Exploring the Use of Digital Therapeutics Alongside a Remote Intensive Lifestyle Programme on Inducing Weight Loss and Diabetes Remission in Patients With Type 2 Diabetes Versus Standard of Care (DIGEST)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Weight loss of ≥15kg
研究概览
简要总结
This is a multicentre, open-label Randomised Controlled Trial run in the United Kingdom. The main aims are to assess whether the Habitual Remission Programme (digital therapeutics + 12-week 800kcal/day low-energy diet, delivered remotely) is more likely to lead to weight loss and remission in adults with type 2 diabetes, when compared to standard of care.
详细描述
Participants will be randomly allocated to the Habitual Programme or standard care as delivered by the National Health Service (NHS). They will take a home blood test for HbA1c at baseline, 3 months and 6 months, and complete online fortnightly surveys to record their weight, waist circumference, blood pressure, side-effects and any changes in medication, for 6 months. These measurements will be taken at 6 months and 12 months after finishing the intervention for those allocated to the intervention.
Participants will be recruited from General Practitioner (GP) surgeries in England, managed by Lindus Health. Research Nurses at Lindus Health will complete screening and informed consent procedures.
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)
盲法说明
Due to the nature of the lifestyle programme, participants, clinicians and data collectors will not be able to be masked, however allocation will be concealed from the statistician in charge of performing the analysis.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able and willing to give consent for the study prior to participation
- •Be aged between 18-75 years, with type 2 Diabetes Mellitus of duration <6years.
- •Has access to a smartphone or computer
- •Has a Body Mass Index (BMI) of ≥28 kg/m2
- •HbA1C between 86 mmol/mol (10%) ≥ 48mmol/mol (6.5%), within the previous 12-months
排除标准
- •Is currently using Insulin
- •Weight of change >5% in the past 3-months
- •Has a history of are known to be suffering with alcohol/substance abuse
- •Has cancer or is knowingly under investigation for cancer
- •Has had a myocardial infarction within the previous 6-months
- •Has severe or unstable heart failure e.g., New York Heart Association (NYHA) grade IV
- •Has porphyria
- •Has learning difficulties
- •Is currently on treatment with anti-obesity drugs
- •Has had bariatric surgery
- •Has been diagnosed with an eating disorder or purging
- •Is pregnant or less than 4-months postpartum or considering pregnancy in the next 2-years
- •Is currently breastfeeding
- •Has required hospitalisation for depression or taking antipsychotic drug
- •Has a history of illnesses that could interfere with the interpretation of the study (e.g. HIV, Cushing syndrome, chronic kidney disease, chronic liver disease, hyperthyroidism, hereditary fructose intolerance, depression or antipsychotic drug use within the past 2 years)
- •Currently talking Glucagon-like peptide-1 receptor agonists (GLP-1 RAs)
- •Has pancreatitis
- •Currently taking part in a Clinical Trial of an Investigative Medicinal Product (CTIMP) trial for antidiabetic medication
- •Abnormal diabetic foot review (QOF codes for diabetic foot at moderate risk, at high risk, at increased risk, ulcerated).
结局指标
主要结局
Weight loss of ≥15kg
时间窗: 6-months
Number of participants that achieved ≥15kg
HbA1C <6.5% (48mmol/mol)
时间窗: 6-months
Number of participants who have achieved HbA1C \<6.5% (48mmol/mol) after at least 2-months of all glucose-lowering medication.
次要结局
- Weight control(3-months- 6-months)
- HbA1C <6.5% (48mmol/mol)(12-months (6-months after completing the trial).)
- Systolic blood pressure (SBP)(3-months- 6-months)
- Diastolic blood pressure (DBP)(3-months- 6-months)
- Medication use(Baseline, 3-months and 6-months)
- Weight loss ≥10kg(6-months)
- Glycaemic Control(3-months- 6-months)
- Safety of Intervention(Baseline- 6-months)