 13 weeks
measure: Area Over the Curve (70 mg/dL)
timeFrame: 13 weeks
measure: Low Blood Glucose Index
timeFrame: 13 weeks
measure: Time >300 mg/dL
timeFrame: 13 weeks
measure: Area Under the Curve (180 mg/dL)
timeFrame: 13 weeks
measure: High Blood Glucose Index
timeFrame: 13 weeks
measure: Time in Range 70-180 mg/dL >70%
timeFrame: 13 weeks
measure: Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5%
timeFrame: 13 weeks
measure: Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10%
timeFrame: 13 weeks
measure: Time <70 mg/dL <4%
timeFrame: 13 weeks
measure: Time <54 mg/dL <1%
timeFrame: 13 weeks
measure: Time in Range 70-180 mg/dL >70% and Time <54 mg/dL <1%
timeFrame: 13 weeks
measure: Total Insulin
timeFrame: 13 weeks
measure: Basal Insulin
timeFrame: 13 weeks
measure: Weight
timeFrame: 13 weeks
measure: Blood Pressure - Systolic
timeFrame: 13 weeks
measure: Blood Pressure - Diastolic
timeFrame: 13 weeks
measure: Lipid Levels - HDL
timeFrame: 13 weeks
measure: Lipid Levels - LDL
timeFrame: 13 weeks
measure: Triglycerides
timeFrame: 13 weeks
measure: Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
timeFrame: 13 weeks
measure: DAWN Impact of Diabetes Profile (DIDP)
timeFrame: 13 weeks
measure: Diabetes Impact and Satisfaction (DIDS) Scale
timeFrame: 13 weeks
measure: PROMIS Sleep-Related Impairment Questionnaire
timeFrame: 13 weeks
measure: System Usability Scale (SUS)
timeFrame: 13 weeks
measure: Hypoglycemia Fear Survey II
timeFrame: 13 weeks
measure: EQ5D-5L
timeFrame: 13 weeks
Locations:
city: Newport Beach
country: United States
facility: Hoag Memorial Hospital Presbyterian
state: California
city: Atlanta
country: United States
facility: Emory University School of Medicine
state: Georgia
city: Idaho Falls
country: United States
facility: Rocky Mountain Clinical Research
state: Idaho
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Baltimore
country: United States
facility: Baltimore VA Medical Center
state: Maryland
city: Boston
country: United States
facility: Boston Medical Center Corporation
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: New York
country: United States
facility: Icahn School of Medicine at Mt. Sinai
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Cleveland
country: United States
facility: UHH Cleveland Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Austin
country: United States
facility: Texas Diabetes and Endocrinology, P.A.
state: Texas
city: Dallas
country: United States
facility: University of Texas Southwestern
state: Texas
city: Sandy
country: United States
facility: Diabetes & Endocrine Treatment Specialists
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
city: Renton
country: United States
facility: Rainier Clinical Research Center
state: Washington
city: Seattle
country: United States
facility: University of Washington
state: Washington
city: London
country: Canada
facility: Lawson Health Research Institute
state: Ontario
city: Montréal
country: Canada
facility: McGill University
state: Quebec
Study officials:
affiliation: Tandem Diabetes Care
name: Jordan Pinsker, MD
role: STUDY_DIRECTOR
affiliation: Mayo Clinic
name: Yogish Kudva, MBBS
role: STUDY_CHAIR
References:
citation: 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.