임상 레이더 AI | ||
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임상시험 NCT03340831 (COACH)은(는) 당뇨병에 대해 미상 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Continuous Monitoring and Control of Hypoglycemia (COACH) 1,388
임상시험 세부 정보는 주로 영어로 제공됩니다. 하지만 임상 레이더 AI가 도와드릴 수 있습니다! '임상시험 설명'를 클릭하여 선택한 언어로 임상시험 정보를 확인하고, 이에 대해 AI와 논의해 보세요.
임상시험 NCT03340831 (COACH)은(는) 당뇨병에 대해 알아보는 관찰연구입니다. 현재 상태는 미상이며, 연구는 2017년 10월 20일에 시작되어 1,388명의 참여자를 모집하고 있습니다. DexCom, Inc.이(가) 진행하며, 2023년 12월 30일까지 완료될 예정입니다. ClinicalTrials.gov의 가장 최근 정보는 2021년 9월 21일에 갱신되었습니다.
간단한 개요
Evaluate safety of non-adjunctive CGM use in CGM naive participants.
상세한 설명
The study comprises recruitment and consenting of pediatric and adult participants. At entry, the following information will be collected: demographics, labs, clinical and diabetes history information (history of mild/severe hypoglycemia or DKA events in the past 6 months and SMBG testing frequency). There are 3 clinic visits: Study Entry, Month 6 and Month 12 . Monthly phone contacts will be made to assess for any m...더 보기
공식 제목
Post Approval Study for Non-Adjunctive Use of Dexcom G5 and G6 CGM System for Diabetes Management
질환명
당뇨병기타 연구 식별자
- COACH
- PTL-901895
NCT 번호
실제 연구 시작일
2017-10-20
최신 업데이트 게시
2021-09-21
예상 연구 완료일
2023-12-30
계획된 등록 인원
1,388
연구종류
관찰연구
상태
미상
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
CGM/BGM Group single-group, whereby participant is their own control. Use of a Blood Glucose Meter (BGM) for 6 months is compared to use of the G5 and G6 CGM System for 6 months, with collection of major diabetes related events (mild/severe hypoglycemia and DKA). | Continuous Glucose Monitoring (CGM) Use of CGM to compare incidence of diabetes events compared to use of a blood glucose meter (BGM) |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Change in hypoglycemic events | Change in average number of hypoglycemic events per patient between CGM use compared to BGM use | 6 months |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Change in A1C | Percent change in A1C lab between CGM use period compared to BGM use period. | 6 months |
Change in incidence of hypoglycemic events | Percent change of participants with at least one event between CGM use period compared to BGM use period. | 6 months |
Change in GMSS PRO scores | Percent change in mean scores for the Glucose monitoring satisfaction survey (GMSS) \[Emotional and Trust subscales\] between CGM use period compared to BGM use period. | 6 months |
Change in Diabetes Distress Scale (DDS) PRO scores | Percent change in mean scores for the DDS between CGM use period compared to BGM use period. | 6 months |
Change in Hypoglycemia Fear PRO scores | Percent change in mean scores for the Hypoglycemia Fear Survey between CGM use period compared to BGM use period. | 6 months |
Change in Hypoglycemia Confidence PRO scores | Percent change in mean scores for the Hypoglycemia Confidence Scale between CGM use period compared to BGM use period. | 6 months |
적격성 기준
연령대
어린이, 성인, 노인
최소 연령
2 Years
참여 가능한 성별
전체
- Naïve to real-time CGM
- Type 1 or insulin-requiring Type 2 diabetes
- ≥ 2 years old
- Use of RT-CGM, within the past 12 months
- Pregnancy
- Concomitant disease or condition that may compromise patient safety including and not limited to severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long term medical condition that would interfere with study related tasks or visits, or ongoing treatment for a significant malignancy.
- Known (or suspected) significant allergy to medical grade adhesives
- Dialysis
DexCom, Inc.연구 대표 연락처
연락처: Stayce Beck, PhD, MPH, 8582036454, [email protected]
연락처: Nelly Njeru, 8582036379, [email protected]
25 1개국에 임상시험 장소
California
Scripps Whittier Diabetes Institute, La Jolla, California, 92037, United States
완료
Diabetes and Endocrine Associates, La Mesa, California, 91942, United States
완료
Centre of Excellence in Diabetes and Endocrinology, Sacramento, California, 95821, United States
Mila Melnik, 연락처, [email protected]
Gnanagurudasan Prakasam, M.D., 책임연구자
모집중
Mills-Peninsula Medical Center, San Mateo, California, 94401, United States
완료
Sansum Diabetes Research Institute, Santa Barbara, California, 93105, United States
완료
Florida
University of Florida Pediatric Endocrinology, Gainesville, Florida, 32608, United States
진행중, 모집종료
Intervent Clinical Research Center, Pembroke Pines, Florida, 33024, United States
Marisela Rodriguez, 연락처, 954-507-6627, [email protected]
Diego Montes, MD, 책임연구자
모집중
University of South Florida Clinical Research Center, Tampa, Florida, 33612, United States
Ponja Hemphill, 연락처, [email protected]
Janet Rodriguez, 연락처, [email protected]
Henry Rodriguez, M.D., 책임연구자
모집중
Georgia
Atlanta Diabetes, Atlanta, Georgia, 30318, United States
완료
Idaho
Rocky Mountain Diabetes Center, Idaho Falls, Idaho, 83404, United States
완료
Illinois
Northshore University Health System, Skokie, Illinois, 60077, United States
완료
Iowa
Iowa Diabetes & Endocrinology Research Center, Des Moines, Iowa, 50314, United States
완료
Kansas
Cotton O'Neil Clinical Research, Topeka, Kansas, 66606, United States
Jaime Berroth, 연락처, [email protected]
Susan Brian, M.D., 책임연구자
모집중
Minnesota
International Diabetes Research Center, Minneapolis, Minnesota, 55416, United States
완료
Missouri
Children's Mercy Hospital, Kansas City, Missouri, 64108, United States
Jennifer L James, 연락처, [email protected];
Mark Clements, M.D.,PhD., 책임연구자
모집중
Nebraska
Methodist Physicians Clinic - Diabetes and Endocrine Specialists, Omaha, Nebraska, 68114, United States
완료
North Carolina
Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
완료
Carteret Medical Group, Morehead City, North Carolina, 28557, United States
완료
Diabetes & Endocrinology Consultants, PC, Morehead City, North Carolina, 28557, United States
완료
Oklahoma
University of Oklahoma Health Sciences Center Department of Pediatric Diabetes and Endocrinology, Oklahoma City, Oklahoma, 73104, United States
LInda Weber, 연락처, [email protected]
David Sparling, M.D., 책임연구자
모집중
Tennessee
Vanderbilt Eskind Diabetes Clinic, Nashville, Tennessee, 37212, United States
완료
Texas
Amarillo Medical Specialists, LLP, Amarillo, Texas, 79106, United States
Becky Cota, RN, CDE, 연락처, 806-358-8331, [email protected]
William Biggs, M.D., 책임연구자
모집중
Texas Diabetes and Endocrine, Austin, Texas, 78731, United States
완료
Research Institute of Dallas, Dallas, Texas, 75231, United States
완료
Utah
Advanced Research Associates, Ogden, Utah, 84405, United States
Hilary Wahlen, 연락처, 801-409-2040, [email protected]
Jack Wahlen, M.D., PhD, 책임연구자
모집중