Trial Outcomes & Findings for Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes (NCT NCT06273124)
NCT ID: NCT06273124
Last Updated: 2025-09-24
Results Overview
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Humalog.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
260 participants
Primary outcome timeframe
12 weeks
Results posted on
2025-09-24
Participant Flow
Participant milestones
| Measure |
SteadiSet Extended Wear Infusion Set - Humalog
Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.
Approximately half of the participants in the study were using Humalog insulin.
|
SteaduSet Extended Wear Infusion Set - Novolog
Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.
Approximately half of the participants in the study were using Novolog insulin.
|
|---|---|---|
|
Overall Study
STARTED
|
128
|
132
|
|
Overall Study
COMPLETED
|
124
|
126
|
|
Overall Study
NOT COMPLETED
|
4
|
6
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
SteadiSet Extended Wear Infusion Set - Humalog
n=128 Participants
Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.
Approximately half of the participants in the study were using Humalog insulin.
|
SteaduSet Extended Wear Infusion Set - Novolog
n=132 Participants
Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.
Approximately half of the participants in the study were using Novolog insulin.
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
40.9 years
STANDARD_DEVIATION 16.0 • n=5 Participants
|
46.8 years
STANDARD_DEVIATION 18.0 • n=7 Participants
|
43.9 years
STANDARD_DEVIATION 17.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
83 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
150 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 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
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
240 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
128 participants
n=5 Participants
|
132 participants
n=7 Participants
|
260 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: To be considered for analysis in the primary outcome, participants had to have successfully inserted at least 6 sets per the study protocol.
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Humalog.
Outcome measures
| Measure |
SteadiSet Extended Wear Infusion Set - Humalog
n=1500 Number of Infusion Sets
Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.
Approximately half of the participants in the study were using Humalog insulin.
|
|---|---|
|
7 Day Survival of Infusion Set for Primary Outcome Measure - Humalog
|
95 percentage of infusion set wears
Standard Error 0.7
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: To be considered for analysis in the primary outcome, participants had to have successfully inserted at least 6 sets per the study protocol.
7-day infusion set survival for primary outcome reasons as defined in the protocol (Hyperglycemia and failure to respond to boluses, Hyperglycemia with ketones \>1.0 mmol/L, or Investigator advised), for participants using Novolog.
Outcome measures
| Measure |
SteadiSet Extended Wear Infusion Set - Humalog
n=1527 Number of Infusion Sets
Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.
Approximately half of the participants in the study were using Humalog insulin.
|
|---|---|
|
7 Day Survival of Infusion Set for Primary Outcome Measure - Novolog
|
95 percentage of infusion set wears
Standard Error 0.8
|
Adverse Events
SteadiSet Extended Wear Infusion Set - Humalog
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
SteaduSet Extended Wear Infusion Set - Novolog
Serious events: 1 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SteadiSet Extended Wear Infusion Set - Humalog
n=128 participants at risk
Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.
Approximately half of the participants in the study were using Humalog insulin.
|
SteaduSet Extended Wear Infusion Set - Novolog
n=132 participants at risk
Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.
Approximately half of the participants in the study were using Novolog insulin.
|
|---|---|---|
|
Endocrine disorders
Severe Hypoglycemia
|
0.00%
0/128 • 12 Weeks
|
0.76%
1/132 • Number of events 1 • 12 Weeks
|
|
Endocrine disorders
Diabetic Ketoacidosis
|
0.00%
0/128 • 12 Weeks
|
0.00%
0/132 • 12 Weeks
|
|
General disorders
Other Serious Adverse Event
|
0.00%
0/128 • 12 Weeks
|
0.00%
0/132 • 12 Weeks
|
Other adverse events
| Measure |
SteadiSet Extended Wear Infusion Set - Humalog
n=128 participants at risk
Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.
Approximately half of the participants in the study were using Humalog insulin.
|
SteaduSet Extended Wear Infusion Set - Novolog
n=132 participants at risk
Each participant will be asked to wear the Investigational Extended Wear Infusion Set for up to 168 hours for 12 consecutive wear periods with the Tandem t:slim X2 insulin pump with Control-IQ technology, and wearing the Dexcom G6 or G7 sensor.
Approximately half of the participants in the study were using Novolog insulin.
|
|---|---|---|
|
Infections and infestations
Abscess NOS
|
0.00%
0/128 • 12 Weeks
|
0.76%
1/132 • Number of events 1 • 12 Weeks
|
|
Infections and infestations
Atopic dermatitis
|
0.00%
0/128 • 12 Weeks
|
0.76%
1/132 • Number of events 2 • 12 Weeks
|
|
Infections and infestations
Candidiasis
|
0.00%
0/128 • 12 Weeks
|
0.76%
1/132 • Number of events 1 • 12 Weeks
|
|
Infections and infestations
Cellulitis
|
0.78%
1/128 • Number of events 1 • 12 Weeks
|
3.0%
4/132 • Number of events 4 • 12 Weeks
|
|
Skin and subcutaneous tissue disorders
Contact dermatitis
|
0.78%
1/128 • Number of events 1 • 12 Weeks
|
0.00%
0/132 • 12 Weeks
|
|
Musculoskeletal and connective tissue disorders
Cycling accident
|
0.00%
0/128 • 12 Weeks
|
0.76%
1/132 • Number of events 1 • 12 Weeks
|
|
Skin and subcutaneous tissue disorders
Erythematous conditions
|
0.00%
0/128 • 12 Weeks
|
1.5%
2/132 • Number of events 3 • 12 Weeks
|
|
Endocrine disorders
Hyperglycemia with or without Ketosis
|
0.78%
1/128 • Number of events 1 • 12 Weeks
|
2.3%
3/132 • Number of events 3 • 12 Weeks
|
|
Infections and infestations
Infection
|
3.1%
4/128 • Number of events 4 • 12 Weeks
|
0.76%
1/132 • Number of events 1 • 12 Weeks
|
|
Skin and subcutaneous tissue disorders
Injection site discomfort
|
2.3%
3/128 • Number of events 6 • 12 Weeks
|
0.00%
0/132 • 12 Weeks
|
|
Infections and infestations
Injection site irritation
|
0.00%
0/128 • 12 Weeks
|
2.3%
3/132 • Number of events 3 • 12 Weeks
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/128 • 12 Weeks
|
0.76%
1/132 • Number of events 1 • 12 Weeks
|
|
Skin and subcutaneous tissue disorders
Localized superficial swelling, mass, or lump
|
0.78%
1/128 • Number of events 3 • 12 Weeks
|
0.00%
0/132 • 12 Weeks
|
|
Skin and subcutaneous tissue disorders
Medical device site inflammation
|
0.00%
0/128 • 12 Weeks
|
0.76%
1/132 • Number of events 1 • 12 Weeks
|
|
Nervous system disorders
Neurologic disorder NOS
|
0.78%
1/128 • Number of events 1 • 12 Weeks
|
0.00%
0/132 • 12 Weeks
|
|
General disorders
Pain in face
|
0.00%
0/128 • 12 Weeks
|
0.76%
1/132 • Number of events 1 • 12 Weeks
|
|
Infections and infestations
Pustule
|
0.78%
1/128 • Number of events 1 • 12 Weeks
|
0.00%
0/132 • 12 Weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.78%
1/128 • Number of events 1 • 12 Weeks
|
3.0%
4/132 • Number of events 5 • 12 Weeks
|
|
Skin and subcutaneous tissue disorders
Skin abrasion
|
0.00%
0/128 • 12 Weeks
|
0.76%
1/132 • Number of events 1 • 12 Weeks
|
|
Infections and infestations
Skin infection
|
0.78%
1/128 • Number of events 1 • 12 Weeks
|
3.0%
4/132 • Number of events 4 • 12 Weeks
|
|
Immune system disorders
Sulfonamide allergy
|
0.00%
0/128 • 12 Weeks
|
0.76%
1/132 • Number of events 1 • 12 Weeks
|
|
Reproductive system and breast disorders
Vulval itching
|
0.00%
0/128 • 12 Weeks
|
0.76%
1/132 • Number of events 1 • 12 Weeks
|
|
Reproductive system and breast disorders
Yeast infection
|
0.00%
0/128 • 12 Weeks
|
0.76%
1/132 • Number of events 1 • 12 Weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place