Trial Outcomes & Findings for Tandem Freedom - Feasibility Trial 2 (NCT NCT06834568)
NCT ID: NCT06834568
Last Updated: 2026-02-06
Results Overview
Number of Participants with One or More 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 Period (7 days), Tandem Freedom (3 days)
Results posted on
2026-02-06
Participant Flow
Participant milestones
| Measure |
Tandem Freedom
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting. Participants will also perform exercise challenges.
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|---|---|
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Overall Study
STARTED
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10
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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 Trial 2
Baseline characteristics by cohort
| Measure |
Tandem Freedom
n=10 Participants
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting. Participants will also perform exercise challenges.
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Age, Continuous
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38.6 years
STANDARD_DEVIATION 19.6 • n=192 Participants
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Sex: Female, Male
Female
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3 Participants
n=192 Participants
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Sex: Female, Male
Male
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7 Participants
n=192 Participants
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Race/Ethnicity, Customized
New Zealand European
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8 Participants
n=192 Participants
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Race/Ethnicity, Customized
Maori
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1 Participants
n=192 Participants
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Race/Ethnicity, Customized
Dutch
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1 Participants
n=192 Participants
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Region of Enrollment
New Zealand
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10 Participants
n=192 Participants
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PRIMARY outcome
Timeframe: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)Number of Participants with One or More Severe Hypoglycemia Events (with cognitive impairment such that assistance of another individual is needed for treatment)
Outcome measures
| Measure |
Tandem Freedom
n=10 Participants
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.
Participants will also perform exercise challenges.
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|---|---|
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Number of Participants With One or More Severe Hypoglycemia Events
Control-IQ Run-in Period (7 days)
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0 Participants
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Number of Participants With One or More Severe Hypoglycemia Events
Tandem Freedom (3 days)
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0 Participants
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PRIMARY outcome
Timeframe: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)Number of Participants with One or More Diabetic Ketoacidosis events
Outcome measures
| Measure |
Tandem Freedom
n=10 Participants
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.
Participants will also perform exercise challenges.
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|---|---|
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Number of Participants With One or More Diabetic Ketoacidosis Events
Control-IQ Run-in Period (7 days)
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0 Participants
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Number of Participants With One or More Diabetic Ketoacidosis Events
Tandem Freedom (3 days)
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0 Participants
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SECONDARY outcome
Timeframe: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)CGM measured percent time \<54 mg/dL
Outcome measures
| Measure |
Tandem Freedom
n=10 Participants
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.
Participants will also perform exercise challenges.
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Percent Time <54 mg/dL
Control-IQ Run-in Period (7 days)
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0.4 percentage of time
Interval 0.2 to 1.1
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Percent Time <54 mg/dL
Tandem Freedom (3 days)
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0.0 percentage of time
Interval 0.0 to 0.0
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SECONDARY outcome
Timeframe: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)CGM measured percent time \<70 mg/dL
Outcome measures
| Measure |
Tandem Freedom
n=10 Participants
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.
Participants will also perform exercise challenges.
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|---|---|
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Percent Time <70 mg/dL
Control-IQ Run-in Period (7 days)
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1.8 percentage of time
Interval 0.8 to 3.0
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Percent Time <70 mg/dL
Tandem Freedom (3 days)
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0.4 percentage of time
Interval 0.0 to 0.8
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SECONDARY outcome
Timeframe: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)CGM measured percent time in range 70 - 180 mg/dL
Outcome measures
| Measure |
Tandem Freedom
n=10 Participants
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.
Participants will also perform exercise challenges.
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Percent Time in Range 70 - 180 mg/dL
Control-IQ Run-in Period (7 days)
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56.3 percentage of time
Interval 50.9 to 64.0
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Percent Time in Range 70 - 180 mg/dL
Tandem Freedom (3 days)
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61.0 percentage of time
Interval 58.9 to 73.0
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SECONDARY outcome
Timeframe: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)CGM measured percent time in range \> 180 mg/dL
Outcome measures
| Measure |
Tandem Freedom
n=10 Participants
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.
Participants will also perform exercise challenges.
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Percent Time in Range > 180 mg/dL
Control-IQ Run-in Period (7 days)
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41.8 percentage of time
Interval 34.0 to 47.5
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Percent Time in Range > 180 mg/dL
Tandem Freedom (3 days)
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38.2 percentage of time
Interval 27.0 to 40.6
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SECONDARY outcome
Timeframe: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)CGM measured percent time in range \> 250 mg/dL
Outcome measures
| Measure |
Tandem Freedom
n=10 Participants
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.
Participants will also perform exercise challenges.
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|---|---|
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Percent Time in Range > 250 mg/dL
Control-IQ Run-in Period (7 days)
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15.0 percentage of time
Interval 12.1 to 18.6
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Percent Time in Range > 250 mg/dL
Tandem Freedom (3 days)
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5.6 percentage of time
Interval 4.9 to 12.6
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SECONDARY outcome
Timeframe: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)CGM measured percent time in range 70 - 140 mg/dL
Outcome measures
| Measure |
Tandem Freedom
n=10 Participants
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.
Participants will also perform exercise challenges.
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Percent Time in Range 70 - 140 mg/dL
Control-IQ Run-in Period (7 days)
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33.8 percentage of time
Interval 30.0 to 46.1
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Percent Time in Range 70 - 140 mg/dL
Tandem Freedom (3 days)
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42.5 percentage of time
Interval 37.9 to 48.6
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SECONDARY outcome
Timeframe: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)CGM measured mean glucose (mg/dL)
Outcome measures
| Measure |
Tandem Freedom
n=10 Participants
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.
Participants will also perform exercise challenges.
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|---|---|
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Mean Glucose (mg/dL)
Control-IQ Run-in Period (7 days)
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178.3 Median of mean glucose values (mg/dL)
Interval 164.6 to 184.7
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Mean Glucose (mg/dL)
Tandem Freedom (3 days)
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166.9 Median of mean glucose values (mg/dL)
Interval 153.3 to 168.0
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SECONDARY outcome
Timeframe: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)CGM measured Coefficient of Variation (%)
Outcome measures
| Measure |
Tandem Freedom
n=10 Participants
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.
Participants will also perform exercise challenges.
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Glucose Coefficient of Variation (%)
Control-IQ Run-in Period (7 days)
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0.4 Percentage of variation
Interval 0.3 to 0.4
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Glucose Coefficient of Variation (%)
Tandem Freedom (3 days)
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0.3 Percentage of variation
Interval 0.3 to 0.4
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SECONDARY outcome
Timeframe: Control-IQ Run-in Period (7 days), Tandem Freedom (3 days)CGM measured Standard Deviation (mg/dL)
Outcome measures
| Measure |
Tandem Freedom
n=10 Participants
After a one week run-in period with Control-IQ technology, participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting.
Participants will also perform exercise challenges.
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Glucose Standard Deviation (mg/dL)
Control-IQ Run-in Period (7 days)
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67.8 mg/dL
Interval 61.0 to 70.2
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Glucose Standard Deviation (mg/dL)
Tandem Freedom (3 days)
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51.3 mg/dL
Interval 45.5 to 64.2
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Adverse Events
Run-in Period
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Tandem Freedom
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 |
Run-in Period
n=10 participants at risk
One week run-in period with Control-IQ technology.
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Tandem Freedom
n=10 participants at risk
Participants will use the Tandem Freedom system for one partial day with user initiated mealtime insulin boluses and three days without user initiated mealtime insulin boluses in a supervised hotel setting. Participants also performed exercise challenges.
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Skin and subcutaneous tissue disorders
Superficial burn
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10.0%
1/10 • Number of events 1 • 10 days
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0.00%
0/10 • 10 days
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Nervous system disorders
Headache
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0.00%
0/10 • 10 days
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10.0%
1/10 • Number of events 1 • 10 days
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Additional Information
Sr. Clinical Research Associate I
Tandem Diabetes Care
Phone: (877) 801-6901
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place