A Prospective, Single Center Study to Assess the Performance, Safety, and Patient Reported Outcomes of Insulin Delivery With PaQ® in Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
研究概览
简要总结
The purpose of the study is to obtain an assessment (efficacy, safety, and patient reported outcomes) of basal bolus insulin delivery with PaQ in insulin-using patients with type 2 diabetes mellitus (T2DM).
详细描述
This is a prospective, single center, open-label, uncontrolled study to assess the efficacy, safety, and patient reported outcomes of insulin delivery with PaQ® in patients with type 2 diabetes mellitus (T2DM) who are currently receiving basal/bolus insulin therapy with or without oral anti-diabetic drugs (OADs) for glycemic control. The patient's participation in the study is comprised of three phases: screening/baseline evaluation, transition to PaQ use and optimization, and PaQ treatment period. The use of these phases will allow an orderly transition to PaQ treatment as well as a reliable construct from which to interpret the final data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Is at least 18 years of age;
- •Has a clinical diagnosis of T2DM, as determined by clinical history and medication usage;
- •Has an A1C ≥ 7.0% and ≤ 11.0%;
- •Is treated with basal-bolus insulin therapy (at least 2 injections per day) with or without OADs, and/or GLP-1 agonist for at least 3 months and has not had a change (addition or discontinuation of existing drug or change in dose) in their OADs for the last 8 weeks, (See Section 7.4 for definition of baseline basal bolus therapy);
- •Determined by the investigator that insulin requirements to achieve glycemic targets can be met by the insulin capacity of the PaQ device;
- •If on concomitant metformin, has serum creatinine <1.5 mg/dL (male) or <1.4 mg/dL (female);
- •If female, and of child-bearing potential, has a negative urine pregnancy test at screening and must be using adequate means of contraception as determined by the Investigator;
- •Is clinically euthyroid as judged by the Investigator;
- •Is able to understand and sign the required study documents and comply with the CIP requirements;
- •Is deemed capable by the Investigator to perform the requirements of the CIP, including use of PaQ, frequent self-monitoring of blood glucose.
排除标准
- •Is poorly compliant with the currently prescribed diabetes regimen, as determined by the Investigator;
- •Is poorly compliant with prescribed self-monitoring of blood glucose, as determined by the Investigator;
- •Is currently taking or has taken sulfonylureas within the last 2 months;
- •Has a BMI greater than 40 kg/m2;
- •Has experienced recurrent severe hypoglycemia (> 2 episodes) requiring assistance during the past 6 months;
- •Has existing dermal irritation/inflammation over the abdominal area that may interfere with use of PaQ, as determined by the Investigator;
- •Has known clinically significant hypersensitivity to skin adhesives;
- •Is female and if of child-bearing potential, is pregnant, lactating, or planning to become pregnant;
- •Is currently being treated with or expected to require or undergo treatment with systemic steroids by oral, intravenous, or intramuscular route (inhaled with low systemic exposure is permitted);
- •Currently abuses drugs or alcohol or has a history of abuse that in the Investigator's opinion would cause the individual to be non-compliant;
- •Has received any investigational drug within 1 month;
- •Has donated blood within 30 days;
- •Has any significant medical condition (including current or past history of cardiovascular disease), laboratory findings, or medical history that in the Investigator's opinion may affect successful completion of the study and/or personal well-being;
- •Is an immediate family member (spouse, parent, child, or sibling) of personnel directly affiliated with the study at the investigative site, or is personally directly affiliated with the study at the investigative site.
研究组 & 干预措施
PaQ® Insulin Delivery Device
The intervention is continuous subcutaneous U 100 Insulin, Asp(B28)-rapid-acting insulin, at a constant basal rate of either 20, 24, 32, 40 or 50 U per day over 3 days and and bolus insulin as needed at meals in 2 U increments.
干预措施: PaQ® Insulin Delivery Device (Device)
PaQ® Insulin Delivery Device
The intervention is continuous subcutaneous U 100 Insulin, Asp(B28)-rapid-acting insulin, at a constant basal rate of either 20, 24, 32, 40 or 50 U per day over 3 days and and bolus insulin as needed at meals in 2 U increments.
干预措施: Insulin, Asp(B28)- (Drug)
结局指标
主要结局
Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)
时间窗: Change from Baseline at 12 weeks
次要结局
- Fasting plasma glucose(Change from Baseline at 12 weeks)
- 7-point blood glucose profiles(Change from Baseline at 12 weeks)
- Glycosylated hemoglobin A1C (HbA1c) (obtained from venous blood)(Change from Baseline at 8 weeks)
- Body weight(Change from Baseline at 12 weeks)
- Barriers to Insulin Treatment questionnaire(Change from Baseline at 12 weeks)
- Adverse events(Collected throughout the study, average 14 weeks)
- Total daily dose of insulin(Change from Baseline at 12 weeks)
- Hypoglycemic events(Collected at baseline (on current insulin therapy) and throughout the study, average 14 weeks)
- Diabetes Treatment Satisfaction Questionnaire(Change from Baseline at 12 weeks)
- Short form 36 Health Survey(Change from Baseline at 12 weeks)