We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04113694
Recruitment Status : Completed
First Posted : October 3, 2019
Results First Posted : October 1, 2021
Last Update Posted : October 1, 2021
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diabetes
Intervention Device: Extended Infusion Set
Enrollment 291
Recruitment Details  
Pre-assignment Details 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.
Arm/Group Title Extended Wear Infusion Set
Hide Arm/Group Description

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.

Period Title: Overall Study
Started 259
Completed 248
Not Completed 11
Reason Not Completed
Adverse Event             2
Lost to Follow-up             2
Withdrawal by Subject             6
Withdrawal due to not meeting inclusion and exclusion criteria             1
Arm/Group Title Humalog Subjects Extended Wear Infusion Set Novolog Subjects Extended Wear Infusion Set Total
Hide Arm/Group Description

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.

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 of all reporting groups
Overall Number of Baseline Participants 132 127 259
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 132 participants 127 participants 259 participants
43.4  (14.3) 46.7  (13.7) 45.0  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 127 participants 259 participants
Female
68
  51.5%
66
  52.0%
134
  51.7%
Male
64
  48.5%
61
  48.0%
125
  48.3%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 132 participants 127 participants 259 participants
Hispanic or Latino
5
   3.8%
4
   3.1%
9
   3.5%
Not Hispanic or Latino
126
  95.5%
123
  96.9%
249
  96.1%
Unknown or Not Reported
1
   0.8%
0
   0.0%
1
   0.4%
BMI (kg/m2)  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 132 participants 127 participants 259 participants
29.0  (5.6) 29.0  (5.9) 29.0  (5.7)
1.Primary Outcome
Title Humalog Subjects - Rate of Infusion Set Failure at the End of Day 6
Hide Description Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.
Time Frame 144 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended Wear Infusion Set
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 132
Overall Number of Units Analyzed
Type of Units Analyzed: EWIS infusion sets
1561
Mean (95% Confidence Interval)
Unit of Measure: Percentage of Extended Wear Infusion Set
0.06
(0.01 to 0.45)
2.Primary Outcome
Title Novolog Subjects - Rate of Infusion Set Failure at the End of Day 6
Hide Description Independently evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.
Time Frame 144 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended Wear Infusion Set
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 127
Overall Number of Units Analyzed
Type of Units Analyzed: EWIS infusion sets
1480
Mean (95% Confidence Interval)
Unit of Measure: Percentage of Extended Wear Infusion Set
0.27
(0.10 to 0.71)
3.Secondary Outcome
Title Humalog Subject - Rate of Infusion Set Failure at the End of Day 7.
Hide Description Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.
Time Frame 168 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended Wear Infusion Set
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 132
Overall Number of Units Analyzed
Type of Units Analyzed: EWIS infusion sets
1561
Mean (95% Confidence Interval)
Unit of Measure: Percentage of Extended Wear Infusion Set
0.13
(0.03 to 0.51)
4.Secondary Outcome
Title Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7.
Hide Description Independently evaluated rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.
Time Frame 168 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Extended Wear Infusion Set
Hide Arm/Group Description:

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.

Overall Number of Participants Analyzed 127
Overall Number of Units Analyzed
Type of Units Analyzed: EWIS infusion sets
1480
Mean (95% Confidence Interval)
Unit of Measure: Percentage of Extended Wear Infusion Set
0.41
(0.16 to 1.00)
Time Frame 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Humalog Subjects Extended Wear Infusion Set Novolog Subjects Extended Wear Infusion Set
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Humalog Subjects Extended Wear Infusion Set Novolog Subjects Extended Wear Infusion Set
Affected / at Risk (%) Affected / at Risk (%)
Total   0/132 (0.00%)      0/127 (0.00%)    
Hide Serious Adverse Events
Humalog Subjects Extended Wear Infusion Set Novolog Subjects Extended Wear Infusion Set
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2/132 (1.52%)      1/127 (0.79%)    
Injury, poisoning and procedural complications     
Tendon rupture  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Metabolism and nutrition disorders     
Hypoglycemia  1  2/132 (1.52%)  2 0/127 (0.00%)  0
1
Term from vocabulary, MedDRA 23.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Humalog Subjects Extended Wear Infusion Set Novolog Subjects Extended Wear Infusion Set
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   59/132 (44.70%)      60/127 (47.24%)    
Blood and lymphatic system disorders     
Neutropenia  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Congenital, familial and genetic disorders     
Tourette's disorder  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Ear and labyrinth disorders     
Vertigo positional  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Eye disorders     
Cataract  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Gastrointestinal disorders     
Nausea  1  0/132 (0.00%)  0 1/127 (0.79%)  1
General disorders     
Complication of device removal  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Fatigue  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Infusion site bruising  1  0/132 (0.00%)  0 2/127 (1.57%)  2
Infusion site dermatitis  1  2/132 (1.52%)  2 1/127 (0.79%)  1
Infusion site discomfort  1  8/132 (6.06%)  13 6/127 (4.72%)  6
Infusion site erythema  1  2/132 (1.52%)  2 3/127 (2.36%)  3
Infusion site haemorrhage  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Infusion site hypersensitivity  1  1/132 (0.76%)  3 0/127 (0.00%)  0
Infusion site irritation  1  0/132 (0.00%)  0 2/127 (1.57%)  5
Infusion site nodule  1  1/132 (0.76%)  2 2/127 (1.57%)  2
Infusion site pain  1  4/132 (3.03%)  7 4/127 (3.15%)  5
Infusion site reaction  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Infusion site swelling  1  3/132 (2.27%)  11 1/127 (0.79%)  1
Infusion site vesicles  1  1/132 (0.76%)  2 0/127 (0.00%)  0
Medical device site discomfort  1  2/132 (1.52%)  2 1/127 (0.79%)  1
Medical device site erythema  1  1/132 (0.76%)  1 1/127 (0.79%)  1
Medical device site irritation  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Medical device site nodule  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Medical device site oedema  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Medical device site swelling  1  1/132 (0.76%)  2 0/127 (0.00%)  0
Pain  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Infections and infestations     
Acute sinusitis  1  0/132 (0.00%)  0 1/127 (0.79%)  1
COVID-19  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Conjunctivitis  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Ear infection  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Folliculitis  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Gingivitis  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Influenza  1  2/132 (1.52%)  2 1/127 (0.79%)  1
Infusion site cellulitis  1  4/132 (3.03%)  5 6/127 (4.72%)  6
Infusion site infection  1  1/132 (0.76%)  1 2/127 (1.57%)  2
Medical device site cellulitis  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Nasopharyngitis  1  10/132 (7.58%)  11 2/127 (1.57%)  2
Onychomycosis  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Oral candidiasis  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Otitis externa  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Pharyngitis  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Pharyngitis streptococcal  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Postoperative wound infection  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Respiratory tract infection  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Sinusitis  1  2/132 (1.52%)  2 0/127 (0.00%)  0
Suspected COVID-19  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Tooth abscess  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Upper respiratory tract infection  1  0/132 (0.00%)  0 2/127 (1.57%)  2
Vulvovaginal mycotic infection  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Injury, poisoning and procedural complications     
Foot fracture  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Incision site complication  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Limb injury  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Sunburn  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Investigations     
Blood glucose increased  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Metabolism and nutrition disorders     
Decreased appetite  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Diabetic ketosis  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Hyperglycaemia  1  23/132 (17.42%)  49 28/127 (22.05%)  43
Musculoskeletal and connective tissue disorders     
Back pain  1  0/132 (0.00%)  0 2/127 (1.57%)  2
Intervertebral disc protrusion  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Musculoskeletal pain  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Osteoarthritis  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Pain in extremity  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Nervous system disorders     
Facial paralysis  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Headache  1  2/132 (1.52%)  2 3/127 (2.36%)  5
Psychiatric disorders     
Stress  1  2/132 (1.52%)  3 1/127 (0.79%)  1
Respiratory, thoracic and mediastinal disorders     
Cough  1  1/132 (0.76%)  1 1/127 (0.79%)  1
Skin and subcutaneous tissue disorders     
Dermatitis  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Dermatitis contact  1  1/132 (0.76%)  1 0/127 (0.00%)  0
Skin irritation  1  0/132 (0.00%)  0 1/127 (0.79%)  1
Vascular disorders     
Varicose vein  1  0/132 (0.00%)  0 1/127 (0.79%)  1
1
Term from vocabulary, MedDRA23.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Emma Pham, MSHS (Clinical Study Manager)
Organization: Medtronic Diabetes
Phone: 818 576 4878
EMail: emma.pham@medtronic.com
Layout table for additonal information
Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT04113694    
Other Study ID Numbers: CEP298
First Submitted: October 1, 2019
First Posted: October 3, 2019
Results First Submitted: August 10, 2021
Results First Posted: October 1, 2021
Last Update Posted: October 1, 2021