NCT05483140已完成不适用
Assessing The Effectiveness of A Digitally Enabled Low Energy Diet on Type 2 Diabetes Management
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 217
- 试验地点
- 4
- 主要终点
- Program Feasibility
研究概览
简要总结
The study (known as clinical audit in UK) will observe and report on a digitally-enabled structured weight management program including use of a meal replacement on clinical and economic outcomes for community-dwelling adults living with type 2 diabetes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •Have a clinical diagnosis of T2DM within the last 6 years
- •Aged 20 - 70 years
- •Have a BMI ≥ 27 kg/m2
- •HbA1c ≥ 48 mmol/mol (≥ 42mmol/mol if prescribed glucose-lowering agents)
- •Have access to the internet and a computer, smartphone or tablet
- •Ability to read and understand English
- •Willing to provide individual consent
排除标准
- •Current insulin use
- •More than two anti-hyperglycemic agents prescribed
- •Recent routine HbA1c ≥ 90 mmol/mol
- •Diagnosed with moderate or severe frailty
- •Diagnosed eating disorder or purging
- •Unable or unwilling to tolerate soy/milk-based meal replacements
- •Myocardial infarction within last 6 months
- •Recent eGFR <30 ml/min/1.73 m2
- •Prescribed SGLT2 inhibitor for diabetic kidney disease (DKD) or left ventricular hypertrophy (LVH)
- •Severe heart failure defined as equivalent to the New York Heart Association grade 3 (NYHA)
- •Current treatment with anti-obesity drugs
- •Learning difficulties that would prevent engagement with the program
- •Having required hospitalization for depression or being prescribed antipsychotic drugs
- •Known cancer
- •Active substance misuse
- •Contraindications to exercise
- •Contraindications to lose weight
- •Mental or physical incapacity that makes self-management inappropriate
- •Pregnant, planning a pregnancy or lactating
- •Currently undergoing palliative care
- •Previous bariatric surgery or on waiting list for bariatric surgery (unless willing to come off waiting list)
- •Unable to commit to long term lifestyle change
- •Known proliferative retinopathy that has not been treated
结局指标
主要结局
Program Feasibility
时间窗: Baseline to 12 Months
Participant and HCP completed program questionnaire scored from 0 to 10 where higher score is more favorable
Program Effectiveness
时间窗: Baseline to 12 Months
Mean Weight Change
次要结局
- Glycemic Control(Baseline to 12 Months)
- Diabetes Distress(Baseline to 12 Months)
- Medication Usage use(Baseline to 12 Months)
研究者
研究点 (4)
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