Here is the design of a clinical trial:

Official Title: Comprehensive Care Protocol in New Diagnosis of Type 2 Diabetes Mellitus and Associated Comorbidities in Primary Care: Quasi-experimental Study.

Included conditions:
- Type 2 Diabetes

Study Armgroups:
- {'label': 'Intervention', 'type': 'EXPERIMENTAL', 'description': 'Group of participants with a recent DM2 debut (less than 5 months) treated according to the comprehensive care protocol in DM2 with comorbidities attended in Primary care nurse office', 'interventionNames': ['Other: Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary Care']}
- {'label': 'comparison group', 'type': 'NO_INTERVENTION', 'description': 'Participants in the study that do not receive the intervention. usual care.'}

Interventions:
- {'type': 'OTHER', 'name': 'Comprehensive care protocol in new diagnosis of Type 2 Diabetes Mellitus and associated comorbidities in Primary Care', 'description': 'This comprehensive intervention is developed in a structured way in the Primary care nurse office. 5 individual intensive visits will be carried out with a weekly or bi-weekly frequency (according to the learning process) to work for an integral care and to transmit the knowledge and skills required. The maximum time expected to receive this 5 visits is 3 months. At least one of the visits, preferably the one that deals with dietary aspects, the patient is asked to be visited with the partner, child or cohabiting person. The research team elaborated the support material with the minimum contents that every patient that begins with T2DM and other chronic pathologies should know. It allows incorporating cultural and emotional aspects. It was agreed with hospital diabetes educators and family doctors. A graphic designer gave an enticing design. A group of patients verified their utility and intelligibility. It is delivered to the person and discussed during the intensification.', 'armGroupLabels': ['Intervention']}

Primary Outcomes:
- {'measure': 'Change is being assessed in Health Related Quality of Life will be measured through the EuroQoL (EQ-5D)', 'description': 'The EQ-5D health questionnaire provides a simple descriptive profile and a single index value for health status.', 'timeFrame': 'The outcome measure will be measured before, up to 3,6 and 12 months to assess its change'}
- {'measure': 'HbA1c', 'description': 'Glycosylated hemoglobin for having a clinical response.', 'timeFrame': 'up to 12 months.'}
- {'measure': 'Change is being assessed in Weigh', 'description': 'Weigh for having a clinical response.', 'timeFrame': 'The outcome measure will be measured before, up to 3,6 and 12 months to assess its change'}

Please estimate the sample size based on the assumption: 
Significance level (alpha) of 0.05, power (beta) of 0.2, design effect of 1.2, and an estimated 10% participant loss.
Sample size
        The change in HRQoL score at 6âmonths from enrolment is the primary effectiveness endpoint. We will recruit and follow 123 participants per group for 2âyears to detect a difference of 20% in HRQoL, accepting an alfa risk of 0.05 and a beta risk of 0.2, and assuming a design effect of 1.2. Additionally, we took into account an estimated 10% participant loss and differences between the groups. The sample size was calculated based on the expected improvement of the HRQoL of the participants. It was assumed that 70% of participants who receive the intervention will improve his/her HRQoL and that only 50% of participants who receive standard care will improve. According to the diabetes incidence of 5.3/1000 patients/year reported in primary healthcare centres in Barcelona city in 2018, a sufficiently large number of patients with a new diagnosis of T2DM will be available to fulfil the sample size.25