Text message-based intervention, Keeping in Touch (KiT), to support youth as they transition to adult type 1 diabetes care: a protocol for a multisite randomised controlled superiority trial.

INTRODUCTION: Transition from paediatric to adult care can be challenging for youth living with type 1 diabetes (T1D), as many youth feel unprepared to transfer to adult care and are at high risk for deterioration of glycaemic management and acute complications. Existing strategies to improve transition experience and outcomes are limited by cost, scalability, generalisability and youth engagement. Text messaging is an acceptable, accessible and cost-effective way of engaging youth. Together with adolescents and emerging adults and paediatric and adult T1D providers, we co-designed a text message-based intervention, Keeping in Touch (KiT), to deliver tailored transition support. Our primary objective is to test the effectiveness of KiT on diabetes self-efficacy in a randomised controlled trial. METHODS AND ANALYSIS: We will randomise 183 adolescents with T1D aged 17-18 years within 4 months of their final paediatric diabetes visit to the intervention or usual care. KiT will deliver tailored T1D transition support via text messages over 12 months based on a transition readiness assessment. The primary outcome, self-efficacy for diabetes self-management, will be measured 12 months after enrolment. Secondary outcomes, measured at 6 and 12 months, include transition readiness, perceived T1D-related stigma, time between final paediatric and first adult diabetes visits, haemoglobin A1c, and other glycaemia measures (for continuous glucose monitor users), diabetes-related hospitalisations and emergency department visits and the cost of implementing the intervention. The analysis will be intention-to-treat comparing diabetes self-efficacy at 12 months between groups. A process evaluation will be conducted to identify elements of the intervention and individual-level factors influencing implementation and outcomes. ETHICS AND DISSEMINATION: The study protocol version 7 July 2022 and accompanying documents were approved by Clinical Trials Ontario (Project ID: 3986) and the McGill University Health Centre (MP-37-2023-8823). Study findings will be presented at scientific conferences and in peer-reviewed publications. TRIAL REGISTRATION NUMBER: NCT05434754.

Testing an audit and feedback-based intervention to improve glycemic control after transfer to adult diabetes care: protocol for a quasi-experimental pre-post design with a control group.

BACKGROUND: When young adults transfer from pediatric to adult diabetes care they are at risk for deterioration of glycemic control, putting them at an increased risk of developing both acute and chronic complications. Despite increased awareness of these risks, there are gaps in care delivery during this vulnerable time and variability in the implementation of recommended transition practice. Audit and feedback (AF) interventions have a positive but variable effect on implementation of best practices. An expert group identified specific suggestions for optimizing the effectiveness of AF interventions. We aim to test an AF-based intervention incorporating these specific suggestions to improve transition practices and glycemic control in the first year after transfer from pediatric to adult diabetes care. METHODS: This is a pragmatic quasi-experimental study; a series of three cohort studies (pre-implementation, early-implementation, and post-implementation) to compare the baseline adjusted hemoglobin A1c (HbA1c) in the 12 months after the final pediatric visit in five pediatric diabetes centres within the Ontario Pediatric Diabetes Network in Ontario, Canada. The intervention includes three components: 1) centre-level feedback reports compiling data from chart abstraction, linked provincial administrative datasets, and patient-reported experience measures; 2) webinars for facilitated conversations/coaching about the feedback; and 3) online repository of curated transition resources for providers. The primary outcome will be analyzed using a multivariable linear regression model. We will conduct a qualitative process evaluation to understand intervention fidelity and to provide insight into the mechanisms of action of our results. DISCUSSION: There is a need to develop an innovative system-level approach to improve outcomes and the quality of care for young adults with type 1 diabetes during the vulnerable time when they transfer to adult care. Our research team, a collaboration of health services, implementation science, and quality improvement researchers, are designing, implementing, and evaluating an AF-based intervention using recommendations about how to optimize effectiveness. This knowledge will be generalizable to other care networks that aim to deliver uniformly high-quality care in diverse care settings. TRIAL REGISTRATION: ClinicalTrials.gov NCT03781973. Registered 13 December 2018. Date of enrolment of the first participant to the trial: June 1, 2019.

Experience with the Enlite sensor in a multicenter pediatric study.

PURPOSE: The purpose of this article is to outline the experience of certified diabetes educators (CDEs) using the Enlite continuous glucose monitoring sensor system in a pediatric multicenter randomized controlled trial. Continuous glucose monitoring (CGM) is becoming popular as a tool for educators and families to improve glycemic control. CGM can be a valuable educational tool to demonstrate to the user the impact of insulin dosing and effects of physical activity, food intake, and other life events such as work, illness, and stress on their glycemic control. The authors will share education tips and practical applications for diabetes educators to facilitate education and sustained use of Enlite glucose sensors in children and adolescents using insulin pump therapy. CONCLUSIONS: The Enlite glucose sensor is a comfortable and user-friendly device. Improvements to both the insertion device and the Enlite glucose sensor have resulted in improved level of comfort on insertion and with ongoing wear, which may translate into greater adherence and effectiveness.