Trial Outcomes & Findings for Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use (NCT NCT05204134)

NCT ID: NCT05204134

Last Updated: 2024-04-05

Results Overview

Number of Severe Hypoglycemic Events (with altered mental status)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 33 participants
• Primary outcome timeframe: 15 weeks
• Results posted on: 2024-04-05

Participant Flow

Study performed at a single clinical site, Barbara Davis Center, from March to September 2022.

Participant milestones

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates 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
Overall Study STARTED	33
Overall Study Completed Run-In	33
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates 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
Overall Study Withdrawal by Subject	3
Overall Study Physician Decision	1

Baseline Characteristics

Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use

Baseline characteristics by cohort

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	32 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	36.1 years STANDARD_DEVIATION 11.6 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	33 participants n=5 Participants
HbA1c at Enrollment	8.5 percentage of glycated hemoglobin STANDARD_DEVIATION 0.8 • n=5 Participants

PRIMARY outcome

Timeframe: 15 weeks

Number of Severe Hypoglycemic Events (with altered mental status)

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Severe Hypoglycemic Events MDI Run-In with CGM (2 Weeks)	0 number of events Standard Deviation 0
Severe Hypoglycemic Events Control-IQ with Adaptation (13 Weeks)	0.06 number of events Standard Deviation 0.35

PRIMARY outcome

Timeframe: 15 weeks

Number of Diabetic Ketoacidosis events as defined by the Diabetes Control and Complications Trial (DCCT)

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Diabetic Ketoacidosis Events MDI Run-In with CGM (2 Weeks)	0 number of events Standard Deviation 0
Diabetic Ketoacidosis Events Control-IQ with Adaptation (13 Weeks)	0 number of events Standard Deviation 0

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time < 54 mg/dL, Overall Study Participation

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent Time < 54 mg/dL, Overall MDI Run-In with CGM (2 Weeks)	0.3 percentage of time Interval 0.1 to 0.7
Percent Time < 54 mg/dL, Overall Control-IQ with Adaptation (at 13 Weeks)	0.2 percentage of time Interval 0.1 to 0.3

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time < 54 mg/dL, Daytime Outcomes between 06:00-00:00

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent Time < 54 mg/dL, Daytime Outcomes MDI Run-In with CGM (2 Weeks)	0.2 percentage of time Interval 0.1 to 0.5
Percent Time < 54 mg/dL, Daytime Outcomes Control-IQ with Adaptation (at 13 Weeks)	0.2 percentage of time Interval 0.0 to 0.3

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time < 54 mg/dL, Overnight Outcomes between 00:00-06:00

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent Time < 54 mg/dL, Overnight Outcomes MDI Run-In with CGM (2 Weeks)	0.2 percentage of time Interval 0.0 to 0.9
Percent Time < 54 mg/dL, Overnight Outcomes Control-IQ with Adaptation (at 13 Weeks)	0.2 percentage of time Interval 0.0 to 0.3

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time < 70 mg/dL, Overall Study Participation

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent Time < 70 mg/dL, Overall MDI Run-In with CGM (2 Weeks)	1.8 percentage of time Interval 1.1 to 3.8
Percent Time < 70 mg/dL, Overall Control-IQ with Adaptation (at 13 Weeks)	1.0 percentage of time Interval 0.8 to 1.7

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time < 70 mg/dL, Daytime Outcomes between 06:00-00:00

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent Time < 70 mg/dL, Daytime Outcomes MDI Run-In with CGM (2 Weeks)	1.5 percentage of time Interval 0.7 to 3.0
Percent Time < 70 mg/dL, Daytime Outcomes Control-IQ with Adaptation (at 13 Weeks)	1.1 percentage of time Interval 0.8 to 1.9

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time < 70 mg/dL, Overnight Outcomes between 00:00-06:00

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent Time < 70 mg/dL, Overnight Outcomes MDI Run-In with CGM (2 Weeks)	2.1 percentage of time Interval 0.9 to 4.6
Percent Time < 70 mg/dL, Overnight Outcomes Control-IQ with Adaptation (at 13 Weeks)	1.0 percentage of time Interval 0.6 to 1.5

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time 70-140 mg/dL, Overall Study Participation

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent of Time 70-140 mg/dL, Overall MDI Run-In with CGM (2 Weeks)	26.0 percentage of time Interval 22.7 to 31.4
Percent of Time 70-140 mg/dL, Overall Control-IQ with Adaptation (at 13 Weeks)	39.2 percentage of time Interval 36.3 to 48.7

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time 70-140 mg/dL, Daytime Outcomes between 06:00-00:00

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent of Time 70-140 mg/dL, Daytime Outcomes MDI Run-In with CGM (2 Weeks)	23.8 percentage of time Interval 19.7 to 29.8
Percent of Time 70-140 mg/dL, Daytime Outcomes Control-IQ with Adaptation (at 13 Weeks)	39.0 percentage of time Interval 33.1 to 46.3

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time 70-140 mg/dL, Overnight Outcomes between 00:00-06:00

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent of Time 70-140 mg/dL, Overnight Outcomes MDI Run-In with CGM (2 Weeks)	29.4 percentage of time Interval 20.8 to 38.2
Percent of Time 70-140 mg/dL, Overnight Outcomes Control-IQ with Adaptation (at 13 Weeks)	45.0 percentage of time Interval 36.6 to 61.6

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time 70-180 mg/dL, Overall Study Participation

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent of Time 70-180 mg/dL, Overall MDI Run-In with CGM (2 Weeks)	45.7 percentage of time Interval 40.5 to 56.7
Percent of Time 70-180 mg/dL, Overall Control-IQ with Adaptation (at 13 Weeks)	69.1 percentage of time Interval 61.8 to 73.1

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time 70-180 mg/dL, Daytime Outcomes between 06:00-00:00

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent of Time 70-180 mg/dL, Daytime Outcomes MDI Run-In with CGM (2 Weeks)	45.5 percentage of time Interval 36.8 to 54.3
Percent of Time 70-180 mg/dL, Daytime Outcomes Control-IQ with Adaptation (at 13 Weeks)	65.4 percentage of time Interval 60.4 to 73.6

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time 70-180 mg/dL, Overnight Outcomes between 00:00-06:00

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent of Time 70-180 mg/dL, Overnight Outcomes MDI Run-In with CGM (2 Weeks)	53.5 percentage of time Interval 36.3 to 64.0
Percent of Time 70-180 mg/dL, Overnight Outcomes Control-IQ with Adaptation (at 13 Weeks)	74.9 percentage of time Interval 64.8 to 82.9

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time > 180 mg/dL, Overall Study Participation

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent Time > 180 mg/dL, Overall MDI Run-In with CGM (2 Weeks)	51.9 percentage of time Interval 42.3 to 57.1
Percent Time > 180 mg/dL, Overall Control-IQ with Adaptation (at 13 Weeks)	29.5 percentage of time Interval 26.2 to 37.4

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time > 180 mg/dL, Daytime Outcomes between 06:00-00:00

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent Time > 180 mg/dL, Daytime Outcomes MDI Run-In with CGM (2 Weeks)	52.5 percentage of time Interval 44.0 to 60.9
Percent Time > 180 mg/dL, Daytime Outcomes Control-IQ with Adaptation (at 13 Weeks)	34.2 percentage of time Interval 24.2 to 38.9

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time > 180 mg/dL, Overnight Outcomes between 00:00-06:00

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent Time > 180 mg/dL, Overnight Outcomes MDI Run-In with CGM (2 Weeks)	38.7 percentage of time Interval 35.4 to 61.1
Percent Time > 180 mg/dL, Overnight Outcomes Control-IQ with Adaptation (at 13 Weeks)	24.6 percentage of time Interval 13.2 to 34.1

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time > 250 mg/dL, Overall Study Participation

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent Time > 250 mg/dL, Overall MDI Run-In with CGM (2 Weeks)	21.8 percentage of time Interval 12.9 to 26.3
Percent Time > 250 mg/dL, Overall Control-IQ with Adaptation (at 13 Weeks)	7.7 percentage of time Interval 6.1 to 11.4

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time > 250 mg/dL, Daytime Outcomes between 06:00-00:00

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent Time > 250 mg/dL, Daytime Outcomes MDI Run-In with CGM (2 Weeks)	19.6 percentage of time Interval 11.2 to 29.4
Percent Time > 250 mg/dL, Daytime Outcomes Control-IQ with Adaptation (at 13 Weeks)	8.5 percentage of time Interval 6.3 to 11.5

SECONDARY outcome

Timeframe: 15 weeks

CGM percent time > 250 mg/dL, Overnight Outcomes between 00:00-06:00

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Percent Time > 250 mg/dL, Overnight Outcomes MDI Run-In with CGM (2 Weeks)	20.1 percentage of time Interval 8.5 to 27.1
Percent Time > 250 mg/dL, Overnight Outcomes Control-IQ with Adaptation (at 13 Weeks)	6.0 percentage of time Interval 3.7 to 10.6

SECONDARY outcome

Timeframe: 15 weeks

CGM-measured median glucose (mg/dL)

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Median Sensor Glucose MDI Run-In with CGM (2 Weeks)	185.0 mg/dL Interval 165.0 to 196.0
Median Sensor Glucose Control-IQ with Adaptation (at 13 Weeks)	149.0 mg/dL Interval 138.0 to 157.0

SECONDARY outcome

Timeframe: 15 weeks

Total Daily Insulin Use (Units/Day)

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Total Daily Insulin Use MDI Run-In with CGM (2 Weeks)	55.0 units/day Interval 40.8 to 71.3
Total Daily Insulin Use Control-IQ with Adaptation (at 13 Weeks)	61.5 units/day Interval 40.4 to 79.9

SECONDARY outcome

Timeframe: 15 weeks

Total Daily Bolus Insulin Use (units/day)

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Total Daily Bolus Insulin Use MDI Run-In with CGM (2 Weeks)	23.0 units/day Interval 19.0 to 25.0
Total Daily Bolus Insulin Use Control-IQ with Adaptation (at 13 Weeks)	25.3 units/day Interval 19.5 to 38.1

SECONDARY outcome

Timeframe: 15 weeks

Total Daily Basal Insulin Use (units/day)

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Total Daily Basal Insulin Use MDI Run-In with CGM (2 Weeks)	32.5 units/day Interval 20.8 to 44.5
Total Daily Basal Insulin Use Control-IQ with Adaptation (at 13 Weeks)	30.1 units/day Interval 17.2 to 44.9

SECONDARY outcome

Timeframe: 13 weeks

Number of physician overrides/physician initiated changes in pump settings during the entire study.

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 Participants 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 over 13 weeks.
Physician Overrides/Physician Initiated Changes in Pump Settings	0.21 number of events Standard Deviation 0.42

SECONDARY outcome

Timeframe: 13 weeks

Population: Participants who completed the study

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

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=29 Participants 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 over 13 weeks.
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 outcome

Timeframe: 13 weeks

Population: Participants who completed the study

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

Outcome measures

Measure	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=29 Participants 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 over 13 weeks.
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

Adverse Events

MDI Run-In With CGM

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Measure	MDI Run-In With CGM n=33 participants at risk Run-In with MDI therapy and CGM for 2 weeks.	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 participants at risk 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 through 13 weeks of use.
Endocrine disorders Severe Hypoglycemia	0.00% 0/33 • 15 weeks	3.0% 1/33 • Number of events 2 • 15 weeks
Infections and infestations Pancreatitis	0.00% 0/33 • 15 weeks	3.0% 1/33 • Number of events 1 • 15 weeks
Gastrointestinal disorders Vomiting	0.00% 0/33 • 15 weeks	3.0% 1/33 • Number of events 1 • 15 weeks

Other adverse events

Measure	MDI Run-In With CGM n=33 participants at risk Run-In with MDI therapy and CGM for 2 weeks.	Control-IQ Technology With Algorithm Derived Initial Profile Settings and Regular Updates n=33 participants at risk 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 through 13 weeks of use.
Skin and subcutaneous tissue disorders Ecchymosis	0.00% 0/33 • 15 weeks	6.1% 2/33 • Number of events 2 • 15 weeks
Endocrine disorders Ketonemia	0.00% 0/33 • 15 weeks	6.1% 2/33 • Number of events 2 • 15 weeks
Infections and infestations COVID-19	0.00% 0/33 • 15 weeks	9.1% 3/33 • Number of events 3 • 15 weeks
Skin and subcutaneous tissue disorders Edema	0.00% 0/33 • 15 weeks	3.0% 1/33 • Number of events 1 • 15 weeks

Additional Information

Supervisor Clinical Operations

Tandem Diabetes Care

Phone: +18778016901

Email: clinicalaffairs@tandemdiabetes.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place