NCT04585139已完成不适用
Assessing Non-adjunctive CGM Safety at Home and in New Markets
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- DexCom, Inc.
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The purpose of the study is to examine whether non-adjunctive (without having to double check using another method) use of Continuous Glucose Monitoring improves A1c in adults or children with diabetes managed by intensive insulin therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 2 years or older
- •A diagnosis of T1D or T2D made at least 6 months prior to enrollment. At least 20 adult participants will have T1D; and 10 will have T2D; 10 participants will be over age 65 years.
- •Using IIT (either an insulin pump or MDI)
- •HbA1c value ≥ 7.5% (≥ 58 mmol/mol) measured by local lab within prior 30-days before enrollment or by point of care at time of screening.
- •eGFR ≥ 30 within the last 90-days prior to enrollment (adult participants only)
- •Currently performing 2 or more SMBG fingersticks a day by historical average and willing to continue this during the blinded CGM wear.
排除标准
- •Use of real-time or intermittently scanned CGM in the 6 months prior to enrollment.
- •Anticipated changes to insulin delivery method or insulin formulation(s).
- •Insulin formulation changes within class will be permitted if required per formulary change and represent equivalent therapy (eg: insulin lispro change to insulin aspart).
- •Pregnancy (as demonstrated by a positive test at study entry) at time of screening or are planning to become pregnant during the study.
- •Applicable only to women of reproductive potential.
- •Planned or currently using weight reduction medications, programs or surgery. Defined as 1) using weight loss medications and losing weight (e.g. chronic use of weight loss medications with stable weight is not exclusionary) or planning on using weight loss prescription medication during the study; 2) currently using or planning on initiating a modified fasting program (e.g. protein-sparing diet plans) during the study; or 3) bariatric surgical procedure within the past year or plans for undergoing bariatric surgery during the study.
- •Concomitant disease or condition that may compromise patient safety including, but not limited to; severe mental illness, a diagnosed or suspected eating disorder or any uncontrolled long-term medical/psychiatric condition that would interfere with study- related tasks or visits, including ongoing treatment for a significant malignancy. These assessments/conditions are made at investigator's discretion.
- •Known (or suspected) significant allergy to medical-grade adhesives.
- •Any condition, per investigator assessment, that could impact the stability of the HbA1c measurement, for example,
- •Acute or chronic blood loss or bleeding disorder,
- •Red blood cell transfusion or erythropoietin, administration in the 3 months prior to enrollment,
- •Or red blood cell transfusion or erythropoietin administration anticipated during the course of the study.
- •Anticipated acute use of oral or injectable glucocorticoids that could affect glycemic control and impact HbA1c, for example,
- •Frequent steroid bursts used for inflammatory arthritis or inflammatory bowel disease,
- •Or recurrent lumbar epidural steroid injections,
- •Current treatment with hydroxyurea
- •Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
研究组 & 干预措施
Phase 1 -- Introduction to Dexcom G6 CGM
Other
A 2 week run-in wear period of blinded CGM followed by 12 weeks of wear of a Commercially available CGM
干预措施: Phase 1- Introduction to Dexcom G6 CGM (Device)
Phase 2 -- Comparison of an Updated G6 Transmitter to Commercial Dexcom G6 CGM
Active Comparator
1 group will wear a Commercially available CGM for 12 weeks while the 2 group will wear an Updated CGM for 12 weeks.
干预措施: Phase 1- Introduction to Dexcom G6 CGM (Device)
结局指标
主要结局
HbA1c
时间窗: 16 weeks
Phase 1 change in HbA1c for the adult cohort only.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
Unknown
不适用
Continuous Monitoring and Control of HypoglycemiaDiabetesNCT03340831DexCom, Inc.1,388
已完成
不适用
Non-interventional Study With NOVOCART® Basic in Patients Treated for Cartilage Defects in the Knee With MACCartilage DiseasesNCT03808623Tetec AG41
招募中
不适用
A Non-interventional, Post-authorisation Safety Study of Patients Treated With Efgartigimod AlfaMyasthenia GravisNCT06298565argenx680
已完成
不适用
Evaluation of the Safety and Precursors of EfficacySubcutaneous FatNCT02098811Cynosure, Inc.10
招募中
Unknown
A non-inferiority study to assess the safety and performance of the Felix System vs the dual Discontinuous Gradient Centrifugation and Swim-Up method to isolate spermatozoa prior to its use in human intracytoplasmic spermatozoa injection (ICSI) assisted reproductive technology (ART)InfertilityJPRN-UMIN000049721Reproduction Clinic Osaka52