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Completed

NCT Number: NCT05785832

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

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.

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Key information

Conditions

Type 2 Diabetes Treated With Insulin Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lawson Health Research Institute, London, Ontario, Canada

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. HbA1c

    Time frame: 13 weeks

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

Secondary outcomes

  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 Per Week

    Time frame: 13 weeks

    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

  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 Per Week

    Time frame: 13 weeks

    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

  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 outcomes

  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 who achieved 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 - Systolic

    Time frame: 13 weeks

    Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups

  24. Blood Pressure - Diastolic

    Time frame: 13 weeks

    Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups

  25. Lipid Levels - HDL

    Time frame: 13 weeks

    Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups

  26. Lipid Levels - LDL

    Time frame: 13 weeks

    Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups

  27. Triglycerides

    Time frame: 13 weeks

    Change in triglycerides (mg/dL), compared between the intervention and control groups

  28. Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)

    Time frame: 13 weeks

    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.

  29. 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. 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.

  30. 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. 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.

  31. 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. 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.

  32. 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. 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.

  33. Hypoglycemia Fear Survey II

    Time frame: 13 weeks

    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.

  34. EQ5D-5L

    Time frame: 13 weeks

    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.

Sponsors and collaborators

Lead sponsor

Tandem Diabetes Care, Inc.

Industry

Collaborators

  • Jaeb Center for Health Research

Registry information

Official study 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)

Acronym: 2IQP

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Mar 27, 2023
Registry last updated
May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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