A Single-centre, Randomised, Cross-over Design Efficacy Study to Assess the Effectiveness of App-based, Assisted Behavioural Change Techniques to Improve HbA1c Levels and Support Diabetes Self-management in Young Adults and Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in HbA1c
研究概览
简要总结
Young people (16-25) with type-1 diabetes have historically struggled with managing their condition. Typically, the average HbA1c levels are significantly higher and as such, the risk of long term complications tend to be far greater.
These sufferers tend to have better management of their condition as they grow older however, the evidence suggests this is too late and these sufferers will likely have some complications later in life. Current cost to the NHS for complications is ~£850 million and expected to rise to ~£1.3 billion in the next 10-15 years.
The LovedBy solution aims to leverage modern technologies such as smartphones, continuous glucose monitors (CGM), and other smart wearables to assist young sufferers managing their condition. The LovedBy platform offers a mobile application which connects to the user's smart wearables and CGM to monitor data streams that have been linked to long term risk. The mobile application is then able to deliver personally relevant educational content to the user through numerous channels including private social media messages.
The study will last 10 months, and the participants are required to download/install the mobile app, integrate their wearables and then simply continue as normal with regular clinical meetings. Participants will be between 16-25 years and comply with the inclusion criteria set out in the protocol.
详细描述
This study will recruit 40 participants suffering from type-1 diabetes, split across 2 groups, with 30 needed for statistical significance (10 extra to allow for dropouts). The participant will have their average HbA1c levels measured (lab based, CONTROL-1). While the participants are participating in the trial, they will receive relevant educational content based on areas of management they are struggling with. The analysis that decides this is automated by the system which explores whether the particular criteria have been met for each educational pieces.
At the end of the study we will be able to compare whether the primary outcome has been met by comparing a final average HbA1c measure to CONTROL-1. Secondary outcomes can be evaluated using the sensor HbA1c recordings.
The entire study can be summarised as a reference to a reduction in long term risk and cost saving to the NHS.
Participant Journey
Pre-Trial (Visit 1):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 16 -
- •Type 1 diabetes, as defined by World Health Organisation (WHO) for at least 1 year or is confirmed C-peptide negative.
- •HbA1c between 7.5 - 14.0% based on analysis from local laboratory or equivalent within 3 months of enrolment.
- •Has an Apple smartphone compatible with Dexcom G
- •Willingness to download the LovedBy app on their smartphone.
- •Willingness to wear an apple smartwatch.
- •Willingness to wear a Dexcom CGM.
- •Literate in English.
排除标准
- •Non-type 1 diabetes mellitus including those secondary to chronic disease.
- •Biphasic insulin MDI pen users.
- •Any other physical or psychological disease is likely to interfere with the normal conduct of the study.
- •Untreated coeliac disease or hypothyroidism.
- •Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, Metformin, SGLT2 inhibitors, GLP-1 agonists, non-selective beta-blockers, MAO inhibitors etc.
- •Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement.
- •Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin disease) located at places of the body, which could potentially be used for localisation of the glucose sensor.
- •Lack of reliable telephone facility for contact.
- •Known or suspected allergy against insulin.
- •Severe visual impairment.
- •Severe hearing impairment.
- •Not proficient in English.
- •Pregnancy, or planning for pregnancy.
结局指标
主要结局
Change in HbA1c
时间窗: 4 months
primary objective is to assess change in HbA1c change at 4 months following use of the LovedBy digital solution and 4 months without the the LovedBy app. (Lab based measures.)
次要结局
- The time with glucose levels in significant hyperglycaemia (>16.7 mmol/l)(10 months)
- Time spent above target glucose (10.0 mmol/l)(10 months)
- Time spent below target glucose (3.9 mmol/l)(10 months)
- Total, basal and bolus insulin dose(10 months)
- AUC of glucose below 3.5 mmol/l(10 months)
- Average, standard deviation, and coefficient of variation of glucose levels(10 months)
- The time with glucose levels in hypoglycaemia at <3.5 mmol/l and <2.8 mmol/l(10 months)