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임상시험 NCT02282397 (DIaMonD)은(는) 당뇨병에 대해 완료 상태입니다. 모든 세부 정보를 보려면 임상시험 레이더 카드 뷰와 AI 발견 도구를 확인하거나 여기에서 무엇이든 물어보세요. | ||
하나의 임상시험이 필터 기준과 일치합니다.
카드 뷰
Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIaMonD) 316
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 NCT02282397 (DIaMonD)은(는) 당뇨병에 대해 알아본 중재연구입니다. 현재 상태는 완료입니다. 연구는 2014년 9월 1일에 시작되어 316명의 참여자와 함께 진행되었습니다. DexCom, Inc.이(가) 진행한 이 연구는 2016년 11월 1일에 마무리되었습니다. ClinicalTrials.gov의 가장 최근 정보는 2017년 5월 15일에 갱신되었습니다.
간단한 개요
Evaluate if addition and use of real time continuous glucose monitoring (RT-CGM) improves glycemic outcome of patients using multiple daily injections (MDI) and self monitoring blood glucose (SMBG) testing, who are not at target glycemic control.
상세한 설명
The study design includes two cohorts that will be treated separately. Phase 1 will include two diabetes cohorts (Type 1 diabetes mellitus and Type 2 diabetes mellitus) who will be randomized independently into two groups, Group 1-CGM and Group 2-SMBG.
The Group-1 CGM cohort who have Type 1 diabetes mellitus will be eligible for Phase 2. Phase 2 will include a separate independent randomization of either MDI therapy...
더 보기공식 제목
Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
질환명
당뇨병출판물
이 임상시험에 대해 발표된 과학 논문 및 연구 자료.기타 연구 식별자
- DIaMonD
- PTL-901148
NCT 번호
실제 연구 시작일
2014-09
최신 업데이트 게시
2017-05-15
예상 연구 완료일
2016-11
계획된 등록 인원
316
연구종류
중재연구
단계/상
해당 없음
상태
완료
키워드
Diabetes Mellitus
주요 목적
진단
설계 할당
무작위배정
중재 모델
평행설계
맹검 (마스킹)
없음 (오픈 라벨)
시험군 / 개입
| 참가자 그룹/시험군 | 개입/치료 |
|---|---|
비개입Phase 1: SMBG Type 1 or Type 2 diabetes mellitus subjects using SMBG testing and usual care for diabetes management. No intervention to be administered | 해당 없음 |
기타Phase 1: CGM Type 1 or Type 2 diabetes mellitus subjects using RT-CGM and SMBG testing for diabetes management. RT-CGM (Continuous Glucose Monitoring) is the intervention. | 연속 혈당 모니터 RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts. |
비개입Phase 2: CGM/MDI Type 1 Diabetes Mellitus subjects using RT-CGM and injections for diabetes management. | 해당 없음 |
비개입Phase 2: CGM/CSII Type 1 Diabetes Mellitus subjects using RT-CGM and CSII for diabetes management. | 해당 없음 |
주요결과변수
이차결과변수
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Phase 1 (T1DM) - A1C | Change in A1C from baseline to 24 weeks | 6 months |
Phase 1 (T2DM) - A1C | Change in A1C from baseline to 24 weeks | 6 months |
Phase 2 (T1DM) | Change in % time in range 70-180 mg/dL from Phase 2 baseline to Phase 2 28 weeks | 6 months |
| 결과변수 | 측정값 설명 | 시간 범위 |
|---|---|---|
Phase 1 (T1DM) - A1C Outcomes | % of subjects with A1C less than 7% | 6 months |
Phase 1 (T1DM) - A1C Outcomes | % of subjects with A1C less than 7.5% | 6 months |
Phase 1 (T1DM) - A1C Outcomes | % of subjects with a relative reduction in A1C greater than or equal to 10% | 6 months |
Phase 1 (T1DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% | 6 months |
Phase 1 (T1DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7% | 6 months |
Phase 1 (T1DM) - CGM Outcomes | Mean glucose (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T1DM) - CGM Outcomes | Glucose variability (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T1DM) - CGM Outcomes | % time in range 70-180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T1DM) - CGM Outcomes | % time less than 70 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T1DM) - CGM Outcomes | % time less than 60 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T1DM) - CGM Outcomes | % time less than 50 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T1DM) - CGM Outcomes | % time greater than 180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T1DM) - CGM Outcomes | % time greater than 250 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T1DM) - CGM Outcomes | % time greater than 300 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T1DM) - Hypoglycemia Awareness | Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks | 6 months |
Phase 1 (T1DM) - SMBG Outcome | Change in SMBG frequency from baseline to 24 weeks | 6 months |
Phase 1 (T1DM) - QoL Outcomes | Quality of life changes from baseline to 24 weeks | 6 months |
Phase 1 (T1DM) - Cost Effectiveness | Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER) | 6 months |
Phase 1 (T1DM) - Adverse Events | Change in the number of SH events from baseline to 24 weeks | 6 months |
Phase 1 (T1DM) - Adverse Events | Change in the number of DKA events from baseline to 24 weeks | 6 months |
Phase 1 (T1DM) - Body Weight | Change in body weight from baseline to 24 weeks | 6 months |
Phase 1 (T1DM) - Insulin Use Outcomes | Change in total daily insulin from baseline to 24 weeks | 6 months |
Phase 1 (T1DM) - Insulin Use Outcomes | Basal to bolus insulin ratio | 6 months |
Phase 1 (T1DM) - Insulin Use Outcomes | Change in the number of boluses/day from baseline to 24 weeks | 6 months |
Phase 1 (T2DM) - A1C Outcomes | % of subjects with A1C less than 7% | 6 months |
Phase 1 (T2DM) - A1C Outcomes | % of subjects with A1C less than 7.5% | 6 months |
Phase 1 (T2DM) - A1C Outcomes | % of subjects with a relative reduction in A1C greater than or equal to 10% | 6 months |
Phase 1 (T2DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7% | 6 months |
Phase 1 (T2DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% | 6 months |
Phase 1 (T2DM) - CGM Outcomes | Mean glucose (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T2DM) - CGM Outcomes | Glucose variability (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T2DM) - CGM Outcomes | % time in range 70-180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T2DM) - CGM Outcomes | % time less than 70 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T2DM) - CGM Outcomes | % time less than 60 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T2DM) - CGM Outcomes | % time less than 50 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T2DM) - CGM Outcomes | % time greater than 180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T2DM) - CGM Outcomes | % time greater than 250 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T2DM) - CGM Outcomes | % time greater than 300 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T2DM) - CGM Outcomes | Area above curve 70 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T2DM) - CGM Outcomes | Area under curve 180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 1 (T2DM) - Hypoglycemia Awareness | Change in Clarke Hypoglycemia Unawareness score from baseline to 24 weeks | 6 months |
Phase 1 (T2DM) - SMBG | Change in SMBG frequency from baseline to 24 weeks | 6 months |
Phase 1 (T2DM) - QoL Outcomes | Quality of life changes from baseline to 24 weeks | 6 months |
Phase 1 (T2DM) - Cost Effectiveness | Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER) | 6 months |
Phase 1 (T2DM) - Adverse Events | Change in the number of SH Events from baseline to 24 weeks | 6 months |
Phase 1 (T2DM) - Adverse Events | Change in the number of DKA Events from baseline to 24 weeks | 6 months |
Phase 1 (T2DM) - Body Weight | Change in body weight from baseline to 24 weeks | 6 months |
Phase 1 (T2DM) - Insulin Use Outcomes | Change in total daily insulin from baseline to 24 weeks | 6 months |
Phase 1 (T2DM) - Insulin Use Outcomes | Basal to bolus insulin ratio | 6 months |
Phase 1 (T2DM) - Insulin Use Outcomes | Change in the number of boluses/day from baseline to 24 weeks | 6 months |
Phase 2 (T1DM) - A1C Outcomes | Change in A1C from Phase 2 baseline to Phase 2 28 weeks | 6 months |
Phase 2 (T1DM) - A1C Outcomes | % of subjects with A1C less than 7% | 6 months |
Phase 2 (T1DM) - A1C Outcomes | % of subjects with A1C less than 7.5% | 6 months |
Phase 2 (T1DM) - A1C Outcomes | % of subjects with a relative reduction in A1C greater than or equal to 10% | 6 months |
Phase 2 (T1DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% | 6 months |
Phase 2 (T1DM) - A1C Outcomes | % of subjects with a reduction in A1C greater than or equal to 1% or A1C less than 7% | 6 months |
Phase 2 (T1DM) - CGM Outcomes | Mean glucose (overall, daytime, and nighttime separately) | 6 months |
Phase 2 (T1DM) - CGM Outcomes | Glucose variability (overall, daytime, and nighttime separately) | 6 months |
Phase 2 (T1DM) - CGM Outcomes | % time less than 70 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 2 (T1DM) - CGM Outcomes | % time less than 60 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 2 (T1DM) - CGM Outcomes | % time less than 50 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 2 (T1DM) - CGM Outcomes | % time greater than 180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 2 (T1DM) - CGM Outcomes | % time greater than 250 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 2 (T1DM) - CGM Outcomes | % time greater than 300 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 2 (T1DM) - CGM Outcomes | Area above curve 70 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 2 (T1DM) - CGM Outcomes | Area above curve 180 mg/dL (overall, daytime, and nighttime separately) | 6 months |
Phase 2 (T1DM) - Hypoglycemia Awareness | Change in Clarke Hypoglycemia Unawareness score from Phase 2 baseline to Phase 2 28 weeks | 6 months |
Phase 2 (T1DM) - CGM Use | Change in frequency of CGM use from Phase 2 baseline to Phase 2 28 weeks | 6 months |
Phase 2 (T1DM) - SMBG | Change in SMBG frequency from Phase 2 baseline to Phase 2 28 weeks | 6 months |
Phase 2 (T1DM) - QoL Outcomes | Quality of life changes from Phase 2 baseline to Phase 2 28 weeks | 6 months |
Phase 2 (T1DM) - Cost Effectiveness | Cost effectiveness measured by the incremental cost-effectiveness ratio (ICER) | 6 months |
Phase 2 (T1DM) - Adverse Events | Change in the number of SH Events from Phase 2 baseline to Phase 2 28 weeks | 6 months |
Phase 2 (T1DM) - Adverse Events | Change in the number of DKA Events from Phase 2 baseline to Phase 2 28 weeks | 6 months |
Phase 2 (T1DM) - Body Weight | Change in body weight from Phase 2 baseline to Phase 2 28 weeks | 6 months |
Phase 2 (T1DM) - Insulin Use Outcomes | Change in total daily insulin from Phase 2 baseline to Phase 2 28 weeks | 6 months |
Phase 2 (T1DM) - Insulin Use Outcomes | Basal to bolus insulin ratio | 6 months |
Phase 2 (T1DM) - Insulin Use Outcomes | Change in the number of boluses/day from Phase 2 baseline to Phase 2 28 weeks | 6 months |
적격성 기준
연령대
성인, 노인
최소 연령
25 Years
참여 가능한 성별
전체
- Age 25 years or older
- Diagnosis of Type 1 diabetes mellitus or insulin-requiring Type 2 diabetes mellitus
- Followed regularly by a physician or diabetes educator
- Using multiple daily injections
- stable control of diabetes
- willing to wear a device such as pump or continuous glucose monitor
- recent or planned use of non-insulin injectable hypoglycemic agents
- Pregnancy or planning to become pregnant during the study
- Medical conditions that make it inappropriate or unsafe to target an A1C of <7%
- Renal disease with Glomerular Filtration Rate <45
- Extensive skin changes/disease that precludes wearing the sensor on normal skin
- Known allergy to medical-grade adhesives
- Recent hospitalization or emergency room visit in the 6 months prior to screening resulting in primary diagnosis of uncontrolled diabetes
DexCom, Inc.Jaeb Center for Health Research연락처 정보가 없습니다.
30 2개국에 임상시험 장소
California
Marin Endocrine Care & Research, Greenbrae, California, 94904, United States
Coastal Metabolic Research Centre, Ventura, California, 93003, United States
Florida
East Coast Institute for Research, LLC, Jacksonville, Florida, 32204, United States
East Coast Institute for Research, LLC, Jacksonville, Florida, 32216, United States
Georgia
Laureate Medical Group at Northside, LLC, Atlanta, Georgia, 30308, United States
Atlanta Diabetes Associates, Atlanta, Georgia, 30318, United States
Columbus Regional Research Institute, Columbus, Georgia, 31904, United States
Physicians Research Associates, LLC, Lawrenceville, Georgia, 30046, United States
Endocrine Research Solutions, Roswell, Georgia, 30076, United States
Idaho
Rocky Mountain Diabetes & Osteoporosis Center, Idaho Falls, Idaho, 83404, United States
Iowa
Iowa Diabetes & Endocrinology Research Center, Des Moines, Iowa, 50314, United States
Massachusetts
Joslin Diabetes Center, Boston, Massachusetts, 02215, United States
Michigan
Henry Ford Health System, Detroit, Michigan, 48202, United States
Minnesota
International Diabetes Center, Minneapolis, Minnesota, 55416, United States
Missouri
Washington University in St. Louis, St Louis, Missouri, 63110, United States
Nebraska
Diabetes & Endocrine Associates, PC, Omaha, Nebraska, 68114, United States
Nevada
Accent Clinical Research, Las Vegas, Nevada, 89106, United States
New York
Albany Medical College, Albany, New York, 12206, United States
North Carolina
Mountain Diabetes and Endocrine Center, Asheville, North Carolina, 28803, United States
Oregon
Legacy Research Institute, Portland, Oregon, 97225, United States
Oregon Health & Science University, Portland, Oregon, 97239, United States
Texas
Amarillo Medical Specialists, LLP, Amarillo, Texas, 79106, United States
Research Institute of Dallas, Dallas, Texas, 75231, United States
Diabetes and Glandular Disease, San Antonio, Texas, 78229, United States
Consano Clinical Research, San Antonio, Texas, 78258, United States
Utah
Advanced Research Associates, Ogden, Utah, 84405, United States
Granger Medical Clinic, Riverton, Utah, 84065, United States
Ontario
LMC Clinical Research, Barrie, Ontario, L4M 7G1, Canada
LMC Clinical Research, Thornhill, Ontario, L4J 8L7, Canada
LMC Clinical Research, Toronto, Ontario, M4G 3E8, Canada