Trial Outcomes & Findings for Control-IQ Observational (CLIO) Post-Approval Study (NCT NCT04503174)
NCT ID: NCT04503174
Last Updated: 2023-12-08
Results Overview
Overall incidence rate of events per 100 patient years
Recruitment status
COMPLETED
Target enrollment
3157 participants
Primary outcome timeframe
12 months
Results posted on
2023-12-08
Participant Flow
3157 participants completed the baseline survey and were enrolled, but only 3061 had started closed-loop and had adequate data available for analysis.
Participant milestones
| Measure |
All Enrolled Participants
All participants with analyzable data (minimum of 75% CGM data available for at least 21 days)
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|
|
Overall Study
STARTED
|
3061
|
|
Overall Study
COMPLETED
|
2998
|
|
Overall Study
NOT COMPLETED
|
63
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
not mutually exclusive, not all participants answered.
Baseline characteristics by cohort
| Measure |
All Enrolled Participants
n=3157 Participants
All participants who started the monthly surveys.
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|
|
Age, Continuous
|
29.0 years
n=3157 Participants
|
|
Sex: Female, Male
Female
|
1759 Participants
n=3157 Participants
|
|
Sex: Female, Male
Male
|
1398 Participants
n=3157 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
271 Participants
n=3157 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2819 Participants
n=3157 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
67 Participants
n=3157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
60 Participants
n=3031 Participants • not mutually exclusive, not all participants answered.
|
|
Race (NIH/OMB)
Asian
|
78 Participants
n=3031 Participants • not mutually exclusive, not all participants answered.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
14 Participants
n=3031 Participants • not mutually exclusive, not all participants answered.
|
|
Race (NIH/OMB)
Black or African American
|
184 Participants
n=3031 Participants • not mutually exclusive, not all participants answered.
|
|
Race (NIH/OMB)
White
|
2628 Participants
n=3031 Participants • not mutually exclusive, not all participants answered.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3031 Participants • not mutually exclusive, not all participants answered.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
67 Participants
n=3031 Participants • not mutually exclusive, not all participants answered.
|
|
Region of Enrollment
United States
|
3157 Participants
n=3157 Participants
|
PRIMARY outcome
Timeframe: 12 monthsOverall incidence rate of events per 100 patient years
Outcome measures
| Measure |
Prior MDI User
n=915 Participants
New to insulin pump use
t:slim X2 pump with Control-IQ technology: Real-world use
|
6-17 YO
n=931 Participants
Subjects between the age of 6-17 years old.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Adults (18+)
n=2130 Participants
Subjects are 18 years old and older.
t:slim X2 pump with Control-IQ technology: Real-world use
|
No Prior CGM Experience
n=392 Participants
Subjects have not used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Greater Than or Equal to 8%
n=1295 Participants
Subjects have an HbA1c greater than or equal to 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Less Than 8%
n=1766 Participants
Subjects have an HbA1c of less than 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior Pump User
n=2146 Participants
Existing insulin pump user
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior CGM Experience
n=2669 Participants
Subjects have used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|---|---|---|---|---|---|---|
|
Incidence Rates of Severe Hypoglycemia (SH)
|
9.65 events per 100 patient years
Standard Deviation 36.47
|
9.31 events per 100 patient years
Standard Deviation 34.31
|
9.77 events per 100 patient years
Standard Deviation 36.97
|
7.99 events per 100 patient years
Standard Deviation 30.04
|
9.58 events per 100 patient years
Standard Deviation 37.03
|
9.66 events per 100 patient years
Standard Deviation 35.55
|
9.61 events per 100 patient years
Standard Deviation 36.06
|
9.87 events per 100 patient years
Standard Deviation 36.99
|
PRIMARY outcome
Timeframe: 12 monthsOverall incidence rate of events per 100 patient years
Outcome measures
| Measure |
Prior MDI User
n=915 Participants
New to insulin pump use
t:slim X2 pump with Control-IQ technology: Real-world use
|
6-17 YO
n=931 Participants
Subjects between the age of 6-17 years old.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Adults (18+)
n=2130 Participants
Subjects are 18 years old and older.
t:slim X2 pump with Control-IQ technology: Real-world use
|
No Prior CGM Experience
n=392 Participants
Subjects have not used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Greater Than or Equal to 8%
n=1295 Participants
Subjects have an HbA1c greater than or equal to 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Less Than 8%
n=1766 Participants
Subjects have an HbA1c of less than 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior Pump User
n=2146 Participants
Existing insulin pump user
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior CGM Experience
n=2669 Participants
Subjects have used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|---|---|---|---|---|---|---|
|
Incidence Rates of Diabetic Ketoacidosis (DKA)
|
2.40 events per 100 patient years
Standard Deviation 16.69
|
1.93 events per 100 patient years
Standard Deviation 13.78
|
1.46 events per 100 patient years
Standard Deviation 13.10
|
3.57 events per 100 patient years
Standard Deviation 19.91
|
2.47 events per 100 patient years
Standard Deviation 16.50
|
0.96 events per 100 patient years
Standard Deviation 10.33
|
1.26 events per 100 patient years
Standard Deviation 11.56
|
1.37 events per 100 patient years
Standard Deviation 12.02
|
PRIMARY outcome
Timeframe: 12 monthsPercent of boluses using the auto population feature resulting in at least one reading less than 70 mg/dL than those not using the feature, in every pre-bolus glucose range examined.
Outcome measures
| Measure |
Prior MDI User
n=3061 Participants
New to insulin pump use
t:slim X2 pump with Control-IQ technology: Real-world use
|
6-17 YO
Subjects between the age of 6-17 years old.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Adults (18+)
Subjects are 18 years old and older.
t:slim X2 pump with Control-IQ technology: Real-world use
|
No Prior CGM Experience
Subjects have not used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Greater Than or Equal to 8%
Subjects have an HbA1c greater than or equal to 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Less Than 8%
Subjects have an HbA1c of less than 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior Pump User
Existing insulin pump user
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior CGM Experience
Subjects have used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|---|---|---|---|---|---|---|
|
Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature
70 to 180 mg/dL Correction Bolus Results within 5 hours after bolus (with CGM auto population)
|
13.18 percentage of boluses
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature
70 to 180 mg/dL Correction Bolus Results within 5 hours after bolus (no CGM auto population)
|
14.52 percentage of boluses
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature
181 to 250 mg/dL Correction Bolus Results within 5 hours after bolus (with CGM auto population)
|
11.06 percentage of boluses
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature
181 to 250 mg/dL Correction Bolus Results within 5 hours after bolus (no CGM auto population)
|
15.61 percentage of boluses
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature
> 250 mg/dL Correction Bolus Results within 5 hours after bolus (with CGM auto population)
|
10.34 percentage of boluses
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature
> 250 mg/dL Correction Bolus Results within 5 hours after bolus (no CGM auto population)
|
13.50 percentage of boluses
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature
All (with CGM auto population)
|
12.22 percentage of boluses
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percent of Boluses Using the Auto Population Feature Resulting in Fewer Readings Less Than 70 mg/dL Than Those Not Using the Feature
All (no CGM auto population)
|
14.60 percentage of boluses
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsCGM measured percent time in range 70 - 180 mg/dL during 12 months of Control-IQ use
Outcome measures
| Measure |
Prior MDI User
n=2130 Participants
New to insulin pump use
t:slim X2 pump with Control-IQ technology: Real-world use
|
6-17 YO
n=412 Participants
Subjects between the age of 6-17 years old.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Adults (18+)
n=519 Participants
Subjects are 18 years old and older.
t:slim X2 pump with Control-IQ technology: Real-world use
|
No Prior CGM Experience
n=3061 Participants
Subjects have not used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Greater Than or Equal to 8%
Subjects have an HbA1c greater than or equal to 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Less Than 8%
Subjects have an HbA1c of less than 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior Pump User
Existing insulin pump user
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior CGM Experience
Subjects have used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|---|---|---|---|---|---|---|
|
Percent Time in Range 70 - 180 mg/dL
|
70.1 percentage of time
Interval 61.0 to 78.8
|
60.9 percentage of time
Interval 50.1 to 71.8
|
61.2 percentage of time
Interval 52.4 to 70.5
|
67.3 percentage of time
Interval 57.4 to 76.9
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsCGM measured percent time greater than 180 mg/dL during 12 months of Control-IQ use
Outcome measures
| Measure |
Prior MDI User
n=2130 Participants
New to insulin pump use
t:slim X2 pump with Control-IQ technology: Real-world use
|
6-17 YO
n=412 Participants
Subjects between the age of 6-17 years old.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Adults (18+)
n=519 Participants
Subjects are 18 years old and older.
t:slim X2 pump with Control-IQ technology: Real-world use
|
No Prior CGM Experience
n=3061 Participants
Subjects have not used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Greater Than or Equal to 8%
Subjects have an HbA1c greater than or equal to 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Less Than 8%
Subjects have an HbA1c of less than 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior Pump User
Existing insulin pump user
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior CGM Experience
Subjects have used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|---|---|---|---|---|---|---|
|
Percent Time Greater Than 180 mg/dL
|
28.6 percentage of time
Interval 19.2 to 37.8
|
37.0 percentage of time
Interval 26.5 to 48.7
|
37.2 percentage of time
Interval 27.5 to 46.3
|
31.4 percentage of time
Interval 20.9 to 41.5
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsCGM measured percent time greater than 250 mg/dL during 12 months of Control-IQ use
Outcome measures
| Measure |
Prior MDI User
n=2130 Participants
New to insulin pump use
t:slim X2 pump with Control-IQ technology: Real-world use
|
6-17 YO
n=412 Participants
Subjects between the age of 6-17 years old.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Adults (18+)
n=519 Participants
Subjects are 18 years old and older.
t:slim X2 pump with Control-IQ technology: Real-world use
|
No Prior CGM Experience
n=3061 Participants
Subjects have not used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Greater Than or Equal to 8%
Subjects have an HbA1c greater than or equal to 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Less Than 8%
Subjects have an HbA1c of less than 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior Pump User
Existing insulin pump user
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior CGM Experience
Subjects have used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|---|---|---|---|---|---|---|
|
Percent Time Greater Than 250 mg/dL
|
6.3 percentage of time
Interval 2.8 to 12.0
|
12.8 percentage of time
Interval 6.1 to 21.9
|
12.7 percentage of time
Interval 7.5 to 21.0
|
8.0 percentage of time
Interval 3.6 to 14.8
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsCGM measured percent time less than 70 mg/dL during 12 months of Control-IQ use
Outcome measures
| Measure |
Prior MDI User
n=2130 Participants
New to insulin pump use
t:slim X2 pump with Control-IQ technology: Real-world use
|
6-17 YO
n=412 Participants
Subjects between the age of 6-17 years old.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Adults (18+)
n=519 Participants
Subjects are 18 years old and older.
t:slim X2 pump with Control-IQ technology: Real-world use
|
No Prior CGM Experience
n=3061 Participants
Subjects have not used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Greater Than or Equal to 8%
Subjects have an HbA1c greater than or equal to 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Less Than 8%
Subjects have an HbA1c of less than 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior Pump User
Existing insulin pump user
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior CGM Experience
Subjects have used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|---|---|---|---|---|---|---|
|
Percent Time Less Than 70 mg/dL
|
1.1 percentage of time
Interval 0.5 to 2.1
|
1.0 percentage of time
Interval 0.5 to 1.9
|
1.1 percentage of time
Interval 0.6 to 2.2
|
1.1 percentage of time
Interval 0.5 to 2.1
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsCGM measured percent time less than 54 mg/dL during 12 months of Control-IQ use
Outcome measures
| Measure |
Prior MDI User
n=2130 Participants
New to insulin pump use
t:slim X2 pump with Control-IQ technology: Real-world use
|
6-17 YO
n=412 Participants
Subjects between the age of 6-17 years old.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Adults (18+)
n=519 Participants
Subjects are 18 years old and older.
t:slim X2 pump with Control-IQ technology: Real-world use
|
No Prior CGM Experience
n=3061 Participants
Subjects have not used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Greater Than or Equal to 8%
Subjects have an HbA1c greater than or equal to 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Less Than 8%
Subjects have an HbA1c of less than 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior Pump User
Existing insulin pump user
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior CGM Experience
Subjects have used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|---|---|---|---|---|---|---|
|
Percent Time Less Than 54 mg/dL
|
0.2 percentage of time
Interval 0.1 to 0.4
|
0.2 percentage of time
Interval 0.1 to 0.4
|
0.2 percentage of time
Interval 0.1 to 0.4
|
0.2 percentage of time
Interval 0.1 to 0.4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsDIDS satisfaction score after 12 months of Control-IQ use. Score range from 0-10 with higher scores indicating better outcome.
Outcome measures
| Measure |
Prior MDI User
n=3061 Participants
New to insulin pump use
t:slim X2 pump with Control-IQ technology: Real-world use
|
6-17 YO
Subjects between the age of 6-17 years old.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Adults (18+)
Subjects are 18 years old and older.
t:slim X2 pump with Control-IQ technology: Real-world use
|
No Prior CGM Experience
Subjects have not used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Greater Than or Equal to 8%
Subjects have an HbA1c greater than or equal to 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Less Than 8%
Subjects have an HbA1c of less than 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior Pump User
Existing insulin pump user
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior CGM Experience
Subjects have used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|---|---|---|---|---|---|---|
|
Diabetes Impact and Satisfaction Scale (DIDS), Satisfaction Score
|
9.14 score on a scale
Interval 8.29 to 9.71
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 12 monthsDIDS impact score after 12 months of Control-IQ use. Score range from 0 -10 with lower scores indicating better outcome.
Outcome measures
| Measure |
Prior MDI User
n=3061 Participants
New to insulin pump use
t:slim X2 pump with Control-IQ technology: Real-world use
|
6-17 YO
Subjects between the age of 6-17 years old.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Adults (18+)
Subjects are 18 years old and older.
t:slim X2 pump with Control-IQ technology: Real-world use
|
No Prior CGM Experience
Subjects have not used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Greater Than or Equal to 8%
Subjects have an HbA1c greater than or equal to 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
HbA1c Less Than 8%
Subjects have an HbA1c of less than 8% in the 6 months prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior Pump User
Existing insulin pump user
t:slim X2 pump with Control-IQ technology: Real-world use
|
Prior CGM Experience
Subjects have used CGM in the 30 days prior to enrollment.
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|---|---|---|---|---|---|---|
|
Diabetes Impact and Satisfaction Scale (DIDS), Impact Score
|
2.75 score on a scale
Interval 2.0 to 4.0
|
—
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
All Enrolled Participants
Serious events: 14 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
All Enrolled Participants
n=3061 participants at risk
All participants with analyzable data
t:slim X2 pump with Control-IQ technology: Real-world use
|
|---|---|
|
Endocrine disorders
Ketosis
|
0.29%
9/3061 • Number of events 9 • 12 months
|
|
Endocrine disorders
Severe Hyperglycemia
|
0.10%
3/3061 • Number of events 3 • 12 months
|
|
Cardiac disorders
Death
|
0.03%
1/3061 • Number of events 1 • 12 months
|
|
Cardiac disorders
Chest pain
|
0.03%
1/3061 • Number of events 1 • 12 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place