Psychometric and biomedical outcomes of glycated haemoglobin target-setting in adults with type 1 and type 2 diabetes: A mixed-methods parallel-group randomised feasibility study
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Background
Glycated haemoglobin (HbA 1c ) targets are commonly used to guide patient management in diabetes to reduce future risk of diabetes complications, but little is known of the psychological impact of HbA 1c target-setting. We explored the feasibility of undertaking a conclusive study evaluating the impact of setting explicit HbA 1c targets in adults with diabetes.
Methods
A randomised, mixed-methods study design was used to quantitatively and qualitatively evaluate the psychometric and biomedical impact of intensified or relaxed glycaemic targets in adults with diabetes. Alongside baseline measurement of HbA 1c , blood pressure and body mass index, patients completed baseline validated psychometric questionnaires (EuroQoL-5D-5L, Problem Areas In Diabetes, Summary of Diabetes Self-Care Activities, Well-Being Quetionnaire-12, Diabetes Empowerment Scale-Long Form) and were randomised 1:1. Participants in group A received explicit HbA 1c target intervention targets 5 mmol/mol above current HbA 1c . Participants in group B received explicit HbA 1c targets 5 mmol/mol below current HbA 1c . Rates of eligibility, recruitment, retention and questionnaire response were recorded. Outcomes were re-measured 3-months post-intervention. Patients and healthcare professionals attended semi-structured interviews for qualitative evaluation.
Results
Fifty participants were recruited. Withdrawal rate was 34% (n=17). Endpoint evaluation revealed no significant between-group differences in patient-reported outcome measures or HbA 1c levels. Overall, levels of distress (-4.4, p=.009), self-efficacy (.25 [.09–.41], p=.004) and subsequent HbA 1c readings (-2.8 [-5.0–-.7], p=.012) improved, with non-significant changes seen in health-related quality of life, wellbeing, and self-care. Patients and healthcare professional interviews demonstrated study acceptability alongside specific motivators (e.g., target achievability, hypoglycaemia avoidance) and demotivators (e.g., lack of understanding, lack of target achievability) for striving to reach glycaemic targets. Combined qualitative data from patient and healthcare professional interviews and quantitative study aspects triangulated, enhancing data trustworthiness, and informing future hypotheses and methodologies.
Discussion
This mixed-methods study demonstrates feasibility and provides a novel insight into the psychological implications of HbA 1c target-setting.
Trial registration
The study is registered with the ISRCTN (registration number: 12461724 ; date registered: 11 th June 2021).
