Trial Outcomes & Findings for Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes (NCT NCT05683392)

NCT ID: NCT05683392

Last Updated: 2024-12-20

Results Overview

Number of severe hypoglycemic events (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry over a 3-month time period

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 72 participants
• Primary outcome timeframe: 2 weeks
• Results posted on: 2024-12-20

Participant Flow

Participant milestones

Measure	Control-IQ 2.0 Lower Range First, Then Standard Range After a 2 week Run-In Period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 at a lower treatment range for two weeks, then at a standard treatment range for 2 weeks.	Control-IQ 2.0 Standard Range First, Then Lower Range After a 2 week Run-In Period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 at a standard treatment range for two weeks, then at a lower treatment range for 2 weeks.
Overall Study STARTED	36	36
Overall Study COMPLETED	36	36
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Use of Control-IQ Technology 2.0 in Adults, Children, and Preschoolers With Type 1 Diabetes

Baseline characteristics by cohort

Measure	Control-IQ 2.0 Lower Range First, Then Standard Range n=36 Participants After a two week run in period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 with a lower range for two weeks, followed by use of t:slim X2 pump with Control-IQ technology 2.0 with a standard range for two weeks.	Control-IQ 2.0 Standard Range First, Then Lower Range n=36 Participants After a two week run in period with Control-IQ 1.5, participants will use t:slim X2 pump with Control-IQ technology 2.0 with a standard range for two weeks, followed by use of t:slim X2 pump with Control-IQ technology 2.0 with a lower range for two weeks.	Total n=72 Participants Total of all reporting groups
Age, Continuous	17.7 years STANDARD_DEVIATION 14.2 • n=5 Participants	16.3 years STANDARD_DEVIATION 12.1 • n=7 Participants	17.0 years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants	18 Participants n=7 Participants	35 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants	32 Participants n=7 Participants	61 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	32 Participants n=5 Participants	32 Participants n=7 Participants	64 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 2 weeks

Number of severe hypoglycemic events (with cognitive impairment such that assistance of another individual is needed for treatment) during study compared with data on severe hypoglycemic events reported by T1D Exchange clinic registry over a 3-month time period

Outcome measures

Measure	Lower Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.	Standard Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.
Number of Severe Hypoglycemic Events	0 events	0 events

PRIMARY outcome

Timeframe: 2 weeks

Number of diabetic ketoacidosis during study compared with data on DKA events, compared with data on DKA events reported by T1D Exchange clinic registry over a 3-month time period

Outcome measures

Measure	Lower Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.	Standard Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.
Number of Diabetic Ketoacidosis (DKA) Events	0 events	0 events

SECONDARY outcome

Timeframe: 2 weeks

CGM percent time <54 mg/dL during each study period.

Outcome measures

Measure	Lower Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.	Standard Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.
Percent of Time <54 mg/dL	0.4 percentage of time Interval 0.1 to 0.8	0.3 percentage of time Interval 0.1 to 0.7

SECONDARY outcome

Timeframe: 2 weeks

CGM percent time <70 mg/dL during each study period.

Outcome measures

Measure	Lower Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.	Standard Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.
Percent of Time <70 mg/dL	2.0 percentage of time Interval 0.9 to 3.3	1.6 percentage of time Interval 0.7 to 3.0

SECONDARY outcome

Timeframe: 2 weeks

CGM percent time 70-140 mg/dL during each study period.

Outcome measures

Measure	Lower Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.	Standard Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.
Percent Time 70-140 mg/dL	43.9 percentage of time Interval 38.2 to 51.3	39.2 percentage of time Interval 30.9 to 48.1

SECONDARY outcome

Timeframe: 2 weeks

CGM percent time 70-180 mg/dL during each study period.

Outcome measures

Measure	Lower Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.	Standard Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.
Percent Time 70-180 mg/dL	68.0 percentage of time Interval 60.5 to 74.3	65.8 percentage of time Interval 54.4 to 73.0

SECONDARY outcome

Timeframe: 2 weeks

CGM percent time >180 mg/dL during each study period.

Outcome measures

Measure	Lower Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.	Standard Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.
Percent Time > 180 mg/dL	30.5 percentage of time Interval 23.9 to 36.3	33.0 percentage of time Interval 25.2 to 43.8

SECONDARY outcome

Timeframe: 2 weeks

CGM percent time >250 mg/dL during each study period.

Outcome measures

Measure	Lower Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.	Standard Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.
Percent Time > 250 mg/dL	9.9 percentage of time Interval 5.1 to 15.3	10.6 percentage of time Interval 5.7 to 18.5

SECONDARY outcome

Timeframe: 2 weeks

Mean CGM glucose mg/dL during each study period.

Outcome measures

Measure	Lower Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.	Standard Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.
Mean Glucose	160.2 mg/dL Interval 149.7 to 172.6	166.0 mg/dL Interval 152.6 to 183.4

SECONDARY outcome

Timeframe: 2 weeks

Glucose SD mg/dL during each study period.

Outcome measures

Measure	Lower Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.	Standard Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.
Glucose SD	63.5 mg/dL Interval 52.5 to 71.0	61.3 mg/dL Interval 53.8 to 72.7

SECONDARY outcome

Timeframe: 2 weeks

Glucose Coefficient of Variation (%) during each study period.

Outcome measures

Measure	Lower Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.	Standard Range n=72 Participants Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.
Glucose Coefficient of Variation	38.1 percentage of coefficient of variation Interval 34.9 to 42.5	37.3 percentage of coefficient of variation Interval 34.0 to 41.4

Adverse Events

Lower Range

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Standard Range

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Lower Range n=72 participants at risk Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.	Standard Range n=72 participants at risk Participants will use t:slim X2 insulin pump with Control-IQ technology 2.0 with a lower range for two weeks.
Renal and urinary disorders Urinary Tract Infection	0.00% 0/72 • Two weeks for each intervention.	1.4% 1/72 • Number of events 1 • Two weeks for each intervention.
Endocrine disorders Hyperglycemia without ketosis	2.8% 2/72 • Number of events 2 • Two weeks for each intervention.	1.4% 1/72 • Number of events 1 • Two weeks for each intervention.
Endocrine disorders Hyperglycemia with ketosis	1.4% 1/72 • Number of events 2 • Two weeks for each intervention.	8.3% 6/72 • Number of events 6 • Two weeks for each intervention.
Musculoskeletal and connective tissue disorders Foot Injury	0.00% 0/72 • Two weeks for each intervention.	1.4% 1/72 • Number of events 1 • Two weeks for each intervention.
Infections and infestations Yeast Infection	0.00% 0/72 • Two weeks for each intervention.	1.4% 1/72 • Number of events 1 • Two weeks for each intervention.
Infections and infestations Skin Infection	0.00% 0/72 • Two weeks for each intervention.	1.4% 1/72 • Number of events 1 • Two weeks for each intervention.
Infections and infestations Upper Respiratory Tract Infection	0.00% 0/72 • Two weeks for each intervention.	4.2% 3/72 • Number of events 3 • Two weeks for each intervention.
Skin and subcutaneous tissue disorders Pain	1.4% 1/72 • Number of events 1 • Two weeks for each intervention.	0.00% 0/72 • Two weeks for each intervention.
Infections and infestations COVID-19	1.4% 1/72 • Number of events 1 • Two weeks for each intervention.	0.00% 0/72 • Two weeks for each intervention.
Musculoskeletal and connective tissue disorders Sprained Ankle	0.00% 0/72 • Two weeks for each intervention.	1.4% 1/72 • Number of events 1 • Two weeks for each intervention.
Infections and infestations Otitis Media	1.4% 1/72 • Number of events 1 • Two weeks for each intervention.	0.00% 0/72 • Two weeks for each intervention.

Additional Information

Supervisor, Clinical Affairs

Tandem Diabetes Care, Inc

Phone: (877) 801-6901

Email: clinicalaffairs@tandemdiabetes.com

Results disclosure agreements

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