Assessment of the Clinical Efficacy and Acceptability of the Think Positive (T+) Diabetes Management System in Insulin Requiring Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Blood sugar levels (HbA1c)
研究概览
简要总结
New telemedicine systems have been designed to assist people suffering from diabetes in the management of their chronic disease. More recently the focus has been moving to portable systems equipped with Bluetooth. This study consists of evaluating an application called the Think Positive (T+) diabetes management software. It is a randomized controlled trial designed to compare, over a nine month period, a group of patients receiving usual care with a group of patients using the T+ system. The objectives of the study are to investigate the extent to which this telemedicine application helps patients control their blood sugar levels (HbA1c), as well as the extent to which its users consider it to be acceptable. The impact of its use on factors such as diabetes self-care, health status, quality of life, self-confidence in diabetes management, fear of hypoglycemia and illness representations will also be examined. Because of the supplementary real-time support and feedback that T+ offers, its use should lead to better outcomes in diabetes management than usual care does.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 and type 2 diabetes patients
- •Insulin requiring patients
- •Sufficiently fluent in english
- •HbA1c > 7.5
- •Last visit with Diabetes Specialist Nurse (DSN) < 12 months
排除标准
- •Psychiatric disorders
- •Poor vision or/and lack of manual dexterity
- •Prior use of T+
- •Participation in another ongoing trial
- •Patients with antenatal/gestational
- •Patients who are in transition between the children services and adult services Insulin pump users
研究组 & 干预措施
T+ Intervention
The intervention group patients will use the T+ telemedicine application whilst completing repeated measures aiming to compare them to a control group receiving standard care.
干预措施: Mobile phone telehealth application: Think Positive (T+) (Device)
Usual care
The control group will be receiving the standard care offered by the NHS to patients suffering from diabetes.
结局指标
主要结局
Blood sugar levels (HbA1c)
时间窗: Baseline, 3 months, 9 months
次要结局
- BMI(Baseline, 3 months, 9 months)
- Number of Hypoglycemic events(Baseline, 3 months, 9 months)
- Blood pressure(Baseline, 3 months, 9 months)
- Diabetes self-care(Baseline, 3 months, 9 months)
- Diabetes self- efficacy(Baseline, 3 months, 9 months)
- Quality of life(Baseline, 3 months, 9 months)
- Health status(Baseline, 3 months, 9 months)
- Illness representations(Baseline, 3 months, 9 months)
- User acceptability of T+(3 months, 9 months)
- Nurses' Perceptions of T+(Baseline, 3 months, 9 months)
- Self efficacy in using T+(3 months, 9 months)
- Health care utilization(baseline, 3 months, 9 months)
- Self management(baseline, 3 months, 9 months)
研究者
Justine Baron
Researcher
University College, London