Type 1 Diabetes
Conditions
Keywords
type 1 diabetes, Control-IQ Technology, automated insulin dosing, automated insulin delivery
Brief summary
Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.
Detailed description
This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by 13 weeks of Control-IQ technology use. By using an algorithm to more accurately initialize insulin delivery settings and adapt them over time, faster than typical HCP visits, users onboarding from multiple daily injections (MDI) will reach optimal glycemic outcomes faster.
Interventions
DEVICEAutomated Insulin Delivery Settings Initialization and Adaptation Algorithm
All participants wearing the t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 sensor, will have algorithm derived insulin delivery profile settings initialization and updates at regular intervals.
Sponsors
Tandem Diabetes Care, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult subjects ≥ age 18 years * Clinical diagnosis of type 1 diabetes for at least one year * Using a basal/bolus regimen by injection (MDI therapy) * Total daily dose ≥10 units/day * Willing to use only aspart (novolog) or lispro (humalog) U-100 insulin with the study pump. * A1c ≥ 7.5% and ≤ 11% at screening * Not pregnant or planning a pregnancy during the time period of the study. * Has current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (will provide prescription if they do not have one) * Willingness to follow study procedures and a signed informed consent form
Exclusion criteria
* Two or more episodes of severe hypoglycemia (needing assistance) in the past 6 months * Two or more episodes of diabetic ketoacidosis in the past 6 months * Inpatient psychiatric treatment in the past 6 months * History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study * Significant chronic kidney disease or hemodialysis * Significant liver disease * History of adrenal insufficiency * Hypothyroidism or hyperthyroidism that is not appropriately treated * Other chronic disease/condition determined by investigator to interfere with participation in the study * Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study * Use of long-acting insulin, inhaled insulin (Afrezza), or use of any non-insulin glucose lowering agents (i.e. SGLT-2 inhibitor) other than Metformin with the study pump * Subject is pregnant or lactating or intending to become pregnant before or during participation in this study * Investigator judgement that subject would not be able to complete the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severe Hypoglycemic Events | 15 weeks | Number of Severe Hypoglycemic Events (with altered mental status) |
| Diabetic Ketoacidosis Events | 15 weeks | Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Time > 180 mg/dL, Daytime Outcomes | 15 weeks | CGM percent time \> 180 mg/dL, Daytime Outcomes between 06:00-00:00 |
| Percent Time > 180 mg/dL, Overnight Outcomes | 15 weeks | CGM percent time \> 180 mg/dL, Overnight Outcomes between 00:00-06:00 |
| Percent Time < 54 mg/dL, Overall | 15 weeks | CGM percent time \< 54 mg/dL, Overall Study Participation |
| Percent Time < 54 mg/dL, Daytime Outcomes | 15 weeks | CGM percent time \< 54 mg/dL, Daytime Outcomes between 06:00-00:00 |
| Percent Time < 54 mg/dL, Overnight Outcomes | 15 weeks | CGM percent time \< 54 mg/dL, Overnight Outcomes between 00:00-06:00 |
| Percent Time < 70 mg/dL, Overall | 15 weeks | CGM percent time \< 70 mg/dL, Overall Study Participation |
| Percent Time < 70 mg/dL, Daytime Outcomes | 15 weeks | CGM percent time \< 70 mg/dL, Daytime Outcomes between 06:00-00:00 |
| Percent Time < 70 mg/dL, Overnight Outcomes | 15 weeks | CGM percent time \< 70 mg/dL, Overnight Outcomes between 00:00-06:00 |
| Percent of Time 70-140 mg/dL, Overall | 15 weeks | CGM percent time 70-140 mg/dL, Overall Study Participation |
| Percent of Time 70-140 mg/dL, Daytime Outcomes | 15 weeks | CGM percent time 70-140 mg/dL, Daytime Outcomes between 06:00-00:00 |
| Percent of Time 70-140 mg/dL, Overnight Outcomes | 15 weeks | CGM percent time 70-140 mg/dL, Overnight Outcomes between 00:00-06:00 |
| Percent Time > 250 mg/dL, Overall | 15 weeks | CGM percent time \> 250 mg/dL, Overall Study Participation |
| Percent of Time 70-180 mg/dL, Daytime Outcomes | 15 weeks | CGM percent time 70-180 mg/dL, Daytime Outcomes between 06:00-00:00 |
| Percent of Time 70-180 mg/dL, Overnight Outcomes | 15 weeks | CGM percent time 70-180 mg/dL, Overnight Outcomes between 00:00-06:00 |
| Percent Time > 250 mg/dL, Daytime Outcomes | 15 weeks | CGM percent time \> 250 mg/dL, Daytime Outcomes between 06:00-00:00 |
| Percent Time > 250 mg/dL, Overnight Outcomes | 15 weeks | CGM percent time \> 250 mg/dL, Overnight Outcomes between 00:00-06:00 |
| Median Sensor Glucose | 15 weeks | CGM-measured median glucose (mg/dL) |
| Total Daily Insulin Use | 15 weeks | Total Daily Insulin Use (Units/Day) |
| Total Daily Bolus Insulin Use | 15 weeks | Total Daily Bolus Insulin Use (units/day) |
| Total Daily Basal Insulin Use | 15 weeks | Total Daily Basal Insulin Use (units/day) |
| Physician Overrides/Physician Initiated Changes in Pump Settings | 13 weeks | Number of physician overrides/physician initiated changes in pump settings during the entire study. |
| Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion | 13 weeks | The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The last 4 questions assess diabetes impact on a scale of 1-10 (1=Never, 10=always), with a lower score means a better outcome. Mean score for overall diabetes impact is reported after 13 weeks using the system with adaptive therapy settings |
| Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion | 13 weeks | The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The first 7 questions assess device satisfaction on a scale of 1-10 (1=strongly disagree, 10=strongly agree), with a higher score means a better outcome. Mean score for overall device satisfaction is reported after 13 weeks using the system with adaptive therapy settings |
| Percent of Time 70-180 mg/dL, Overall | 15 weeks | CGM percent time 70-180 mg/dL, Overall Study Participation |
| Percent Time > 180 mg/dL, Overall | 15 weeks | CGM percent time \> 180 mg/dL, Overall Study Participation |
Countries
United States
Participant flow
Recruitment details
Study performed at a single clinical site, Barbara Davis Center, from March to September 2022.
Participants by arm
| Arm | Count |
|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates After CGM run-in, participants will begin use of Control-IQ technology with algorithm derived initial insulin delivery settings, then have regular settings updates from the algorithm through 13 weeks of use. | 33 |
| Total | 33 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 32 Participants |
| Age, Continuous | 36.1 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 29 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants |
| HbA1c at Enrollment | 8.5 percentage of glycated hemoglobin STANDARD_DEVIATION 0.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 25 Participants |
| Region of Enrollment United States | 33 participants |
| Sex: Female, Male Female | 19 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 33 |
| other Total, other adverse events | 0 / 33 | 8 / 33 |
| serious Total, serious adverse events | 0 / 33 | 2 / 33 |
Outcome results
Primary
Diabetic Ketoacidosis Events
Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT)
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Diabetic Ketoacidosis Events | MDI Run-In with CGM (2 Weeks) | 0 number of events | Standard Deviation 0 |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Diabetic Ketoacidosis Events | Control-IQ with Adaptation (13 Weeks) | 0 number of events | Standard Deviation 0 |
Primary
Severe Hypoglycemic Events
Number of Severe Hypoglycemic Events (with altered mental status)
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Severe Hypoglycemic Events | MDI Run-In with CGM (2 Weeks) | 0 number of events | Standard Deviation 0 |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Severe Hypoglycemic Events | Control-IQ with Adaptation (13 Weeks) | 0.06 number of events | Standard Deviation 0.35 |
Secondary
Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion
The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The last 4 questions assess diabetes impact on a scale of 1-10 (1=Never, 10=always), with a lower score means a better outcome. Mean score for overall diabetes impact is reported after 13 weeks using the system with adaptive therapy settings
Time frame: 13 weeks
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Device Impact Score, as Reported on the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion | 3.5 units on a scale | Standard Deviation 2.2 |
Secondary
Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion
The Diabetes Impact and Satisfaction (DIDS) scale is an 11-item questionnaire focused on satisfaction related to insulin delivery devices (e.g., trust and ease of use) and diabetes- elated impact on daily life, such as worry around hypoglycemia and sleep interruptions. The first 7 questions assess device satisfaction on a scale of 1-10 (1=strongly disagree, 10=strongly agree), with a higher score means a better outcome. Mean score for overall device satisfaction is reported after 13 weeks using the system with adaptive therapy settings
Time frame: 13 weeks
Population: Participants who completed the study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Device Satisfaction Score, as Reported on the the Diabetes Impact and Satisfaction (DIDS) Scale at Study Completion | 8.9 units on a scale | Standard Deviation 1.1 |
Secondary
Median Sensor Glucose
CGM-measured median glucose (mg/dL)
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Median Sensor Glucose | MDI Run-In with CGM (2 Weeks) | 185.0 mg/dL |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Median Sensor Glucose | Control-IQ with Adaptation (at 13 Weeks) | 149.0 mg/dL |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent of Time 70-140 mg/dL, Daytime Outcomes
CGM percent time 70-140 mg/dL, Daytime Outcomes between 06:00-00:00
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent of Time 70-140 mg/dL, Daytime Outcomes | MDI Run-In with CGM (2 Weeks) | 23.8 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent of Time 70-140 mg/dL, Daytime Outcomes | Control-IQ with Adaptation (at 13 Weeks) | 39.0 percentage of time |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent of Time 70-140 mg/dL, Overall
CGM percent time 70-140 mg/dL, Overall Study Participation
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent of Time 70-140 mg/dL, Overall | MDI Run-In with CGM (2 Weeks) | 26.0 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent of Time 70-140 mg/dL, Overall | Control-IQ with Adaptation (at 13 Weeks) | 39.2 percentage of time |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent of Time 70-140 mg/dL, Overnight Outcomes
CGM percent time 70-140 mg/dL, Overnight Outcomes between 00:00-06:00
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent of Time 70-140 mg/dL, Overnight Outcomes | MDI Run-In with CGM (2 Weeks) | 29.4 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent of Time 70-140 mg/dL, Overnight Outcomes | Control-IQ with Adaptation (at 13 Weeks) | 45.0 percentage of time |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent of Time 70-180 mg/dL, Daytime Outcomes
CGM percent time 70-180 mg/dL, Daytime Outcomes between 06:00-00:00
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent of Time 70-180 mg/dL, Daytime Outcomes | MDI Run-In with CGM (2 Weeks) | 45.5 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent of Time 70-180 mg/dL, Daytime Outcomes | Control-IQ with Adaptation (at 13 Weeks) | 65.4 percentage of time |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent of Time 70-180 mg/dL, Overall
CGM percent time 70-180 mg/dL, Overall Study Participation
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent of Time 70-180 mg/dL, Overall | MDI Run-In with CGM (2 Weeks) | 45.7 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent of Time 70-180 mg/dL, Overall | Control-IQ with Adaptation (at 13 Weeks) | 69.1 percentage of time |
Comparison: Comparison between 2 week run-in and 13 weeks Control-IQ use with adaptation.p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent of Time 70-180 mg/dL, Overnight Outcomes
CGM percent time 70-180 mg/dL, Overnight Outcomes between 00:00-06:00
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent of Time 70-180 mg/dL, Overnight Outcomes | MDI Run-In with CGM (2 Weeks) | 53.5 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent of Time 70-180 mg/dL, Overnight Outcomes | Control-IQ with Adaptation (at 13 Weeks) | 74.9 percentage of time |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent Time > 180 mg/dL, Daytime Outcomes
CGM percent time \> 180 mg/dL, Daytime Outcomes between 06:00-00:00
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time > 180 mg/dL, Daytime Outcomes | MDI Run-In with CGM (2 Weeks) | 52.5 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time > 180 mg/dL, Daytime Outcomes | Control-IQ with Adaptation (at 13 Weeks) | 34.2 percentage of time |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent Time > 180 mg/dL, Overall
CGM percent time \> 180 mg/dL, Overall Study Participation
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time > 180 mg/dL, Overall | MDI Run-In with CGM (2 Weeks) | 51.9 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time > 180 mg/dL, Overall | Control-IQ with Adaptation (at 13 Weeks) | 29.5 percentage of time |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent Time > 180 mg/dL, Overnight Outcomes
CGM percent time \> 180 mg/dL, Overnight Outcomes between 00:00-06:00
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time > 180 mg/dL, Overnight Outcomes | MDI Run-In with CGM (2 Weeks) | 38.7 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time > 180 mg/dL, Overnight Outcomes | Control-IQ with Adaptation (at 13 Weeks) | 24.6 percentage of time |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent Time > 250 mg/dL, Daytime Outcomes
CGM percent time \> 250 mg/dL, Daytime Outcomes between 06:00-00:00
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time > 250 mg/dL, Daytime Outcomes | MDI Run-In with CGM (2 Weeks) | 19.6 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time > 250 mg/dL, Daytime Outcomes | Control-IQ with Adaptation (at 13 Weeks) | 8.5 percentage of time |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent Time > 250 mg/dL, Overall
CGM percent time \> 250 mg/dL, Overall Study Participation
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time > 250 mg/dL, Overall | MDI Run-In with CGM (2 Weeks) | 21.8 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time > 250 mg/dL, Overall | Control-IQ with Adaptation (at 13 Weeks) | 7.7 percentage of time |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent Time > 250 mg/dL, Overnight Outcomes
CGM percent time \> 250 mg/dL, Overnight Outcomes between 00:00-06:00
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time > 250 mg/dL, Overnight Outcomes | MDI Run-In with CGM (2 Weeks) | 20.1 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time > 250 mg/dL, Overnight Outcomes | Control-IQ with Adaptation (at 13 Weeks) | 6.0 percentage of time |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Percent Time < 54 mg/dL, Daytime Outcomes
CGM percent time \< 54 mg/dL, Daytime Outcomes between 06:00-00:00
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time < 54 mg/dL, Daytime Outcomes | MDI Run-In with CGM (2 Weeks) | 0.2 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time < 54 mg/dL, Daytime Outcomes | Control-IQ with Adaptation (at 13 Weeks) | 0.2 percentage of time |
p-value: 0.11Wilcoxon (Mann-Whitney)
Secondary
Percent Time < 54 mg/dL, Overall
CGM percent time \< 54 mg/dL, Overall Study Participation
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time < 54 mg/dL, Overall | MDI Run-In with CGM (2 Weeks) | 0.3 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time < 54 mg/dL, Overall | Control-IQ with Adaptation (at 13 Weeks) | 0.2 percentage of time |
p-value: 0.06Wilcoxon (Mann-Whitney)
Secondary
Percent Time < 54 mg/dL, Overnight Outcomes
CGM percent time \< 54 mg/dL, Overnight Outcomes between 00:00-06:00
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time < 54 mg/dL, Overnight Outcomes | MDI Run-In with CGM (2 Weeks) | 0.2 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time < 54 mg/dL, Overnight Outcomes | Control-IQ with Adaptation (at 13 Weeks) | 0.2 percentage of time |
p-value: 0.04Wilcoxon (Mann-Whitney)
Secondary
Percent Time < 70 mg/dL, Daytime Outcomes
CGM percent time \< 70 mg/dL, Daytime Outcomes between 06:00-00:00
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time < 70 mg/dL, Daytime Outcomes | MDI Run-In with CGM (2 Weeks) | 1.5 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time < 70 mg/dL, Daytime Outcomes | Control-IQ with Adaptation (at 13 Weeks) | 1.1 percentage of time |
p-value: 0.26Wilcoxon (Mann-Whitney)
Secondary
Percent Time < 70 mg/dL, Overall
CGM percent time \< 70 mg/dL, Overall Study Participation
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time < 70 mg/dL, Overall | MDI Run-In with CGM (2 Weeks) | 1.8 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time < 70 mg/dL, Overall | Control-IQ with Adaptation (at 13 Weeks) | 1.0 percentage of time |
p-value: 0.03Wilcoxon (Mann-Whitney)
Secondary
Percent Time < 70 mg/dL, Overnight Outcomes
CGM percent time \< 70 mg/dL, Overnight Outcomes between 00:00-06:00
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time < 70 mg/dL, Overnight Outcomes | MDI Run-In with CGM (2 Weeks) | 2.1 percentage of time |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Percent Time < 70 mg/dL, Overnight Outcomes | Control-IQ with Adaptation (at 13 Weeks) | 1.0 percentage of time |
p-value: 0.005Wilcoxon (Mann-Whitney)
Secondary
Physician Overrides/Physician Initiated Changes in Pump Settings
Number of physician overrides/physician initiated changes in pump settings during the entire study.
Time frame: 13 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Physician Overrides/Physician Initiated Changes in Pump Settings | 0.21 number of events | Standard Deviation 0.42 |
Secondary
Total Daily Basal Insulin Use
Total Daily Basal Insulin Use (units/day)
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Total Daily Basal Insulin Use | MDI Run-In with CGM (2 Weeks) | 32.5 units/day |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Total Daily Basal Insulin Use | Control-IQ with Adaptation (at 13 Weeks) | 30.1 units/day |
p-value: 0.69Wilcoxon (Mann-Whitney)
Secondary
Total Daily Bolus Insulin Use
Total Daily Bolus Insulin Use (units/day)
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Total Daily Bolus Insulin Use | MDI Run-In with CGM (2 Weeks) | 23.0 units/day |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Total Daily Bolus Insulin Use | Control-IQ with Adaptation (at 13 Weeks) | 25.3 units/day |
p-value: 0.03Wilcoxon (Mann-Whitney)
Secondary
Total Daily Insulin Use
Total Daily Insulin Use (Units/Day)
Time frame: 15 weeks
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Total Daily Insulin Use | MDI Run-In with CGM (2 Weeks) | 55.0 units/day |
| Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates | Total Daily Insulin Use | Control-IQ with Adaptation (at 13 Weeks) | 61.5 units/day |
p-value: 0.17Wilcoxon (Mann-Whitney)