A Study Evaluating the Feasibility of Use and Performance of PaQ™ in Patients With Type 2 Diabetes Mellitus Who Are Currently Treated With Basal/Bolus Insulin Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Patients ability to successfully assemble, fill, prime, apply and use the PaQ™ device
研究概览
简要总结
The purpose of this study is to evaluate the ability of a patient, who has type 2 diabetes (T2DM) who is currently treated with basal/bolus insulin therapy, to use PaQ™ (a simple patch on insulin delivery device) to control his/her blood glucose.
详细描述
This is a single center, open label, feasibility of use and performance evaluation of PaQ™ (using insulin aspart) in patients with 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 four phases: screening, baseline evaluation, transition to PaQ™ use, 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
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/female patient's ≥ 30 ≤ 65 years of age.
- •Clinical confirmation of T2DM diagnosis by history and medication usage or glucose tolerance test.
- •Currently treated with insulin using a basal/bolus regimen with or without concurrent use of OADs (metformin and/or glitazone).
- •Currently on a stable insulin regimen "as judged by the investigator" (using an estimate of their basal dose of insulin does not fluctuate by more than ±10% every day) and if he/she is receiving a concurrent oral agent, the dose has remained unchanged for the last 30 days.
- •Currently uses between 20 to 50 units/day basal insulin.
排除标准
- •Uncontrolled hyperglycemia, HbA1c > 9.0% requiring adjustment to his/her insulin regimen.
- •Treated with premixed insulin, or neutral protamine hagedorn (NPH)/glargine/detemir insulin without use of bolus/meal time insulin.
- •Patient has had an episode of severe (assisted) hypoglycemia within the past 30 days.
- •Currently treated with sulfonylurea or incretin-based therapy [glucagon-like peptide-1(GLP-1) agonist or dipeptidyl peptidase-4 (DPP-4) inhibitor].
- •Total daily dose (TDD) of insulin is >100 units/day.
- •Have a meal-time bolus doses that exceeds the capacity of the bolus Insulin Reservoir at any given meal.
- •Have existing dermal irritation on their abdomen or have known hypersensitivity to skin adhesives.
- •Taking or has taken prednisone or cortisone medications in the previous 30 days.
- •Pregnant or is planning to become pregnant during the study period.
- •Has severe medical or psychological condition(s) or chronic conditions/infections that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.
- •Unable to follow the study clinical investigational plan (CIP)
结局指标
主要结局
Patients ability to successfully assemble, fill, prime, apply and use the PaQ™ device
时间窗: End of two week transition period
次要结局
- Infection at cannula insertion site(During transition and PaQ™ treatment period)
- Occurence of adverse experiences and the number and severity of hypoglycemic episodes(During baseline, transition and PaQ™ treatment period)
- Quality of Life Questionnaire(At the end of the study)
- Dermal Irritation(During transition and PaQ™ treatment period)
- Insulin usage(End of two baseline period and end of 2 week treatment period)
- 7-point blood glucose reading(Twice per week during baseline period (weeks 1 & 2) and PaQ™ Treatment period (weeks 5 & 6))
- Glucose variability(During baseline and PaQ™ treatment period)
- Glucose exposure(During baseline and PaQ™ treatment period)
- Glucose Stability(During baseline and PaQ™ Treatment Period)