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.

Habitual Health Ltd0 个研究点目标入组 100 人开始时间: 2023年1月4日最近更新: 2024年7月8日

适应症

试验速览

暂无简介。

•1. Able and willing to give consent for the study prior to participation
•2. Be aged 18 - 75 years, with type 2 diabetes mellitus of duration <6 years
•3. Have access to a smartphone or a computer
•4. Have a Body Mass Index (BMI) of at least 28 kg/m²
•5. A HbA1c test >48 mmol/mol (6.5%) and =86 mmol/mol (10%), within the previous 12 months

•1. Are currently using insulin
•2. Weight change of >5% in the past 3 months
•3. Have a history or are known to be suffering with alcohol/substance abuse
•4. Have cancer or currently under investigation for cancer
•5. Have had a myocardial infarction within the previous 6 months
•6. Have severe or unstable heart failure e.g. NYHA grade IV
•7. Have porphyria
•8. Have learning difficulties
•9. Are currently on treatment with anti-obesity drugs
•10. Have had bariatric surgery
•11. Have been diagnosed with eating disorder or purging
•12. Are pregnant or less than 4 months postpartum or considering pregnancy in the next 2 years
•13. Are currently breastfeeding
•14. Have required hospitalisation for depression or taking antipsychotic drug
•15. Have a history of illnesses that could interfere with the interpretation of the study results(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)
•16. Currently taking Glucagon-like peptide-1 receptor agonists (GLP-1 RAs)
•17. Have pancreatitis
•18. Currently taking part in a CTIMP trial for antidiabetic medication
•19. Abnormal diabetic foot review (QOF codes for diabetic foot at moderate risk, at high risk, at increased risk, ulcerated).

发起方

Habitual Health Ltd