Technological devices utilization and its effect on psychological health status and glycemic control in emerging adults with type 1 diabetes: a 3-years prospective study

Aims: Various studies have investigated the relationship between depressive symptoms, diabetes distress, low adherence and glycemic control in adolescents with type 1 diabetes. Less is known about the impact of technological devices on diabetes management in young adults and its relationship with psychological well-being. The aim of the study is to investigate psychological health status and glycemic control during a three years period in a population of emerging adults (18-25 years) with type 1 diabetes. The relationship between technology utilization and psychological health status and glycemic control will be then investigated. Design: This is an observational, prospective (3 years) and multi-centric national study. Experimental sites: University of Padova, University of Bologna and University of Verona. Methods: Participant recruitment will be face to face or online. We aim to recruit at least 200 participants. Emerging adults will be recruited in Diabetology Units or in University Faculties. The study will be advertised via social media and posters. Socio-demographic and clinical data will be asked to participants. Glycemic control will be detected with HbA1c test (mmol/mol). Psychological health status will be assessed with generic and diabetes specific self-administered questionnaires, evaluating: depressive symptoms (PHQ-9), anxiety (GAD-7), adult attachment style (ECRR), sleep quality (PSQI), diabetes distress (PAID), self-efficacy in diabetes management (IT-DMSES), fear of hypoglicaemia (HFS-II), and treatment satisfaction (DTSQ). In patients using Continuous Subcutaneous Insulin Infusion (CSII), beneficial and barriers related to technology utilization will be investigated using the Insulin Pump Attitudes questionnaire (IPA) recently developed in Germany. The questionnaire will be firstly translated and adapted from German to Italian and, then, administered with the other questionnaires. With their permission, participants will be contacted after 12, 24 and 36 months to repeat the evaluation with the questionnaires previously used. Planned analysis: Primary endpoint: Descriptive statistics will examine participants’ clinical characteristics at baseline. To analyze the trend of glycemic control and psychological health status over time (T0=baseline, T1=12 months, T2=24 months and T3=36 months), repeated measures mixed models will be used. These models are suitable in the presence of missing data. The effects that will be investigated in these analyses are: the mean effect of technological devices utilization (yes vs. no); the time trend of scores regardless of the technological devices utilization; and the time trend in each group. Secondary endpoint: Psychometric testing included construct validity (principal component analysis), internal consistency (Cronbach’s α coefficient) and convergent/discriminant validity (Spearman’s correlation coefficient) will be performed for the Italian validation of the IPA questionnaire. Expected outcomes:  IPA Questionnaire will be validated in the Italian language in a population of emerging adults with type 1 diabetes.  Prevalence data on psychological health status of emerging adults with type 1 diabetes.  Longitudinal data (3 years) on psychological health status of emerging adults with type 1 diabetes.  Longitudinal data on the relationship between the use of technological device, glycemic control, and psychological health status in emerging adults with type 1 diabetes. Problems/Questions: 1) To include only patients who use technology devices or all patients with type 1 diabetes 2) Would be appropriate to build a questionnaire ad hoc to investigate the prevalence of use of proximal technology such as apps? PSAD