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

• ClinicalTrials.gov Identifier: NCT05785832
• Recruitment Status: Recruiting
• First Posted: March 27, 2023
• Last Update Posted: February 5, 2024
• Sponsor: Tandem Diabetes Care, Inc.
• Collaborator: Jaeb Center for Health Research
• Information provided by (Responsible Party): Tandem Diabetes Care, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Type 2 Diabetes Treated With Insulin	Device: t:slim X2 insulin pump with Control-IQ technology 1.5 and Dexcom G6 CGM; Device: Standard Therapy plus continuous glucose monitoring (CGM)	Not Applicable

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 1.5 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.

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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)
• Actual Study Start Date: June 1, 2023
• Estimated Primary Completion Date: March 2024
• Estimated Study Completion Date: May 2024

Arms and Interventions

Arm	Intervention/treatment
Experimental: Intervention group; Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the Intervention group using t:slim X2 insulin pump with Control-IQ technology 1.5 and Dexcom G6 CGM for 13 weeks.	Device: t:slim X2 insulin pump with Control-IQ technology 1.5 and Dexcom G6 CGM; The t:slim X2 insulin pump with Control-IQ technology 1.5 is derived from the commercially available t:slim X2 with Control-IQ, with additional features. It will be 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).	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.

Outcome Measures

Primary Outcome Measures :

1. HbA1c [ Time Frame: 13 weeks ]
   Change in HbA1c (%) from baseline between the intervention and control groups

Secondary Outcome Measures :

1. Time in range 70-180 mg/dL [ Time Frame: 13 weeks ]
   Change in CGM percent time 70-180 mg/dL from baseline, compared between the intervention and control groups
2. Mean glucose [ Time Frame: 13 weeks ]
   Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups
3. Time >180 mg/dL [ Time Frame: 13 weeks ]
   Change in CGM percent time >180 mg/dL from baseline, compared between the intervention and control groups
4. Time >250 mg/dL [ Time Frame: 13 weeks ]
   Change in CGM percent time >250 mg/dL from baseline, compared between the intervention and control groups
5. Prolonged hyperglycemia events [ Time Frame: 13 weeks ]
   Change in number of prolonged hyperglycemia events (>90 minutes >300 mg/dL within a 120-minute period) from baseline, compared between the intervention and control groups
6. Time <70 mg/dL [ Time Frame: 13 weeks ]
   Change in CGM percent time <70 mg/dL from baseline, compared between the intervention and control groups
7. Time <54 mg/dL [ Time Frame: 13 weeks ]
   Change in CGM percent time <54 mg/dL from baseline, compared between the intervention and control groups
8. CGM-measured hypoglycemia events [ Time Frame: 13 weeks ]
   Change in number of CGM-measured hypoglycemia events (15 or more consecutive minutes <54 mg/dL) from baseline, compared between the intervention and control groups
9. Coefficient of variation [ Time Frame: 13 weeks ]
   Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups

Other Outcome Measures:

1. HbA1c <7.0% [ Time Frame: 13 weeks ]
   Number of participants with HbA1c <7.0% at 13 weeks, compared between the intervention and control groups
2. HbA1c <7.0% in participants with baseline HbA1c >7.5% [ Time Frame: 13 weeks ]
   Number of participants with HbA1c <7.0% at 13 weeks, in participants with baseline HbA1c >7.5%, compared between the intervention and control groups
3. HbA1c <7.5% [ Time Frame: 13 weeks ]
   Number of participants with HbA1c <7.5% at 13 weeks, compared between the intervention and control groups
4. HbA1c improvement from baseline to 13 weeks >0.5% [ Time Frame: 13 weeks ]
   Number of participants with HbA1c improvement from baseline to 13 weeks >0.5%, compared between the intervention and control groups
5. HbA1c improvement from baseline to 13 weeks >1.0% [ Time Frame: 13 weeks ]
   Number of participants with HbA1c improvement from baseline to 13 weeks >1.0%, compared between the intervention and control groups
6. HbA1c relative improvement from baseline to 13 weeks >10% [ Time Frame: 13 weeks ]
   Number of participants with HbA1c relative improvement from baseline to 13 weeks >10%, compared between the intervention and control groups
7. HbA1c improvement from baseline to 13 weeks >1.0% or HbA1c <7.0% at 13 weeks [ Time Frame: 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
8. Time in range 70-140 mg/dL [ Time Frame: 13 weeks ]
   Change in CGM percent time 70-140 mg/dL from baseline, compared between the intervention and control groups
9. Area over the curve (70 mg/dL) [ Time Frame: 13 weeks ]
   CGM area over the curve (70 mg/dL), compared between the intervention and control groups
10. Low blood glucose index [ Time Frame: 13 weeks ]
    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.
11. Time >300 mg/dL [ Time Frame: 13 weeks ]
    Change in CGM percent time >300 mg/dL from baseline, compared between the intervention and control groups
12. Area under the curve (180 mg/dL) [ Time Frame: 13 weeks ]
    CGM area under the curve (180 mg/dL), compared between the intervention and control groups
13. High blood glucose index [ Time Frame: 13 weeks ]
    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.
14. Time in range 70-180 mg/dL >70% [ Time Frame: 13 weeks ]
    Number of participants with time in range 70-180 mg/dL >70%, compared between the intervention and control groups
15. Time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5% [ Time Frame: 13 weeks ]
    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
16. Time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10% [ Time Frame: 13 weeks ]
    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
17. Time <70 mg/dL <4% [ Time Frame: 13 weeks ]
    Number of participants with CGM time <70 mg/dL <4%, compared between the intervention and control groups
18. Time <54 mg/dL <1% [ Time Frame: 13 weeks ]
    Number of participants with CGM time <54 mg/dL <1%, compared between the intervention and control groups
19. Time in range 70-180 mg/dL >70% and time <54 mg/dL <1% [ Time Frame: 13 weeks ]
    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
20. Total Insulin [ Time Frame: 13 weeks ]
    Total daily insulin delivery (units), compared between the intervention and control groups
21. Basal insulin [ Time Frame: 13 weeks ]
    Percentage of insulin delivered as basal, compared between the intervention and control groups
22. Weight [ Time Frame: 13 weeks ]
    Change in weight (kg) from baseline, compared between the intervention and control groups
23. Blood Pressure [ Time Frame: 13 weeks ]
    Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups
24. Lipid levels [ Time Frame: 13 weeks ]
    Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups
25. Cardiovascular events [ Time Frame: 13 weeks ]
    Number of cardiovascular events, compared between the intervention and control groups
26. Type 2 Diabetes Distress Assessment System (T2-DDAS Combined - Core and Source) [ Time Frame: 13 weeks ]
    Patient-reported outcome (PRO) measures from Type 2 Diabetes Distress Assessment System (T2-DDAS Combined - Core and Source) questionnaire, compared between the intervention and control groups
27. DAWN Impact of Diabetes Profile (DIDP) [ Time Frame: 13 weeks ]
    Patient-reported outcome (PRO) measures from DAWN Impact of Diabetes Profile (DIDP) questionnaire, compared between the intervention and control groups
28. Diabetes Impact and Satisfaction (DIDS) Scale [ Time Frame: 13 weeks ]
    Patient-reported outcome (PRO) measures from Diabetes Impact and Satisfaction (DIDS) Scale questionnaire, compared between the intervention and control groups
29. PROMIS Sleep-Related Impairment Questionnaire [ Time Frame: 13 weeks ]
    Patient-reported outcome (PRO) measures from PROMIS Sleep-Related Impairment questionnaire, compared between the intervention and control groups
30. System Usability Scale (SUS) [ Time Frame: 13 weeks ]
    Patient-reported outcome (PRO) measures from System Usability Scale (SUS) questionnaire, compared between the intervention and control groups
31. Hypoglycemia Fear Survey II [ Time Frame: 13 weeks ]
    Patient-reported outcome (PRO) measures from Hypoglycemia Fear Survey II, compared between the intervention and control groups
32. EQ5D-5L [ Time Frame: 13 weeks ]
    Patient-reported outcome (PRO) measures from EQ5D-5L questionnaire, compared between the intervention and control groups
33. Study-specific survey [ Time Frame: 13 weeks ]
    Patient-reported outcome (PRO) measures from study-specific survey exploring time spent on insulin management and insulin dosing with meals, compared between the intervention and control groups
34. Hypoglycemia Frequency Last 3 Months Survey [ Time Frame: 13 weeks ]
    Number of non-severe hypoglycemic events reported, compared between the intervention and control groups from baseline report to 13 weeks.
35. Severe hypoglycemia [ Time Frame: 13 weeks ]
    Number of Severe hypoglycemia events, compared between the intervention and control groups
36. Diabetic ketoacidosis [ Time Frame: 13 weeks ]
    Number of Diabetic ketoacidosis events, compared between the intervention and control groups
37. Hyperosmolar hyperglycemic syndrome [ Time Frame: 13 weeks ]
    Number of Hyperosmolar hyperglycemic syndrome events, compared between the intervention and control groups
38. Other serious adverse events [ Time Frame: 13 weeks ]
    Number of other serious adverse events
39. Unanticipated adverse device effects [ Time Frame: 13 weeks ]
    Number of Unanticipated adverse device effects
40. Infusion set failures [ Time Frame: 13 weeks ]
    Number of infusion set failures
41. Other device malfunctions/device issues [ Time Frame: 13 weeks ]
    Number of other device malfunctions/device issues

Eligibility Criteria

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

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.

Contacts and Locations

Locations

United States, California

Hoag Memorial Hospital Presbyterian; Recruiting

Newport Beach, California, United States, 92663

Contact: Brittany Dennis 949-764-4577 Brittany.dennis@hoag.org

Principal Investigator: David Ahn, MD

United States, Georgia

Emory University School of Medicine; Recruiting

Atlanta, Georgia, United States, 30303

Contact: Farbod Zahedi Tajrishi 404-251-8958 fzahedi@emory.edu

Principal Investigator: Francisco Pasquel, MD

United States, Idaho

Rocky Mountain Clinical Research; Recruiting

Idaho Falls, Idaho, United States, 83404

Contact: Rochelle Christensen 208-522-6005 rochelle.christensen@idahomed.com

Principal Investigator: David Liljenquist, MD

United States, Illinois

Northwestern University; Recruiting

Chicago, Illinois, United States, 60611

Contact: Evelyn Fronczyk 312-908-9002 Evelyn.guevara@northwestern.edu

Principal Investigator: Grazia Aleppo, MD

United States, Maryland

Baltimore VA Medical Center; Recruiting

Baltimore, Maryland, United States, 21201

Contact: William Scott 410-605-7000 ext 53558 william.scott5@va.gov

Principal Investigator: Ilias Spanakis, MD

United States, Massachusetts

Boston Medical Center Corporation; Recruiting

Boston, Massachusetts, United States, 02118

Contact: Astrid Atakov-Castillo 617-638-5906 astrid.atakovcastillo@bmc.org

Principal Investigator: Devin Steenkamp, MD

United States, Michigan

Henry Ford Health System; Recruiting

Detroit, Michigan, United States, 48202

Contact: Paula Layton 313-916-3906 playton2@hfhs.org

Principal Investigator: Davida Kruger, MD

United States, Minnesota

Mayo Clinic; Recruiting

Rochester, Minnesota, United States, 55905

Contact: Corey Reid 507-255-0316 reid.corey@mayo.edu

Principal Investigator: Yogish Kudva, MD

United States, New York

Icahn School of Medicine at Mt. Sinai; Recruiting

New York, New York, United States, 10029

Contact: Camilla Levister 212-241-5177 camilla.levister@mssm.edu

Principal Investigator: Carol Levy, MD

SUNY Upstate Medical University; Recruiting

Syracuse, New York, United States, 13210

Contact: Suzan Bzdick, RN, CDCES 315-464-9006 bzdicks@upstate.edu

Principal Investigator: Ruth Weinstock, MD

United States, Ohio

UHH Cleveland Medical Center; Recruiting

Cleveland, Ohio, United States, 44106

Contact: Megan Tribout 216-286-0763 Megan.Tribout@uhhospitals.org

Principal Investigator: Betul Hatipolgu, MD

United States, Oregon

Oregon Health & Science University; Recruiting

Portland, Oregon, United States, 97239

Contact: Deborah Branigan 503-418-9070 branigad@ohsu.edu

Principal Investigator: Andrew Ahmann, MD

United States, Pennsylvania

University of Pennsylvania; Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contact: Cornelia Dalton-Bakes 215-746-2085 corneliv@pennmedicine.upenn.edu

Principal Investigator: Michael Rickels, MD,MS

United States, Texas

Texas Diabetes and Endocrinology, P.A.; Recruiting

Austin, Texas, United States, 78731

Contact: Chloe Armstrong 512-334-3505 ext 1 carmstrong@tderesearch.com

Principal Investigator: Thomas Blevins, MD

University of Texas Southwestern; Recruiting

Dallas, Texas, United States, 75013

Contact: Lin Jordan 214-843-8233 Lin.Fan@UTSouthwestern.edu

Principal Investigator: Philip Raskin, MD

United States, Utah

Diabetes & Endocrine Treatment Specialists; Recruiting

Sandy, Utah, United States, 84093

Contact: Aisha Fairclough 801-816-1010 ext 108 aisha@detsutah.com

Principal Investigator: Timothy Graham, MD

United States, Virginia

University of Virginia; Recruiting

Charlottesville, Virginia, United States, 22903

Contact: Jasmeen Dhillon 434-982-0602 JKD9UD@uvahealth.org

Principal Investigator: Sue Brown, MD

United States, Washington

Rainier Clinical Research Center; Recruiting

Renton, Washington, United States, 98057

Contact: Alissa Levinson 425-251-1720 alevinson@rainier-research.com

Principal Investigator: Frances Broyles, MD

University of Washington; Recruiting

Seattle, Washington, United States, 98109

Contact: Xenia Averkiou 206-598-4882 averkiou@uw.edu

Principal Investigator: Irl Hirsch, MD

Canada, Ontario

Lawson Health Research Institute; Recruiting

London, Ontario, Canada, N6A 4V2

Contact: Marsha Driscoll (519) 646-6370 marsha.driscoll@sjhc.london.on.ca

Principal Investigator: Tamara Spaic, MD

Canada, Quebec

McGill University; Recruiting

Montréal, Quebec, Canada, H4A 3J1

Contact: Adelyn Moore (438) 866-4807 adelyn.moore@mail.mcgill.ca

Principal Investigator: Michael Tsoukas, MD

Sponsors and Collaborators

Tandem Diabetes Care, Inc.

Jaeb Center for Health Research

Investigators

• Study Director: Jordan Pinsker, MD; Tandem Diabetes Care
• Study Chair: Yogish Kudva, MBBS; Mayo Clinic

More Information

• Responsible Party: Tandem Diabetes Care, Inc.
• ClinicalTrials.gov Identifier: NCT05785832
• Other Study ID Numbers: TP-0013437
• First Posted: March 27, 2023
• Last Update Posted: February 5, 2024
• Last Verified: February 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Device Product Not Approved or Cleared by U.S. FDA: Yes

Keywords provided by Tandem Diabetes Care, Inc.:

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

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Insulin; Hypoglycemic Agents; Physiological Effects of Drugs