Patient-reported outcomes following islet cell or pancreas transplantation (alone or after kidney) in type 1 diabetes: a systematic review

Aims For selected individuals with complex Type 1 diabetes, pancreatic islet transplantation (IT) offers the potential of excellent glycaemic controlwithout significant hypoglycaemia, balanced by the need for ongoing systemic immunosuppression. Increasingly, patient-reported outcomes (PROs) are considered alongside biomedical outcomes as a measure of transplant success. PROs in IT have not previously been compared directlywith the closest alternate treatment option, pancreas transplant alone (PTA) or pancreas after kidney (PAK).

Methods We used a Population, Intervention, Comparisons, Outcomes (PICO) strategy to search Scopus and screened 314 references for inclusion.

Results Twelve studies [including PRO assessment of PAK, PTA, islet-after kidney (IAK) and islet transplant alone (ITA); n = 7–205] used a total of nine specified and two unspecified PRO measures. Results were mixed but identified some benefits which remained apparent up to 36 months post-transplant, including improvements in fear of hypoglycaemia, as well as some aspects of diabetes-specific quality of life (QoL) and general health status. Negative outcomes included short-term pain associated with the procedure, immunosuppressant side effects and depressed mood associated with loss of graft function.

Conclusions The mixed resultsmay be attributable to limited sample sizes. Also, some PROmeasures may lack sensitivity to detect actual changes, as they exclude issues and domains of life likely to be important forQoL post-transplantation and when patients may no longer perceive themselves to have diabetes. Thus, the full impact of islet ⁄ pancreas transplantation (alone or after kidney) on QoL is unknown. Furthermore, no studies have assessed patient satisfaction, which may highlight further advantages and disadvantages of transplantation.

The impact of hypoglycaemia on quality of life and related patient-reported outcomes in Type 2 diabetes : a narrative review

As a common side effect of insulin treatment for diabetes, hypoglycaemia is a constant threat and can have far-reaching and potentially devastating consequences, including immediate physical injury as well as more pervasive cognitive, behavioural and emotional effects. Moreover, as a significant limiting factor in achieving optimal glycaemic control, exposure to hypoglycaemia can influence diabetes self-management.

Although hypoglycaemia is known to occur in Type 2 diabetes, its morbidity and impact on the individual are not well recognized. The aim of the current review is to examine published evidence to achieve a synthesis of the scope and significance of the potential detriment caused by hypoglycaemia to individuals with Type 2 diabetes. The implications of these observations for treatment and research have also been considered.

A narrative review was performed of empirical papers published in English since 1966, reporting the effect of hypoglycaemia on quality of life and related outcomes (including generic and diabetes specificquality of life, emotional well-being and health utilities) in Type 2 diabetes.

Research demonstrates the potential impact of hypoglycaemia on the lives of people with Type 2 diabetes, from an association with depressive symptoms and heightened anxiety, to impairment of the ability to drive, work and function in ways that are important for quality of life. Few studies consider hypoglycaemia as an explanatory variable in combination with quality of life or related primary endpoints. As a consequence, there is a pressing need for high-quality research into the overall impact of hypoglycaemia on the lives of people with Type 2 diabetes.

Predicting outcomes in the Dose Adjustment For Normal Eating (DAFNE) trial

Background: In the UK, DAFNE training in flexible intensive insulin therapy significantly reduced the negative impact of diabetes on quality of life (QoL) and improved blood glucose (BG) control without significantly increasing severe hypoglycaemia or body mass index (BMI). Analyses were conducted to predict who would benefit most from the generally highly successful DAFNE training and who might experience undesirable effects (e.g. weight gain).

Methods: Multiple regression was used to predict change in outcomes (6-months post-DAFNE) using baseline data: demographic, biomedical, ADDQoL (measure of the impact of diabetes on QoL), extended DTSQ (Diabetes Treatment Satisfaction Questionnaire), and other psychological measures including diabetes-specific well-being and locus of control.

Findings: Greatest improvement in ADDQoL scores was achieved by those reporting less dietary freedom and less treatment satisfaction at baseline (R2=0.21). BG improvement was predicted by higher baseline BG, lower perceived frequency of hypoglycaemia, greater expectations of DAFNE, and greater BMI (R2=0.30). Increase in BMI was predicted by less dietary freedom, DAFNE training centre, and less ‘satisfaction with insulin’ at baseline (R2=0.23).

Conclusions/Discussion: DAFNE has important benefits to offer. Lifting dietary restrictions had substantial benefits for QoL. BG improvement was predicted by baseline BG but also by expectations (perhaps reflecting greater optimism or determination). Prediction of weight gain was more complex. The influence of training centre will have involved implicit messages conveyed by Educators before and during DAFNE. While DAFNE was successful overall, outcomes are likely to be maximised for individuals if their expectations and personal goals are considered by DAFNE Educators.