Benefits of a Long Term Implantable Continuous Glucose Monitoring System for Adults With Diabetes - France Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 239
- 试验地点
- 40
- 主要终点
- Cohort 2: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) From Day 90 to Day 120
研究概览
简要总结
This study will be conducted in France and will evaluate the usefulness of using a long-term subcutaneously inserted continuous glucose monitoring (CGM) sensor (the Eversense XL CGM System) to improve glycemic control in patients with either Type 1 or Type 2 diabetes mellitus under insulin therapy. Participants will be enrolled into one of two cohorts (Cohorts 1 and 2). Cohort 1 will be focused on participants with Type 1 or Type 2 diabetes with hemoglobin A1C (HbA1c) >8%. Cohort 2 will be focused on participants with Type 1 diabetes spending more than 1.5 hours per day with mean glucose <70 mg/dL, including excursions below 54 mg/dL, for at least 28 days. Within each cohort, participants will be randomized in a 2:1 ratio to one of two groups: the Enabled and Control groups, respectively. The Enabled group will be trained to use the CGM system, whereas the Control group will continue with their usual glucose monitoring system (self-monitoring of blood glucose [SMBG] or flash glucose monitoring [FGM]).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants at least 18 years of age
- •Clinically confirmed diagnosis of Type 1 or Type 2 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and an HbA1c > 8% (Cohort 1)
- •Clinically confirmed diagnosis of Type 1 diabetes mellitus for ≥1 year and using insulin by multiple-daily subcutaneous injections or insulin pump and spending more than more than 1.5 hour with sensor glucose <70 mg/dl per day including excursions below 54 mg/dl as a mean for at least 28 days (Cohort 2)
- •Participant is willing to comply with protocol
排除标准
- •Female participants of childbearing capacity (defined as not surgically sterile or not menopausal for ≥ 1 year) who are lactating or pregnant, intending to become pregnant, or not practicing birth control during the course of the study
- •A condition preventing or complicating the placement, operation or removal of the Sensor or wearing of transmitter, including upper extremity deformities or skin condition
- •History of hepatitis B, hepatitis C, or HIV
- •Currently receiving (or likely to need during the study period): immunosuppressant therapy; chemotherapy; anticoagulant/antithrombotic therapy (excluding aspirin < 2000 mg per day); antibiotics for chronic infection (e.g. osteomyelitis, endocarditis)
- •A condition requiring or likely to require magnetic resonance imaging (MRI)
- •Known topical or local anesthetic allergy
- •Known allergy to glucocorticoids or using systemic glucocorticoids (excluding topical, optical or nasal but including inhaled)
- •Any condition that in the investigator's opinion would make the participant unable to complete the study or would make it not in the participant's best interest to participate in the study. Conditions include, but are not limited to, psychiatric conditions, known current or recent alcohol abuse or drug abuse by participant history, a condition that may increase the risk of induced hypoglycemia or risk related to repeated blood testing. Investigator will supply rationale for exclusion
- •Participation in another clinical investigation (drug or device) within 2 weeks prior to screening or intent to participate during the study period
- •Legal incompetence or limited legal competence
- •Dependency on sponsor or Investigator (e.g. co-worker or family member)
- •The presence of any other active implanted device
结局指标
主要结局
Cohort 2: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) From Day 90 to Day 120
时间窗: From Day 90 to Day 120
The analysis of the primary outcome measure for Cohort 2 was an analysis of covariance (ANCOVA) comparing the percentage of time participants in each treatment arm spent in hypoglycemia with a blood glucose level \<54 milligrams per decilitre (mg/dL) between the Day 90 and Day 120 visits, based on the total duration of time with available CGM data (i.e., excluding temporary discontinuations). The statistical model included the randomization arm and center as fixed classification effects and the level of hypoglycemia at baseline (i.e. percentage of time spent in hypoglycemia \<54 mg/dL between the Day 0 and Day 30 visits) as baseline covariates. Adjusted means with their 95% confidence intervals are provided.
Cohort 1: HbA1c (%) Levels at Day 180
时间窗: Day 180
The analysis of the primary outcome measure for Cohort 1 was an analysis of covariance (ANCOVA) comparing the HbA1c (%), defined as the percentage of hemoglobin proteins that are glycated (i.e., chemically linked to a sugar), at the Day 180 visit between the Enabled and Control arms. The statistical model included the randomization arm, center, and diabetes type as fixed classification effects, and HbA1c (%) at Day 0 as baseline covariates. Adjusted means with their 95% confidence intervals are provided.
次要结局
- Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 90 to Day 120(From Day 90 to Day 120)
- Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 90 to Day 120(From Day 90 to Day 120)
- Cohort 1: Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 90 to Day 120(From Day 90 to Day 120)
- Change From Baseline in the Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Day 180(Baseline (Day 0) and Day 180)
- Number of Participants Issued at Least One Type of Alarm or Alert by the CGM System During the Study(From Day 0 up to Day 180)
- Change From Baseline in the DTSQs Treatment Satisfaction Score at Day 60 and Day 180(Baseline (Day 0), Day 60, and Day 180)
- Audit of Diabetes-Dependent Quality of Life (ADDQoL) Score at Baseline and Day 180(Baseline (Day 0) and Day 180)
- Diabetes Treatment Satisfaction Questionnaire - Original Status (DTSQs) Treatment Satisfaction Score at Baseline, Day 60, and Day 180(Baseline (Day 0), Day 60, and Day 180)
- Change From Baseline in the Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Day 60 and Day 180(Baseline (Day 0), Day 60, and Day 180)
- Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 150 to Day 180(From Day 150 to Day 180)
- Cohort 2, Enabled Arm: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) During the Day 90-120 Period Compared With the Day 150-180 Period for the Enabled Group(Day 90 to Day 120; Day 150 to Day 180)
- Cohort 2, Control Arm: Percentage of Time Spent in Hypoglycemia (<54 mg/dL) During the Control Period (Days 90-120) Compared With the Enabled Period (Days 150-180) for Participants Who Switched to Use the CGM System(For Cohort 2, Control arm: Day 90 to Day 120; For Cohort 2, Switch from Control to Enabled arm: Day 150 to Day 180)
- Number of Participants With the First Sensor Operating at Day 150 and Day 180(From Day 0 up to Day 150 and Day 180)
- Mean Lifespan of the First Sensor(From Day 0 up to Day 180)
- Mean Lifespan of the First Transmitter(From Day 0 up to Day 180)
- Diabetes Treatment Satisfaction Questionnaire - Change Version (DTSQc) Treatment Satisfaction Score at Day 180(Day 180)
- Change From Day 60 in the CGM-SAT Questionnaire Overall Score at Day 180(Day 60 and Day 180)
- Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Baseline, Day 60, and Day 180(Baseline (Day 0), Day 60, and Day 180)
- Change From Baseline in the Diabetes Distress Scale 2 (DDS2) Questionnaire Score at Day 60 and Day 180(Baseline (Day 0), Day 60, and Day 180)
- Hypoglycemia Fear Survey, Part 2 (HFS2) Worry Subscale Score at Baseline, Day 60, and Day 180(Baseline (Day 0), Day 60, and Day 180)
- Percentage of Time Spent in Hypoglycemia (<70mg/dL) From Day 150 to Day 180(From Day 150 to Day 180)
- Percentage of Time Spent in Hypoglycemia (<54mg/dL) From Day 150 to Day 180(From Day 150 to Day 180)
- HbA1c (%) Levels at Day 120(Day 120)
- Number of Participants With the First Transmitter Operating at Day 150 and Day 180(From Day 0 up to Day 150 and Day 180)
- Median Number of Transmitters Used by Each Participant During the Study(From Day 0 to Day 180)
- Number of Participants Who Accessed CGM Application Pages at Days 60, 120, and 180(At Days 60, 120, and 180)
- Percentage of Time Spent in Hyperglycemia (>180mg/dL) From Day 90 to Day 120(From Day 90 to Day 120)
- Percentage of Time Spent in the Euglycemic Range (70mg/dL-180mg/dL) From Day 150 to Day 180(From Day 150 to Day 180)
- Glucose Variability From Day 90 to Day 120, as Estimated With a Coefficient of Variation(From Day 90 to Day 120)
- Glucose Variability From Day 150 to Day 180, as Estimated by a Coefficient of Variation(From Day 150 to Day 180)
- Median Number of Sensors Used by Each Participant During the Study(From Day 0 to Day 180)
- Cohort 2: HbA1c (%) Levels at Day 180(Day 180)
- The Continuous Glucose Monitoring Satisfaction (CGM-SAT) Questionnaire Overall Score at Day 60 and Day 180(Day 60 and Day 180)
- Change From Baseline in the Partner Diabetes Distress Scale (Partner-DDS) Questionnaire Total and Subscale Scores at Day 60 and Day 180(Baseline (Day 0), Day 60, and Day 180)
- Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Insertion(At sensor insertion (Day 0))
- Number of Participants With at Least One Pre-Specified Adverse Event That Occurred Following Sensor Removal(At sensor removal (up to Day 180))
- Overall Number of Participants With at Least One Adverse Event(From Day 0 (Insertion) up to Day 180; for Cohort 2, Contol: From Day 0 to Day 120 and From Day 120 to Day 180)
- Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 90 to Day 120(From Day 90 to Day 120)
- Percentage of Time Spent in Hyperglycemia (>250mg/dL) From Day 150 to Day 180(From Day 150 to Day 180)