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.

Tracking Information

• First Submitted Date: March 14, 2023
• First Posted Date: March 27, 2023
• Last Update Posted Date: February 5, 2024
• Actual Study Start Date: June 1, 2023
• Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 14, 2023)

HbA1c [ Time Frame: 13 weeks ]

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: March 14, 2023)

• 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
• Mean glucose [ Time Frame: 13 weeks ]
  Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups
• 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
• 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
• 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
• 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
• 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
• 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
• Coefficient of variation [ Time Frame: 13 weeks ]
  Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups

• Original Secondary Outcome Measures: Same as current

Current Other Pre-specified Outcome Measures (submitted: March 14, 2023)

• HbA1c <7.0% [ Time Frame: 13 weeks ]
  Number of participants with HbA1c <7.0% at 13 weeks, compared between the intervention and control groups
• 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
• HbA1c <7.5% [ Time Frame: 13 weeks ]
  Number of participants with HbA1c <7.5% at 13 weeks, compared between the intervention and control groups
• 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
• 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
• 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
• 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
• 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
• 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
• 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.
• 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
• 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
• 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.
• 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
• 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
• 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
• 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
• 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
• 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
• Total Insulin [ Time Frame: 13 weeks ]
  Total daily insulin delivery (units), compared between the intervention and control groups
• Basal insulin [ Time Frame: 13 weeks ]
  Percentage of insulin delivered as basal, compared between the intervention and control groups
• Weight [ Time Frame: 13 weeks ]
  Change in weight (kg) from baseline, compared between the intervention and control groups
• Blood Pressure [ Time Frame: 13 weeks ]
  Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups
• Lipid levels [ Time Frame: 13 weeks ]
  Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups
• Cardiovascular events [ Time Frame: 13 weeks ]
  Number of cardiovascular events, compared between the intervention and control groups
• 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
• 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
• 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
• 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
• 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
• 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
• EQ5D-5L [ Time Frame: 13 weeks ]
  Patient-reported outcome (PRO) measures from EQ5D-5L questionnaire, compared between the intervention and control groups
• 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
• 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.
• Severe hypoglycemia [ Time Frame: 13 weeks ]
  Number of Severe hypoglycemia events, compared between the intervention and control groups
• Diabetic ketoacidosis [ Time Frame: 13 weeks ]
  Number of Diabetic ketoacidosis events, compared between the intervention and control groups
• Hyperosmolar hyperglycemic syndrome [ Time Frame: 13 weeks ]
  Number of Hyperosmolar hyperglycemic syndrome events, compared between the intervention and control groups
• Other serious adverse events [ Time Frame: 13 weeks ]
  Number of other serious adverse events
• Unanticipated adverse device effects [ Time Frame: 13 weeks ]
  Number of Unanticipated adverse device effects
• Infusion set failures [ Time Frame: 13 weeks ]
  Number of infusion set failures
• Other device malfunctions/device issues [ Time Frame: 13 weeks ]
  Number of other device malfunctions/device issues

• Original Other Pre-specified Outcome Measures: Same as current

Descriptive Information

• Brief Title: 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)
• 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 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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Type 2 Diabetes Treated With Insulin

Intervention

• 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.
• 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.

Study Arms

• 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.
  Intervention: Device: t:slim X2 insulin pump with Control-IQ technology 1.5 and Dexcom G6 CGM
• Active Comparator: Control group
  Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6).
  Intervention: Device: Standard Therapy plus continuous glucose monitoring (CGM)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: March 14, 2023): 300
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: May 2024
• Estimated Primary Completion Date: March 2024 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Listed Location Countries: Canada, United States

Administrative Information

• NCT Number: NCT05785832
• Other Study ID Numbers: TP-0013437
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Tandem Diabetes Care, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Tandem Diabetes Care, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Jaeb Center for Health Research

Investigators

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

• PRS Account: Tandem Diabetes Care, Inc.
• Verification Date: February 2024