Trial to Determine Safety And Efficacy of a Digital Low-Calorie Diet Programme (SAFE-LCD) for Insulin-treated Adults Living With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Weight loss
研究概览
简要总结
SAFE-LCD study is a randomised controlled trial aiming to develop and evaluate a safe, cost-effective, easily accessible, digital Low-Calorie Diet (LCD) programme for insulin-treated adults with Type 2 diabetes (T2D), a world-first innovation.
The study plans to enrol 72 participants who will be randomly allocated to either receive the intervention or will be provided with weight loss advice suitable for insulin-treated patients through accessing the NHS 12-week weight loss plan. The intervention arm will follow Oviva Diabetes Remission Insulin (ODR-I) programme which includes expert dietitian coaching, support of a Diabetes Nurse, the Oviva app (with a 12-month weight prediction chart), a Capilar Blood Glucose (CBG) meters (for enhanced safety in view of concerns re hypo- and hyper-glycaemia), and BodyTrace weight scales.
If successful, this project will provide game-changing evidence for the support of insulin-treated T2D patients and for NHS commissioning of the digital Low-Calorie programme driving patient benefits and cost-savings.
详细描述
Insulin treatment in Type 2 diabetes (T2D) patients is linked to poorer quality of life and and increased risk of complications due to disease progression.
This research study will be a randomised control trial (RCT) which is the highest quality form of medical evidence. It aims to develop and evaluate a safe, efficacious, cost-effective, easily accessible, digital Low-Calorie Diet (LCD) programme for insulin-treated adults with Type 2 diabetes (T2D), a world-first innovation.
The study plans to enrol 72 participants who will be randomly allocated to either receive the intervention or will be provided with weight loss advice through accessing the NHS 12-week weight loss plan.
The intervention will involve a 12-week Total Diet Replacement (TDR) diet of approximately 850 calories per day through four TDR products daily, followed by a 6-week food reintroduction period and weight maintenance support for 8 months. Care will be delivered fully remotely by Oviva's Diabetes Specialist Dietitians and Diabetes Specialist Nurse. Treatment aims are to achieve weight loss, improve diabetes control quality of life and decrease or in some cases discontinue insulin treatment.
The evaluation of ODR-I with independent clinical and health-economic evaluations will be undertaken by University College London and Insight Health Improvement and will be published in respected academic journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
Due to the nature of the intervention, participants will not be blinded, thus they will be aware of the group allocation. However, the statistician will be blinded to participant allocation.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Registered with a GP practice within the confirmed NHS site - Humber and North Yorkshire
- •Diagnosis of type 2 diabetes treated with insulin
- •Age 18-70 years inclusive
- •BMI ≥30kg/m² (adjusted to ≥27 kg/m² in ethnic minority groups)
- •Upper body weight limit of 180kg (if using BodyTrace scales)
- •Ability to speak, read and receive care in English language
- •Access to the internet and a personal email address
- •Access to and ability to use a smartphone
- •Willing to test blood glucose up to 7 times a day (for up to 4 months) to ensure clinical safety.
- •Participants capable to provide written informed consent and willing to comply with the trial protocol
排除标准
- •C-peptide <200 pmol/L AND positive Glutamic Acid Decarboxylase(GAD) antibodies assessing for misdiagnosed Type 1 diabetes and risk of diabetic ketoacidosis.
- •Type 1 diabetes mellitus, Mitochondrial diabetes, Maturity-Onset Diabetes of the Young (MODY) diabetes or diagnostic uncertainty (e.g. dual codes on patient record) Type 2 diabetes with history of diabetic ketoacidosis (DKA) or ketosis prone
- •Clinically assessed hypoglycemia unawareness (via GOLD score (11, 12))
- •Concomitant medication use clinically deemed to affect metabolic rate and body weight
- •A major cardiovascular event within 6 months
- •Severe angina, uncontrolled arrhythmia or known prolonged QT syndrome
- •Warfarin or Rivaroxoban therapy
- •Estimated glomerular filtration rate (eGFR) of less than 30 mL/min/1.73m²
- •A condition precipitating fluid overload (e.g. New York Heart Association class III-IV congestive heart failure)
- •Active liver disease (except non-alcoholic fatty liver disease (NAFLD)
- •Active gallstone disease or known presence of gallstones
- •Active cancer, receiving cancer treatment or received cancer treatment within past 24 months
- •Known proliferative retinopathy that has not been treated
- •Uncontrolled epilepsy
- •Uncontrolled thyroid dysfunction
- •Active or suspected peptic ulcer disease
- •History of bariatric surgery (previous band/balloon allowed if removed<12 months)
- •Clinically diagnosed with an active eating disorder
- •Clinically significant diagnosed/self-reported psychiatric disease that may interfere with study compliance
- •Known or suspected alcohol or recreational drug misuse
- •Milk allergy (Nualtra, TDR allergens)
- •Soya allergy (Nualtra, TDR allergens)
- •Vegan (Nualtra, animal derived Vit D)
- •Pregnancy or planning pregnancy within study period
- •Lactating
- •Currently on a weight management programme or had in last 3 months or had over 5% weight loss in previous 6 months
- •Current participation in other clinical intervention trials
研究组 & 干预措施
Intervention (Oviva ODR-I programme)
The intervention arm will follow Oviva ODR-I programe: a 12-week TDR of approximately 850 calories per day through four TDR products daily, supported by the digital scales, CBG meters and link to the OVIVA app.
干预措施: Oviva programme (Other)
Control (NHS 12 weeks programme)
The control group will follow usual care, which will be the NHS 12-week digital weight-loss programme
干预措施: Usual care (Other)
结局指标
主要结局
Weight loss
时间窗: at 12 months
absolute: kg weight loss
次要结局
- The number of participants reducing or ceasing blood pressure medications(at month 3, 6, 12 and 24)
- Weight loss(at 3, 6 and 24 months)
- Diabetes-related emotional distress (DDS17)(at month 6, 12 and 24)
- The number of participants reducing or ceasing insulin(at month 3, 6, 12 and 24)
- The number of participants reducing or ceasing cholesterol medications(at month 3, 6, 12 and 24)
- Diabetes remission rate(at months 3, 6, 12 and 24)
- The number of participants reducing or ceasing other diabetes medications(at month 3, 6, 12 and 24)
- Hba1c (mmol/l) changes(at month 3, 6, 12 and 24)
- Fasting and 2 hour postprandial/random glucose (mmol/L)(1 year, throughout the study)
- Cardiovascular disease risk score (QRisk)(at months 12 and 24)
- Diabetes Stigma Assessment Scale Type 2 (DSAS-2)(at months 6, 12, and 24)
- EuroQol 5 Dimension 5 Level (EQ-5D)(at month 6, 12 and 24)