Protocol for a feasibility study and process evaluation of a psychosocially modelled diabetes education programme for young people with type 1 diabetes: the Youth Empowerment Skills (YES) programme.

INTRODUCTION: Adolescence is a challenging period for young people with type 1 diabetes, associated with worsening glycaemia and care disengagement. Educational interventions in this period tend to focus on diabetes-specific skills, with less emphasis on the psychosocial challenges associated with diabetes experienced by young people. To address this limitation, we codesigned with young people a psychosocially modelled programme of diabetes education, named 'Youth Empowerment Skills' (YES). The programme aims to facilitate a positive adaptation to life with diabetes and engagement with diabetes care through peer-based learning, immersive simulations and support from an outreach youth worker. Here, we present a protocol for a feasibility study of the YES programme. METHODS AND ANALYSIS: The study was designed following the Medical Research Council Complex Intervention Evaluation Framework to: test the feasibility (acceptance, implementability, recruitment and completion) of the YES programme; and estimate its efficacy in relation to metabolic and psychosocial outcomes. The study will take place in diabetes centres serving socioculturally diverse populations. We will conduct a feasibility randomised controlled trial (waiting-list design) with integrated process evaluation. Fifty young people with type 1 diabetes (aged 14-19 years) will be randomly allocated to either the YES intervention or a waiting-list control. Randomisation acceptability will be assessed with provision for a preference allocation. Outcomes will be evaluated at 6 months, at which point the waiting list participants will be exposed to the YES programme with further follow-up to 12 months. A simultaneous process evaluation will use a mixed-methods approach collecting qualitative and quantitative data. Study findings will be used to optimise the intervention components, outcome measures and recruitment methods to inform a subsequent definitive trial. ETHICS AND DISSEMINATION: The protocol has ethical approval from the UK Health Research Authority (approval IRAS project ID: 279877). Findings will be disseminated in multiple formats for lay and professional audiences. PROTOCOL DATE AND VERSION: 7 April 2021, V.1.1. TRIAL REGISTRATION NUMBER: NCT04670198.

Nonmetabolic complications of continuous subcutaneous insulin infusion: a patient survey.

BACKGROUND: Little is known about the frequencies and types of nonmetabolic complications occurring in type 1 diabetes patients being treated by modern insulin pump therapy (continuous subcutaneous insulin infusion [CSII]), when recorded by standardized questionnaire rather than clinical experience. SUBJECTS AND METHODS: A self-report questionnaire was completed by successive subjects with type 1 diabetes attending an insulin pump clinic, and those with a duration of CSII of ≥6 months were selected for analysis (n=92). Questions included pump manufacturer, insulin, infusion set type and duration of use, frequency of infusion set and site problems, pump malfunctions, and patient-related problems such as weight change since starting CSII. RESULTS: Median (range) duration of CSII was 3.3 (0.5-32.0) years, and mean ± SD duration of infusion set use was 3.2 ± 0.7 (range 2-6) days. The commonest infusion set problems were kinking (64.1% of subjects) and blockage (54.3%). Blockage was associated with >3 days of use of infusion sets plus lispro insulin in the pump (relative risk [95% confidence interval], 1.71 [1.03-2.85]; P=0.07). The commonest infusion site problem was lipohypertrophy (26.1%), which occurred more often in those with long duration of CSII (4.8 [2.38-9.45] vs. 3.0 [1.50-4.25] years; P=0.01). Pump malfunction had occurred in 48% of subjects (43% in the first year of CSII), with "no delivery," keypad, and battery problems commonly occurring. Although some patients reported weight gain (34%) and some weight loss (15%) on CSII, most patients (51%) reported no change in weight. CONCLUSIONS: Pump, infusion set, and infusion site problems remain common with CSII, even with contemporary technology.

Determinants of glycaemic control in type 1 diabetes during intensified therapy with multiple daily insulin injections or continuous subcutaneous insulin infusion: importance of blood glucose variability.

BACKGROUND AND METHODS: We investigated the factors that determine the best glycaemic control on multiple daily insulin (MDI) injections and continuous subcutaneous insulin infusion (CSII), and the hypothesis that blood glucose variability is a major determinant of control and that the resultant HbA(1c) on MDI correlates with the improvement achieved by CSII. We studied 30 type 1 diabetic subjects already receiving MDI. Renewed attempts to improve control on MDI were made for a median of five months, and then the subjects were switched to CSII. The variability of within-day and between-day blood glucose concentrations was calculated from blood glucose self-monitoring data. RESULTS: HbA(1c) during MDI varied from 5.7 to 11.7% (mean +/- SD, 8.5 +/- 1.4%). Within- and between-day blood glucose variability correlated with HbA(1c) on MDI (r = 0.59, p < 0.001; r = 0.48, p < 0.03). Within-day variability remained an independent predictor of HbA(1c) on MDI. Mean HbA(1c) improved with CSII (to 7.3 +/- 0.9%, p < 0.001), but reduction in HbA(1c) was variable and was related to the HbA(1c) on MDI (r = 0.79, p < 0.001) and within-day variability (r = 0.56, p < 0.01). Similar results were observed for subjects treated only with glargine-based MDI. CONCLUSIONS: The best glycaemic control achievable on MDI is related to blood glucose variability-those with the largest swings in blood glucose retaining the highest HbA(1c). The improvement in control achieved by CSII is related to HbA(1c) and blood glucose variability on MDI. Pump therapy is most effective in those worst controlled on MDI.