Trial Outcomes & Findings for Control-IQ Technology 2.0 Adult and Adolescent Feasibility Study (NCT NCT05014789)
NCT ID: NCT05014789
Last Updated: 2026-06-01
Results Overview
Number of Diabetic Ketoacidosis events with different feature use of the pump each week.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Data collected over 1 week for each intervention, up to 5 weeks
Results posted on
2026-06-01
Participant Flow
33 participants signed the consent form, and therefore were considered enrolled. 33 local contacts were also consented. No baseline information was collected for local contacts.
2 screen failures, and 1 additional participant dropped out immediately after the screening visit, along with their local contacts.
Participant milestones
| Measure |
Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump
After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
Week A: Week A (Lower Target, Auto-bolus on, no late meal bolus) Week B (Lower Target, Auto-bolus off, no late meal bolus) Week C (Lower Target, Auto-bolus on, late meal bolus as needed) Week D (Standard Target, Auto-bolus on, late meal bolus as needed)
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
Week B, Week A, Week C, Week D
|
7
|
|
Overall Study
Week A, Week C, Week D, Week B
|
7
|
|
Overall Study
Week D, Week B, Week C, Week A
|
8
|
|
Overall Study
Week A, Week B, Week C, Week D
|
8
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Control-IQ Technology 2.0 Adult and Adolescent Feasibility Study
Baseline characteristics by cohort
| Measure |
Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump
n=30 Participants
After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
|
|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=24 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
23 Participants
n=24 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=24 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=24 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=24 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=24 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=24 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=24 Participants
|
|
Region of Enrollment
United States
|
30 Participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Data collected over 1 week for each intervention, up to 5 weeksCGM overall percent time less than 54 mg/dL, with different feature use of the pump each week.
Outcome measures
| Measure |
Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump
n=30 Participants
After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
|
|---|---|
|
Overall Percent Time Less Than 54 mg/dL
Week D (Standard Target, Auto-bolus on, late meal bolus as needed)
|
0.2 percentage of time
Interval 0.0 to 0.6
|
|
Overall Percent Time Less Than 54 mg/dL
Run-In Week with home pump
|
0.1 percentage of time
Interval 0.0 to 0.5
|
|
Overall Percent Time Less Than 54 mg/dL
Week A (Lower Target, Auto-bolus on, no late meal bolus)
|
0.1 percentage of time
Interval 0.0 to 0.3
|
|
Overall Percent Time Less Than 54 mg/dL
Week B (Lower Target, Auto-bolus off, no late meal bolus)
|
0.2 percentage of time
Interval 0.0 to 0.4
|
|
Overall Percent Time Less Than 54 mg/dL
Week C (Lower Target, Auto-bolus on, late meal bolus as needed)
|
0.2 percentage of time
Interval 0.0 to 0.4
|
PRIMARY outcome
Timeframe: Data collected over 1 week for each intervention, up to 5 weeksNumber of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment), with different feature use of the pump each week.
Outcome measures
| Measure |
Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump
n=30 Participants
After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
|
|---|---|
|
Severe Hypoglycemia
Run-In Week with home pump
|
0.0 number of events
Interval 0.0 to 0.0
|
|
Severe Hypoglycemia
Week A (Lower Target, Auto-bolus on, no late meal bolus)
|
0.0 number of events
Interval 0.0 to 0.0
|
|
Severe Hypoglycemia
Week B (Lower Target, Auto-bolus off, no late meal bolus)
|
0.0 number of events
Interval 0.0 to 0.0
|
|
Severe Hypoglycemia
Week C (Lower Target, Auto-bolus on, late meal bolus as needed)
|
0.0 number of events
Interval 0.0 to 0.0
|
|
Severe Hypoglycemia
Week D (Standard Target, Auto-bolus on, late meal bolus as needed)
|
0.0 number of events
Interval 0.0 to 0.0
|
PRIMARY outcome
Timeframe: Data collected over 1 week for each intervention, up to 5 weeksNumber of Diabetic Ketoacidosis events with different feature use of the pump each week.
Outcome measures
| Measure |
Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump
n=30 Participants
After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
|
|---|---|
|
Diabetic Ketoacidosis
Run-In Week with home pump
|
0 number of events
Interval 0.0 to 0.0
|
|
Diabetic Ketoacidosis
Week A (Lower Target, Auto-bolus on, no late meal bolus)
|
0.0 number of events
Interval 0.0 to 0.0
|
|
Diabetic Ketoacidosis
Week B (Lower Target, Auto-bolus off, no late meal bolus)
|
0.0 number of events
Interval 0.0 to 0.0
|
|
Diabetic Ketoacidosis
Week C (Lower Target, Auto-bolus on, late meal bolus as needed)
|
0.0 number of events
Interval 0.0 to 0.0
|
|
Diabetic Ketoacidosis
Week D (Standard Target, Auto-bolus on, late meal bolus as needed)
|
0.0 number of events
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Data collected over 1 week for each intervention, up to 5 weeksCGM percent time \<70 mg/dL, with different feature use of the pump each week.
Outcome measures
| Measure |
Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump
n=30 Participants
After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
|
|---|---|
|
Percent Time <70 mg/dL
Run-In Week with home pump
|
1.1 percentage of time
Interval 0.5 to 2.1
|
|
Percent Time <70 mg/dL
Week A (Lower Target, Auto-bolus on, no late meal bolus)
|
1.5 percentage of time
Interval 0.7 to 2.1
|
|
Percent Time <70 mg/dL
Week B (Lower Target, Auto-bolus off, no late meal bolus)
|
1.4 percentage of time
Interval 0.7 to 2.9
|
|
Percent Time <70 mg/dL
Week C (Lower Target, Auto-bolus on, late meal bolus as needed)
|
1.6 percentage of time
Interval 0.6 to 2.7
|
|
Percent Time <70 mg/dL
Week D (Standard Target, Auto-bolus on, late meal bolus as needed)
|
1.7 percentage of time
Interval 0.6 to 2.7
|
SECONDARY outcome
Timeframe: Data collected over 1 week for each intervention, up to 5 weeksCGM percent time 70-140 mg/dL, with different feature use of the pump each week.
Outcome measures
| Measure |
Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump
n=30 Participants
After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
|
|---|---|
|
Percent Time 70-140 mg/dL
Week C (Lower Target, Auto-bolus on, late meal bolus as needed)
|
53.7 percentage of time
Interval 49.3 to 60.1
|
|
Percent Time 70-140 mg/dL
Week D (Standard Target, Auto-bolus on, late meal bolus as needed)
|
51.0 percentage of time
Interval 41.1 to 59.0
|
|
Percent Time 70-140 mg/dL
Week B (Lower Target, Auto-bolus off, no late meal bolus)
|
52.7 percentage of time
Interval 45.2 to 57.0
|
|
Percent Time 70-140 mg/dL
Run-In Week with home pump
|
46.0 percentage of time
Interval 37.7 to 54.3
|
|
Percent Time 70-140 mg/dL
Week A (Lower Target, Auto-bolus on, no late meal bolus)
|
53.5 percentage of time
Interval 38.9 to 57.9
|
SECONDARY outcome
Timeframe: Data collected over 1 week for each intervention, up to 5 weeksCGM percent time 70-180 mg/dL, with different feature use of the pump each week.
Outcome measures
| Measure |
Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump
n=30 Participants
After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
|
|---|---|
|
Percent Time 70-180 mg/dL
Run-In Week with home pump
|
75.1 percentage of time
Interval 66.5 to 80.2
|
|
Percent Time 70-180 mg/dL
Week A (Lower Target, Auto-bolus on, no late meal bolus)
|
76.5 percentage of time
Interval 66.8 to 81.7
|
|
Percent Time 70-180 mg/dL
Week B (Lower Target, Auto-bolus off, no late meal bolus)
|
76.8 percentage of time
Interval 72.4 to 81.5
|
|
Percent Time 70-180 mg/dL
Week C (Lower Target, Auto-bolus on, late meal bolus as needed)
|
78.2 percentage of time
Interval 73.9 to 83.1
|
|
Percent Time 70-180 mg/dL
Week D (Standard Target, Auto-bolus on, late meal bolus as needed)
|
76.6 percentage of time
Interval 71.7 to 81.7
|
SECONDARY outcome
Timeframe: Data collected over 1 week for each intervention, up to 5 weeksCGM percent time \>180 mg/dL, with different feature use of the pump each week.
Outcome measures
| Measure |
Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump
n=30 Participants
After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
|
|---|---|
|
Percent Time >180 mg/dL
Run-In Week with home pump
|
23.1 percentage of time
Interval 19.0 to 32.5
|
|
Percent Time >180 mg/dL
Week A (Lower Target, Auto-bolus on, no late meal bolus)
|
22.2 percentage of time
Interval 15.9 to 30.1
|
|
Percent Time >180 mg/dL
Week B (Lower Target, Auto-bolus off, no late meal bolus)
|
21.4 percentage of time
Interval 15.8 to 26.9
|
|
Percent Time >180 mg/dL
Week C (Lower Target, Auto-bolus on, late meal bolus as needed)
|
19.5 percentage of time
Interval 13.2 to 24.5
|
|
Percent Time >180 mg/dL
Week D (Standard Target, Auto-bolus on, late meal bolus as needed)
|
21.0 percentage of time
Interval 13.9 to 27.4
|
SECONDARY outcome
Timeframe: Data collected over 1 week for each intervention, up to 5 weeksCGM percent time \>250 mg/dL, with different feature use of the pump each week.
Outcome measures
| Measure |
Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump
n=30 Participants
After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
|
|---|---|
|
Percent Time >250 mg/dL
Run-In Week with home pump
|
3.8 percentage of time
Interval 2.3 to 7.5
|
|
Percent Time >250 mg/dL
Week A (Lower Target, Auto-bolus on, no late meal bolus)
|
4.0 percentage of time
Interval 2.3 to 6.6
|
|
Percent Time >250 mg/dL
Week B (Lower Target, Auto-bolus off, no late meal bolus)
|
4.1 percentage of time
Interval 1.3 to 6.3
|
|
Percent Time >250 mg/dL
Week C (Lower Target, Auto-bolus on, late meal bolus as needed)
|
2.4 percentage of time
Interval 1.5 to 5.8
|
|
Percent Time >250 mg/dL
Week D (Standard Target, Auto-bolus on, late meal bolus as needed)
|
3.1 percentage of time
Interval 1.9 to 5.5
|
SECONDARY outcome
Timeframe: Data collected over 1 week for each intervention, up to 5 weeksMedian of individual participants CGM Mean Glucose values (mg/dL), with different feature use of the pump each week.
Outcome measures
| Measure |
Control-IQ 2.0 Technology 2.0 on the t:Slim X2 Insulin Pump
n=30 Participants
After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
|
|---|---|
|
Median of Mean Glucose (mg/dL)
Week B (Lower Target, Auto-bolus off, no late meal bolus)
|
145.2 mg/dL
Interval 137.7 to 154.8
|
|
Median of Mean Glucose (mg/dL)
Week C (Lower Target, Auto-bolus on, late meal bolus as needed)
|
144.2 mg/dL
Interval 134.4 to 150.0
|
|
Median of Mean Glucose (mg/dL)
Week D (Standard Target, Auto-bolus on, late meal bolus as needed)
|
145.3 mg/dL
Interval 136.4 to 156.0
|
|
Median of Mean Glucose (mg/dL)
Run-In Week with home pump
|
150.5 mg/dL
Interval 143.3 to 161.5
|
|
Median of Mean Glucose (mg/dL)
Week A (Lower Target, Auto-bolus on, no late meal bolus)
|
145.3 mg/dL
Interval 140.3 to 161.7
|
Adverse Events
Control-IQ Technology 2.0 on the Tandem t:Slim X2 Insulin Pump
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Control-IQ Technology 2.0 on the Tandem t:Slim X2 Insulin Pump
n=30 participants at risk
After a run-in week, each subject will use different combinations of new features of the system each week, in random order, for 4 weeks, using the t:slim X2 insulin pump with Control-IQ technology 2.0.
|
|---|---|
|
Endocrine disorders
Hyperglycemia with ketosis
|
3.3%
1/30 • Number of events 1 • 5 weeks, inclusive of one week Run-In then four weeks using the system.
Because each participant used different features of the pump each week, each adverse event denotes which features were active that week in the footnote.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place