eHealth Diabetes Remission Trial (Swedish: Remission av Typ 2 Diabetes Med hjälp av eHälsa
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 106
- 试验地点
- 4
- 主要终点
- HbA1c
研究概览
简要总结
Overweight patients with type 2 diabetes are offered a total diet replacement with the goal of weight loss and diabetes remission. Study participants are randomised to eHealth follow-up or face-to-face follow-up, but the dietary advice is the same in both groups. A healthy control group with normal glucose tolerance is examined once but is not randomised and does not receive any intervention.
详细描述
One hundred and six overweight patients with type 2 diabetes replace usual foods with total diet replacement (850 kcal/day) for 3 months with the goal of 15 kg weight loss and diabetes remission (HbA1c < 48 mmol/mol without diabetes medication). After 3 months of total diet replacement, food is reintroduced stepwise, and an individually tailored energy prescription is used to prevent weight regain. If study participants do not reach the weight loss goal at 3 months, they are recommended two additional months of total diet replacement. If weight regain occurs during the weight maintenance phase, a rescue plan with total diet replacement will be recommended. To increase the chances to maintain their lower body weight, participants will use a program specifically design for that purpose based on cognitive behavioural therapy. Total study duration is two years.
The one hundred and six participants are randomised to either the eHealth follow-up or the face-to-face follow-up. The dietary advice to achieve and maintain weight loss is the same in both groups and delivered by the same dietician, physician, and nurse but the method of follow-up differs between groups (eHealth vs face-to-face).
eHealth group:
All study information and the cognitive behavioural therapy program is given by an eHealth application in Stöd och behandling which is part of 1177.se. Participants register body weight, fasting blood glucose, and blood pressure every morning at 1177.se. Regularly a measurement of HbA1c is taken at home. Participants will have scheduled video appointments with the study dietician, study nurse or study physician.
Face-to-face group:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetes with duration 0-6 years
- •BMI 27 kg/m2 and higher
- •HbA1c 43 mmol/mol or higher (48 or higher if without diabetes medication)
排除标准
- •Insulin treatment
- •Weight loss more than 5 kg during the past 6 months
- •Diagnosed eating disorder
- •eGFR < 30 ml/min/1,73m2
- •Myocardial infarction last six months
- •Severe heart failure (NYHA class III)
- •Ongoing cancer
- •Pregnancy
- •Treatment with antipsychotic drugs
结局指标
主要结局
HbA1c
时间窗: 12 months
HbA1c without diabetes medication as a continuous outcome (HbA1c correction according to Tsapas et al 2020 if on diabetes medication). The outcome will be tested for non-inferiority first, with a non-inferiority margin of 8 mmol/mol; followed by a test for superiority.
次要结局
- Diabetes remission(6, 12 and 24 months)
- Achieved weight loss of at least 15 kg(6, 12 and 24 months)
- Estimated lifetime costs per quality-adjusted life-year (QALY)(24 months)
- Incremental costs per diabetes remission(24 months)
- Study experience(24 months)
- Estimated lifetime costs(24 months)
- P-glucose 120 minutes after the oral glucose tolerance test(6, 12, 24 months)
- Blood pressure (systolic/diastolic)(6, 12, 24 months)
- Blood pressure(6, 12, 24 months)
- Waist circumference(6, 12, 24 months)
- Body weight follow-up(Yearly up to 20 years)
- Usage of diabetes medication follow-up(Yearly up to 20 years)
- Usage of hypertension medication follow-up(Yearly up to 20 years)
- HbA1c(6 and 24 months)
- Body weight(6, 12 and 24 months)
- Number of prescribed oral anti diabetic medications(6, 12, 24 months)
- Fasting blood glucose(6, 12, 24 months)
- Liver enzymes(6, 12, 24 months)
- Number of participants that discontinue the intervention(6, 12, 24 months)
- Quality of life accoring to Brunnsviken Brief Quality of Life Scale(6, 12, 24 months)
- Eating habits(6, 12, 24 months)
- Number of prescribed antihypertensive medications(6, 12, 24 months)
- Plasma lipid profile(6, 12, 24 months)
- Estimation of exhaustion(6, 12, 24 months)
- Quality of life according to EQ-5D-5L(6, 12, 24 months)
- HbA1c follow-up(Yearly up to 20 years)
- Blood pressure follow-up(Yearly up to 20 years)
- Diabetes complications follow-up(Yearly up to 20 years)
- Relation to food(6, 12, 24 months)
- Estimation of health(6, 12, 24 months)
- Daily steps(6, 12, 24 months)
研究者
Julia Otten
Principal investigator
Umeå University