NCT00486109已完成不适用
A Study Assessing an Injection Port for Administration of Insulin
Patton Medical Devices5 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2006年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 74
- 试验地点
- 5
- 主要终点
- Glycosylated albumin levels
研究概览
简要总结
This study investigated wearability and usability of the I-PORT™ Injection Port (I-PORT™), a new disposable injection port through which prescribed medication is injected subcutaneously from a standard syringe or pen. Additional investigation compared subject opinion towards using the I-PORT™ device compared to standard injection therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female subjects, 14-70 years of age, with type 1 and type 2 diabetes mellitus for a minimum of six (6) months
- •Subjects must be utilizing a regimen of at least two (2)injections daily of either Novolin®, Humulin®, NovoLog®, Humalog® or Apidra® and no more than one (1) injection of Lantus® daily using a standard syringe or insulin pen
- •Current regimen of intensified insulin therapy (defined as separate injections of basal and prandial insulin with at least three (3) insulin injections per day) for a minimum of three (3) months
- •Body Mass Index <35 kg/m2
- •HbA1c ≤ 10 %
- •If medications (other than oral anti-diabetic agents) in addition to insulin are taken at screening, the subject must be on a stable regimen as defined by continued use of the same dose of each medication for a period of at least three (3) months prior to study enrollment
- •Subjects must be willing to provide written informed consent
排除标准
- •Use of Continuous Subcutaneous Insulin Infusion (CSII) at any time within the preceding three (3) months
- •History or current diagnosis of chronic diseases which in the view of the PI would interfere with adequate involvement in and completion of the requirements of the study
- •Use of short term or chronic steroids within two (2) months of entry into the study or likelihood that same might be required during the conduct of the study
- •Use of hydrochlorthiazide at doses >25 mg daily
- •Use of beta-blocker drugs
- •Regular pre-prandial doses of SC insulin >30 IU per meal
- •Intake of any drug or herbal preparation which, in the evaluation of the PI, may interfere with the interpretation of clinical study results or that is known to cause clinically relevant interference with insulin action, glucose utilization or ability to detect or recover from hypoglycemia (e.g., systemic steroids)
- •History of known hypersensitivity to plastics or polymers
- •Treatment with any investigational drug within two (2) months prior to enrollment or during this study
- •Progressive fatal disease
- •History of malignancy within five (5) years of study entry(other than basal cell carcinoma)
- •Evidence of severe secondary complications of diabetes(neuropathy, nephropathy as evidenced by creatinine >1.5 mg/dL for females or >1.8 mg/dL for males, grade III or IV retinopathy or severe peripheral vascular disease)
- •Evidence of gastroparesis, orthostatic hypotension or hypoglycemia unawareness (autonomic neuropathy)
- •Myocardial infarction or stroke within the preceding six (6)months
- •Positive hepatitis B (HBsAg) and/or hepatitis C (Hep C AB)serology and/or positive HIV serology
- •History or presence of clinically significant cardiovascular, hepatic (as evidenced by ALT or AST >3 times the upper limit of normal), gastrointestinal, neurological or infectious disorders capable of altering the absorption, metabolism or elimination of drugs, or constituting a significant risk factor when using the study device
- •Anemia (hemoglobin levels <11 g/dL for females or <12 g/dL for males)
- •Pregnancy, lactation, or intention to become pregnant
- •Female subjects of childbearing potential practicing inadequate birth control (adequate birth control is defined as using oral
- •Regular alcohol intake greater than 18 units*/week, or subjects unwilling to stop alcohol for the duration of the study (* 1 unit = 8 g ethanol, ¼ liter of beer or 1 glass wine or 1 ounce of spirits)
- •PI or clinical site personnel directly affiliated with this study and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biological or legally adopted
- •A lack of compliance (including the inability to maintain a minimum of 75% compliance with study device administration) or other reasons, which in the opinion of the PI may preclude the participation of the subject in the study
结局指标
主要结局
Glycosylated albumin levels
时间窗: 7 weeks
次要结局
- Participants' satisfaction evaluated with standard quality of life questionnaires and adverse events related to the study device including incidents of erythema > 2cm diameter, incidence of induration > 1cm dimater and incidence of suppuration.(7 weeks)
研究者
研究点 (5)
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