Type 2 Diabetes Treated With Insulin
Conditions
Keywords
Control-IQ+ technology, type 2 diabetes, automated insulin dosing, automated insulin delivery
Brief summary
A randomized controlled trial (RCT) to assess the safety and efficacy of use of Control-IQ+ technology in adults with type 2 diabetes using basal-bolus insulin therapy.
Detailed description
A randomized controlled trial (RCT) will evaluate 13 weeks of home use of the t:slim X2 insulin pump with Control-IQ+ technology in adults with type 2 diabetes age 18 and older using basal-bolus insulin therapy compared with continuation of pre-study insulin delivery plus continuous glucose monitoring (CGM). At least 300 participants will complete the trial at up to 25 clinical sites, across the United States and Canada. Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the intervention group using the t:slim X2 insulin pump with Control-IQ+ technology or to continue their pretrial insulin-delivery method for 13 weeks. Both arms used the Dexcom G6 CGM. The primary outcome is change in hemoglobin A1c (HbA1c) compared between the intervention and control group. The secondary endpoints will be tested for superiority, with a hierarchical testing approach. Additional outcomes are exploratory.
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.
Sponsors
Tandem Diabetes Care, Inc.
Jaeb Center for Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 13 weeks | Change in HbA1c (%) from baseline between the intervention and control groups |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time in Range 70-180 mg/dL | 13 weeks | Change in CGM percent time 70-180 mg/dL from baseline, compared between the intervention and control groups |
| Mean Glucose | 13 weeks | Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups |
| Time >180 mg/dL | 13 weeks | Change in CGM percent time \>180 mg/dL from baseline, compared between the intervention and control groups |
| Time >250 mg/dL | 13 weeks | Change in CGM percent time \>250 mg/dL from baseline, compared between the intervention and control groups |
| Prolonged Hyperglycemia Events Per Week | 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 |
| Time <70 mg/dL | 13 weeks | Change in CGM percent time \<70 mg/dL from baseline, compared between the intervention and control groups |
| Time <54 mg/dL | 13 weeks | Change in CGM percent time \<54 mg/dL from baseline, compared between the intervention and control groups |
| CGM-measured Hypoglycemia Events Per Week | 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 |
| Coefficient of Variation | 13 weeks | Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups |
Countries
Canada, United States
Contacts
STUDY_DIRECTORJordan Pinsker, MD
Tandem Diabetes Care
STUDY_CHAIRYogish Kudva, MBBS
Mayo Clinic
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control-IQ+ AID t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks. | 215 |
| CGM Arm Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks. | 104 |
| Total | 319 |
Baseline characteristics
| Characteristic | Control-IQ+ AID | CGM Arm | Total |
|---|---|---|---|
| Age, Continuous | 59 year STANDARD_DEVIATION 12 | 57 year STANDARD_DEVIATION 12 | 57 year STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 10 Participants | 3 Participants | 13 Participants |
| Race (NIH/OMB) Black or African American | 45 Participants | 24 Participants | 69 Participants |
| Race (NIH/OMB) More than one race | 6 Participants | 2 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) White | 148 Participants | 74 Participants | 222 Participants |
| Region of Enrollment Canada | 14 participants | 6 participants | 20 participants |
| Region of Enrollment United States | 201 participants | 98 participants | 299 participants |
| Sex: Female, Male Female | 105 Participants | 49 Participants | 154 Participants |
| Sex: Female, Male Male | 110 Participants | 55 Participants | 165 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 215 | 1 / 104 |
| other Total, other adverse events | 60 / 215 | 18 / 104 |
| serious Total, serious adverse events | 17 / 215 | 7 / 104 |
Outcome results
Primary
HbA1c
Change in HbA1c (%) from baseline between the intervention and control groups
Time frame: 13 weeks
Population: Data were missing because the sample that was obtained from one patient could not be analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | HbA1c | Baseline | 8.2 percentage of glycated hemoglobin | Standard Deviation 1.4 |
| Control-IQ+ AID | HbA1c | 13 Weeks | 7.3 percentage of glycated hemoglobin | Standard Deviation 0.9 |
| Control-IQ+ AID | HbA1c | Change from Baseline | -0.9 percentage of glycated hemoglobin | Standard Deviation 1.1 |
| CGM Arm | HbA1c | Baseline | 8.1 percentage of glycated hemoglobin | Standard Deviation 1.2 |
| CGM Arm | HbA1c | 13 Weeks | 7.7 percentage of glycated hemoglobin | Standard Deviation 1.1 |
| CGM Arm | HbA1c | Change from Baseline | -0.3 percentage of glycated hemoglobin | Standard Deviation 0.9 |
Comparison: Adjusted Difference Between Groupsp-value: <0.00195% CI: [-0.8, -0.4]Regression, Linear
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | CGM-measured Hypoglycemia Events Per Week | Baseline | 0.2 events per week | Standard Deviation 0.3 |
| Control-IQ+ AID | CGM-measured Hypoglycemia Events Per Week | 13 Weeks | 0.1 events per week | Standard Deviation 0.2 |
| Control-IQ+ AID | CGM-measured Hypoglycemia Events Per Week | Change from Baseline | -0.1 events per week | Standard Deviation 0.6 |
| CGM Arm | CGM-measured Hypoglycemia Events Per Week | Baseline | 0.1 events per week | Standard Deviation 0 |
| CGM Arm | CGM-measured Hypoglycemia Events Per Week | 13 Weeks | 0.1 events per week | Standard Deviation 0.2 |
| CGM Arm | CGM-measured Hypoglycemia Events Per Week | Change from Baseline | 0.1 events per week | Standard Deviation 0.3 |
Comparison: Adjusted Difference Between Groups95% CI: [-0.1, 0]Regression, Linear
Secondary
Coefficient of Variation
Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups
Time frame: 13 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Coefficient of Variation | Baseline | 28 percentage SD of Mean | Standard Deviation 6 |
| Control-IQ+ AID | Coefficient of Variation | 13 Weeks | 30 percentage SD of Mean | Standard Deviation 5 |
| Control-IQ+ AID | Coefficient of Variation | Change from Baseline | 2 percentage SD of Mean | Standard Deviation 5 |
| CGM Arm | Coefficient of Variation | Baseline | 27 percentage SD of Mean | Standard Deviation 5 |
| CGM Arm | Coefficient of Variation | 13 Weeks | 29 percentage SD of Mean | Standard Deviation 5 |
| CGM Arm | Coefficient of Variation | Change from Baseline | 2 percentage SD of Mean | Standard Deviation 3 |
Comparison: Adjusted Difference Between Groups95% CI: [-0.5, 1.2]Regression, Linear
Secondary
Mean Glucose
Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups
Time frame: 13 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Mean Glucose | Baseline | 194 mg/dL | Standard Deviation 43 |
| Control-IQ+ AID | Mean Glucose | 13 Weeks | 170 mg/dL | Standard Deviation 23 |
| Control-IQ+ AID | Mean Glucose | Change from Baseline | -24 mg/dL | Standard Deviation 34 |
| CGM Arm | Mean Glucose | Baseline | 190 mg/dL | Standard Deviation 35 |
| CGM Arm | Mean Glucose | 13 Weeks | 188 mg/dL | Standard Deviation 34 |
| CGM Arm | Mean Glucose | Change from Baseline | -1 mg/dL | Standard Deviation 24 |
Comparison: Adjusted Difference Between Groupsp-value: <0.00195% CI: [-26, -15]Regression, Linear
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Prolonged Hyperglycemia Events Per Week | Baseline | 1.7 events per week | Standard Deviation 1.7 |
| Control-IQ+ AID | Prolonged Hyperglycemia Events Per Week | 13 Weeks | 0.9 events per week | Standard Deviation 0.9 |
| Control-IQ+ AID | Prolonged Hyperglycemia Events Per Week | Change from Baseline | -0.7 events per week | Standard Deviation 1.5 |
| CGM Arm | Prolonged Hyperglycemia Events Per Week | Baseline | 1.6 events per week | Standard Deviation 1.7 |
| CGM Arm | Prolonged Hyperglycemia Events Per Week | 13 Weeks | 1.6 events per week | Standard Deviation 1.5 |
| CGM Arm | Prolonged Hyperglycemia Events Per Week | Change from Baseline | 0.0 events per week | Standard Deviation 1 |
Comparison: Adjusted Difference Between Groupsp-value: <0.00195% CI: [-1, -0.4]Regression, Linear
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Time >180 mg/dL | Baseline | 51 percentage of time | Standard Deviation 25 |
| Control-IQ+ AID | Time >180 mg/dL | 13 Weeks | 35 percentage of time | Standard Deviation 16 |
| Control-IQ+ AID | Time >180 mg/dL | Change from Baseline | -16 percentage of time | Standard Deviation 19 |
| CGM Arm | Time >180 mg/dL | Baseline | 49 percentage of time | Standard Deviation 21 |
| CGM Arm | Time >180 mg/dL | 13 Weeks | 48 percentage of time | Standard Deviation 21 |
| CGM Arm | Time >180 mg/dL | Change from Baseline | -1 percentage of time | Standard Deviation 14 |
Comparison: Adjusted Difference Between Groupsp-value: <0.00195% CI: [-17, -11]Regression, Linear
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Time >250 mg/dL | Baseline | 19.5 percentage of time | Standard Deviation 17.3 |
| Control-IQ+ AID | Time >250 mg/dL | 13 Weeks | 9.7 percentage of time | Standard Deviation 7.8 |
| Control-IQ+ AID | Time >250 mg/dL | Change from Baseline | -9.7 percentage of time | Standard Deviation 17.1 |
| CGM Arm | Time >250 mg/dL | Baseline | 15.8 percentage of time | Standard Deviation 13.6 |
| CGM Arm | Time >250 mg/dL | 13 Weeks | 16.7 percentage of time | Standard Deviation 14.1 |
| CGM Arm | Time >250 mg/dL | Change from Baseline | 1.0 percentage of time | Standard Deviation 11.4 |
Comparison: Adjusted Difference Between Groupsp-value: <0.00195% CI: [-11.7, -6.6]Regression, Linear
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Time <54 mg/dL | Baseline | 0.16 percentage of time | Standard Deviation 0.16 |
| Control-IQ+ AID | Time <54 mg/dL | 13 Weeks | 0.09 percentage of time | Standard Deviation 0.09 |
| Control-IQ+ AID | Time <54 mg/dL | Change from Baseline | -0.06 percentage of time | Standard Deviation 0.42 |
| CGM Arm | Time <54 mg/dL | Baseline | 0.05 percentage of time | Standard Deviation 0.05 |
| CGM Arm | Time <54 mg/dL | 13 Weeks | 0.09 percentage of time | Standard Deviation 0.1 |
| CGM Arm | Time <54 mg/dL | Change from Baseline | 0.04 percentage of time | Standard Deviation 0.22 |
Comparison: Adjusted Difference Between Groups95% CI: [-0.09, 0.04]Regression, Linear
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Time <70 mg/dL | Baseline | 0.7 percentage of time | Standard Deviation 0.8 |
| Control-IQ+ AID | Time <70 mg/dL | 13 Weeks | 0.4 percentage of time | Standard Deviation 0.4 |
| Control-IQ+ AID | Time <70 mg/dL | Change from Baseline | -0.2 percentage of time | Standard Deviation 1.2 |
| CGM Arm | Time <70 mg/dL | Baseline | 0.3 percentage of time | Standard Deviation 0.3 |
| CGM Arm | Time <70 mg/dL | 13 Weeks | 0.4 percentage of time | Standard Deviation 0.4 |
| CGM Arm | Time <70 mg/dL | Change from Baseline | 0.1 percentage of time | Standard Deviation 0.6 |
Comparison: Adjusted Difference Between Groups95% CI: [-0.4, 0.1]Regression, Linear
Secondary
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Time in Range 70-180 mg/dL | Baseline | 48 percentage of time | Standard Deviation 24 |
| Control-IQ+ AID | Time in Range 70-180 mg/dL | 13 Weeks | 64 percentage of time | Standard Deviation 16 |
| Control-IQ+ AID | Time in Range 70-180 mg/dL | Change from Baseline | 16 percentage of time | Standard Deviation 19 |
| CGM Arm | Time in Range 70-180 mg/dL | Baseline | 51 percentage of time | Standard Deviation 21 |
| CGM Arm | Time in Range 70-180 mg/dL | 13 Weeks | 52 percentage of time | Standard Deviation 21 |
| CGM Arm | Time in Range 70-180 mg/dL | Change from Baseline | 1 percentage of time | Standard Deviation 14 |
Comparison: Adjusted Difference Between Groupsp-value: <0.00195% CI: [11, 17]Regression, Linear
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Area Over the Curve (70 mg/dL) | Baseline | 0.07 mg*hr/dL | Standard Deviation 0.08 |
| Control-IQ+ AID | Area Over the Curve (70 mg/dL) | 13 Weeks | 0.04 mg*hr/dL | Standard Deviation 0.04 |
| Control-IQ+ AID | Area Over the Curve (70 mg/dL) | Change from Baseline | -0.03 mg*hr/dL | Standard Deviation 0.16 |
| CGM Arm | Area Over the Curve (70 mg/dL) | Baseline | 0.03 mg*hr/dL | Standard Deviation 0.03 |
| CGM Arm | Area Over the Curve (70 mg/dL) | 13 Weeks | 0.04 mg*hr/dL | Standard Deviation 0.04 |
| CGM Arm | Area Over the Curve (70 mg/dL) | Change from Baseline | 0.02 mg*hr/dL | Standard Deviation 0.08 |
95% CI: [-0.02, 0.01]
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Area Under the Curve (180 mg/dL) | Baseline | 34 mg*hr/dL | Standard Deviation 26 |
| Control-IQ+ AID | Area Under the Curve (180 mg/dL) | 13 Weeks | 19 mg*hr/dL | Standard Deviation 12 |
| Control-IQ+ AID | Area Under the Curve (180 mg/dL) | Change from Baseline | -16 mg*hr/dL | Standard Deviation 27 |
| CGM Arm | Area Under the Curve (180 mg/dL) | Baseline | 29 mg*hr/dL | Standard Deviation 21 |
| CGM Arm | Area Under the Curve (180 mg/dL) | 13 Weeks | 30 mg*hr/dL | Standard Deviation 21 |
| CGM Arm | Area Under the Curve (180 mg/dL) | Change from Baseline | 1 mg*hr/dL | Standard Deviation 18 |
Comparison: Adjusted Difference Between Groups95% CI: [-18, -10]
Other Pre-specified
Basal Insulin
Percentage of insulin delivered as basal, compared between the intervention and control groups
Time frame: 13 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Basal Insulin | Baseline | 54.4 percentage of units of insulin | Standard Deviation 16.1 |
| Control-IQ+ AID | Basal Insulin | 13 Weeks | 54.2 percentage of units of insulin | Standard Deviation 11.9 |
| Control-IQ+ AID | Basal Insulin | Change from Baseline | -0.2 percentage of units of insulin | Standard Deviation 18.5 |
| CGM Arm | Basal Insulin | Baseline | 52.6 percentage of units of insulin | Standard Deviation 16.8 |
| CGM Arm | Basal Insulin | 13 Weeks | 54.1 percentage of units of insulin | Standard Deviation 16.4 |
| CGM Arm | Basal Insulin | Change from Baseline | 1.5 percentage of units of insulin | Standard Deviation 17.8 |
Comparison: Adjusted Difference Between Groups.95% CI: [-4.4, 3.4]
Other Pre-specified
Blood Pressure - Diastolic
Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups
Time frame: 13 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Blood Pressure - Diastolic | Baseline | 77 mm Hg | Standard Deviation 11 |
| Control-IQ+ AID | Blood Pressure - Diastolic | 13 Weeks | 77 mm Hg | Standard Deviation 11 |
| Control-IQ+ AID | Blood Pressure - Diastolic | Change from Baseline | 0 mm Hg | Standard Deviation 10 |
| CGM Arm | Blood Pressure - Diastolic | Baseline | 77 mm Hg | Standard Deviation 10 |
| CGM Arm | Blood Pressure - Diastolic | 13 Weeks | 78 mm Hg | Standard Deviation 10 |
| CGM Arm | Blood Pressure - Diastolic | Change from Baseline | 1 mm Hg | Standard Deviation 9 |
Comparison: Adjusted Difference Between Groups.95% CI: [-3.4, 0.7]
Other Pre-specified
Blood Pressure - Systolic
Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups
Time frame: 13 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Blood Pressure - Systolic | Baseline | 130 mm Hg | Standard Deviation 17 |
| Control-IQ+ AID | Blood Pressure - Systolic | 13 Weeks | 131 mm Hg | Standard Deviation 17 |
| Control-IQ+ AID | Blood Pressure - Systolic | Change from Baseline | 1 mm Hg | Standard Deviation 17 |
| CGM Arm | Blood Pressure - Systolic | Baseline | 128 mm Hg | Standard Deviation 17 |
| CGM Arm | Blood Pressure - Systolic | 13 Weeks | 129 mm Hg | Standard Deviation 17 |
| CGM Arm | Blood Pressure - Systolic | Change from Baseline | 1 mm Hg | Standard Deviation 15 |
Comparison: Adjusted Difference Between Groups.95% CI: [-2.5, 4.7]
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | DAWN Impact of Diabetes Profile (DIDP) | Baseline | 59 score on a scale | Standard Deviation 19 |
| Control-IQ+ AID | DAWN Impact of Diabetes Profile (DIDP) | 13 Weeks | 59 score on a scale | Standard Deviation 18 |
| CGM Arm | DAWN Impact of Diabetes Profile (DIDP) | Baseline | 62 score on a scale | Standard Deviation 15 |
| CGM Arm | DAWN Impact of Diabetes Profile (DIDP) | 13 Weeks | 63 score on a scale | Standard Deviation 15 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Diabetes Impact and Satisfaction (DIDS) Scale | Device Satisfaction - Baseline | 6.7 score on a scale | Standard Deviation 1.9 |
| Control-IQ+ AID | Diabetes Impact and Satisfaction (DIDS) Scale | Device Satisfaction - 13 Weeks | 8.2 score on a scale | Standard Deviation 1.6 |
| Control-IQ+ AID | Diabetes Impact and Satisfaction (DIDS) Scale | Diabetes Impact - Baseline | 3.4 score on a scale | Standard Deviation 1.7 |
| Control-IQ+ AID | Diabetes Impact and Satisfaction (DIDS) Scale | Diabetes Impact - 13 Weeks | 3.1 score on a scale | Standard Deviation 1.7 |
| CGM Arm | Diabetes Impact and Satisfaction (DIDS) Scale | Diabetes Impact - 13 Weeks | 3.4 score on a scale | Standard Deviation 1.8 |
| CGM Arm | Diabetes Impact and Satisfaction (DIDS) Scale | Device Satisfaction - Baseline | 7.0 score on a scale | Standard Deviation 1.9 |
| CGM Arm | Diabetes Impact and Satisfaction (DIDS) Scale | Diabetes Impact - Baseline | 3.3 score on a scale | Standard Deviation 1.8 |
| CGM Arm | Diabetes Impact and Satisfaction (DIDS) Scale | Device Satisfaction - 13 Weeks | 7.2 score on a scale | Standard Deviation 1.8 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | EQ5D-5L | EQ-Index - Baseline | 0.76 score on a scale | Standard Deviation 0.22 |
| Control-IQ+ AID | EQ5D-5L | EQ-Index - 13 Weeks | 0.77 score on a scale | Standard Deviation 0.24 |
| CGM Arm | EQ5D-5L | EQ-Index - 13 Weeks | 0.74 score on a scale | Standard Deviation 0.29 |
| CGM Arm | EQ5D-5L | EQ-Index - Baseline | 0.75 score on a scale | Standard Deviation 0.27 |
Other Pre-specified
HbA1c <7.0%
Number of participants with HbA1c \<7.0% at 13 weeks, compared between the intervention and control groups
Time frame: 13 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control-IQ+ AID | HbA1c <7.0% | Baseline | 28 Participants |
| Control-IQ+ AID | HbA1c <7.0% | 13 Weeks | 78 Participants |
| CGM Arm | HbA1c <7.0% | Baseline | 15 Participants |
| CGM Arm | HbA1c <7.0% | 13 Weeks | 28 Participants |
95% CI: [1, 21]
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control-IQ+ AID | HbA1c <7.0% in Participants With Baseline HbA1c >7.5% | 33 Participants |
| CGM Arm | HbA1c <7.0% in Participants With Baseline HbA1c >7.5% | 6 Participants |
95% CI: [2, 32]
Other Pre-specified
HbA1c <7.5%
Number of participants with HbA1c \<7.5% at 13 weeks, compared between the intervention and control groups
Time frame: 13 weeks
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control-IQ+ AID | HbA1c <7.5% | Baseline | 60 Participants |
| Control-IQ+ AID | HbA1c <7.5% | 13 Weeks | 132 Participants |
| CGM Arm | HbA1c <7.5% | Baseline | 33 Participants |
| CGM Arm | HbA1c <7.5% | 13 Weeks | 44 Participants |
95% CI: [12, 33]
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control-IQ+ AID | HbA1c Improvement From Baseline to 13 Weeks >0.5% | 123 Participants |
| CGM Arm | HbA1c Improvement From Baseline to 13 Weeks >0.5% | 31 Participants |
95% CI: [11, 38]
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control-IQ+ AID | HbA1c Improvement From Baseline to 13 Weeks >1.0% | 81 Participants |
| CGM Arm | HbA1c Improvement From Baseline to 13 Weeks >1.0% | 14 Participants |
95% CI: [11, 33]
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control-IQ+ AID | HbA1c Improvement From Baseline to 13 Weeks >1.0% or HbA1c <7.0% at 13 Weeks | 130 Participants |
| CGM Arm | HbA1c Improvement From Baseline to 13 Weeks >1.0% or HbA1c <7.0% at 13 Weeks | 42 Participants |
95% CI: [9, 31]
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control-IQ+ AID | HbA1c Relative Improvement From Baseline to 13 Weeks >10% | 92 Participants |
| CGM Arm | HbA1c Relative Improvement From Baseline to 13 Weeks >10% | 20 Participants |
95% CI: [10, 32]
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | High Blood Glucose Index | Baseline | 12.6 units on a scale | Standard Deviation 7.1 |
| Control-IQ+ AID | High Blood Glucose Index | 13 Weeks | 8.1 units on a scale | Standard Deviation 3.6 |
| Control-IQ+ AID | High Blood Glucose Index | Change from Baseline | -4.4 units on a scale | Standard Deviation 6.8 |
| CGM Arm | High Blood Glucose Index | Baseline | 11.4 units on a scale | Standard Deviation 5.6 |
| CGM Arm | High Blood Glucose Index | 13 Weeks | 11.4 units on a scale | Standard Deviation 5.8 |
| CGM Arm | High Blood Glucose Index | Change from Baseline | 0.0 units on a scale | Standard Deviation 4.7 |
Comparison: Adjusted Difference Between Groups95% CI: [-5.2, -2.7]
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Hypoglycemia Fear Survey II | Behavior - Baseline | 27 score on a scale | Standard Deviation 18 |
| Control-IQ+ AID | Hypoglycemia Fear Survey II | Behavior - 13 Weeks | 26 score on a scale | Standard Deviation 17 |
| Control-IQ+ AID | Hypoglycemia Fear Survey II | Worry - Baseline | 22 score on a scale | Standard Deviation 23 |
| Control-IQ+ AID | Hypoglycemia Fear Survey II | Worry - 13 Weeks | 19 score on a scale | Standard Deviation 20 |
| CGM Arm | Hypoglycemia Fear Survey II | Worry - 13 Weeks | 21 score on a scale | Standard Deviation 21 |
| CGM Arm | Hypoglycemia Fear Survey II | Behavior - Baseline | 30 score on a scale | Standard Deviation 18 |
| CGM Arm | Hypoglycemia Fear Survey II | Worry - Baseline | 22 score on a scale | Standard Deviation 19 |
| CGM Arm | Hypoglycemia Fear Survey II | Behavior - 13 Weeks | 28 score on a scale | Standard Deviation 17 |
Other Pre-specified
Lipid Levels - HDL
Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups
Time frame: 13 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Lipid Levels - HDL | Baseline | 45.3 mg/dL | Standard Deviation 11.9 |
| Control-IQ+ AID | Lipid Levels - HDL | 13 Weeks | 45.7 mg/dL | Standard Deviation 12.3 |
| Control-IQ+ AID | Lipid Levels - HDL | Change from Baseline | 0.7 mg/dL | Standard Deviation 5.8 |
| CGM Arm | Lipid Levels - HDL | Baseline | 44.9 mg/dL | Standard Deviation 15.5 |
| CGM Arm | Lipid Levels - HDL | 13 Weeks | 43.7 mg/dL | Standard Deviation 13 |
| CGM Arm | Lipid Levels - HDL | Change from Baseline | -1.3 mg/dL | Standard Deviation 7.1 |
Comparison: Adjusted Difference Between Groups.95% CI: [0.5, 3.7]
Other Pre-specified
Lipid Levels - LDL
Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups
Time frame: 13 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Lipid Levels - LDL | Baseline | 75.6 mg/dL | Standard Deviation 39.8 |
| Control-IQ+ AID | Lipid Levels - LDL | 13 Weeks | 77.9 mg/dL | Standard Deviation 40.2 |
| Control-IQ+ AID | Lipid Levels - LDL | Change from Baseline | 2.0 mg/dL | Standard Deviation 27.1 |
| CGM Arm | Lipid Levels - LDL | Baseline | 82.6 mg/dL | Standard Deviation 40.6 |
| CGM Arm | Lipid Levels - LDL | 13 Weeks | 78.8 mg/dL | Standard Deviation 36.6 |
| CGM Arm | Lipid Levels - LDL | Change from Baseline | -5.3 mg/dL | Standard Deviation 26.5 |
Comparison: Adjusted Difference Between Groups.95% CI: [-1.4, 11.1]
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Low Blood Glucose Index | Baseline | 0.23 units on a scale | Standard Deviation 0.24 |
| Control-IQ+ AID | Low Blood Glucose Index | 13 Weeks | 0.19 units on a scale | Standard Deviation 0.15 |
| Control-IQ+ AID | Low Blood Glucose Index | Change from Baseline | -0.04 units on a scale | Standard Deviation 0.31 |
| CGM Arm | Low Blood Glucose Index | Baseline | 0.12 units on a scale | Standard Deviation 0.1 |
| CGM Arm | Low Blood Glucose Index | 13 Weeks | 0.17 units on a scale | Standard Deviation 0.14 |
| CGM Arm | Low Blood Glucose Index | Change from Baseline | 0.05 units on a scale | Standard Deviation 0.17 |
Comparison: Adjusted Difference Between Groups95% CI: [-0.07, 0.01]
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | PROMIS Sleep-Related Impairment Questionnaire | Baseline | 22.4 score on a scale | Standard Deviation 7.3 |
| Control-IQ+ AID | PROMIS Sleep-Related Impairment Questionnaire | 13 Weeks | 19.6 score on a scale | Standard Deviation 6.9 |
| CGM Arm | PROMIS Sleep-Related Impairment Questionnaire | Baseline | 22.0 score on a scale | Standard Deviation 7.1 |
| CGM Arm | PROMIS Sleep-Related Impairment Questionnaire | 13 Weeks | 21.8 score on a scale | Standard Deviation 7.4 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | System Usability Scale (SUS) | Baseline | 69 score on a scale | Standard Deviation 18 |
| Control-IQ+ AID | System Usability Scale (SUS) | 13 Weeks | 75 score on a scale | Standard Deviation 19 |
| CGM Arm | System Usability Scale (SUS) | Baseline | 70 score on a scale | Standard Deviation 18 |
| CGM Arm | System Usability Scale (SUS) | 13 Weeks | 73 score on a scale | Standard Deviation 17 |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Time >300 mg/dL | Baseline | 8.6 percentage of time | Standard Deviation 9.4 |
| Control-IQ+ AID | Time >300 mg/dL | 13 Weeks | 3.5 percentage of time | Standard Deviation 3.6 |
| Control-IQ+ AID | Time >300 mg/dL | Change from Baseline | -5.1 percentage of time | Standard Deviation 12.1 |
| CGM Arm | Time >300 mg/dL | Baseline | 6.4 percentage of time | Standard Deviation 6.6 |
| CGM Arm | Time >300 mg/dL | 13 Weeks | 6.8 percentage of time | Standard Deviation 7.2 |
| CGM Arm | Time >300 mg/dL | Change from Baseline | 0.5 percentage of time | Standard Deviation 8.5 |
Comparison: Adjusted Difference Between Groups95% CI: [-6, -2.7]
Other Pre-specified
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control-IQ+ AID | Time <54 mg/dL <1% | Baseline | 205 Participants |
| Control-IQ+ AID | Time <54 mg/dL <1% | 13 Weeks | 212 Participants |
| CGM Arm | Time <54 mg/dL <1% | Baseline | 103 Participants |
| CGM Arm | Time <54 mg/dL <1% | 13 Weeks | 104 Participants |
Other Pre-specified
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control-IQ+ AID | Time <70 mg/dL <4% | Baseline | 207 Participants |
| Control-IQ+ AID | Time <70 mg/dL <4% | 13 Weeks | 212 Participants |
| CGM Arm | Time <70 mg/dL <4% | Baseline | 104 Participants |
| CGM Arm | Time <70 mg/dL <4% | 13 Weeks | 104 Participants |
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Time in Range 70-140 mg/dL | Baseline | 23 percentage of time | Standard Deviation 18 |
| Control-IQ+ AID | Time in Range 70-140 mg/dL | 13 Weeks | 35 percentage of time | Standard Deviation 15 |
| Control-IQ+ AID | Time in Range 70-140 mg/dL | Change from Baseline | 12 percentage of time | Standard Deviation 13 |
| CGM Arm | Time in Range 70-140 mg/dL | Baseline | 23 percentage of time | Standard Deviation 15 |
| CGM Arm | Time in Range 70-140 mg/dL | 13 Weeks | 25 percentage of time | Standard Deviation 15 |
| CGM Arm | Time in Range 70-140 mg/dL | Change from Baseline | 2 percentage of time | Standard Deviation 11 |
Comparison: Adjusted Difference Between Groups95% CI: [7, 12]
Other Pre-specified
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control-IQ+ AID | Time in Range 70-180 mg/dL >70% | Baseline | 46 Participants |
| Control-IQ+ AID | Time in Range 70-180 mg/dL >70% | 13 Weeks | 81 Participants |
| CGM Arm | Time in Range 70-180 mg/dL >70% | Baseline | 18 Participants |
| CGM Arm | Time in Range 70-180 mg/dL >70% | 13 Weeks | 23 Participants |
95% CI: [8, 24]
Other Pre-specified
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
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Control-IQ+ AID | Time in Range 70-180 mg/dL >70% and Time <54 mg/dL <1% | Baseline | 43 Participants |
| Control-IQ+ AID | Time in Range 70-180 mg/dL >70% and Time <54 mg/dL <1% | 13 Weeks | 80 Participants |
| CGM Arm | Time in Range 70-180 mg/dL >70% and Time <54 mg/dL <1% | Baseline | 17 Participants |
| CGM Arm | Time in Range 70-180 mg/dL >70% and Time <54 mg/dL <1% | 13 Weeks | 23 Participants |
95% CI: [8, 22]
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control-IQ+ AID | Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10% | 122 Participants |
| CGM Arm | Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10% | 20 Participants |
95% CI: [21, 45]
Other Pre-specified
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Control-IQ+ AID | Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5% | 149 Participants |
| CGM Arm | Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5% | 43 Participants |
95% CI: [12, 41]
Other Pre-specified
Total Insulin
Total daily insulin delivery (units), compared between the intervention and control groups
Time frame: 13 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Total Insulin | Baseline | 95 units/day | Standard Deviation 47 |
| Control-IQ+ AID | Total Insulin | 13 Weeks | 87 units/day | Standard Deviation 46 |
| Control-IQ+ AID | Total Insulin | Change from Baseline | -8 units/day | Standard Deviation 38 |
| CGM Arm | Total Insulin | Baseline | 102 units/day | Standard Deviation 50 |
| CGM Arm | Total Insulin | 13 Weeks | 104 units/day | Standard Deviation 56 |
| CGM Arm | Total Insulin | Change from Baseline | 2 units/day | Standard Deviation 39 |
Comparison: Adjusted Difference Between Groups.95% CI: [-20, 0]
Other Pre-specified
Triglycerides
Change in triglycerides (mg/dL), compared between the intervention and control groups
Time frame: 13 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Triglycerides | Baseline | 164 mg/dL | Standard Deviation 82 |
| Control-IQ+ AID | Triglycerides | 13 Weeks | 157 mg/dL | Standard Deviation 78 |
| Control-IQ+ AID | Triglycerides | Change from Baseline | -7 mg/dL | Standard Deviation 77 |
| CGM Arm | Triglycerides | 13 Weeks | 187 mg/dL | Standard Deviation 108 |
| CGM Arm | Triglycerides | Baseline | 180 mg/dL | Standard Deviation 96 |
| CGM Arm | Triglycerides | Change from Baseline | 7 mg/dL | Standard Deviation 119 |
Comparison: Adjusted Difference Between Groups.95% CI: [-45, 4]
Other Pre-specified
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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Intensity Score - Baseline | 2.6 score on a scale | Standard Deviation 1.1 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Intensity Score - 13 Weeks | 2.2 score on a scale | Standard Deviation 1 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Hypoglycemia - Baseline | 2.0 score on a scale | Standard Deviation 1.1 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Hypoglycemia - 13 Weeks | 1.9 score on a scale | Standard Deviation 1 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Long-term health - Baseline | 2.6 score on a scale | Standard Deviation 1.1 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Long-term health - 13 Weeks | 2.4 score on a scale | Standard Deviation 1.1 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Healthcare provider - Baseline | 1.7 score on a scale | Standard Deviation 0.9 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Healthcare provider - 13 Weeks | 1.5 score on a scale | Standard Deviation 0.8 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Interpersonal issues - Baseline | 1.9 score on a scale | Standard Deviation 1 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Interpersonal issues - 13 Weeks | 1.7 score on a scale | Standard Deviation 0.9 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Shame/stigma - Baseline | 1.5 score on a scale | Standard Deviation 0.8 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Shame/stigma - 13 Weeks | 1.4 score on a scale | Standard Deviation 0.7 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Healthcare access - Baseline | 2.0 score on a scale | Standard Deviation 0.9 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Healthcare access - 13 Weeks | 1.9 score on a scale | Standard Deviation 0.9 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Management demands - Baseline | 2.6 score on a scale | Standard Deviation 1 |
| Control-IQ+ AID | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Management demands - 13 Weeks | 2.3 score on a scale | Standard Deviation 1 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Management demands - 13 Weeks | 2.3 score on a scale | Standard Deviation 1 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Intensity Score - Baseline | 2.6 score on a scale | Standard Deviation 1 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Interpersonal issues - Baseline | 1.9 score on a scale | Standard Deviation 1 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Intensity Score - 13 Weeks | 2.4 score on a scale | Standard Deviation 1 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Healthcare access - Baseline | 2.1 score on a scale | Standard Deviation 0.9 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Hypoglycemia - Baseline | 2.0 score on a scale | Standard Deviation 1.1 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Interpersonal issues - 13 Weeks | 1.7 score on a scale | Standard Deviation 1 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Hypoglycemia - 13 Weeks | 1.8 score on a scale | Standard Deviation 1 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Management demands - Baseline | 2.6 score on a scale | Standard Deviation 1.1 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Long-term health - Baseline | 2.8 score on a scale | Standard Deviation 1.2 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Shame/stigma - Baseline | 1.5 score on a scale | Standard Deviation 0.8 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Long-term health - 13 Weeks | 2.5 score on a scale | Standard Deviation 1.1 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Healthcare access - 13 Weeks | 2.0 score on a scale | Standard Deviation 0.9 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Healthcare provider - Baseline | 1.7 score on a scale | Standard Deviation 0.8 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Shame/stigma - 13 Weeks | 1.3 score on a scale | Standard Deviation 0.8 |
| CGM Arm | Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source) | Healthcare provider - 13 Weeks | 1.6 score on a scale | Standard Deviation 0.8 |
Other Pre-specified
Weight
Change in weight (kg) from baseline, compared between the intervention and control groups
Time frame: 13 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ+ AID | Weight | Baseline | 100.5 kg | Standard Deviation 23 |
| Control-IQ+ AID | Weight | 13 Weeks | 103.1 kg | Standard Deviation 24.2 |
| Control-IQ+ AID | Weight | Change from Baseline | 2.4 kg | Standard Deviation 4.4 |
| CGM Arm | Weight | 13 Weeks | 105.5 kg | Standard Deviation 24.5 |
| CGM Arm | Weight | Baseline | 104.8 kg | Standard Deviation 25.5 |
| CGM Arm | Weight | Change from Baseline | 0.9 kg | Standard Deviation 3.3 |
Comparison: Adjusted Difference Between Groups.95% CI: [0.5, 2.5]