Here is the design of a clinical trial:

Official Title: A Randomised Feasibility Trial of an Intermittent Low Energy Diet (ILED) and Continuous Low Energy Diet (CLED) in Patients With Type 1 Diabetes and Obesity

Included conditions:
- Type 1 Diabetes
- Obesity

Study Armgroups:
- {'label': 'Intermittent Low Energy Diet (ILED)', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Dietary Supplement: Optifast meal replacement shakes']}
- {'label': 'Continuous Low Energy Diet (CLED)', 'type': 'ACTIVE_COMPARATOR', 'interventionNames': ['Dietary Supplement: Optifast meal replacement shakes']}

Interventions:
- {'type': 'DIETARY_SUPPLEMENT', 'name': 'Optifast meal replacement shakes', 'description': 'Optifast® is provided as 53g sachet. Each sachet replaces one meal. It is available in 5 flavours: vanilla, strawberry, chocolate and coffee shakes and vegetable soup.', 'armGroupLabels': ['Continuous Low Energy Diet (CLED)', 'Intermittent Low Energy Diet (ILED)']}

Primary Outcomes:
- {'measure': 'Number of episodes of severe hypoglycaemia i.e. capillary blood glucose < 3.0 mmol/l or requiring 3rd party assistance or any episodes of nocturnal hypoglycaemia <3.0 mmol/l.', 'timeFrame': '14 week duration of study'}
- {'measure': 'Time spent in target (3.9-10mmol/l), below target (<3.9mmol/l and <3.0mmol/l) and above target (>10 mmol/l) on the Freestyle Libre® flash glucose monitoring system over 12 weeks.', 'timeFrame': '14 week duration of study'}
- {'measure': 'Number of episodes of Diabetic Ketoacidosis (DKA) and blood ketone β-hydroxybutyrate levels above 1.0mmol/l.', 'timeFrame': '14 week duration of study'}
- {'measure': 'Occurrence of Serious Adverse Events (SAEs) deemed potentially related to the dietary programmes.', 'timeFrame': '14 week duration of study'}

Please estimate the sample size based on the assumption: 
This study will not undertake significance tests. Descriptive, graphical and/or basic inferential statistics of endpoints will be presented. Levels of missing data will be investigated and used to inform future studies. No imputation will be used. There will be no interim analysis or stopping guidelines.
Sample size and statistical analysis
        The target sample size is 12 participants. This was chosen pragmatically to obtain sufficient data on the safety and feasibility of an ILED and CLED in people with T1D and overweight and obesity, while balancing cost and time. With this sample size there is a high probability of seeing at least one episode of severe hypoglycaemia or DKA.
        This study will not undertake significance tests. Descriptive, graphical and/or basic inferential statistics of endpoints will be presented, for example, frequencies and percentages, mean and SD or median and quartiles, as appropriate. Levels of missing data will be investigated and used to inform future studies. No imputation will be used. There will be no interim analysis or stopping guidelines. A full statistical analysis plan will be prepared prior to data analysis.