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临床试验 NCT02282397 (DIaMonD) 针对糖尿病目前已完成。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes (DIaMonD) 316
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临床试验NCT02282397 (DIaMonD)是一项针对糖尿病的干预性研究试验，试验状态为已完成。试验开始于2014年9月1日，共计划招募316名患者。该研究由DexCom, Inc.主导，已于2016年11月1日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2017年5月15日。
简要概括
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.
详细描述
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...
显示更多官方标题
Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
疾病
糖尿病出版物
关于此临床试验发表的科学文章和研究论文：其他研究标识符
- DIaMonD
- PTL-901148
NCT编号
实际开始日期
2014-09
最近更新发布
2017-05-15
预计完成日期
2016-11
计划入组人数
316
研究类型
干预性研究
试验分期 (阶段)
不适用
试验状态
已完成
关键词
Diabetes Mellitus
主要目的
诊断
分配方式
随机
干预模型
平行
盲法
无（开放性试验）
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
无干预Phase 1: SMBG Type 1 or Type 2 diabetes mellitus subjects using SMBG testing and usual care for diabetes management. No intervention to be administered | 不适用 |
其他Phase 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. | 连续血糖监测 RT-CGM are adjunctive devices with glucose trend graphs and user-configurable low and high glucose alerts. |
无干预Phase 2: CGM/MDI Type 1 Diabetes Mellitus subjects using RT-CGM and injections for diabetes management. | 不适用 |
无干预Phase 2: CGM/CSII Type 1 Diabetes Mellitus subjects using RT-CGM and CSII for diabetes management. | 不适用 |
主要终点
次要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
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 |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
25 Years
适龄性别
全部
- 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 Research没有联系数据。
30 位于 2 个国家/地区的研究中心
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