The eHealth Diabetes Remission Trial - Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
Ten study participants will consume a low-calorie total diet replacement for 12 weeks, have a 6-week food reintroduction phase (week 13-18) and continue with the weight loss maintenance phase until the end of the study (week 19-26). The weight loss goal is 15 kg (or 15% if body weight is bellow 80 kg). The primary study outcome iw weight loss after 6 months and the co-primary outcome is diabetes remission after 6 months (HbA1c < 48 mmol/mol). During the weight maintenance phase, if weight regain occurs or if HbA1c increases a rescue plan of total diet replacement will be recommended.
The participants will be supplied with the total diet replacement Modifast free of charge. Participants will be supplied with a scale, a finger-stick blood glucose meter and a blood pressure monitor. Participants will be advised to measure body weight, blood glucose and blood pressure every morning. The results are registered in the mobile phone application Telia Health Monitoring and are wirelessly transmitted to the project's physician, nurse and dietician. At the beginning of the food reintroduction phase the participants will receive an activity tracer and will be advised to increase their physical activity. Primary and secondary outcome measures will be estimated at the beginning and after 3 and 6 months. At the end of the study, all participants will take part in an individual semi-structured interview to investigate the participants' experience of diabetes remission and of the eHealth contact with the healthcare provider. After participants have completed the study, they will be followed at least once per year by obtaining data on blood sugar, HbA1c, body weight, blood pressure, medication usage and diabetes complications from the healthcare computer system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes with diabetes duration 0 to 6 years
- •BMI 27-45 kg/m2
- •Owning a smartphone
- •HbA1c 43-107 mmol/mol during the past 12 months (48-107 mmol/mol without blood sugar lowering medication)
排除标准
- •Insulin treatment
- •Weight loss 5 kg or more during the past 6 months
- •Treatment with weight loss medication
- •Diagnosed eating disorder
- •eGFR < 30 ml/min/1.73m2
- •Substance abuse
- •Myocardial infarction during the past 6 months
- •Severe heart failure
- •Pregnancy
结局指标
主要结局
Weight loss
时间窗: 6 months
Weight loss goal of 15 kg, measured at the research facilities
HbA1c
时间窗: 6 months
The goal is diabetes remission with HbA1c \< 48 mmol/mol without any diabetes medication. (Secondary goal \< 42 mmol/mol.)
次要结局
- Fasting blood glucose(6 months)
- P-glucose 120 minutes after the oral glucose tolerance test(6 months)
- Insulin secretion(At baseline, 3 months and 6 months)
- Insulin sensitivity(At baseline, 3 months and 6 months)
- Blood pressure (systolic/diastolic)(Daily measurements up to 6 months)
- Diabetes medication(6 months)
- EQ-5D-5L(At baseline, 3 months and 6 months)
- Food frequency form(At baseline and 6 months)
- Antidiabetic medication usage follow up(Yearly up to 20 years)
- Blood pressure medication usage follow up(Yearly up to 20 years)
- Semi-structured interviews(6 months)
- Metabolic flexibility(At baseline, 3 months and 6 months)
- Blood pressure medication(6 months)
- Daily steps(During the second three months of the study)
- Diabetes complications follow up(Yearly up to 20 years)
- Body weight(Daily measurements up to 6 months)
- HbA1c(Monthly measurement up to 6 months)
- Blood pressure follow up (systolic/diastolic)(Yearly up to 20 years)
- Plasma lipid profile(At baseline, 3 months and 6 months)
- HbA1c follow up(Yearly up to 20 years)
- Body weight follow up(Yearly up to 20 years)
- Waist circumference(Baseline, 3 months and 6 months)
研究者
Julia Otten
MD, PhD
Umeå University