The Relative Effectiveness of Pumps Over Multiple Dose Injections and Structured Education Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 16
- 主要终点
- The change in HbA1c after 2 years in those participants whose baseline HbA1c was at or above 7.5% (58mmol/mol).
研究概览
简要总结
For type-1 diabetes, the aim of insulin therapy is to keep blood glucose close to normal while avoiding hypoglycaemia but this is severely limited by the relative crudeness of current insulin delivery in comparison with the physiology of the β-cells which secrete insulin. Insulin is generally administered by multiple injections MDI with the dose adjusted according to eating and exercise. Insulin can now also be administered using a pump (CSII), which is a device, roughly the size of a mobile phone and containing sufficient insulin to supply both the needs of basal metabolism throughout the day, and the boluses which have to cover meals. The use of CSII is expensive compared to injections, but there are important potential benefits which include improved glycaemic control, reduced risk of hypoglycaemia (low blood sugar) and a more flexible lifestyle and better quality of life. There have been no trials in adults that have compared CSII treatment with MDI where the same structured training in intensive insulin therapy has been given, so the precise benefit of the pump technology is still unclear. There is a need to establish this, and identify patients who benefit the most so that the Department of Health can calculate the proportion of adults that would benefit from CSII therapy and so ensure that commissioning bodies provide the necessary reimbursement. The aim of the trial is therefore to establish the added benefit of CSII therapy over multiple injections on glycaemic control and hypoglycaemia in individuals with Type 1 diabetes receiving similar high quality structured training (Dose Adjustment For Normal Eating:DAFNE) in insulin therapy. Additional assessments will include effects on quality of life and cost effectiveness.
详细描述
The trial is a multi-centre randomised controlled trial whereby between 40 and 49 type-1 diabetic, adult volunteers, aged 18 and above, will be recruited per site from 7 secondary care centres (Sheffield, Kings College Hospital London, Harrogate District Hospital, Addenbrookes Hospital Cambridge, Glasgow Royal Infirmary, Dumfries and Galloway Royal Infirmary and Edinburgh Royal Infirmary). The sites will be required to recruit participants to at least 3 CSII DAFNE (Dose Adjustment for Normal Eating)courses and 3 MDI DAFNE courses. This will mean that in total on the trial, 140 participants are randomised to CSII and 140 to MDI. Participants will be recruited through direct approach if already on the waiting list for a DAFNE course or through advertisement in various clinics.
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
- •Is aged 18 yrs and above.
- •Have had type-1 diabetes for at least 12 months (as assessed by date clinically diagnosed).
- •Is fluent in speaking, reading and understanding English.
- •Has no preference to either CSII or MDI arm of the study and is happy to be randomised.
- •Is currently using or willing to switch to Detemir.
- •Is willing to undertake self-monitoring of blood glucose (SMBG), carbohydrate counting and insulin self-adjustment. (Enrolment staff should check that any participant with a baseline HbA1c of above 12% is willing to complete SMBG).
- •Has a need for structured education to optimise diabetes control in the opinion of the investigator.
- •Exclusion criteria:
- •Inability to give informed consent.
- •Is pregnant or planning to become pregnant within the next 2 years.
- •Has used CSII within the last 3 years.
- •Has already completed a diabetes education course.
- •Has severe needle phobia.
- •Has a current history of alcohol or drug abuse.
- •Has a history of heart disease within the past 3 months.
- •Has hypertension that is not under control with hypertensive medication (diastolic blood pressure >100mmHg and or sustained systolic level >160).
- •Has renal impairment with a chance of needing renal replacement therapy within the next 2 years (Enrolment staff should check that creatinine levels are not above 200 µmol/L).
- •Has recurrent episodes of skin infections.
- •Has serious or unstable medical or psychological conditions.
- •Has taken part in any other investigational clinical trial during the 4 months prior to screening.
- •Has any other issue that may preclude the participant from satisfactory participation in the study based on investigatory judgement.
- •Has a strong need for pump therapy in the opinion of the investigator.
排除标准
- 未提供
结局指标
主要结局
The change in HbA1c after 2 years in those participants whose baseline HbA1c was at or above 7.5% (58mmol/mol).
时间窗: 2 years
The change in HbA1c after 2 years in those participants whose baseline HbA1c was at or above 7.5% (58mmol/mol). (Change will be calculated from baseline at 24 months)
次要结局
- Incremental cost-effectiveness ratio(6, 12 and 24 months)
- Hypoglycaemia (severe & moderate)(6, 12 and 24 months)
- Diabetic Ketoacidosis(6, 12 and 24 months)
- Costs and Outcomes(6, 12 and 24 months)
- Costs(6, 12 and 24 months)
- Participant views regarding the pump/multiple injection course & treatment(6, 12 and 24 months)
- The proportion of participants reaching the NICE target of an HbA1c level of 7.5% (58mmol/mol) or less(6, 12 and 24 months)
- Diabetes specific quality of life(6, 12 and 24 months)
- Fear of hypoglycaemia(6, 12 and 24 months)
- Emotional Wellbeing(6, 12 and 24 months)
- Insulin dose(6, 12 and 24 months)
- Body weight(6, 12 and 24 months)
- Blood lipids & proteinuria(6, 12 and 24 months)
- Diabetes Treatment Satisfaction(6, 12 and 24 months)
- Educator views regarding the pump/multiple injection course & treatment(6, 12 and 24 months)
- General Quality of Life(6, 12 and 24 months)
- Quality of adjusted life years(6, 12 and 24 months)