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.

Training in flexible, intensive insulin management to enable dietary freedom in people with type 1 diabetes : dose adjustment for normal eating (DAFNE) randomised controlled trial

Objectives: To evaluate whether a course teaching flexible intensive insulin treatment combining dietary freedom and insulin adjustment can improve both glycaemic control and quality of life in type 1 diabetes.

Design: Randomised design with participants either attending training immediately (immediate DAFNE) or acting as waiting list controls and attending “delayed DAFNE” training 6 months later.
Setting: Secondary care diabetes clinics in three English health districts.

Participants: 169 adults with type 1 diabetes and moderate or poor glycaemic control.

Main outcome measures: Glycated haemoglobin (HbA1c), severe hypoglycaemia, impact of diabetes on quality of life (ADDQoL).

Results: At 6 months, HbA1c was significantly better in immediate DAFNE patients (mean 8.4%) than in delayed DAFNE patients (9.4%) (t=6.1, P<0.0001). The impact of diabetes on dietary freedom was significantly improved in immediate DAFNE patients compared with delayed DAFNE patients (t=&minus;5.4, P<0.0001), as was the impact of diabetes on overall quality of life (t=2.9, P<0.01). General wellbeing and treatment satisfaction were also significantly improved, but severe hypoglycaemia, weight, and lipids remained unchanged. Improvements in “present quality of life” did not reach significance at 6 months but were significant by 1 year.

Conclusion: Skills training promoting dietary freedom improved quality of life and glycaemic control in people with type 1 diabetes without worsening severe hypoglycaemia or cardiovascular risk. This approach has the potential to enable more people to adopt intensive insulin treatment and is worthy of further investigation.

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.

The impact of hypoglycemia on quality of life in type 2 diabetes : a systematic review.

Hypoglycemia is the commonest and most serious side-effect of insulin treatment for Type 1 diabetes (T1DM). The prevalence of hypoglycemia is lower in insulin-treated Type 2 diabetes (T2DM) than in T1DM but the prevalence increases with duration of insulin therapy and increasingly resembles T1DM. As hypoglycemia has not been widely recognised to affect people with T2DM, its impact on quality of life (QoL) has received little attention.

A systematic literature review was performed to identify empirical papers published in English since 1966 reporting the effect of hypoglycemia on any patient-reported outcomes (PROs), including QoL, in T2DM. Despite our specific interest in QoL, the inclusion criteria were defined broadly to encompass a range of self-assessed psychosocial outcomes, including generic and diabetes-specific QoL, emotional well-being and health utilities. Studies were excluded in which the impact of hypoglycemia was confounded by treatment effects. Our search included: MEDLINE, PsycINFO, CINAHL. Abstracts were screened independently by two investigators.

Of 2,469 abstracts, Thirty-one met the inclusion criteria and were subjected to data extraction and analysis. These comprised four controlled trials and twenty-seven others (including cross-sectional and health utility studies). The results indicate associations between the experience of hypoglycemia and a range of adverse PROs, including impaired QoL and well-being, higher levels of anxiety, depression and anger and loss of health utility. Fear of hypoglycemia was also associated with compensatory lifestyle limitations and changes.

Publications suggest that QoL and other psychosocial outcomes are impaired by the experience and/or fear of hypoglycemia in T2DM, however, very few studies have directly investigated this phenomenon to date. Interpretation of the evidence is hampered by inconsistent or inadequate definitions and measurement of both hypoglycemia and QoL outcomes, by confounding of the impact of hypoglycemia and by treatment factors. Targeted research using appropriate study design is needed to quantify and qualify the true impact of hypoglycemia on QoL in people with T2DM.