Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy
Prospective, Open-Label, Randomized, Controlled, Multi-Center Study Comparing Efficacy and Safety of Frequently Modified Insulin Therapy Using Dosage Recommending Device
研究概览
详细说明
The purpose of this study is to demonstrate that the use of d-Nav (d-Nav group) is superior to titration of insulin dosage relying on data from glucose meters with health care provider support (Control) in the management of insulin treated diabetes, by randomizing 200 insulin treated subjects with type 2 diabetes.
Primary Objective: To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users compared to control patients in the primary cohort.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Minnesota
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Minneapolis、Minnesota、美国、55416-2699
- Park Nicollet Institute / International Diabetes Center, Minneapolis, MN
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 21 to 70 years of age
- If female, must be of non-childbearing potential or have a negative urine pregnancy test at screening and using adequate method of contraception throughout conduct of the study
- Clinical diagnosis of Type-2 diabetes for at least 1-year
- HbA1c 7.5% to 11% inclusive
Total daily dose of insulin of 25 units or more (10 units if on Lantus® alone) using one of these insulin regimens:
- Regimen 1 - a single injection of the long-acting insulin analog Lantus® (Glargine) per day (limited to a daily dose that is no more than 0.7 units per kg of body weight);
- Regimen 2 - twice daily biphasic insulin (i.e., Humalog® Mix 75/25, NovoLog® Mix 70/30) or pre-mixed insulin (i.e., Humulin® 70/30, Novolin® 70/30);
- Regimen 3 - a short-acting insulin analog (i.e., Humalog®-Lispro, NovoLog®-Aspart, Apidra®-Glulisine) before each meal and are treated with a single injection of the long-acting insulin analog Lantus® (Glargine) per day and do not utilize an insulin/carbohydrate ratio for calculating their short-acting insulin doses; or
- Regimen 4 - with a short-acting insulin analog (i.e., Humalog®-Lispro, NovoLog®-Aspart, Apidra®-Glulisine) before each meal and a single injection of the long-acting insulin analog Lantus® (Glargine) per day and utilize an insulin/carbohydrate ratio for calculating their short-acting insulin doses.
- On same insulin regimen for the previous 3-months
- May be using other diabetes agents at a stable dose for the last 3-months
- Signed and dated informed consent document, which contains HIPAA waiver information informing about all of the aspects of the clinical study;
Will regularly conduct Self-Monitored Blood Glucose. Prior to randomization must meet the following .
Minimum number of tests required from all subjects:
- Basal insulin subjects at least 4 fasting glucose readings/wk
- Premixed insulin subjects at least 8 readings/wk
- Basal-bolus insulin therapy subjects at least 16 total readings/wk
Willing and able to comply with the scheduled clinical study activities and glucose testing:
- Basal insulin subjects at least 5 fasting glucose readings/wk
- Premixed insulin subjects at least 5 pre-breakfast and 5 pre-evening meal readings/wk
- Basal-bolus insulin therapy subjects at least 20 total readings/wk which include 5 readings before each of the following time points: breakfast, lunch, evening meal and bedtime.
Note: All subjects may be asked to test during the night if clinically indicated.
- Participant must have a primary care provider
Exclusion Criteria:
- History >2 episodes of severe hypoglycemia (see definition below) in the past year, or hypoglycemic unawareness when glucose levels are ≤ 50 mg/dl;
- Significant physical, psychological, or cognitive impairment that would prohibit adherence to the protocol at the discretion of the PI;
- Splitting Lantus and taking Lantus twice a day
- Severe cardiovascular disease including a history of congestive heart failure, unstable angina, myocardial infarction or stroke within the 6-months preceding enrollment;
- Active anemia w/ hematocrit ≤ 25% in women or 30% in men;
- Advanced kidney disease Stage 4 (eGFR < 30 ml/min) and above
- Active cancer or cancer in the past 2-years (except non-melanoma skin cancer)
- History of significant liver disease including cirrhosis or elevated liver enzymes (e.g., AST and ALT greater than 3 times the upper limit of normal values).
- BMI > 45 kg/m2
- Are pregnant, plan to become pregnant during the study period, or are breastfeeding.
- Have a BGMS that cannot be downloaded.
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:d-Nav Device
d-Nav Device: daily use to provide insulin dosage updates weekly - or sooner when needed based on analyzes and evaluates the historical blood glucose patterns. Insulin dosage is adjusted as required |
Insulin dosage is adjusted as required
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有源比较器:Blood Glucose Monitoring System
Patient's personal Over the Counter Blood Glucose Monitoring System (OTC BGMS) for daily glucose testing to determine insulin dosage needed. Insulin dosage is adjusted as required |
Insulin dosage is adjusted as required
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Reduction in HbA1C
大体时间:6 months
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To demonstrate a greater reduction in HbA1c at 6-months for d-Nav users compared to control patients in the primary cohort.
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6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Comparison Percent Reduction HbA1c
大体时间:6 months
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To determine the difference between the Control and d-Nav group in the percent of participants who achieve A1c < 7.0%, < 8.0%, and >9.0% at 6 months
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6 months
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Number of Glucose Readings <70 mg/dl
大体时间:3 and 6 months
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To determine the difference between the Control and d-Nav group in the number of glucose readings <70 mg/dl (symptomatic or asymptomatic) utilizing the documented downloaded glucose values.
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3 and 6 months
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Change in Rate of Hypoglycemia
大体时间:6 months
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To determine change (if any) in rate of hypoglycemia, during the study for d-Nav users in the secondary cohort
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6 months
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Comparison Percent Reduction HbA1c w/out Hypoglycemia
大体时间:6 months
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To determine the difference between the Control and d-Nav group in the percent of participants who achieve A1c < 7.0%, < 8.0% without a severe hypoglycemia event at 6 months.
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6 months
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合作者和调查者
调查人员
- 首席研究员:Richard M Bergenstal, MD、Executive Director International Diabetes Center
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
d-Nav的临床试验
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Biosense Webster, Inc.完全的
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University of California, San DiegoNational Institute of Mental Health (NIMH); Kaiser Permanente邀请报名
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The Hospital for Sick ChildrenCanadian Institutes of Health Research (CIHR); SickKids Foundation招聘中
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NORCE Norwegian Research Centre ASNorwegian Labour and Welfare Administration完全的
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GlaxoSmithKline完全的