Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DexCom, Inc.
- 入组人数
- 316
- 试验地点
- 57
- 主要终点
- Phase 1 (T1DM) - A1C
研究概览
简要总结
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 (Group 1a- CGM/MDI) or CSII therapy (Group 1b-CGM/CSII).
Additional assessments will be made to evaluate the incremental benefits of changing the insulin delivery method from MDI to CSII in patients already using CGM.
Cost effectiveness and quality of life will be measured between the two groups in each phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Phase 1 (T1DM) - A1C
时间窗: 6 months
Change in A1C from baseline to 24 weeks
Phase 2 (T1DM)
时间窗: 6 months
Change in % time in range 70-180 mg/dL from Phase 2 baseline to Phase 2 28 weeks
Phase 1 (T2DM) - A1C
时间窗: 6 months
Change in A1C from baseline to 24 weeks
次要结局
- Phase 1 (T1DM) - Hypoglycemia Awareness(6 months)
- Phase 1 (T1DM) - SMBG Outcome(6 months)
- Phase 2 (T1DM) - QoL Outcomes(6 months)
- Phase 2 (T1DM) - Body Weight(6 months)
- Phase 1 (T1DM) - Body Weight(6 months)
- Phase 1 (T2DM) - Hypoglycemia Awareness(6 months)
- Phase 1 (T2DM) - Cost Effectiveness(6 months)
- Phase 2 (T1DM) - CGM Use(6 months)
- Phase 2 (T1DM) - Cost Effectiveness(6 months)
- Phase 1 (T1DM) - QoL Outcomes(6 months)
- Phase 1 (T1DM) - Cost Effectiveness(6 months)
- Phase 1 (T2DM) - QoL Outcomes(6 months)
- Phase 1 (T2DM) - Body Weight(6 months)
- Phase 2 (T1DM) - SMBG(6 months)
- Phase 1 (T2DM) - SMBG(6 months)
- Phase 2 (T1DM) - Hypoglycemia Awareness(6 months)
- Phase 1 (T1DM) - CGM Outcomes(6 months)
- Phase 1 (T1DM) - Adverse Events(6 months)
- Phase 1 (T1DM) - Insulin Use Outcomes(6 months)
- Phase 1 (T2DM) - A1C Outcomes(6 months)
- Phase 1 (T2DM) - CGM Outcomes(6 months)
- Phase 1 (T2DM) - Adverse Events(6 months)
- Phase 1 (T2DM) - Insulin Use Outcomes(6 months)
- Phase 2 (T1DM) - A1C Outcomes(6 months)
- Phase 2 (T1DM) - CGM Outcomes(6 months)
- Phase 2 (T1DM) - Adverse Events(6 months)
- Phase 2 (T1DM) - Insulin Use Outcomes(6 months)
- Phase 1 (T1DM) - A1C Outcomes(6 months)