The Role of Proper Insulin Injection Technique in the Treatment of Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 8
- 主要终点
- Change in Glycemic Control
研究概览
简要总结
This is a prospective, post-marketing, single-arm clinical investigation on the effects of optimal insulin injection technique, in conjunction with the use of disposable Becton Dickinson (BD) Micro-Fine Plus 32G pen needles, by Type I and Type II Diabetes Mellitus patients, with or without lipohypertrophy, on clinical outcomes like HbA1c and hypoglycemic events, as well as changes in insulin Total Daily Dose (TDD) and patient's Quality of Life (QoL). During this study, each subject will be trained in the optimal insulin injection technique by personal training as well as by following online video training modules on a specific web-based platform.
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
- •Type 1 or type 2 diabetes mellitus;
- •At least 1 year of experience with insulin self-administration;
- •Use of insulin pen for insulin injections.
- •HbA1c > 7.5 % measured at study entry or maximally 30 days prior to screening.
- •BMI below 40 kg/m2 at study entry.
- •Daily self-control of blood glucose level;
- •Access to the internet for watching video lessons.
- •Only outpatients are eligible for the study.
- •Availability of signed informed consent of the patient for inclusion in the study.
排除标准
- •Pregnant women or women planning to become pregnant during the time of study, breastfeeding women;
- •Subjects using an insulin pump;
- •Those using treatment with a Glucagon-Like Peptide (GLP)-1 receptor agonists alone;
- •Subjects not fluent in Russian (reading and writing).
- •Patients at high risk for ketoacidosis and/or hyperglycemia.
- •Psychic, physical or any other reasons hampering patient participation in the study (based on the reasonable opinion of the physician-investigator).
研究组 & 干预措施
Optimal insulin injection
Study subjects will receive personal training from the Investigator on how to optimally inject insulin to treat their Diabetes Mellitus. In addition, each subject receives instruction how to use a web-based platform with online video training modules on optimal injection technique.
干预措施: Optimal insulin injection (Behavioral)
结局指标
主要结局
Change in Glycemic Control
时间窗: up to 6 months
Change in HbA1c for subjects from Baseline to 6 months; expressed as theHbA1c% levels at Baseline and 6-months
次要结局
- Change in Insulin Total Daily Dose (TDD)(up to 6 months)
- Incidence of Hypoglycemic Events(up to 6 months)
- Change in Blood Glucose Levels(up to 6 months)