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CompletedNCT057858322IQPUpdated May 22, 2026Results posted

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

An interventional study of t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM and Standard Therapy plus continuous glucose monitoring (CGM) in Type 2 Diabetes Treated With Insulin, sponsored by Tandem Diabetes Care, Inc.. Completed at 21 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-22.

Sponsored by Tandem Diabetes Care, Inc. · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
319
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes Treated With Insulin

Keywords

  • Control-IQ+ technology
  • type 2 diabetes
  • automated insulin dosing
  • automated insulin delivery
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 319 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Tandem Diabetes Care, Inc. is the lead sponsor of 18 studies on the registry; 2 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 11 (92%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
319 participants (actual)

Study arms

  • 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

  • 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)

Interventions

  • Devicet: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.

  • DeviceStandard Therapy plus continuous glucose monitoring (CGM)

    Standard therapy is continuation of pre-study basal-bolus insulin delivery method, plus use of Dexcom G6 CGM.

06

What researchers measure

Primary outcomes

  1. HbA1c

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

    Time frame: 13 weeks

Secondary outcomes

  1. 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

    Time frame: 13 weeks

  2. Mean Glucose

    Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups

    Time frame: 13 weeks

  3. Time >180 mg/dL

    Change in CGM percent time \>180 mg/dL from baseline, compared between the intervention and control groups

    Time frame: 13 weeks

  4. Time >250 mg/dL

    Change in CGM percent time \>250 mg/dL from baseline, compared between the intervention and control groups

    Time frame: 13 weeks

  5. 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

    Time frame: 13 weeks

  6. Time <70 mg/dL

    Change in CGM percent time \<70 mg/dL from baseline, compared between the intervention and control groups

    Time frame: 13 weeks

  7. Time <54 mg/dL

    Change in CGM percent time \<54 mg/dL from baseline, compared between the intervention and control groups

    Time frame: 13 weeks

  8. 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

    Time frame: 13 weeks

  9. Coefficient of Variation

    Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups

    Time frame: 13 weeks

Other outcomes

  1. HbA1c <7.0%

    Number of participants with HbA1c \<7.0% at 13 weeks, compared between the intervention and control groups

    Time frame: 13 weeks

  2. 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

    Time frame: 13 weeks

  3. HbA1c <7.5%

    Number of participants with HbA1c \<7.5% at 13 weeks, compared between the intervention and control groups

    Time frame: 13 weeks

  4. 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

    Time frame: 13 weeks

  5. 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

    Time frame: 13 weeks

  6. 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

    Time frame: 13 weeks

  7. 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

    Time frame: 13 weeks

  8. 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

    Time frame: 13 weeks

  9. Area Over the Curve (70 mg/dL)

    CGM area over the curve (70 mg/dL), compared between the intervention and control groups

    Time frame: 13 weeks

  10. 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.

    Time frame: 13 weeks

  11. Time >300 mg/dL

    Change in CGM percent time \>300 mg/dL from baseline, compared between the intervention and control groups

    Time frame: 13 weeks

  12. Area Under the Curve (180 mg/dL)

    CGM area under the curve (180 mg/dL), compared between the intervention and control groups

    Time frame: 13 weeks

  13. 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.

    Time frame: 13 weeks

  14. 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

    Time frame: 13 weeks

  15. 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

    Time frame: 13 weeks

  16. 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

    Time frame: 13 weeks

  17. Time <70 mg/dL <4%

    Number of participants with CGM time \<70 mg/dL \<4%, compared between the intervention and control groups

    Time frame: 13 weeks

  18. Time <54 mg/dL <1%

    Number of participants with CGM time \<54 mg/dL \<1%, compared between the intervention and control groups

    Time frame: 13 weeks

  19. 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

    Time frame: 13 weeks

  20. Total Insulin

    Total daily insulin delivery (units), compared between the intervention and control groups

    Time frame: 13 weeks

  21. Basal Insulin

    Percentage of insulin delivered as basal, compared between the intervention and control groups

    Time frame: 13 weeks

  22. Weight

    Change in weight (kg) from baseline, compared between the intervention and control groups

    Time frame: 13 weeks

  23. Blood Pressure - Systolic

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

    Time frame: 13 weeks

  24. Blood Pressure - Diastolic

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

    Time frame: 13 weeks

  25. Lipid Levels - HDL

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

    Time frame: 13 weeks

  26. Lipid Levels - LDL

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

    Time frame: 13 weeks

  27. Triglycerides

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

    Time frame: 13 weeks

  28. 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.

    Time frame: 13 weeks

  29. 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.

    Time frame: 13 weeks

  30. 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.

    Time frame: 13 weeks

  31. 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.

    Time frame: 13 weeks

  32. 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.

    Time frame: 13 weeks

  33. 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.

    Time frame: 13 weeks

  34. 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.

    Time frame: 13 weeks

07

Results

Posted Jun 3, 2025

Participant flow

Participant flow — Overall Study
MilestoneControl-IQ+ AIDCGM Arm
Started215104
Completed211102
Not completed42

Outcome measures

PrimaryHbA1c

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

Time frame:
13 weeks
Reported as:
Mean · percentage of glycated hemoglobin
HbA1c
percentage of glycated hemoglobinControl-IQ+ AIDCGM Arm
Baseline8.2 ± 1.48.1 ± 1.2
13 Weeks7.3 ± 0.97.7 ± 1.1
Change from Baseline-0.9 ± 1.1-0.3 ± 0.9
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Regression, Linear · p = <0.001 · Mean difference (net): -0.6 · 95% CI -0.8 to -0.4
SecondaryTime in Range 70-180 mg/dL

Change in CGM percent time 70-180 mg/dL from baseline, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · percentage of time
Time in Range 70-180 mg/dL
percentage of timeControl-IQ+ AIDCGM Arm
Baseline48 ± 2451 ± 21
13 Weeks64 ± 1652 ± 21
Change from Baseline16 ± 191 ± 14
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Regression, Linear · p = <0.001 · Mean difference (net): 14 · 95% CI 11 to 17
SecondaryMean Glucose

Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · mg/dL
Mean Glucose
mg/dLControl-IQ+ AIDCGM Arm
Baseline194 ± 43190 ± 35
13 Weeks170 ± 23188 ± 34
Change from Baseline-24 ± 34-1 ± 24
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Regression, Linear · p = <0.001 · Mean difference (net): -21 · 95% CI -26 to -15
SecondaryTime >180 mg/dL

Change in CGM percent time \>180 mg/dL from baseline, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · percentage of time
Time >180 mg/dL
percentage of timeControl-IQ+ AIDCGM Arm
Baseline51 ± 2549 ± 21
13 Weeks35 ± 1648 ± 21
Change from Baseline-16 ± 19-1 ± 14
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Regression, Linear · p = <0.001 · Mean difference (net): -14 · 95% CI -17 to -11
SecondaryTime >250 mg/dL

Change in CGM percent time \>250 mg/dL from baseline, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · percentage of time
Time >250 mg/dL
percentage of timeControl-IQ+ AIDCGM Arm
Baseline19.5 ± 17.315.8 ± 13.6
13 Weeks9.7 ± 7.816.7 ± 14.1
Change from Baseline-9.7 ± 17.11.0 ± 11.4
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Regression, Linear · p = <0.001 · Mean difference (net): -9.1 · 95% CI -11.7 to -6.6
SecondaryProlonged 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

Time frame:
13 weeks
Reported as:
Mean · events per week
Prolonged Hyperglycemia Events Per Week
events per weekControl-IQ+ AIDCGM Arm
Baseline1.7 ± 1.71.6 ± 1.7
13 Weeks0.9 ± 0.91.6 ± 1.5
Change from Baseline-0.7 ± 1.50.0 ± 1.0
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Regression, Linear · p = <0.001 · Mean difference (net): -0.7 · 95% CI -1.0 to -0.4
SecondaryTime <70 mg/dL

Change in CGM percent time \<70 mg/dL from baseline, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · percentage of time
Time <70 mg/dL
percentage of timeControl-IQ+ AIDCGM Arm
Baseline0.7 ± 0.80.3 ± 0.3
13 Weeks0.4 ± 0.40.4 ± 0.4
Change from Baseline-0.2 ± 1.20.1 ± 0.6
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Regression, Linear · Mean difference (net): -0.1 · 95% CI -0.4 to 0.1
SecondaryTime <54 mg/dL

Change in CGM percent time \<54 mg/dL from baseline, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · percentage of time
Time <54 mg/dL
percentage of timeControl-IQ+ AIDCGM Arm
Baseline0.16 ± 0.160.05 ± 0.05
13 Weeks0.09 ± 0.090.09 ± 0.10
Change from Baseline-0.06 ± 0.420.04 ± 0.22
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Regression, Linear · Mean difference (net): -0.02 · 95% CI -0.09 to 0.04
SecondaryCGM-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

Time frame:
13 weeks
Reported as:
Mean · events per week
CGM-measured Hypoglycemia Events Per Week
events per weekControl-IQ+ AIDCGM Arm
Baseline0.2 ± 0.30.1 ± 0.0
13 Weeks0.1 ± 0.20.1 ± 0.2
Change from Baseline-0.1 ± 0.60.1 ± 0.3
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Regression, Linear · Mean difference (net): 0.0 · 95% CI -0.1 to 0.0
SecondaryCoefficient of Variation

Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · percentage SD of Mean
Coefficient of Variation
percentage SD of MeanControl-IQ+ AIDCGM Arm
Baseline28 ± 627 ± 5
13 Weeks30 ± 529 ± 5
Change from Baseline2 ± 52 ± 3
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Regression, Linear · Mean difference (net): 0.3 · 95% CI -0.5 to 1.2
Other pre-specifiedHbA1c <7.0%

Number of participants with HbA1c \<7.0% at 13 weeks, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Count of participants · Participants
HbA1c <7.0%
ParticipantsControl-IQ+ AIDCGM Arm
Baseline2815
13 Weeks7828
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Difference in percent of participants.: 12 · 95% CI 1 to 21Estimation represents the difference in percent of participants in each arm who achieved the outcome.
Other pre-specifiedHbA1c <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

Time frame:
13 weeks
Reported as:
Count of participants · Participants
HbA1c <7.0% in Participants With Baseline HbA1c >7.5%
ParticipantsControl-IQ+ AIDCGM Arm
HbA1c <7.0% in Participants With Baseline HbA1c >7.5%336
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Difference in percent of participants.: 18 · 95% CI 2 to 32Estimation represents the difference in percent of participants in each arm who achieved the outcome.
Other pre-specifiedHbA1c <7.5%

Number of participants with HbA1c \<7.5% at 13 weeks, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Count of participants · Participants
HbA1c <7.5%
ParticipantsControl-IQ+ AIDCGM Arm
Baseline6033
13 Weeks13244
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Difference in percent of participants.: 23 · 95% CI 12 to 33Estimation represents the difference in percent of participants in each arm who achieved the outcome.
Other pre-specifiedHbA1c 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

Time frame:
13 weeks
Reported as:
Count of participants · Participants
HbA1c Improvement From Baseline to 13 Weeks >0.5%
ParticipantsControl-IQ+ AIDCGM Arm
HbA1c Improvement From Baseline to 13 Weeks >0.5%12331
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Difference in percent of participants.: 25 · 95% CI 11 to 38Estimation represents the difference in percent of participants in each arm who achieved the outcome.
Other pre-specifiedHbA1c 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

Time frame:
13 weeks
Reported as:
Count of participants · Participants
HbA1c Improvement From Baseline to 13 Weeks >1.0%
ParticipantsControl-IQ+ AIDCGM Arm
HbA1c Improvement From Baseline to 13 Weeks >1.0%8114
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Difference in percent of participants.: 22 · 95% CI 11 to 33Estimation represents the difference in percent of participants in each arm who achieved the outcome.
Other pre-specifiedHbA1c 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

Time frame:
13 weeks
Reported as:
Count of participants · Participants
HbA1c Relative Improvement From Baseline to 13 Weeks >10%
ParticipantsControl-IQ+ AIDCGM Arm
HbA1c Relative Improvement From Baseline to 13 Weeks >10%9220
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Difference in percent of participants.: 21 · 95% CI 10 to 32Estimation represents the difference in percent of participants in each arm who achieved the outcome.
Other pre-specifiedHbA1c 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

Time frame:
13 weeks
Reported as:
Count of participants · Participants
HbA1c Improvement From Baseline to 13 Weeks >1.0% or HbA1c <7.0% at 13 Weeks
ParticipantsControl-IQ+ AIDCGM Arm
HbA1c Improvement From Baseline to 13 Weeks >1.0% or HbA1c <7.0% at 13 Weeks13042
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Difference in percent of participants.: 21 · 95% CI 9 to 31Estimation represents the difference in percent of participants in each arm who achieved the outcome.
Other pre-specifiedTime in Range 70-140 mg/dL

Change in CGM percent time 70-140 mg/dL from baseline, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · percentage of time
Time in Range 70-140 mg/dL
percentage of timeControl-IQ+ AIDCGM Arm
Baseline23 ± 1823 ± 15
13 Weeks35 ± 1525 ± 15
Change from Baseline12 ± 132 ± 11
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Median difference (net): 10 · 95% CI 7 to 12
Other pre-specifiedArea Over the Curve (70 mg/dL)

CGM area over the curve (70 mg/dL), compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · mg*hr/dL
Area Over the Curve (70 mg/dL)
mg*hr/dLControl-IQ+ AIDCGM Arm
Baseline0.07 ± 0.080.03 ± 0.03
13 Weeks0.04 ± 0.040.04 ± 0.04
Change from Baseline-0.03 ± 0.160.02 ± 0.08
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Mean difference (net): -0.01 · 95% CI -0.02 to 0.01
Other pre-specifiedLow 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.

Time frame:
13 weeks
Reported as:
Mean · units on a scale
Low Blood Glucose Index
units on a scaleControl-IQ+ AIDCGM Arm
Baseline0.23 ± 0.240.12 ± 0.10
13 Weeks0.19 ± 0.150.17 ± 0.14
Change from Baseline-0.04 ± 0.310.05 ± 0.17
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Mean difference (net): -0.03 · 95% CI -0.07 to 0.01
Other pre-specifiedTime >300 mg/dL

Change in CGM percent time \>300 mg/dL from baseline, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · percentage of time
Time >300 mg/dL
percentage of timeControl-IQ+ AIDCGM Arm
Baseline8.6 ± 9.46.4 ± 6.6
13 Weeks3.5 ± 3.66.8 ± 7.2
Change from Baseline-5.1 ± 12.10.5 ± 8.5
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Mean difference (net): -4.4 · 95% CI -6.0 to -2.7
Other pre-specifiedArea Under the Curve (180 mg/dL)

CGM area under the curve (180 mg/dL), compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · mg*hr/dL
Area Under the Curve (180 mg/dL)
mg*hr/dLControl-IQ+ AIDCGM Arm
Baseline34 ± 2629 ± 21
13 Weeks19 ± 1230 ± 21
Change from Baseline-16 ± 271 ± 18
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Mean difference (net): -14 · 95% CI -18 to -10
Other pre-specifiedHigh 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.

Time frame:
13 weeks
Reported as:
Mean · units on a scale
High Blood Glucose Index
units on a scaleControl-IQ+ AIDCGM Arm
Baseline12.6 ± 7.111.4 ± 5.6
13 Weeks8.1 ± 3.611.4 ± 5.8
Change from Baseline-4.4 ± 6.80.0 ± 4.7
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Mean difference (net): -3.9 · 95% CI -5.2 to -2.7
Other pre-specifiedTime 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

Time frame:
13 weeks
Reported as:
Count of participants · Participants
Time in Range 70-180 mg/dL >70%
ParticipantsControl-IQ+ AIDCGM Arm
Baseline4618
13 Weeks8123
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Difference in percent of participants.: 16 · 95% CI 8 to 24Estimation represents the difference in percent of participants in each arm who achieved the outcome.
Other pre-specifiedTime 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

Time frame:
13 weeks
Reported as:
Count of participants · Participants
Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5%
ParticipantsControl-IQ+ AIDCGM Arm
Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5%14943
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Difference in percent of participants.: 26 · 95% CI 12 to 41Estimation represents the difference in percent of participants in each arm who achieved the outcome.
Other pre-specifiedTime 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

Time frame:
13 weeks
Reported as:
Count of participants · Participants
Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10%
ParticipantsAID ArmCGM Arm
Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10%12220
Statistical analysis
  • AID Arm vs CGM Arm · Difference in percent of participants.: 34 · 95% CI 21 to 45Estimation represents the difference in percent of participants in each arm who achieved the outcome.
Other pre-specifiedTime <70 mg/dL <4%

Number of participants with CGM time \<70 mg/dL \<4%, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Count of participants · Participants
Time <70 mg/dL <4%
ParticipantsControl-IQ+ AIDCGM Arm
Baseline207104
13 Weeks212104
Other pre-specifiedTime <54 mg/dL <1%

Number of participants with CGM time \<54 mg/dL \<1%, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Count of participants · Participants
Time <54 mg/dL <1%
ParticipantsControl-IQ+ AIDCGM Arm
Baseline205103
13 Weeks212104
Other pre-specifiedTime 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

Time frame:
13 weeks
Reported as:
Count of participants · Participants
Time in Range 70-180 mg/dL >70% and Time <54 mg/dL <1%
ParticipantsControl-IQ+ AIDCGM Arm
Baseline4317
13 Weeks8023
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Difference in percent of participants.: 15 · 95% CI 8 to 22Estimation represents the difference in percent of participants in each arm who achieved the outcome.
Other pre-specifiedTotal Insulin

Total daily insulin delivery (units), compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · units/day
Total Insulin
units/dayControl-IQ+ AIDCGM Arm
Baseline95 ± 47102 ± 50
13 Weeks87 ± 46104 ± 56
Change from Baseline-8 ± 382 ± 39
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Mean difference (net): -10 · 95% CI -20 to 0
Other pre-specifiedBasal Insulin

Percentage of insulin delivered as basal, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · percentage of units of insulin
Basal Insulin
percentage of units of insulinControl-IQ+ AIDCGM Arm
Baseline54.4 ± 16.152.6 ± 16.8
13 Weeks54.2 ± 11.954.1 ± 16.4
Change from Baseline-0.2 ± 18.51.5 ± 17.8
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Mean difference (net): -0.5 · 95% CI -4.4 to 3.4
Other pre-specifiedWeight

Change in weight (kg) from baseline, compared between the intervention and control groups

Time frame:
13 weeks
Reported as:
Mean · kg
Weight
kgControl-IQ+ AIDCGM Arm
Baseline100.5 ± 23.0104.8 ± 25.5
13 Weeks103.1 ± 24.2105.5 ± 24.5
Change from Baseline2.4 ± 4.40.9 ± 3.3
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Median difference (net): 1.5 · 95% CI 0.5 to 2.5
Other pre-specifiedBlood Pressure - Systolic

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

Time frame:
13 weeks
Reported as:
Mean · mm Hg
Blood Pressure - Systolic
mm HgControl-IQ+ AIDCGM Arm
Baseline130 ± 17128 ± 17
13 Weeks131 ± 17129 ± 17
Change from Baseline1 ± 171 ± 15
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Mean difference (net): 1.1 · 95% CI -2.5 to 4.7
Other pre-specifiedBlood Pressure - Diastolic

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

Time frame:
13 weeks
Reported as:
Mean · mm Hg
Blood Pressure - Diastolic
mm HgControl-IQ+ AIDCGM Arm
Baseline77 ± 1177 ± 10
13 Weeks77 ± 1178 ± 10
Change from Baseline0 ± 101 ± 9
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Mean difference (net): -1.3 · 95% CI -3.4 to 0.7
Other pre-specifiedLipid Levels - HDL

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

Time frame:
13 weeks
Reported as:
Mean · mg/dL
Lipid Levels - HDL
mg/dLControl-IQ+ AIDCGM Arm
Baseline45.3 ± 11.944.9 ± 15.5
13 Weeks45.7 ± 12.343.7 ± 13.0
Change from Baseline0.7 ± 5.8-1.3 ± 7.1
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Median difference (net): 2.1 · 95% CI 0.5 to 3.7
Other pre-specifiedLipid Levels - LDL

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

Time frame:
13 weeks
Reported as:
Mean · mg/dL
Lipid Levels - LDL
mg/dLControl-IQ+ AIDCGM Arm
Baseline75.6 ± 39.882.6 ± 40.6
13 Weeks77.9 ± 40.278.8 ± 36.6
Change from Baseline2.0 ± 27.1-5.3 ± 26.5
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Mean difference (net): 4.9 · 95% CI -1.4 to 11.1
Other pre-specifiedTriglycerides

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

Time frame:
13 weeks
Reported as:
Mean · mg/dL
Triglycerides
mg/dLControl-IQ+ AIDCGM Arm
Baseline164 ± 82180 ± 96
13 Weeks157 ± 78187 ± 108
Change from Baseline-7 ± 777 ± 119
Statistical analysis
  • Control-IQ+ AID vs CGM Arm · Mean difference (net): -20 · 95% CI -45 to 4
Other pre-specifiedType 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.

Time frame:
13 weeks
Reported as:
Mean · score on a scale
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
score on a scaleControl-IQ+ AIDCGM Arm
Intensity Score - Baseline2.6 ± 1.12.6 ± 1.0
Intensity Score - 13 Weeks2.2 ± 1.02.4 ± 1.0
Hypoglycemia - Baseline2.0 ± 1.12.0 ± 1.1
Hypoglycemia - 13 Weeks1.9 ± 1.01.8 ± 1.0
Long-term health - Baseline2.6 ± 1.12.8 ± 1.2
Long-term health - 13 Weeks2.4 ± 1.12.5 ± 1.1
Healthcare provider - Baseline1.7 ± 0.91.7 ± 0.8
Healthcare provider - 13 Weeks1.5 ± 0.81.6 ± 0.8
Interpersonal issues - Baseline1.9 ± 1.01.9 ± 1.0
Interpersonal issues - 13 Weeks1.7 ± 0.91.7 ± 1.0
Shame/stigma - Baseline1.5 ± 0.81.5 ± 0.8
Shame/stigma - 13 Weeks1.4 ± 0.71.3 ± 0.8
Healthcare access - Baseline2.0 ± 0.92.1 ± 0.9
Healthcare access - 13 Weeks1.9 ± 0.92.0 ± 0.9
Management demands - Baseline2.6 ± 1.02.6 ± 1.1
Management demands - 13 Weeks2.3 ± 1.02.3 ± 1.0
Other pre-specifiedDAWN 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.

Time frame:
13 weeks
Reported as:
Mean · score on a scale
DAWN Impact of Diabetes Profile (DIDP)
score on a scaleControl-IQ+ AIDCGM Arm
Baseline59 ± 1962 ± 15
13 Weeks59 ± 1863 ± 15
Other pre-specifiedDiabetes 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.

Time frame:
13 weeks
Reported as:
Mean · score on a scale
Diabetes Impact and Satisfaction (DIDS) Scale
score on a scaleControl-IQ+ AIDCGM Arm
Device Satisfaction - Baseline6.7 ± 1.97.0 ± 1.9
Device Satisfaction - 13 Weeks8.2 ± 1.67.2 ± 1.8
Diabetes Impact - Baseline3.4 ± 1.73.3 ± 1.8
Diabetes Impact - 13 Weeks3.1 ± 1.73.4 ± 1.8
Other pre-specifiedPROMIS 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.

Time frame:
13 weeks
Reported as:
Mean · score on a scale
PROMIS Sleep-Related Impairment Questionnaire
score on a scaleControl-IQ+ AIDCGM Arm
Baseline22.4 ± 7.322.0 ± 7.1
13 Weeks19.6 ± 6.921.8 ± 7.4
Other pre-specifiedSystem 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.

Time frame:
13 weeks
Reported as:
Mean · score on a scale
System Usability Scale (SUS)
score on a scaleControl-IQ+ AIDCGM Arm
Baseline69 ± 1870 ± 18
13 Weeks75 ± 1973 ± 17
Other pre-specifiedHypoglycemia 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.

Time frame:
13 weeks
Reported as:
Mean · score on a scale
Hypoglycemia Fear Survey II
score on a scaleControl-IQ+ AIDCGM Arm
Behavior - Baseline27 ± 1830 ± 18
Behavior - 13 Weeks26 ± 1728 ± 17
Worry - Baseline22 ± 2322 ± 19
Worry - 13 Weeks19 ± 2021 ± 21
Other pre-specifiedEQ5D-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.

Time frame:
13 weeks
Reported as:
Mean · score on a scale
EQ5D-5L
score on a scaleControl-IQ+ AIDCGM Arm
EQ-Index - Baseline0.76 ± 0.220.75 ± 0.27
EQ-Index - 13 Weeks0.77 ± 0.240.74 ± 0.29

Adverse events

Collected over 13 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control-IQ+ AID0/215 (0%)17/215 (7.9%)60/215 (27.9%)
CGM Arm1/104 (1%)7/104 (6.7%)18/104 (17.3%)
Most frequent serious events
Showing 10 of 26
Most frequent serious events
EventControl-IQ+ AIDCGM Arm
Congestive heart failureCardiac disorders1/2151/104
Coronary artery diseaseVascular disorders0/2151/104
HeadacheGeneral disorders0/2151/104
Pancreatitis (Fatal)Gastrointestinal disorders0/2151/104
PneumoniaInfections and infestations0/2151/104
Tooth abscessInfections and infestations0/2151/104
Unstable anginaCongenital, familial and genetic disorders0/2151/104
COVID-19Infections and infestations2/2150/104
Severe HypoglycemiaEndocrine disorders1/2150/104
Back surgeryMusculoskeletal and connective tissue disorders1/2150/104
Most frequent other events
Most frequent other events
EventControl-IQ+ AIDCGM Arm
Other reportable adverse eventsGeneral disorders37/21514/104
Hyperglycemia with or without ketosis related to study deviceEndocrine disorders13/2150/104
Non-severe hypoglycemiaEndocrine disorders9/2152/104
Hyperglycemia with or without ketosis not related to study deviceEndocrine disorders1/2152/104

Baseline characteristics

Age, Continuous
Age, Continuous(year)Control-IQ+ AIDCGM ArmTotal
Mean59 ± 1257 ± 1257 ± 12
Sex: Female, Male
Sex: Female, Male(Participants)Control-IQ+ AIDCGM ArmTotal
Female10549154
Male11055165
Race (NIH/OMB)
Race (NIH/OMB)(Participants)Control-IQ+ AIDCGM ArmTotal
American Indian or Alaska Native112
Asian10313
Native Hawaiian or Other Pacific Islander202
Black or African American452469
White14874222
More than one race628
Unknown or Not Reported303
Region of Enrollment
Region of Enrollment(participants)Control-IQ+ AIDCGM ArmTotal
Canada14620
United States20198299
08

Study locations

21 sites
  • Hoag Memorial Hospital Presbyterian
    Newport Beach, California 92663, United States
  • Emory University School of Medicine
    Atlanta, Georgia 30303, United States
  • Rocky Mountain Clinical Research
    Idaho Falls, Idaho 83404, United States
  • Northwestern University
    Chicago, Illinois 60611, United States
  • Baltimore VA Medical Center
    Baltimore, Maryland 21201, United States
  • Boston Medical Center Corporation
    Boston, Massachusetts 02118, United States
  • Henry Ford Health System
    Detroit, Michigan 48202, United States
  • Mayo Clinic
    Rochester, Minnesota 55905, United States
  • Icahn School of Medicine at Mt. Sinai
    New York, New York 10029, United States
  • SUNY Upstate Medical University
    Syracuse, New York 13210, United States
  • UHH Cleveland Medical Center
    Cleveland, Ohio 44106, United States
  • Oregon Health & Science University
    Portland, Oregon 97239, United States
  • University of Pennsylvania
    Philadelphia, Pennsylvania 19104, United States
  • Texas Diabetes and Endocrinology, P.A.
    Austin, Texas 78731, United States
  • University of Texas Southwestern
    Dallas, Texas 75013, United States
  • Diabetes & Endocrine Treatment Specialists
    Sandy City, Utah 84093, United States
  • University of Virginia
    Charlottesville, Virginia 22903, United States
  • Rainier Clinical Research Center
    Renton, Washington 98057, United States
  • University of Washington
    Seattle, Washington 98109, United States
  • Lawson Health Research Institute
    London, Ontario N6A 4V2, Canada
  • McGill University
    Montreal, Quebec H4A 3J1, Canada
09

References and documents

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. PubMed 40105270 ↗
  • 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. PubMed 40953318 ↗
  • 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. PubMed 41264828 ↗
  • 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. 2026 May;28(5):501-508. doi: 10.1177/15209156251395035. Epub 2025 Nov 14. PubMed 41264341 ↗
  • 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. PubMed 41574573 ↗
  • 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. PubMed 41348329 ↗
  • 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 Jul;28(7):6280-6290. doi: 10.1111/dom.70759. Epub 2026 May 5. PubMed 42086278 ↗

Study documents

  • Study protocol · Oct 31, 2023
  • Statistical analysis plan · Apr 18, 2023

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 22, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT05785832
Lead sponsor
Tandem Diabetes Care, Inc.
Collaborators
Jaeb Center for Health Research
Responsible party
Sponsor
First posted
Mar 27, 2023
Start date
Jun 1, 2023
Primary completion
Sep 24, 2024
Completion
Sep 24, 2024
Results posted
Jun 3, 2025
Last update
May 22, 2026

Study contacts

Jordan Pinsker, MD
study director · Tandem Diabetes Care
Yogish Kudva, MBBS
study chair · Mayo Clinic

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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