The Impact of ROTO Track® in Helping Patients With Diabetes Rotate Their Insulin Injections Better - a Proof-of-concept Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- rotation of insulin injections
研究概览
简要总结
The ROTO track® is an electronic injection form and injection log for keeping track of injection sites in the abdominal region. The device attaches directly to the insulin pen and activates whenever the insulin pen is picked up. Small LED lights on the device will indicate where the next injection site is according to the individual patient's injection plan. By moving the pen and device to an "anchor point" in front of the navel, the device is able to start tracking where the insulin pen is being moved to. The device additionally contains a haptic interface to indicate to the user when the device has been moved to the next area in the injection plan.
The device registers the location, the time and the dosage automatically when the patient injects insulin with the pen
The rationale of the trial is that the ROTO track® can help patients rotate their injections sites and that this will provide the healthcare system with a new cost-effective tool for improving insulin injection techniques.
详细描述
Both observational and interventional studies have reported that proper rotation of injection sites can be obtained through intensive injection technique training, education and follow up of patients. Furthermore, this has significant beneficial effects on daily glycaemic variations, hypoglycaemic events, long term blood glucose levels, and insulin dose requirements. This is however frequently not done appropriately in every day practice.
At a small workshop at Nordsjællands Hospital in November 2017 with patients with type 1 diabetes the value of a device to registrar time, dose and rotation of insulin injections were discussed. All patients considered their own injection patterns as satisfying - although only one in four used a systematic approach. Most patients relied on their healthcare provider to identify side effects like lipohypertrophy, half of the patients re-used needles more than once and two took injections through the clothes now and then. All subjects would prefer a simple and small device to be used with the pen for the lifetime of the pen to minimize time used for injections and attraction of attention from other people.
The hypothesis is that the ROTO track® can reduce the number of insulin injections in the same subcutaneous skin area as compared with standard insulin injection instructions in patients with type 1 diabetes. The reduction of injection in same skin area will be quantified by a rotation score
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
During the baseline period patients will be blinded to the feature of the ROTO track®, which registers site of insulin injection and the features (vibration and light) that can assist the patient in rotation of injections. Patients will in the first week of the study be informed, that the ROTO track® is being developed as a new automatic device to register data on insulin injections including day, time and dose of insulin.
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
- •Written informed consent obtained before any trial related procedures are performed
- •Male or female aged 18 years
- •Type 1 diabetes with a duration of two or more years
- •Treated with three or more daily pen injections of Novo Rapid™ in the abdominal region
- •The subject must be willing and able to comply with trial protocol
排除标准
- •Blind or severely impaired eyesight
- •History of alcohol or drug abuse
研究组 & 干预措施
ROTO Track
The individual patient will serve as his/her own control before intervention with ROTO Track
干预措施: ROTO track® (Device)
结局指标
主要结局
rotation of insulin injections
时间窗: 6 days
Number of insulin injections taken in a given subcutaneous skin area will be captured in a rotation score by the ROTO track® . The rotation score is a single ratio value that combines the distribution over the skin areas used with the time between re-use of a field. The value is set from 0 (meaning every injections in a single area) to 1 (meaning perfect rotation with the maximum possible time between two injections in the same skin area).
次要结局
- Patient reported outcomes(12 weeks)
- glucose variability(12 weeks)
- number of insulin infiltrates(12 weeks)
- Insulin dose requirement(12 weeks)
- Hypoglycaemic events(12 weeks)
- Accuracy of the ROTO track® injection log(12 weeks)
- rotation of insulin injections(12 weeks)
- glycaemic control(12 weeks)
研究者
Peter Lommer
Head of Department, Endocrinology and Nephrology Department
Nordsjaellands Hospital