The STAR 3 Study - A Prospective, Randomized, Two-Arm Study to Compare the Efficacy of the MiniMed Paradigm REAL-Time System Versus Multiple Daily Injections (MDI) in Subjects Naïve to Insulin Pump Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 485
- 试验地点
- 60
- 主要终点
- Change in A1c From Baseline to 52 Weeks
研究概览
简要总结
Primary Outcomes: Average decrease in A1c from baseline to end of Study Phase (52 weeks) for subjects in the "722 Group" is greater than that for subjects in the "Control (MDI) Group".
Secondary Outcomes: Incidence and frequency of severe hypoglycemia; Measure of glycemic variability, Area Under the Curve (AUC); Quality of Life; and Health Economic Outcomes (MRU)
详细描述
Glycemic control remains a significant challenge for adult, adolescent and pediatric Type 1 diabetics. The current first line standard of care continues to be MDI therapy utilizing a long acting analog insulin. Continuous Glucose Monitoring (CGMS) is currently used by clinicians to record continuous, retrospective glucose measurements, which aid in identification of glycemic excursion patterns. This data is then used to make future therapy change recommendations. The MiniMed Paradigm REAL-Time System transmits real-time glucose measurements to the insulin pump every 5 minutes, allowing users to view their current glucose values, as well as to review glycemic excursions and trends over a 24-hour period. Additionally, data can be downloaded from the monitor to a personal computer, using appropriate software, so that the patient and physician can see a complete picture of glucose trends over time. The System will also alert users of high and low glucose levels, and allow subjects and their clinicians to treat to a therapeutic target HbA1c under carefully monitored conditions.
Subjects wearing the MiniMed Paradigm REAL-Time System will be compared to subjects that continue on their current MDI therapy, that includes a long acting analog insulin, over a 12 month period to evaluate changes in glycemic control (HbA1c).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 7 to 70 years
- •Has been treated by the Principal Investigator or referring physician within the same practice for at least six months prior to screening
- •Is fluent in speaking, reading and understanding English
- •Has Type 1 diabetes mellitus, diagnosed by c-peptide, insulin antibodies, or prior documented DKA, or by a clinical picture consistent with Type 1 diabetes and excluding type 2 diabetes i.e. - previous ketosis as evidenced by laboratory evidence of urine ketones or alteration in bicarbonate levels with corresponding increased glucose levels, diagnosed at least 6 months prior to study entry, or has a fasting C-peptide that meet criteria of 110% of lower limit of normal or 200% of lower limit of normal in the presence of renal insufficiency (creatinine clearance < 50ml/min) at screening
- •Is insulin infusion pump naїve or has not used an insulin pump within the last three years
- •Currently is treated with insulin administration by injection > (greater or equal to) three (3) times daily and therapy has included the use of a long acting analog insulin for at least the previous 3 months prior to screening
- •Performs fingerstick blood glucose (BG) testing an average of four times per day in the 30 days prior to screening
- •Within 6 months prior to study entry and at Screening Visit 1, subject has a documented A1c level =/> 7.4% and =/< 9.5%
排除标准
- •Is pregnant or planning to become pregnant during the course of the study
- •Has suffered two or more documented events of severe hypoglycemia without warning of impending low glucose levels, within the previous 12 months
- •Currently using oral or injectable steroids or immunosuppressant medications
- •Use of any other pharmaceutical agent, other than insulin to treat diabetes, within the three months prior to screening;
- •Has a current history of alcohol or drug abuse
- •Has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), or thromboembolic disease in the 3 months prior to screening
- •Has uncontrolled hypertension (diastolic blood pressure >100 mmHg and/or sustained systolic level [3 successive readings] > 160). Subjects who are taking antihypertensive medication will not be excluded provided they are maintained at a stable dose for 3 months prior to screening
- •Has serious or unstable medical or psychological conditions (e.g., eating disorders, clinical depression, anxiety disorder) which, in the opinion of the Investigator, would compromise the subject's safety or successful participation in the study
- •Is undergoing renal dialysis, including hemodialysis and continuous ambulatory peritoneal dialysis (CAPD)
- •Has evidence of any allergic dermatological condition (e.g., severe adhesive sensitivity)
- •Has recurrent episodes of skin infections or history of staphylococcus infection carrier state
- •Has potential for lack of compliance or any other issue that may preclude the subject from satisfactory participation in the study, based on Investigatory judgment
研究组 & 干预措施
722 sensor augmented pump
722 arm: MiniMed Paradigm REAL-Time System using NovoLog/NovoRapid for 1 year
干预措施: MiniMed Paradigm REAL-Time System (Device)
Multiple Daily Injections (MDI)
MDI arm: Continue with current MDI therapy using Lantus and NovoLog/NovoRapid for 1 year
结局指标
主要结局
Change in A1c From Baseline to 52 Weeks
时间窗: Baseline and 52 weeks
Change is defined as A1c at Week 52 minus A1c at Baseline in each study arm. The difference between the change in each group will then be analyzed. A1c measure is defined as the percent of glycated hemoglobin using one standardized assay for all subjects.
次要结局
- Health Economic Outcome(Baseline and 52 weeks)
- Difference in Frequency of Severe Hypoglycemia From Baseline to Week 52;(Baseline and 52 weeks)
- Overall Difference in Rate of Severe Hypoglycemia Events Between Study Arms From Baseline to Week 52(Baseline and 52 weeks)
- Changes in Hypoglycemia Area Under the Curve (AUC) From Baseline to Week 52;(Baseline and 52 weeks)
- Changes From Baseline in Hyperglycemia Area Under the Curve (AUC) From Baseline to Week 52(Baseline and 52 weeks)
- Quality of Life - Hypoglycemia Fear Scale (HFS), Overall Score(Baseline and 52 weeks)
- Quality of Life - Short Form-36 (SF-36v2™), General Health(Baseline and 52 Weeks)
- Quality of Life - Insulin Delivery System Rating Questionnaire (IDSRQ) for Subject Satisfaction With Type of Insulin Therapy(Baseline and 52 Weeks)