Alharbi, Muneera
(2024)
Using a capillary ketone monitor as part of a self-management programme to prevent diabetic
ketoacidosis among adults in Saudi Arabia: a feasibility randomised controlled trial.
PhD thesis, University of Nottingham.
Abstract
Background: Diabetic ketoacidosis (DKA) remains a life-threatening complication arising after prolonged hyperglycaemic episodes, with possible fatal consequences. Despite the improvement in the management of DKA in hospital settings, DKA contributes to 54%–76% of deaths among all T1DM-related deaths for patients aged less than 30 years old. Around one-fifth of deaths occurred at home or on arrival at the hospital. The routine self-monitoring of blood glucose and ketone bodies play a significant role in the early detection and management of DKA. Thus, allowing patients with T1DM to self-manage their diabetes and associated ketonaemia prevents the development of DKA and any related complications. However, the Kingdom of Saudi Arabia (KSA) has no guidelines for the self-monitoring and management of ketone body elevation among patients with diabetes mellitus (DM).
Aim: The primary objective of the study is to explore the feasibility and acceptability of conducting full-scale trial using a self-management programme (SMP) intervention to prevent the occurrence of DKA among individuals with T1DM in the KSA. The secondary objective is to determine the potential changes in outcome measures that will be assessed to evaluate the effectiveness of an SMP in a future randomised controlled trial (RCT).
Method: This study conducted a feasibility RCT with an embedded mixed-method process of evaluation. Eighty adult patients with Type 1 diabetes mellitus (T1DM) were recruited from the Diabetes and Endocrine Centre (DEC) in Buraydah, KSA. These participants were randomised to an intervention group (receiving SMP plus usual care; n=40) or a control group (receiving usual care; n=40). The SMP included the monitoring and management of ketonaemia associated with diabetes. The participants were followed up for three months to assess the feasibility and acceptability of the SMP.
The primary outcomes were predefined progression criteria assessing acceptability and feasibility of the intervention and a proposed full-scale trial of the SMP intervention for adults with T1DM in Saudi Arabia. These outcomes included the recruitment rate, attrition rate, acceptability of randomisation, feasibility of outcome measures, intervention adherence and acceptability of intervention. The secondary outcomes involved an exploratory analysis of DKA-related measures, including the frequency and severity of DKA occurrences, number of hospitalisations and emergency department visits.
The quantitative data was collected monthly from the two groups using structured questionnaires. Descriptive and inferential statistics were used to analyse the quantitative data, using SPSS. A subsample of the intervention participants was interviewed on completion of the study using semi-structured interviews. The qualitative data was thematically analysed using MAXQDA software.
Results: Eight of the eligible participants, with an average age of 21 years (IQR: 26-19 years), were recruited for the study resulting in a participation rate of 94.5%. The participant’s randomisation was acceptable, with 88% reported acceptability of the randomisation process. Seven participants withdrew from the study, resulting in a retention rate of 91.25%. The adherence rate to the SMP was 91.5% and no adverse events were observed as result of using SMP. In total, 86% of participants reported the intervention was easy to use and 81% would use the SMP in the future. In addition, 100% of the questionnaires were completed with no missing data. The findings from the quantitative data indicated the feasibility of the primary outcomes. Six out of seven progression criteria were meet (retention rate, acceptability of randomisation, adherence rate, acceptability of outcomes measures and outcomes measure completion rate) while the recruitment rate was met with some modification. Participants in the intervention group improved in their secondary outcome measures after the SMP intervention. Thematic analysis of the interview data from the 14 participants revealed four themes relating to the necessary features required of the SMP intervention to enable its successful use among adults with T1DM. The themes indicated the barriers to the intervention delivery and engagement included diabetes distress and feeling embarrassed about using the SMP in outside the home.
Conclusion: Using an SMP to prevent the development of DKA in adults with T1DM in Saudi Arabia is feasible and acceptable. The key criteria for progressing to full-scale study were met. However, the SMP and research process used in this study require some modification prior to proceeding to a full-scale trial.
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