Trial Outcomes & Findings for Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes (NCT NCT04113694)
NCT ID: NCT04113694
Last Updated: 2021-10-01
Results Overview
Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
291 participants
Primary outcome timeframe
144 hours
Results posted on
2021-10-01
Participant Flow
291 subjects consented and enrolled in the overall study. Of the 291, 28 subjects failed screening, 4 subjects passed screening but did not attempt any EWIS, 259 subjects wore at least one EWIS, 11 subjects early withdraw, 248 subjects completed the study.
Participant milestones
| Measure |
Extended Wear Infusion Set
Each subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: each subject was asked to wear each Extended Wear Infusion Set for at least 174 hours.
|
|---|---|
|
Overall Study
STARTED
|
259
|
|
Overall Study
COMPLETED
|
248
|
|
Overall Study
NOT COMPLETED
|
11
|
Reasons for withdrawal
| Measure |
Extended Wear Infusion Set
Each subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: each subject was asked to wear each Extended Wear Infusion Set for at least 174 hours.
|
|---|---|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Withdrawal by Subject
|
6
|
|
Overall Study
Withdrawal due to not meeting inclusion and exclusion criteria
|
1
|
Baseline Characteristics
Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Humalog Subjects Extended Wear Infusion Set
n=132 Participants
Each Humalog subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: Humalog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours.
|
Novolog Subjects Extended Wear Infusion Set
n=127 Participants
Each Novolog subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: Novolog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours.
|
Total
n=259 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.4 years
STANDARD_DEVIATION 14.3 • n=5 Participants
|
46.7 years
STANDARD_DEVIATION 13.7 • n=7 Participants
|
45.0 years
STANDARD_DEVIATION 14.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
134 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
64 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
126 Participants
n=5 Participants
|
123 Participants
n=7 Participants
|
249 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
BMI (kg/m2)
|
29.0 kg/m^2
STANDARD_DEVIATION 5.6 • n=5 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 5.9 • n=7 Participants
|
29.0 kg/m^2
STANDARD_DEVIATION 5.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 144 hoursEvaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.
Outcome measures
| Measure |
Extended Wear Infusion Set
n=1561 EWIS infusion sets
Each Humalog subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: Humalog subjects were asked to wear Extended Wear Infusion Set for at least 174 hours.
|
|---|---|
|
Humalog Subjects - Rate of Infusion Set Failure at the End of Day 6
|
0.06 Percentage of Extended Wear Infusion Set
Interval 0.01 to 0.45
|
PRIMARY outcome
Timeframe: 144 hoursIndependently evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.
Outcome measures
| Measure |
Extended Wear Infusion Set
n=1480 EWIS infusion sets
Each Humalog subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: Humalog subjects were asked to wear Extended Wear Infusion Set for at least 174 hours.
|
|---|---|
|
Novolog Subjects - Rate of Infusion Set Failure at the End of Day 6
|
0.27 Percentage of Extended Wear Infusion Set
Interval 0.1 to 0.71
|
SECONDARY outcome
Timeframe: 168 hoursEvaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.
Outcome measures
| Measure |
Extended Wear Infusion Set
n=1561 EWIS infusion sets
Each Humalog subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: Humalog subjects were asked to wear Extended Wear Infusion Set for at least 174 hours.
|
|---|---|
|
Humalog Subject - Rate of Infusion Set Failure at the End of Day 7.
|
0.13 Percentage of Extended Wear Infusion Set
Interval 0.03 to 0.51
|
SECONDARY outcome
Timeframe: 168 hoursIndependently evaluated rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.
Outcome measures
| Measure |
Extended Wear Infusion Set
n=1480 EWIS infusion sets
Each Humalog subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: Humalog subjects were asked to wear Extended Wear Infusion Set for at least 174 hours.
|
|---|---|
|
Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7.
|
0.41 Percentage of Extended Wear Infusion Set
Interval 0.16 to 1.0
|
Adverse Events
Humalog Subjects Extended Wear Infusion Set
Serious events: 2 serious events
Other events: 59 other events
Deaths: 0 deaths
Novolog Subjects Extended Wear Infusion Set
Serious events: 1 serious events
Other events: 60 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Humalog Subjects Extended Wear Infusion Set
n=132 participants at risk
Each Humalog subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: Humalog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours.
|
Novolog Subjects Extended Wear Infusion Set
n=127 participants at risk
Each Novolog subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: Novolog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Hypoglycemia
|
1.5%
2/132 • Number of events 2 • 3 months
|
0.00%
0/127 • 3 months
|
Other adverse events
| Measure |
Humalog Subjects Extended Wear Infusion Set
n=132 participants at risk
Each Humalog subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: Humalog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours.
|
Novolog Subjects Extended Wear Infusion Set
n=127 participants at risk
Each Novolog subject was given 12 Extended Wear Infusion Sets to wear.
Extended Infusion Set: Novolog subjects were asked to wear each Extended Wear Infusion Set for at least 174 hours.
|
|---|---|---|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/132 • 3 months
|
1.6%
2/127 • Number of events 2 • 3 months
|
|
Investigations
Blood glucose increased
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Infections and infestations
COVID-19
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Eye disorders
Cataract
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
General disorders
Complication of device removal
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Infections and infestations
Conjunctivitis
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Metabolism and nutrition disorders
Diabetic ketosis
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Infections and infestations
Ear infection
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
General disorders
Fatigue
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Infections and infestations
Folliculitis
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Infections and infestations
Gingivitis
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Nervous system disorders
Headache
|
1.5%
2/132 • Number of events 2 • 3 months
|
2.4%
3/127 • Number of events 5 • 3 months
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
17.4%
23/132 • Number of events 49 • 3 months
|
22.0%
28/127 • Number of events 43 • 3 months
|
|
Injury, poisoning and procedural complications
Incision site complication
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Infections and infestations
Influenza
|
1.5%
2/132 • Number of events 2 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
General disorders
Infusion site bruising
|
0.00%
0/132 • 3 months
|
1.6%
2/127 • Number of events 2 • 3 months
|
|
Infections and infestations
Infusion site cellulitis
|
3.0%
4/132 • Number of events 5 • 3 months
|
4.7%
6/127 • Number of events 6 • 3 months
|
|
General disorders
Infusion site dermatitis
|
1.5%
2/132 • Number of events 2 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
General disorders
Infusion site discomfort
|
6.1%
8/132 • Number of events 13 • 3 months
|
4.7%
6/127 • Number of events 6 • 3 months
|
|
General disorders
Infusion site erythema
|
1.5%
2/132 • Number of events 2 • 3 months
|
2.4%
3/127 • Number of events 3 • 3 months
|
|
General disorders
Infusion site haemorrhage
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
General disorders
Infusion site hypersensitivity
|
0.76%
1/132 • Number of events 3 • 3 months
|
0.00%
0/127 • 3 months
|
|
Infections and infestations
Infusion site infection
|
0.76%
1/132 • Number of events 1 • 3 months
|
1.6%
2/127 • Number of events 2 • 3 months
|
|
General disorders
Infusion site irritation
|
0.00%
0/132 • 3 months
|
1.6%
2/127 • Number of events 5 • 3 months
|
|
General disorders
Infusion site nodule
|
0.76%
1/132 • Number of events 2 • 3 months
|
1.6%
2/127 • Number of events 2 • 3 months
|
|
General disorders
Infusion site pain
|
3.0%
4/132 • Number of events 7 • 3 months
|
3.1%
4/127 • Number of events 5 • 3 months
|
|
General disorders
Infusion site reaction
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
General disorders
Infusion site swelling
|
2.3%
3/132 • Number of events 11 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
General disorders
Infusion site vesicles
|
0.76%
1/132 • Number of events 2 • 3 months
|
0.00%
0/127 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Infections and infestations
Medical device site cellulitis
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
General disorders
Medical device site discomfort
|
1.5%
2/132 • Number of events 2 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
General disorders
Medical device site erythema
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
General disorders
Medical device site irritation
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
General disorders
Medical device site nodule
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
General disorders
Medical device site oedema
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
General disorders
Medical device site swelling
|
0.76%
1/132 • Number of events 2 • 3 months
|
0.00%
0/127 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Infections and infestations
Nasopharyngitis
|
7.6%
10/132 • Number of events 11 • 3 months
|
1.6%
2/127 • Number of events 2 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Infections and infestations
Otitis externa
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
General disorders
Pain
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Infections and infestations
Pharyngitis
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Infections and infestations
Respiratory tract infection
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Infections and infestations
Sinusitis
|
1.5%
2/132 • Number of events 2 • 3 months
|
0.00%
0/127 • 3 months
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Psychiatric disorders
Stress
|
1.5%
2/132 • Number of events 3 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Infections and infestations
Suspected COVID-19
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Congenital, familial and genetic disorders
Tourette's disorder
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/132 • 3 months
|
1.6%
2/127 • Number of events 2 • 3 months
|
|
Vascular disorders
Varicose vein
|
0.00%
0/132 • 3 months
|
0.79%
1/127 • Number of events 1 • 3 months
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.76%
1/132 • Number of events 1 • 3 months
|
0.00%
0/127 • 3 months
|
Additional Information
Emma Pham, MSHS (Clinical Study Manager)
Medtronic Diabetes
Phone: 818 576 4878
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60