ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT03908125 (PAS) के लिए मधुमेह मेलिटस, मधुमेह मेलिटस प्रकार 1, मधुमेह मेलिटस, प्रकार 2 वर्तमान में पूर्ण है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
Post Approval Study of the Eversense® Continuous Glucose Monitoring (PAS) 273
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'अध्ययन समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल ट्रायल NCT03908125 (PAS) एक हस्तक्रियात्मक चिकित्सकीय अध्ययन था जो मधुमेह मेलिटस, मधुमेह मेलिटस प्रकार 1, मधुमेह मेलिटस, प्रकार 2 से जुड़ा हुआ था। परीक्षण अब पूर्ण हो चुका है। इसकी शुरुआत 19 मार्च 2019 को हुई थी और इसमें कुल 273 प्रतिभागियों को शामिल किया गया था। Senseonics, Inc. ने इस परीक्षण का नेतृत्व किया और यह 1 फ़रवरी 2024 को पूरा हुआ। ClinicalTrials.gov वेबसाइट पर यह जानकारी 12 जून 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
A Post Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System over repeat insertion and removal cycles and to demonstrate the long-term safety of the Eversense® CGM System
विस्तृत विवरण
The purpose of this post-approval study (PAS) is to provide long-term safety and effectiveness of the Eversense CGM System (PMA Application P160048) in the post-market setting. In the premarket setting, the PRECISE II and PRECISION studies demonstrated safety and accuracy of the CGM system in estimating blood glucose levels compared to reference blood glucose analyzer levels to 90 days.
The PROMISE study demonstrate...
और दिखाएँआधिकारिक शीर्षक
A Post- Approval Study to Evaluate the Long-term Safety and Effectiveness of the Eversense® Continuous Glucose Monitoring (CGM) System
स्वास्थ्य स्थितियां
मधुमेह मेलिटसमधुमेह मेलिटस प्रकार 1मधुमेह मेलिटस, प्रकार 2अन्य अध्ययन आईडी
- PAS
- CTP-0034
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2019-03-19
अंतिम अद्यतन प्रकाशित
2025-06-12
अध्ययन की समाप्ति तिथि (अनुमानित)
2024-02-01
नामांकन (अनुमानित)
273
अध्ययन प्रकार
हस्तक्रियात्मक
चरण
निर्दिष्ट नहीं
स्थिति
पूर्ण
प्राथमिक उद्देश्य
निदानात्मक
डिज़ाइन आवंटन
निर्दिष्ट नहीं
हस्तक्षेप मॉडल
एकल समूह
अंधकरण
कोई नहीं (खुला लेबल)
समूह/हस्तक्षेप
| प्रतिभागी समूह/शाखा | हस्तक्षेप/उपचार |
|---|---|
अन्यContinuous Glucose Monitoring Device Commercial Continuous Glucose Monitoring Device | Eversense® CGM System Continuous Glucose monitoring device |
प्राथमिक परिणाम माप
द्वितीयक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
The Long-term Safety of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. | The primary safety endpoint was the incidence of the composite of infection, secondary procedures to remove the Sensor, or procedure-related adverse events of at least moderate severity, with a performance goal of \< 4%. | up to 27 months |
The Long-term Effectiveness of the Eversense CGM Systems Over Repeat Insertion and Removal Cycles in the Post-market Setting. | The primary effectiveness endpoint was Time in Range, which is defined as glucose values between 70 mg/dL and 180 mg/dL, at 12 months post-first Sensor insertion compared to the first month post-first Sensor insertion. | Baseline and Month 12 |
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
The Additional Effectiveness Endpoint of Average Hours of Use Per Day | up to 27 months | |
The Additional Effectiveness Endpoint of Change in HbA1c Levels at Each 6-month Interval From Baseline | Baseline, Month 6, Month 12, Month 18, and Month 24 | |
Patient Satisfaction With CGM System Use (CGM-SAT Scale) | CGM-Sat is a 44 question, 5-point scale (1 = strongly agree, 5 = strongly disagree); higher scores reflect more satisfaction with CGM. | up to 27 months |
Patient Reported Diabetes Distress Scale (DDS) | The DDS score over the two-year period. DDS17 is a 17 question, 6-point scale (1 = not a problem, 6 = a very serious problem); lower score depicts less distress with diabetes. | Screening, Day 180, Day 360, and Day 720 |
Success Rate of Insertion Procedures: Overall and by HCP Experience | Success rate was measured for the first 3 insertions for each inserting HCP, the remaining insertions, as well as overall insertions. | up to 27 months |
Success Rate of Removal Procedures: Overall and by HCP Experience | Success rate was measured for the first 3 removals for each inserting HCP, the remaining removals, as well as overall removals. | up to 27 months |
Rate of Insertion Procedures With Serious Adverse Events | up to 27 months | |
Rate of Removal Procedures With Serious Adverse Events | up to 27 months | |
HCP Feedback Questionnaire Regarding Insertion | The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree. | up to 27 Months |
HCP Feedback Questionnaire Regarding Removal | The questions were on a scale of 1-5, with 1 indicating Strongly Agree and 5 indicating Strongly Disagree. | up to 27 Months |
Residual Dexamethasone Level in Explanted Sensors | The residual dexamethasone (DXA) content in Sensors was analyzed after removal. | up to 27 months |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
- Subject has diabetes
- Subject is greater than 18 years of age
- Subject is critically ill or hospitalized
- Subject has a known contraindication to dexamethasone or dexamethasone acetate
- Subjects requiring intravenous mannitol or mannitol irrigation solutions
- Female subjects who are pregnant, planning on becoming pregnant or nursing
- Subjects on hybrid closed loop systems or closed loop systems
- Subjects on other CGM systems
Senseonics, Inc.कोई संपर्क डेटा नहीं।
17 1 देशों में अध्ययन स्थान
California
Hoag Memorial Hospital Presbyterian/Mary Dick Allen Diabetes Center, Newport Beach, California, 92663, United States
Colorado
Denver Endocrinology, Diabetes & Thyroid Center, Englewood, Colorado, 80113, United States
Florida
The Center for Diabetes and Endocrine Care, Fort Lauderdale, Florida, 33312, United States
Georgia
Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States
Maryland
MODEL Clinical research, Baltimore, Maryland, 21204, United States
Michigan
Metro Detroit Endocrinology Center, Dearborn, Michigan, 48126, United States
Missouri
Diabetes and Endocrinology Specialists, Inc., Chesterfield, Missouri, 63017, United States
New York
Albany Medical College, Albany, New York, 12206, United States
North Carolina
Physicians East, Greenville, North Carolina, 27834, United States
PMG Research of Wilmington, LLC, Wilmington, North Carolina, 28401, United States
Pennsylvania
Diabetes & Endocrinology Consultants of Pennsylvania, LLC, Feasterville, Pennsylvania, 19053, United States
Tennessee
AM Diabetes & Endocrinology, Bartlett, Tennessee, 38133, United States
Texas
Texas Diabetes and Endocrinology, Austin, Texas, 78731, United States
Clinical Research Solution, LLC, Cypress, Texas, 77433, United States
Javara, Inc, Houston, Texas, 77095, United States
Diabetes and Glandular Disease Clinic, San Antonio, Texas, 78229, United States
Consano Clinical Research, LLC, Shavano Park, Texas, 78231, United States