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The purpose of this study is to collect confirmatory clinical data to support 6 or 7 days wear of EWIS (Extended Wear Infusion Set).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Wear Infusion Set | Experimental | Each subject is given 12 Extended Wear Infusion Sets to wear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Infusion Set | Device | Each subject is asked to wear each Extended Wear Infusion Set for at least 174 hours. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Humalog Subjects - Rate of Infusion Set Failure at the End of Day 6 | Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6. | 144 hours |
| Novolog Subjects - Rate of Infusion Set Failure at the End of Day 6 | Independently evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6. | 144 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Humalog Subject - Rate of Infusion Set Failure at the End of Day 7. | Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7. | 168 hours |
| Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7. |
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Inclusion Criteria:
Subject is age 18 - 80 years at the time of screening
Subject has type 1 diabetes for more than one year Study specific inclusion criteria
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.
Subject is willing and able to perform study procedures as per investigator discretion
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):
Exclusion Criteria:
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.
Subject is female and has a positive pregnancy screening test
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
Subject is female and plans to become pregnant during the course of the study
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.
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
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.
Subject is unable to tolerate tape adhesive in the area of infusion set
Subject has any unresolved adverse skin condition in the area of infusion set placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
Subject has infection in the area of infusion set placement at time of screening
Subject has had Diabetic Ketoacidosis (DKA) in the 12 months prior to screening visit.
Subject is currently abusing illicit drugs
Subject is currently abusing alcohol
Subject is on dialysis (for renal failure)
Subject has history of adrenal disorder
Subject has a history of inpatient psychiatric treatment in the past 6 months prior to screening
Subject has any condition that the Investigator believes would interfere with study participation
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
Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
Subject is using pramlintide (Symlin), SGLT2 inhibitors, GLP agonists, biguanides, DPP-4 inhibitors or sulfonylureas more than 2 weeks from time of screening
Subject has been diagnosed with chronic kidney disease requiring dialysis or resulting in chronic anemia
Subject has history of cardiovascular disease defined as any ischemic related event or clinically significant arrythmia.
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Investigations | Little Rock | Arkansas | 72205 | United States | ||
| AMCR Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35263188 | Derived | Brazg R, Garg SK, Bhargava A, Thrasher JR, Latif K, Bode BW, Bailey TS, Horowitz BS, Cavale A, Kudva YC, Kaiserman KB, Grunberger G, Reed JC, Chattaraj S, Zhang G, Shin J, Chen V, Lee SW, Cordero TL, Rhinehart AS, Vigersky RA, Buckingham BA. Evaluation of Extended Infusion Set Performance in Adults with Type 1 Diabetes: Infusion Set Survival Rate and Glycemic Outcomes from a Pivotal Trial. Diabetes Technol Ther. 2022 Aug;24(8):535-543. doi: 10.1089/dia.2021.0540. Epub 2022 Mar 24. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 25, 2019 | Jun 22, 2021 |
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Independently evaluated rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7. |
| 168 hours |
| Escondido |
| California |
| 92025 |
| United States |
| Stanford University | Palo Alto | California | 94304 | United States |
| SoCal Diabetes | West Covina | California | 91790 | United States |
| Barbara Davis Center for Childhood Diabetes | Aurora | Colorado | 80045 | United States |
| Metabolic Research Institute | West Palm Beach | Florida | 33401 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Endocrine Research Solutions | Roswell | Georgia | 30076 | United States |
| Iowa Diabetes and Endocrinology Center | West Des Moines | Iowa | 50265 | United States |
| Grunberger Diabetes Institute | Bloomfield Hills | Michigan | 48302 | United States |
| Mayo Clinic (Rochester MN) | Rochester | Minnesota | 55905 | United States |
| Diabetes and Endocrinology Consultants of Pennsylvania | Feasterville-Trevose | Pennsylvania | 19053 | United States |
| AM Diabetes and Endocrinology Center | Memphis | Tennessee | 38133 | United States |
| University of Virginia Health System | Charlottesville | Virginia | 22908 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Humalog Subjects Extended Wear Infusion Set | 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. |
| BG001 | Novolog Subjects Extended Wear Infusion Set | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| BMI (kg/m2) | Mean | Standard Deviation | kg/m^2 |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Humalog Subjects - Rate of Infusion Set Failure at the End of Day 6 | Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6. | Posted | Mean | 95% Confidence Interval | Percentage of Extended Wear Infusion Set | 144 hours | EWIS infusion sets | EWIS infusion sets |
|
|
| ||||||||||||||||||||||||||
| Primary | Novolog Subjects - Rate of Infusion Set Failure at the End of Day 6 | Independently evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 6. | Posted | Mean | 95% Confidence Interval | Percentage of Extended Wear Infusion Set | 144 hours | EWIS infusion sets | EWIS infusion sets |
|
| |||||||||||||||||||||||||||
| Secondary | Humalog Subject - Rate of Infusion Set Failure at the End of Day 7. | Evaluate rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7. | Posted | Mean | 95% Confidence Interval | Percentage of Extended Wear Infusion Set | 168 hours | EWIS infusion sets | EWIS infusion sets |
|
| |||||||||||||||||||||||||||
| Secondary | Novolog Subjects - Rate of Infusion Set Failure at the End of Day 7. | Independently evaluated rate of infusion set failure due to unexplained hyperglycemia (i.e. suspected occlusion) at the end of Day 7. | Posted | Mean | 95% Confidence Interval | Percentage of Extended Wear Infusion Set | 168 hours | EWIS infusion sets | EWIS infusion sets |
|
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Humalog Subjects Extended Wear Infusion Set | 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. | 0 | 132 | 2 | 132 | 59 | 132 |
| EG001 | Novolog Subjects Extended Wear Infusion Set | 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. | 0 | 127 | 1 | 127 | 60 | 127 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tendon rupture | Injury, poisoning and procedural complications | MedDRA 23.0 | Systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute sinusitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Blood glucose increased | Investigations | MedDRA23.0 | Systematic Assessment |
| |
| COVID-19 | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA23.0 | Systematic Assessment |
| |
| Complication of device removal | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Conjunctivitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
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| Decreased appetite | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
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| Diabetic ketosis | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Facial paralysis | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Gingivitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Incision site complication | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Infusion site bruising | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Infusion site cellulitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Infusion site dermatitis | General disorders | MedDRA23.0 | Systematic Assessment |
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| Infusion site discomfort | General disorders | MedDRA23.0 | Systematic Assessment |
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| Infusion site erythema | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Infusion site haemorrhage | General disorders | MedDRA23.0 | Systematic Assessment |
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| Infusion site hypersensitivity | General disorders | MedDRA23.0 | Systematic Assessment |
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| Infusion site infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Infusion site irritation | General disorders | MedDRA23.0 | Systematic Assessment |
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| Infusion site nodule | General disorders | MedDRA23.0 | Systematic Assessment |
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| Infusion site pain | General disorders | MedDRA23.0 | Systematic Assessment |
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| Infusion site reaction | General disorders | MedDRA23.0 | Systematic Assessment |
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| Infusion site swelling | General disorders | MedDRA23.0 | Systematic Assessment |
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| Infusion site vesicles | General disorders | MedDRA23.0 | Systematic Assessment |
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| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Medical device site cellulitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Medical device site discomfort | General disorders | MedDRA23.0 | Systematic Assessment |
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| Medical device site erythema | General disorders | MedDRA23.0 | Systematic Assessment |
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| Medical device site irritation | General disorders | MedDRA23.0 | Systematic Assessment |
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| Medical device site nodule | General disorders | MedDRA23.0 | Systematic Assessment |
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| Medical device site oedema | General disorders | MedDRA23.0 | Systematic Assessment |
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| Medical device site swelling | General disorders | MedDRA23.0 | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
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| Neutropenia | Blood and lymphatic system disorders | MedDRA23.0 | Systematic Assessment |
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| Onychomycosis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Oral candidiasis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
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| Otitis externa | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Pain | General disorders | MedDRA23.0 | Systematic Assessment |
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| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Pharyngitis streptococcal | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Postoperative wound infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Respiratory tract infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Sinusitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
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| Stress | Psychiatric disorders | MedDRA23.0 | Systematic Assessment |
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| Sunburn | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
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| Suspected COVID-19 | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Tooth abscess | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Tourette's disorder | Congenital, familial and genetic disorders | MedDRA23.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Varicose vein | Vascular disorders | MedDRA23.0 | Systematic Assessment |
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| Vertigo positional | Ear and labyrinth disorders | MedDRA23.0 | Systematic Assessment |
| |
| Vulvovaginal mycotic infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Emma Pham, MSHS (Clinical Study Manager) | Medtronic Diabetes | 818 576 4878 | emma.pham@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 19, 2020 | Jun 22, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| EWIS infusion sets |
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| EWIS infusion sets |
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| EWIS infusion sets |
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