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Trial Outcomes & Findings for A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes (NCT NCT05785832)

NCT ID: NCT05785832

Last Updated: 2025-09-29

Results Overview

Change in HbA1c (%) from baseline between the intervention and control groups

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

319 participants

Primary outcome timeframe

13 weeks

Results posted on

2025-09-29

Participant Flow

Participant milestones

Participant milestones
Measure
Control-IQ+ AID
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Overall Study
STARTED
215
104
Overall Study
COMPLETED
211
102
Overall Study
NOT COMPLETED
4
2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

A Randomized Trial Evaluating Control-IQ+ Technology in Adults With Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Total
n=319 Participants
Total of all reporting groups
Age, Continuous
59 year
STANDARD_DEVIATION 12 • n=5 Participants
57 year
STANDARD_DEVIATION 12 • n=7 Participants
57 year
STANDARD_DEVIATION 12 • n=5 Participants
Sex: Female, Male
Female
105 Participants
n=5 Participants
49 Participants
n=7 Participants
154 Participants
n=5 Participants
Sex: Female, Male
Male
110 Participants
n=5 Participants
55 Participants
n=7 Participants
165 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants
n=5 Participants
1 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Asian
10 Participants
n=5 Participants
3 Participants
n=7 Participants
13 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants
n=5 Participants
0 Participants
n=7 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
45 Participants
n=5 Participants
24 Participants
n=7 Participants
69 Participants
n=5 Participants
Race (NIH/OMB)
White
148 Participants
n=5 Participants
74 Participants
n=7 Participants
222 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
6 Participants
n=5 Participants
2 Participants
n=7 Participants
8 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=5 Participants
0 Participants
n=7 Participants
3 Participants
n=5 Participants
Region of Enrollment
Canada
14 participants
n=5 Participants
6 participants
n=7 Participants
20 participants
n=5 Participants
Region of Enrollment
United States
201 participants
n=5 Participants
98 participants
n=7 Participants
299 participants
n=5 Participants

PRIMARY outcome

Timeframe: 13 weeks

Population: Data were missing because the sample that was obtained from one patient could not be analyzed.

Change in HbA1c (%) from baseline between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=214 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
HbA1c
Baseline
8.2 percentage of glycated hemoglobin
Standard Deviation 1.4
8.1 percentage of glycated hemoglobin
Standard Deviation 1.2
HbA1c
13 Weeks
7.3 percentage of glycated hemoglobin
Standard Deviation 0.9
7.7 percentage of glycated hemoglobin
Standard Deviation 1.1
HbA1c
Change from Baseline
-0.9 percentage of glycated hemoglobin
Standard Deviation 1.1
-0.3 percentage of glycated hemoglobin
Standard Deviation 0.9

SECONDARY outcome

Timeframe: 13 weeks

Change in CGM percent time 70-180 mg/dL from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time in Range 70-180 mg/dL
Baseline
48 percentage of time
Standard Deviation 24
51 percentage of time
Standard Deviation 21
Time in Range 70-180 mg/dL
13 Weeks
64 percentage of time
Standard Deviation 16
52 percentage of time
Standard Deviation 21
Time in Range 70-180 mg/dL
Change from Baseline
16 percentage of time
Standard Deviation 19
1 percentage of time
Standard Deviation 14

SECONDARY outcome

Timeframe: 13 weeks

Change in mean CGM glucose mg/dL from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Mean Glucose
Baseline
194 mg/dL
Standard Deviation 43
190 mg/dL
Standard Deviation 35
Mean Glucose
13 Weeks
170 mg/dL
Standard Deviation 23
188 mg/dL
Standard Deviation 34
Mean Glucose
Change from Baseline
-24 mg/dL
Standard Deviation 34
-1 mg/dL
Standard Deviation 24

SECONDARY outcome

Timeframe: 13 weeks

Change in CGM percent time \>180 mg/dL from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time >180 mg/dL
Baseline
51 percentage of time
Standard Deviation 25
49 percentage of time
Standard Deviation 21
Time >180 mg/dL
13 Weeks
35 percentage of time
Standard Deviation 16
48 percentage of time
Standard Deviation 21
Time >180 mg/dL
Change from Baseline
-16 percentage of time
Standard Deviation 19
-1 percentage of time
Standard Deviation 14

SECONDARY outcome

Timeframe: 13 weeks

Change in CGM percent time \>250 mg/dL from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time >250 mg/dL
Baseline
19.5 percentage of time
Standard Deviation 17.3
15.8 percentage of time
Standard Deviation 13.6
Time >250 mg/dL
13 Weeks
9.7 percentage of time
Standard Deviation 7.8
16.7 percentage of time
Standard Deviation 14.1
Time >250 mg/dL
Change from Baseline
-9.7 percentage of time
Standard Deviation 17.1
1.0 percentage of time
Standard Deviation 11.4

SECONDARY outcome

Timeframe: 13 weeks

Change in number of prolonged hyperglycemia events (\>90 minutes \>300 mg/dL within a 120-minute period) per week from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Prolonged Hyperglycemia Events Per Week
Baseline
1.7 events per week
Standard Deviation 1.7
1.6 events per week
Standard Deviation 1.7
Prolonged Hyperglycemia Events Per Week
13 Weeks
0.9 events per week
Standard Deviation 0.9
1.6 events per week
Standard Deviation 1.5
Prolonged Hyperglycemia Events Per Week
Change from Baseline
-0.7 events per week
Standard Deviation 1.5
0.0 events per week
Standard Deviation 1.0

SECONDARY outcome

Timeframe: 13 weeks

Change in CGM percent time \<70 mg/dL from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time <70 mg/dL
Baseline
0.7 percentage of time
Standard Deviation 0.8
0.3 percentage of time
Standard Deviation 0.3
Time <70 mg/dL
13 Weeks
0.4 percentage of time
Standard Deviation 0.4
0.4 percentage of time
Standard Deviation 0.4
Time <70 mg/dL
Change from Baseline
-0.2 percentage of time
Standard Deviation 1.2
0.1 percentage of time
Standard Deviation 0.6

SECONDARY outcome

Timeframe: 13 weeks

Change in CGM percent time \<54 mg/dL from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time <54 mg/dL
Baseline
0.16 percentage of time
Standard Deviation 0.16
0.05 percentage of time
Standard Deviation 0.05
Time <54 mg/dL
13 Weeks
0.09 percentage of time
Standard Deviation 0.09
0.09 percentage of time
Standard Deviation 0.10
Time <54 mg/dL
Change from Baseline
-0.06 percentage of time
Standard Deviation 0.42
0.04 percentage of time
Standard Deviation 0.22

SECONDARY outcome

Timeframe: 13 weeks

Change in number of CGM-measured hypoglycemia events per week (15 or more consecutive minutes \<54 mg/dL) from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
CGM-measured Hypoglycemia Events Per Week
Baseline
0.2 events per week
Standard Deviation 0.3
0.1 events per week
Standard Deviation 0.0
CGM-measured Hypoglycemia Events Per Week
13 Weeks
0.1 events per week
Standard Deviation 0.2
0.1 events per week
Standard Deviation 0.2
CGM-measured Hypoglycemia Events Per Week
Change from Baseline
-0.1 events per week
Standard Deviation 0.6
0.1 events per week
Standard Deviation 0.3

SECONDARY outcome

Timeframe: 13 weeks

Change in coefficient of variation mg/dL from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Coefficient of Variation
Baseline
28 percentage SD of Mean
Standard Deviation 6
27 percentage SD of Mean
Standard Deviation 5
Coefficient of Variation
13 Weeks
30 percentage SD of Mean
Standard Deviation 5
29 percentage SD of Mean
Standard Deviation 5
Coefficient of Variation
Change from Baseline
2 percentage SD of Mean
Standard Deviation 5
2 percentage SD of Mean
Standard Deviation 3

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants with HbA1c \<7.0% at 13 weeks, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=214 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
HbA1c <7.0%
Baseline
28 Participants
15 Participants
HbA1c <7.0%
13 Weeks
78 Participants
28 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants with HbA1c \<7.0% at 13 weeks, in participants with baseline HbA1c \>7.5%, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=214 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
HbA1c <7.0% in Participants With Baseline HbA1c >7.5%
33 Participants
6 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants with HbA1c \<7.5% at 13 weeks, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=214 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
HbA1c <7.5%
Baseline
60 Participants
33 Participants
HbA1c <7.5%
13 Weeks
132 Participants
44 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants with HbA1c improvement from baseline to 13 weeks \>0.5%, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=214 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
HbA1c Improvement From Baseline to 13 Weeks >0.5%
123 Participants
31 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants with HbA1c improvement from baseline to 13 weeks \>1.0%, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=214 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
HbA1c Improvement From Baseline to 13 Weeks >1.0%
81 Participants
14 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants with HbA1c relative improvement from baseline to 13 weeks \>10%, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=214 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
HbA1c Relative Improvement From Baseline to 13 Weeks >10%
92 Participants
20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants with HbA1c improvement from baseline to 13 weeks \>1.0% or HbA1c \<7.0% at 13 weeks, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=214 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
HbA1c Improvement From Baseline to 13 Weeks >1.0% or HbA1c <7.0% at 13 Weeks
130 Participants
42 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Change in CGM percent time 70-140 mg/dL from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time in Range 70-140 mg/dL
Baseline
23 percentage of time
Standard Deviation 18
23 percentage of time
Standard Deviation 15
Time in Range 70-140 mg/dL
13 Weeks
35 percentage of time
Standard Deviation 15
25 percentage of time
Standard Deviation 15
Time in Range 70-140 mg/dL
Change from Baseline
12 percentage of time
Standard Deviation 13
2 percentage of time
Standard Deviation 11

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

CGM area over the curve (70 mg/dL), compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Area Over the Curve (70 mg/dL)
Baseline
0.07 mg*hr/dL
Standard Deviation 0.08
0.03 mg*hr/dL
Standard Deviation 0.03
Area Over the Curve (70 mg/dL)
13 Weeks
0.04 mg*hr/dL
Standard Deviation 0.04
0.04 mg*hr/dL
Standard Deviation 0.04
Area Over the Curve (70 mg/dL)
Change from Baseline
-0.03 mg*hr/dL
Standard Deviation 0.16
0.02 mg*hr/dL
Standard Deviation 0.08

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia, compared between the intervention and control groups. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 \< LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 \< LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI \> 5.0 is associated with high risk of hypoglycemia.

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Low Blood Glucose Index
Baseline
0.23 units on a scale
Standard Deviation 0.24
0.12 units on a scale
Standard Deviation 0.10
Low Blood Glucose Index
13 Weeks
0.19 units on a scale
Standard Deviation 0.15
0.17 units on a scale
Standard Deviation 0.14
Low Blood Glucose Index
Change from Baseline
-0.04 units on a scale
Standard Deviation 0.31
0.05 units on a scale
Standard Deviation 0.17

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Change in CGM percent time \>300 mg/dL from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time >300 mg/dL
13 Weeks
3.5 percentage of time
Standard Deviation 3.6
6.8 percentage of time
Standard Deviation 7.2
Time >300 mg/dL
Baseline
8.6 percentage of time
Standard Deviation 9.4
6.4 percentage of time
Standard Deviation 6.6
Time >300 mg/dL
Change from Baseline
-5.1 percentage of time
Standard Deviation 12.1
0.5 percentage of time
Standard Deviation 8.5

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

CGM area under the curve (180 mg/dL), compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Area Under the Curve (180 mg/dL)
Baseline
34 mg*hr/dL
Standard Deviation 26
29 mg*hr/dL
Standard Deviation 21
Area Under the Curve (180 mg/dL)
13 Weeks
19 mg*hr/dL
Standard Deviation 12
30 mg*hr/dL
Standard Deviation 21
Area Under the Curve (180 mg/dL)
Change from Baseline
-16 mg*hr/dL
Standard Deviation 27
1 mg*hr/dL
Standard Deviation 18

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

High Blood Glucose Index (HBGI) by CGM, compared between the intervention and control groups., as a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI \< 4.5 is associated with lower risk of hyperglycemia, 4.5 \< HBGI \< 9 is associated with a moderate risk of hyperglycemia and HBGI \> 9 is associated with high risk of hyperglycemia.

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
High Blood Glucose Index
Baseline
12.6 units on a scale
Standard Deviation 7.1
11.4 units on a scale
Standard Deviation 5.6
High Blood Glucose Index
13 Weeks
8.1 units on a scale
Standard Deviation 3.6
11.4 units on a scale
Standard Deviation 5.8
High Blood Glucose Index
Change from Baseline
-4.4 units on a scale
Standard Deviation 6.8
0.0 units on a scale
Standard Deviation 4.7

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants who achieved time in range 70-180 mg/dL \>70%, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time in Range 70-180 mg/dL >70%
Baseline
46 Participants
18 Participants
Time in Range 70-180 mg/dL >70%
13 Weeks
81 Participants
23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants with time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥5%, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥5%
149 Participants
43 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants with time in range 70-180 mg/dL improvement from baseline to 13 weeks ≥10%, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time in Range 70-180 mg/dL Improvement From Baseline to 13 Weeks ≥10%
122 Participants
20 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants with CGM time \<70 mg/dL \<4%, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time <70 mg/dL <4%
Baseline
207 Participants
104 Participants
Time <70 mg/dL <4%
13 Weeks
212 Participants
104 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants with CGM time \<54 mg/dL \<1%, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time <54 mg/dL <1%
Baseline
205 Participants
103 Participants
Time <54 mg/dL <1%
13 Weeks
212 Participants
104 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Number of participants with time in range 70-180 mg/dL \>70% and time \<54 mg/dL \<1%, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Time in Range 70-180 mg/dL >70% and Time <54 mg/dL <1%
Baseline
43 Participants
17 Participants
Time in Range 70-180 mg/dL >70% and Time <54 mg/dL <1%
13 Weeks
80 Participants
23 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Total daily insulin delivery (units), compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Total Insulin
Baseline
95 units/day
Standard Deviation 47
102 units/day
Standard Deviation 50
Total Insulin
13 Weeks
87 units/day
Standard Deviation 46
104 units/day
Standard Deviation 56
Total Insulin
Change from Baseline
-8 units/day
Standard Deviation 38
2 units/day
Standard Deviation 39

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Percentage of insulin delivered as basal, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Basal Insulin
Baseline
54.4 percentage of units of insulin
Standard Deviation 16.1
52.6 percentage of units of insulin
Standard Deviation 16.8
Basal Insulin
13 Weeks
54.2 percentage of units of insulin
Standard Deviation 11.9
54.1 percentage of units of insulin
Standard Deviation 16.4
Basal Insulin
Change from Baseline
-0.2 percentage of units of insulin
Standard Deviation 18.5
1.5 percentage of units of insulin
Standard Deviation 17.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Change in weight (kg) from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Weight
Baseline
100.5 kg
Standard Deviation 23.0
104.8 kg
Standard Deviation 25.5
Weight
13 Weeks
103.1 kg
Standard Deviation 24.2
105.5 kg
Standard Deviation 24.5
Weight
Change from Baseline
2.4 kg
Standard Deviation 4.4
0.9 kg
Standard Deviation 3.3

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Blood Pressure - Systolic
Baseline
130 mm Hg
Standard Deviation 17
128 mm Hg
Standard Deviation 17
Blood Pressure - Systolic
13 Weeks
131 mm Hg
Standard Deviation 17
129 mm Hg
Standard Deviation 17
Blood Pressure - Systolic
Change from Baseline
1 mm Hg
Standard Deviation 17
1 mm Hg
Standard Deviation 15

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Change in blood pressure (mm Hg) from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Blood Pressure - Diastolic
Baseline
77 mm Hg
Standard Deviation 11
77 mm Hg
Standard Deviation 10
Blood Pressure - Diastolic
13 Weeks
77 mm Hg
Standard Deviation 11
78 mm Hg
Standard Deviation 10
Blood Pressure - Diastolic
Change from Baseline
0 mm Hg
Standard Deviation 10
1 mm Hg
Standard Deviation 9

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Lipid Levels - HDL
Baseline
45.3 mg/dL
Standard Deviation 11.9
44.9 mg/dL
Standard Deviation 15.5
Lipid Levels - HDL
13 Weeks
45.7 mg/dL
Standard Deviation 12.3
43.7 mg/dL
Standard Deviation 13.0
Lipid Levels - HDL
Change from Baseline
0.7 mg/dL
Standard Deviation 5.8
-1.3 mg/dL
Standard Deviation 7.1

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Change in lipid levels (mg/dL) from baseline, compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Lipid Levels - LDL
Change from Baseline
2.0 mg/dL
Standard Deviation 27.1
-5.3 mg/dL
Standard Deviation 26.5
Lipid Levels - LDL
Baseline
75.6 mg/dL
Standard Deviation 39.8
82.6 mg/dL
Standard Deviation 40.6
Lipid Levels - LDL
13 Weeks
77.9 mg/dL
Standard Deviation 40.2
78.8 mg/dL
Standard Deviation 36.6

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Change in triglycerides (mg/dL), compared between the intervention and control groups

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Triglycerides
Baseline
164 mg/dL
Standard Deviation 82
180 mg/dL
Standard Deviation 96
Triglycerides
13 Weeks
157 mg/dL
Standard Deviation 78
187 mg/dL
Standard Deviation 108
Triglycerides
Change from Baseline
-7 mg/dL
Standard Deviation 77
7 mg/dL
Standard Deviation 119

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Patient-reported outcome (PRO) measures from the Type 2 Diabetes Distress Assessment System (Core and Source) questionnaire, compared between the intervention and control groups. The T2-DDAS includes a Core measure that precisely characterizes the intensity of the emotional DD experience, and a set of Sources measures that identifies the key contributors or specific sources of distress. The seven Sources are: management demands, healthcare provider, hypoglycemia, long-term health, interpersonal issues, shame/stigma and healthcare access. Scoring for each question is on a scale of 1-5, with higher scores indicating more problems/distress. Scores are reported individually per domain area at baseline and 13 weeks.

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Healthcare provider - 13 Weeks
1.5 score on a scale
Standard Deviation 0.8
1.6 score on a scale
Standard Deviation 0.8
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Interpersonal issues - Baseline
1.9 score on a scale
Standard Deviation 1.0
1.9 score on a scale
Standard Deviation 1.0
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Intensity Score - Baseline
2.6 score on a scale
Standard Deviation 1.1
2.6 score on a scale
Standard Deviation 1.0
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Intensity Score - 13 Weeks
2.2 score on a scale
Standard Deviation 1.0
2.4 score on a scale
Standard Deviation 1.0
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Hypoglycemia - Baseline
2.0 score on a scale
Standard Deviation 1.1
2.0 score on a scale
Standard Deviation 1.1
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Hypoglycemia - 13 Weeks
1.9 score on a scale
Standard Deviation 1.0
1.8 score on a scale
Standard Deviation 1.0
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Long-term health - Baseline
2.6 score on a scale
Standard Deviation 1.1
2.8 score on a scale
Standard Deviation 1.2
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Long-term health - 13 Weeks
2.4 score on a scale
Standard Deviation 1.1
2.5 score on a scale
Standard Deviation 1.1
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Healthcare provider - Baseline
1.7 score on a scale
Standard Deviation 0.9
1.7 score on a scale
Standard Deviation 0.8
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Interpersonal issues - 13 Weeks
1.7 score on a scale
Standard Deviation 0.9
1.7 score on a scale
Standard Deviation 1.0
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Shame/stigma - Baseline
1.5 score on a scale
Standard Deviation 0.8
1.5 score on a scale
Standard Deviation 0.8
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Shame/stigma - 13 Weeks
1.4 score on a scale
Standard Deviation 0.7
1.3 score on a scale
Standard Deviation 0.8
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Healthcare access - Baseline
2.0 score on a scale
Standard Deviation 0.9
2.1 score on a scale
Standard Deviation 0.9
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Healthcare access - 13 Weeks
1.9 score on a scale
Standard Deviation 0.9
2.0 score on a scale
Standard Deviation 0.9
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Management demands - Baseline
2.6 score on a scale
Standard Deviation 1.0
2.6 score on a scale
Standard Deviation 1.1
Type 2 Diabetes Distress Assessment System (T2-DDAS Core and Source)
Management demands - 13 Weeks
2.3 score on a scale
Standard Deviation 1.0
2.3 score on a scale
Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Patient-reported outcome (PRO) measures from DAWN Impact of Diabetes Profile (DIDP) questionnaire, compared between the intervention and control groups. The DIDP provides a brief assessment of the perceived impact of diabetes on six key dimensions of life. Participants rate the impact of diabetes on each domain on a 7-point scale, with 1 being a very positive impact and 7 being a very negative impact. A converted percentage (0-100%) scale scores are reported. Lower scale scores indicate greater positive impact and higher scale scores indicate greater negative impact across global life dimensions.

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=214 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=102 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
DAWN Impact of Diabetes Profile (DIDP)
Baseline
59 score on a scale
Standard Deviation 19
62 score on a scale
Standard Deviation 15
DAWN Impact of Diabetes Profile (DIDP)
13 Weeks
59 score on a scale
Standard Deviation 18
63 score on a scale
Standard Deviation 15

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Patient-reported outcome (PRO) measures from Diabetes Impact and Satisfaction (DIDS) Scale questionnaire, compared between the intervention and control groups. For the DIDS satisfaction score, scores range from 0-10 with higher scores indicating better outcome. For the DIDS impact score, scores range from 0-10 with lower scores indicating better outcome.

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Diabetes Impact and Satisfaction (DIDS) Scale
Device Satisfaction - Baseline
6.7 score on a scale
Standard Deviation 1.9
7.0 score on a scale
Standard Deviation 1.9
Diabetes Impact and Satisfaction (DIDS) Scale
Device Satisfaction - 13 Weeks
8.2 score on a scale
Standard Deviation 1.6
7.2 score on a scale
Standard Deviation 1.8
Diabetes Impact and Satisfaction (DIDS) Scale
Diabetes Impact - Baseline
3.4 score on a scale
Standard Deviation 1.7
3.3 score on a scale
Standard Deviation 1.8
Diabetes Impact and Satisfaction (DIDS) Scale
Diabetes Impact - 13 Weeks
3.1 score on a scale
Standard Deviation 1.7
3.4 score on a scale
Standard Deviation 1.8

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Patient-reported outcome (PRO) measures from PROMIS Sleep-Related Impairment questionnaire, compared between the intervention and control groups. The PROMIS Sleep-Related Impairment Questionnaire utilizes a T-score metric for scoring, with a mean of 50 and a standard deviation of 10. Higher T-scores indicate greater sleep-related impairment. The questionnaire uses a 5-point Likert scale (1=never to 5=always) for each item, and the responses are summed to calculate a total raw score. This raw score is then converted to a T-score using a lookup table provided in the scoring manual.

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=214 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
PROMIS Sleep-Related Impairment Questionnaire
Baseline
22.4 score on a scale
Standard Deviation 7.3
22.0 score on a scale
Standard Deviation 7.1
PROMIS Sleep-Related Impairment Questionnaire
13 Weeks
19.6 score on a scale
Standard Deviation 6.9
21.8 score on a scale
Standard Deviation 7.4

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Patient-reported outcome (PRO) measures from System Usability Scale (SUS) questionnaire, compared between the intervention and control groups. 10 items rated on 5-point Likert scale (1=Strongly Disagree, 5=Strongly Agree). Total score is on a 100 point scale (0 - 100), with higher scores indicating greater usability.

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
System Usability Scale (SUS)
Baseline
69 score on a scale
Standard Deviation 18
70 score on a scale
Standard Deviation 18
System Usability Scale (SUS)
13 Weeks
75 score on a scale
Standard Deviation 19
73 score on a scale
Standard Deviation 17

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Patient-reported outcome (PRO) measures from Hypoglycemia Fear Survey II Behavior and Worry Scores, compared between the intervention and control groups. The HFS-II consists of 33 items, which are organized into two subscales: HFS-B (Behavior): A 15 item subscale that focuses on behaviors to avoid hypoglycemia, and HFS-W (Worry): a 18 item subscale that focuses on worries about hypoglycemia and its consequences. The HFS-II subscale scores range from 0-60 and 0-72 for the HFS-B and HFS-W, respectively. Higher scores indicate higher fear of hypoglycemia.

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Hypoglycemia Fear Survey II
Worry - 13 Weeks
19 score on a scale
Standard Deviation 20
21 score on a scale
Standard Deviation 21
Hypoglycemia Fear Survey II
Behavior - Baseline
27 score on a scale
Standard Deviation 18
30 score on a scale
Standard Deviation 18
Hypoglycemia Fear Survey II
Behavior - 13 Weeks
26 score on a scale
Standard Deviation 17
28 score on a scale
Standard Deviation 17
Hypoglycemia Fear Survey II
Worry - Baseline
22 score on a scale
Standard Deviation 23
22 score on a scale
Standard Deviation 19

OTHER_PRE_SPECIFIED outcome

Timeframe: 13 weeks

Patient-reported outcome (PRO) measures from EQ5D-5L questionnaire, compared between the intervention and control groups, showing EQ-Index Scores. The EQ5D utility index consists of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five response categories, from which a single EQ-5D index score can be calculated ranging from 0 (worst imaginable health) to 1 (best imaginable health) on which participants have to indicate their current health.

Outcome measures

Outcome measures
Measure
Control-IQ+ AID
n=215 Participants
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 Participants
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
EQ5D-5L
EQ-Index - Baseline
0.76 score on a scale
Standard Deviation 0.22
0.75 score on a scale
Standard Deviation 0.27
EQ5D-5L
EQ-Index - 13 Weeks
0.77 score on a scale
Standard Deviation 0.24
0.74 score on a scale
Standard Deviation 0.29

Adverse Events

Control-IQ+ AID

Serious events: 17 serious events
Other events: 60 other events
Deaths: 0 deaths

CGM Arm

Serious events: 7 serious events
Other events: 18 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
Control-IQ+ AID
n=215 participants at risk
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 participants at risk
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Endocrine disorders
Severe Hypoglycemia
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Endocrine disorders
Diabetic ketoacidosis
0.00%
0/215 • 13 weeks
0.00%
0/104 • 13 weeks
Endocrine disorders
Hyperosmolar hyperglycemic syndrome
0.00%
0/215 • 13 weeks
0.00%
0/104 • 13 weeks
Musculoskeletal and connective tissue disorders
Back surgery
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast ductal carcinoma
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Infections and infestations
COVID-19
0.93%
2/215 • Number of events 2 • 13 weeks
0.00%
0/104 • 13 weeks
Cardiac disorders
Cardiomyopathy
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Cardiac disorders
Chest pressure
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Cardiac disorders
Congestive heart failure
0.47%
1/215 • Number of events 1 • 13 weeks
0.96%
1/104 • Number of events 1 • 13 weeks
Vascular disorders
Coronary artery disease
0.00%
0/215 • 13 weeks
0.96%
1/104 • Number of events 1 • 13 weeks
Respiratory, thoracic and mediastinal disorders
Exacerbation of asthma
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Infections and infestations
Foot infection
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
General disorders
Headache
0.00%
0/215 • 13 weeks
0.96%
1/104 • Number of events 1 • 13 weeks
Surgical and medical procedures
Hip fracture
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Vascular disorders
Hypotension
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Infections and infestations
Infection (chronic) of amputation stump
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Surgical and medical procedures
Knee surgery NOS
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Metabolism and nutrition disorders
Multinodular goiter
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
General disorders
Other specified adverse effect, not elsewhere classified
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Gastrointestinal disorders
Pancreatitis
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Gastrointestinal disorders
Pancreatitis (Fatal)
0.00%
0/215 • 13 weeks
0.96%
1/104 • Number of events 1 • 13 weeks
Infections and infestations
Pneumonia
0.00%
0/215 • 13 weeks
0.96%
1/104 • Number of events 1 • 13 weeks
Infections and infestations
Tooth abscess
0.00%
0/215 • 13 weeks
0.96%
1/104 • Number of events 1 • 13 weeks
Surgical and medical procedures
Total knee replacement
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks
Congenital, familial and genetic disorders
Unstable angina
0.00%
0/215 • 13 weeks
0.96%
1/104 • Number of events 1 • 13 weeks
Vascular disorders
Vitreous hemorrhage
0.47%
1/215 • Number of events 1 • 13 weeks
0.00%
0/104 • 13 weeks

Other adverse events

Other adverse events
Measure
Control-IQ+ AID
n=215 participants at risk
t:slim X2 insulin pump with Control-IQ+ technology and Dexcom G6 CGM for 13 weeks.
CGM Arm
n=104 participants at risk
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6) for 13 weeks.
Endocrine disorders
Hyperglycemia with or without ketosis related to study device
6.0%
13/215 • Number of events 20 • 13 weeks
0.00%
0/104 • 13 weeks
Endocrine disorders
Hyperglycemia with or without ketosis not related to study device
0.47%
1/215 • Number of events 1 • 13 weeks
1.9%
2/104 • Number of events 2 • 13 weeks
Endocrine disorders
Non-severe hypoglycemia
4.2%
9/215 • Number of events 10 • 13 weeks
1.9%
2/104 • Number of events 2 • 13 weeks
General disorders
Other reportable adverse events
17.2%
37/215 • Number of events 56 • 13 weeks
13.5%
14/104 • Number of events 15 • 13 weeks

Additional Information

Sr. Supervisor of Clinical Operations

Tandem Diabetes Care

Phone: 18583666900

Results disclosure agreements

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