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

• Sponsor: Medtronic Diabetes (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04113694
• Collaborator: (none)
• Enrollment: 291
• Locations: 15
• Arm: 1
• Actual Duration (Months): 12.7
• Patients Per Site: 19.4
• Patients Per Site Per Month: 1.5

Study Details

Study Description

Brief Summary

The purpose of this study is to collect confirmatory clinical data to support 6 or 7 days wear of EWIS (Extended Wear Infusion Set).

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Device: Extended Infusion Set	N/A

Detailed Description

This study is a multi-center, non-randomized, prospective single arm study with Type 1 patients with diabetes on insulin pump therapy with Continuous Glucose Monitoring (CGM). A total of up to 300 subjects age 18-80 will be enrolled at up to 20 investigational centers in the US. Each subject will wear their own MiniMed™ 670G insulin system. Each subject will be given 12 infusion sets to wear (each infusion set for at least 174 hours, or until infusion set failure if this occurs before 174 hours). Subjects will change insulin reservoirs at least every 174 hours. The time of infusion set insertion will be taken from Daily Log. Subjects can expect to participate for approximately 12-16 weeks.

Study Design

• Study Type: Interventional
• Actual Enrollment: 291 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Evaluation of Extended Wear Infusion Set (EWIS) in Patients With Type 1 Diabetes
• Actual Study Start Date: Oct 14, 2019
• Actual Primary Completion Date: Nov 5, 2020
• Actual Study Completion Date: Nov 5, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Extended Wear Infusion Set Each subject is given 12 Extended Wear Infusion Sets to wear.	Device: Extended Infusion Set; Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours.; Other Names: Extended Wear Infusion Set

Outcome Measures

Primary Outcome Measures

1. Humalog Subjects - Rate of Infusion Set Failure at the End of Day 6 [144 hours]

   Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.

2. Novolog Subjects - Rate of Infusion Set Failure at the End of Day 6 [144 hours]

   Independently evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6.

Secondary Outcome Measures

1. Humalog Subject - Rate of Infusion Set Failure at the End of Day 7. [168 hours]

   Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.

2. Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7. [168 hours]

   Independently evaluated rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Subject is age 18 - 80 years at the time of screening

2. Subject has type 1 diabetes for more than one year Study specific inclusion criteria

3. Subject is on the MiniMed™ 670G insulin pump therapy within 1 year prior to screening and willing to utilize Auto Mode and CGM with Guardian™ Sensor (3) during the study.

4. Subject is willing and able to perform study procedures as per investigator discretion

5. Subject is willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount):

6. Humalog™* (insulin lispro injection)

7. NovoLog™* (insulin aspart)

Exclusion Criteria:

1. Subject is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.

2. Subject is female and has a positive pregnancy screening test

3. Subject is female of child bearing age and who is sexually active should be excluded if she is not using a form of contraception deemed reliable by investigator

4. Subject is female and plans to become pregnant during the course of the study

5. Subject has Glycosylated hemoglobin (HbA1c) > 8.5 % at time of screening. Note: All HbA1c blood specimens will be sent to and tested by a NGSP certified Central Laboratory. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.

6. Subject has had a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening

7. Medical assistance (i.e. Paramedics, Emergency Room [ER] or Hospitalization)

8. Coma

9. Seizures

10. Subject has taken any oral, injectable, or IV glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.

11. Subject is unable to tolerate tape adhesive in the area of infusion set

12. Subject has any unresolved adverse skin condition in the area of infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)

13. Subject has infection in the area of infusion set placement at time of screening

14. Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.

15. Subject is currently abusing illicit drugs

16. Subject is currently abusing alcohol

17. Subject is on dialysis (for renal failure)

18. Subject has history of adrenal disorder

19. Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening

20. Subject has any condition that the Investigator believes would interfere with study participation

21. Subject has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator

22. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening

23. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation

24. Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening

25. Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia

26. Subject has history of cardiovascular disease defined as any ischemic related event or clinically significant arrythmia.

27. Subject has hypothyroidism and has out of reference range thyroid-stimulating hormone (TSH) on screening visit (prior labs in the last 3 months are sufficient). Subject may repeat TSH draw to verify eligibility if not in range

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Medical Investigations	Little Rock	Arkansas	United States	72205
2	AMCR Institute	Escondido	California	United States	92025
3	Stanford University	Palo Alto	California	United States	94304
4	SoCal Diabetes	West Covina	California	United States	91790
5	Barbara Davis Center for Childhood Diabetes	Aurora	Colorado	United States	80045
6	Metabolic Research Institute	West Palm Beach	Florida	United States	33401
7	Atlanta Diabetes Associates	Atlanta	Georgia	United States	30318
8	Endocrine Research Solutions	Roswell	Georgia	United States	30076
9	Iowa Diabetes and Endocrinology Center	West Des Moines	Iowa	United States	50265
10	Grunberger Diabetes Institute	Bloomfield Hills	Michigan	United States	48302
11	Mayo Clinic (Rochester MN)	Rochester	Minnesota	United States	55905
12	Diabetes and Endocrinology Consultants of Pennsylvania	Feasterville-Trevose	Pennsylvania	United States	19053
13	AM Diabetes and Endocrinology Center	Memphis	Tennessee	United States	38133
14	University of Virginia Health System	Charlottesville	Virginia	United States	22908
15	Rainier Clinical Research Center	Renton	Washington	United States	98057

Sponsors and Collaborators

• Medtronic Diabetes

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Sep 25, 2019
• Statistical Analysis Plan - Nov 19, 2020

More Information

Publications

None provided.

• Responsible Party: Medtronic Diabetes
• ClinicalTrials.gov Identifier: NCT04113694
• Other Study ID Numbers: CEP298
• First Posted: Oct 3, 2019
• Last Update Posted: Oct 1, 2021
• Last Verified: Sep 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

Participant Flow

Pre-assignment Detail	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
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

Baseline Characteristics

Arm/Group Title	Humalog Subjects Extended Wear Infusion Set	Novolog Subjects Extended Wear Infusion Set	Total
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 Participants	132	127	259
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	43.4 (14.3)	46.7 (13.7)	45.0 (14.1)
Sex: Female, Male (Count of Participants)
Female	68 51.5%	66 52%	134 51.7%
Male	64 48.5%	61 48%	125 48.3%
Ethnicity (NIH/OMB) (Count of 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%	1 0.4%
BMI (kg/m2) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	29.0 (5.6)	29.0 (5.9)	29.0 (5.7)

Outcome Measures

1. Primary Outcome

Title	Humalog Subjects - Rate of Infusion Set Failure at the End of Day 6
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended Wear Infusion Set
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.
Measure Participants	132
Measure EWIS infusion sets	1561
Mean (95% Confidence Interval) [Percentage of Extended Wear Infusion Set]	0.06

2. Primary Outcome

Title	Novolog Subjects - Rate of Infusion Set Failure at the End of Day 6
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended Wear Infusion Set
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.
Measure Participants	127
Measure EWIS infusion sets	1480
Mean (95% Confidence Interval) [Percentage of Extended Wear Infusion Set]	0.27

3. Secondary Outcome

Title	Humalog Subject - Rate of Infusion Set Failure at the End of Day 7.
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended Wear Infusion Set
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.
Measure Participants	132
Measure EWIS infusion sets	1561
Mean (95% Confidence Interval) [Percentage of Extended Wear Infusion Set]	0.13

4. Secondary Outcome

Title	Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7.
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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Extended Wear Infusion Set
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.
Measure Participants	127
Measure EWIS infusion sets	1480
Mean (95% Confidence Interval) [Percentage of Extended Wear Infusion Set]	0.41

Adverse Events

Time Frame	3 months
Arm/Group Title	Humalog Subjects Extended Wear Infusion Set		Novolog Subjects Extended Wear Infusion Set
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/132 (0%)		0/127 (0%)
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 (1.5%)		1/127 (0.8%)
Injury, poisoning and procedural complications
Tendon rupture	0/132 (0%)	0	1/127 (0.8%)	1
Metabolism and nutrition disorders
Hypoglycemia	2/132 (1.5%)	2	0/127 (0%)	0
Other (Not Including Serious) Adverse Events
	Humalog Subjects Extended Wear Infusion Set		Novolog Subjects Extended Wear Infusion Set
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	59/132 (44.7%)		60/127 (47.2%)
Blood and lymphatic system disorders
Neutropenia	1/132 (0.8%)	1	0/127 (0%)	0
Congenital, familial and genetic disorders
Tourette's disorder	1/132 (0.8%)	1	0/127 (0%)	0
Ear and labyrinth disorders
Vertigo positional	1/132 (0.8%)	1	0/127 (0%)	0
Eye disorders
Cataract	1/132 (0.8%)	1	0/127 (0%)	0
Gastrointestinal disorders
Nausea	0/132 (0%)	0	1/127 (0.8%)	1
General disorders
Complication of device removal	1/132 (0.8%)	1	0/127 (0%)	0
Fatigue	1/132 (0.8%)	1	0/127 (0%)	0
Infusion site bruising	0/132 (0%)	0	2/127 (1.6%)	2
Infusion site dermatitis	2/132 (1.5%)	2	1/127 (0.8%)	1
Infusion site discomfort	8/132 (6.1%)	13	6/127 (4.7%)	6
Infusion site erythema	2/132 (1.5%)	2	3/127 (2.4%)	3
Infusion site haemorrhage	0/132 (0%)	0	1/127 (0.8%)	1
Infusion site hypersensitivity	1/132 (0.8%)	3	0/127 (0%)	0
Infusion site irritation	0/132 (0%)	0	2/127 (1.6%)	5
Infusion site nodule	1/132 (0.8%)	2	2/127 (1.6%)	2
Infusion site pain	4/132 (3%)	7	4/127 (3.1%)	5
Infusion site reaction	1/132 (0.8%)	1	0/127 (0%)	0
Infusion site swelling	3/132 (2.3%)	11	1/127 (0.8%)	1
Infusion site vesicles	1/132 (0.8%)	2	0/127 (0%)	0
Medical device site discomfort	2/132 (1.5%)	2	1/127 (0.8%)	1
Medical device site erythema	1/132 (0.8%)	1	1/127 (0.8%)	1
Medical device site irritation	0/132 (0%)	0	1/127 (0.8%)	1
Medical device site nodule	1/132 (0.8%)	1	0/127 (0%)	0
Medical device site oedema	0/132 (0%)	0	1/127 (0.8%)	1
Medical device site swelling	1/132 (0.8%)	2	0/127 (0%)	0
Pain	0/132 (0%)	0	1/127 (0.8%)	1
Infections and infestations
Acute sinusitis	0/132 (0%)	0	1/127 (0.8%)	1
COVID-19	1/132 (0.8%)	1	0/127 (0%)	0
Conjunctivitis	1/132 (0.8%)	1	0/127 (0%)	0
Ear infection	1/132 (0.8%)	1	0/127 (0%)	0
Folliculitis	0/132 (0%)	0	1/127 (0.8%)	1
Gingivitis	0/132 (0%)	0	1/127 (0.8%)	1
Influenza	2/132 (1.5%)	2	1/127 (0.8%)	1
Infusion site cellulitis	4/132 (3%)	5	6/127 (4.7%)	6
Infusion site infection	1/132 (0.8%)	1	2/127 (1.6%)	2
Medical device site cellulitis	0/132 (0%)	0	1/127 (0.8%)	1
Nasopharyngitis	10/132 (7.6%)	11	2/127 (1.6%)	2
Onychomycosis	0/132 (0%)	0	1/127 (0.8%)	1
Oral candidiasis	0/132 (0%)	0	1/127 (0.8%)	1
Otitis externa	0/132 (0%)	0	1/127 (0.8%)	1
Pharyngitis	1/132 (0.8%)	1	0/127 (0%)	0
Pharyngitis streptococcal	0/132 (0%)	0	1/127 (0.8%)	1
Postoperative wound infection	0/132 (0%)	0	1/127 (0.8%)	1
Respiratory tract infection	1/132 (0.8%)	1	0/127 (0%)	0
Sinusitis	2/132 (1.5%)	2	0/127 (0%)	0
Suspected COVID-19	1/132 (0.8%)	1	0/127 (0%)	0
Tooth abscess	0/132 (0%)	0	1/127 (0.8%)	1
Upper respiratory tract infection	0/132 (0%)	0	2/127 (1.6%)	2
Vulvovaginal mycotic infection	1/132 (0.8%)	1	0/127 (0%)	0
Injury, poisoning and procedural complications
Foot fracture	1/132 (0.8%)	1	0/127 (0%)	0
Incision site complication	1/132 (0.8%)	1	0/127 (0%)	0
Limb injury	0/132 (0%)	0	1/127 (0.8%)	1
Sunburn	0/132 (0%)	0	1/127 (0.8%)	1
Investigations
Blood glucose increased	0/132 (0%)	0	1/127 (0.8%)	1
Metabolism and nutrition disorders
Decreased appetite	1/132 (0.8%)	1	0/127 (0%)	0
Diabetic ketosis	1/132 (0.8%)	1	0/127 (0%)	0
Hyperglycaemia	23/132 (17.4%)	49	28/127 (22%)	43
Musculoskeletal and connective tissue disorders
Back pain	0/132 (0%)	0	2/127 (1.6%)	2
Intervertebral disc protrusion	0/132 (0%)	0	1/127 (0.8%)	1
Musculoskeletal pain	0/132 (0%)	0	1/127 (0.8%)	1
Osteoarthritis	0/132 (0%)	0	1/127 (0.8%)	1
Pain in extremity	0/132 (0%)	0	1/127 (0.8%)	1
Nervous system disorders
Facial paralysis	0/132 (0%)	0	1/127 (0.8%)	1
Headache	2/132 (1.5%)	2	3/127 (2.4%)	5
Psychiatric disorders
Stress	2/132 (1.5%)	3	1/127 (0.8%)	1
Respiratory, thoracic and mediastinal disorders
Cough	1/132 (0.8%)	1	1/127 (0.8%)	1
Skin and subcutaneous tissue disorders
Dermatitis	0/132 (0%)	0	1/127 (0.8%)	1
Dermatitis contact	1/132 (0.8%)	1	0/127 (0%)	0
Skin irritation	0/132 (0%)	0	1/127 (0.8%)	1
Vascular disorders
Varicose vein	0/132 (0%)	0	1/127 (0.8%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.