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$\textbf{Introduction:}$ Despite therapeutic advances, many individuals with type 1 diabetes are unable to achieve tight glycaemic target without increasing the risk of hypoglycaemia. The objective of this study is to determine the effectiveness of a 3-month day-and-night home closed-loop glucose control combined with a pump suspend feature, compared with sensor-augmented insulin pump therapy in youths and adults with suboptimally controlled type 1 diabetes. $\textbf{Methods and analysis:}$ The study adopts an open-label, multi-centre, multi-national (UK and USA), randomised, single-period, parallel design and aims for 84 randomised patients. Participants are youths (6-21 years) or adults (>21 years) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control (glycated haemoglobin (HbA1c) ≥7.5% (58 mmol/mol) and ≤10% (86 mmol/mol)). Following a 4-week run-in period, eligible participants will be randomised to a 3-month use of automated closed-loop insulin delivery combined with pump suspend feature or to sensor-augmented insulin pump therapy. Analyses will be conducted on an intention-to-treat basis. The primary outcome is the time spent in the target glucose range from 3.9 to 10.0 mmol/L based on continuous glucose monitoring levels during the 3-month free-living phase. Secondary outcomes include HbA1c at 3 months, mean glucose, time spent below and above target; time with glucose levels 16.7 mmol/L, glucose variability; total, basal and bolus insulin dose and change in body weight. Participants' and their families' perception in terms of lifestyle change, daily diabetes management and fear of hypoglycaemia will be evaluated. $\textbf{Ethics and dissemination:}$ Ethics/institutional review board approval has been obtained. Before screening, all participants/guardians will be provided with oral and written information about the trial. The study will be disseminated by peer-reviewed publications and conference presentations. $\textbf{Trial registration number:}$ NCT02523131; Pre-results.

The purpose of this multicenter longitudinal randomized controlled trial was to examine the efficacy of self-administered stress management training (SSMT) in improving quality of life and reducing psychological distress among patients receiving cancer chemotherapy. Participants were randomized to SSMT (n = 111) or usual psychosocial care only (n = 109). Mixed linear modeling demonstrated no significant improvements in primary outcome measures; however, participants assigned to SSMT reported using significantly more relaxation techniques (p < 0.0001), showed improvements on emotional adjustment scores, and demonstrated a stabilizing effect on the functional adjustment scores. Findings highlight the usefulness of SSMT in community clinical settings.

The H. Lee Moffitt Cancer Center & Research Institute serves as a Research Base for its cancer center affiliates and for the NCI-funded Community Clinical Oncology Programs (CCOPs). Through this program, community physicians can participate in NCI-supported cancer control clinical trials. These trials test new approaches towards the prevention and detection of cancer and its outcomes. A database-driven secure web site has been developed to facilitate communications between the Moffitt CCOP Research Base and members. The specific subsystem of the secure web site being described on this poster is an automated mechanism for managing the complex life cycle of a research protocol. This database-driven web-delivered solution is particularly important in the context of the Moffitt CCOP Research Base, which manages a number of research protocols in various stages of development and execution.

INTRODUCTION Despite therapeutic advances, many individuals with type 1 diabetes are unable to achieve tight glycaemic target without increasing the risk of hypoglycaemia. The objective of this study is to determine the effectiveness of a 3-month day-and-night home closed-loop glucose control combined with a pump suspend feature, compared with sensor-augmented insulin pump therapy in youths and adults with suboptimally controlled type 1 diabetes. METHODS AND ANALYSIS The study adopts an open-label, multi-centre, multi-national (UK and USA), randomised, single-period, parallel design and aims for 84 randomised patients. Participants are youths (6-21 years) or adults (>21 years) with type 1 diabetes treated with insulin pump therapy and suboptimal glycaemic control (glycated haemoglobin (HbA1c) ≥7.5% (58 mmol/mol) and ≤10% (86 mmol/mol)). Following a 4-week run-in period, eligible participants will be randomised to a 3-month use of automated closed-loop insulin delivery combined with pump suspend feature or to sensor-augmented insulin pump therapy. Analyses will be conducted on an intention-to-treat basis. The primary outcome is the time spent in the target glucose range from 3.9 to 10.0 mmol/L based on continuous glucose monitoring levels during the 3-month free-living phase. Secondary outcomes include HbA1c at 3 months, mean glucose, time spent below and above target; time with glucose levels 16.7 mmol/L, glucose variability; total, basal and bolus insulin dose and change in body weight. Participants' and their families' perception in terms of lifestyle change, daily diabetes management and fear of hypoglycaemia will be evaluated. ETHICS AND DISSEMINATION Ethics/institutional review board approval has been obtained. Before screening, all participants/guardians will be provided with oral and written information about the trial. The study will be disseminated by peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER NCT02523131; Pre-results.