ISRCTN73786674
Active, not recruiting
未知
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 sites100 target enrollmentJanuary 4, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Remission in patients with type 2 diabetes
- Sponsor
- Habitual Health Ltd
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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