Trial Outcomes & Findings for Tandem Freedom Feasibility Study 1 (NCT NCT06428591)
NCT ID: NCT06428591
Last Updated: 2025-11-18
Results Overview
Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
10 participants
Primary outcome timeframe
Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolus
Results posted on
2025-11-18
Participant Flow
Ten adults with type 1 diabetes (all existing Control-IQ users) were recruited for this study.
Participant milestones
| Measure |
Tandem Freedom
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
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|---|---|
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Overall Study
STARTED
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10
|
|
Overall Study
COMPLETED
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10
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Tandem Freedom Feasibility Study 1
Baseline characteristics by cohort
| Measure |
t:Slim X2 Insulin Pump With Tandem Freedom Algorithm
n=10 Participants
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
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|---|---|
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Sex: Female, Male
Female
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3 Participants
n=202 Participants
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Sex: Female, Male
Male
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7 Participants
n=202 Participants
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Race/Ethnicity, Customized
New Zealand European
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9 Participants
n=202 Participants
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Race/Ethnicity, Customized
Maori
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1 Participants
n=202 Participants
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HbA1c at Enrollment
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6.8 percentage of glycated hemoglobin
STANDARD_DEVIATION 0.7 • n=202 Participants
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Total Daily Insulin Dose at Enrollment
|
62.3 units/day
STANDARD_DEVIATION 22.7 • n=202 Participants
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Duration of Diabetes
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18.1 years
STANDARD_DEVIATION 12.5 • n=202 Participants
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BMI at Enrollment
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27.3 kg/m^2
STANDARD_DEVIATION 5.8 • n=202 Participants
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Number of DKA events in the last 6 months
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0 DKA events
n=202 Participants
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Number of severe hypoglycemic events (required assistance) in the last 6 months
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0 Severe Hypoglycemic Events
n=202 Participants
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Age, Continuous
|
37.3 years
STANDARD_DEVIATION 19.6 • n=202 Participants
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PRIMARY outcome
Timeframe: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolusNumber of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment)
Outcome measures
| Measure |
t:slim X2 insulin pump with Tandem Freedom Algorithm
n=10 Participants
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
|
|---|---|
|
Severe Hypoglycemia Events
Control-IQ Run-In with Boluses (7 Days)
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0 number of events
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Severe Hypoglycemia Events
Freedom with Meal Boluses (24 Hours)
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0 number of events
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Severe Hypoglycemia Events
Freedom without Meal Boluses (24 Hours)
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0 number of events
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PRIMARY outcome
Timeframe: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolusNumber of diabetic ketoacidosis events
Outcome measures
| Measure |
t:slim X2 insulin pump with Tandem Freedom Algorithm
n=10 Participants
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
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|---|---|
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Diabetic Ketoacidosis Events
Control-IQ Run-In with Boluses (7 Days)
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0 number of events
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Diabetic Ketoacidosis Events
Freedom with Meal Boluses (24 Hours)
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0 number of events
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Diabetic Ketoacidosis Events
Freedom without Meal Boluses (24 Hours)
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0 number of events
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SECONDARY outcome
Timeframe: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolusCGM measured percent time \<54 mg/dL
Outcome measures
| Measure |
t:slim X2 insulin pump with Tandem Freedom Algorithm
n=10 Participants
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
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|---|---|
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Percent Time <54 mg/dL
Freedom without Meal Boluses (24 Hours)
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0.0 percentage of time
Interval 0.0 to 0.0
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Percent Time <54 mg/dL
Control-IQ Run-In with Boluses (7 Days)
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0.1 percentage of time
Interval 0.0 to 0.3
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Percent Time <54 mg/dL
Freedom with Meal Boluses (24 Hours)
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0.0 percentage of time
Interval 0.0 to 0.3
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SECONDARY outcome
Timeframe: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolusCGM measured percent time \<70 mg/dL
Outcome measures
| Measure |
t:slim X2 insulin pump with Tandem Freedom Algorithm
n=10 Participants
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
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|---|---|
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Percent Time <70 mg/dL
Control-IQ Run-In with Boluses (7 Days)
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1.3 percentage of time
Interval 1.1 to 1.8
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Percent Time <70 mg/dL
Freedom with Meal Boluses (24 Hours)
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1.4 percentage of time
Interval 0.0 to 5.1
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Percent Time <70 mg/dL
Freedom without Meal Boluses (24 Hours)
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0.0 percentage of time
Interval 0.0 to 1.3
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SECONDARY outcome
Timeframe: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolusCGM measured percent time in range 70 - 180 mg/dL
Outcome measures
| Measure |
t:slim X2 insulin pump with Tandem Freedom Algorithm
n=10 Participants
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
|
|---|---|
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Percent Time in Range 70 - 180 mg/dL
Control-IQ Run-In with Boluses (7 Days)
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61.8 percentage of time
Interval 56.0 to 72.8
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Percent Time in Range 70 - 180 mg/dL
Freedom with Boluses (24 Hours)
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82.4 percentage of time
Interval 52.2 to 86.5
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Percent Time in Range 70 - 180 mg/dL
Freedom without Boluses (24 Hours)
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54.7 percentage of time
Interval 47.1 to 73.7
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SECONDARY outcome
Timeframe: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolusCGM measured percent time in range 70 - 140 mg/dL
Outcome measures
| Measure |
t:slim X2 insulin pump with Tandem Freedom Algorithm
n=10 Participants
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
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|---|---|
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Percent Time in Range 70 - 140 mg/dL
Control-IQ Run-In with Boluses (7 Days)
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37.2 percentage of time
Interval 30.1 to 49.8
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Percent Time in Range 70 - 140 mg/dL
Freedom with Boluses (24 Hours)
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46.5 percentage of time
Interval 26.1 to 60.8
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Percent Time in Range 70 - 140 mg/dL
Freedom without Boluses (24 Hours)
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34.7 percentage of time
Interval 25.7 to 37.8
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SECONDARY outcome
Timeframe: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolusCGM measured percent time \>180 mg/dL
Outcome measures
| Measure |
t:slim X2 insulin pump with Tandem Freedom Algorithm
n=10 Participants
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
|
|---|---|
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Percent Time >180 mg/dL
Control-IQ Run-In with Boluses (7 Days)
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36.9 percentage of time
Interval 25.5 to 43.0
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Percent Time >180 mg/dL
Freedom with Meal Boluses (24 Hours)
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13.5 percentage of time
Interval 9.3 to 46.2
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Percent Time >180 mg/dL
Freedom without Meal Boluses (24 Hours)
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44.4 percentage of time
Interval 26.3 to 51.9
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SECONDARY outcome
Timeframe: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolusCGM measured percent time \>250mg/dL
Outcome measures
| Measure |
t:slim X2 insulin pump with Tandem Freedom Algorithm
n=10 Participants
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
|
|---|---|
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Percent Time >250 mg/dL
Freedom without Meal Boluses (24 Hours)
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3.5 percentage of time
Interval 1.4 to 11.5
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Percent Time >250 mg/dL
Control-IQ Run-In with Boluses (7 Days)
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9.1 percentage of time
Interval 5.2 to 15.2
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Percent Time >250 mg/dL
Freedom with Meal Boluses (24 Hours)
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0.0 percentage of time
Interval 0.0 to 12.4
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SECONDARY outcome
Timeframe: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolusCGM measured mean glucose (mg/dL)
Outcome measures
| Measure |
t:slim X2 insulin pump with Tandem Freedom Algorithm
n=10 Participants
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
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|---|---|
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Mean Glucose (mg/dL)
Freedom without Meal Boluses (24 Hours)
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175.6 mg/dL
Interval 151.5 to 182.2
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Mean Glucose (mg/dL)
Control-IQ Run-In with Boluses (7 Days)
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170.6 mg/dL
Interval 151.3 to 176.7
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Mean Glucose (mg/dL)
Freedom with Meal Boluses (24 Hours)
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139.6 mg/dL
Interval 127.2 to 180.5
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SECONDARY outcome
Timeframe: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolusCGM measured Coefficient of Variation (%)
Outcome measures
| Measure |
t:slim X2 insulin pump with Tandem Freedom Algorithm
n=10 Participants
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
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|---|---|
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Glucose Coefficient of Variation (%)
Control-IQ Run-In with Boluses (7 Days)
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35.9 percentage
Interval 34.4 to 37.6
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Glucose Coefficient of Variation (%)
Freedom with Meal Boluses (24 Hours)
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29.1 percentage
Interval 22.0 to 32.5
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Glucose Coefficient of Variation (%)
Freedom without Meal Boluses (24 Hours)
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27.4 percentage
Interval 25.7 to 30.1
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SECONDARY outcome
Timeframe: Control-IQ Run-in with boluses 7 days, day 8 freedom with meal bolus and day 9 freedom without meal bolusCGM measured Standard Deviation (mg/dL)
Outcome measures
| Measure |
t:slim X2 insulin pump with Tandem Freedom Algorithm
n=10 Participants
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
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|---|---|
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Glucose Standard Deviation (mg/dL)
Control-IQ Run-In with Boluses (7 Days)
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59.6 mg/dL
Interval 51.3 to 67.2
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Glucose Standard Deviation (mg/dL)
Freedom with Meal Boluses (24 Hours)
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37.1 mg/dL
Interval 29.0 to 61.6
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Glucose Standard Deviation (mg/dL)
Freedom without Meal Boluses (24 Hours)
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44.4 mg/dL
Interval 42.0 to 49.6
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Adverse Events
t:slim X2 insulin pump with Tandem Freedom Algorithm
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 |
t:slim X2 insulin pump with Tandem Freedom Algorithm
n=10 participants at risk
After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system 1 day with boluses, and 1 day without boluses, performing meal and exercise challenges.
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|---|---|
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Endocrine disorders
Hyperglycemia with ketosis, due to infusion set failure
|
10.0%
1/10 • Number of events 1 • 9 days, to include a 7 day run-in with Control-IQ technology, followed by one day of Freedom with boluses and one day of Freedom without boluses.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place