Assessing patient-reported outcomes for automated insulin delivery systems: the psychometric properties of the INSPIRE measures.

AIM: Participants in clinical trials assessing automated insulin delivery systems report perceived benefits and burdens that reflect their experiences and may predict their likelihood of uptake and continued use of this novel technology. Despite the importance of understanding their perspectives, there are no available validated and reliable measures assessing the psychosocial aspects of automated insulin delivery systems. The present study assesses the initial psychometric properties of the INSPIRE measures, which were developed for youth and adults with Type 1 diabetes, as well as parents and partners. METHODS: Data from 292 youth, 159 adults, 150 parents of youth and 149 partners of individuals recruited from the Type 1 Diabetes Exchange Registry were analysed. Participants completed INSPIRE questionnaires and measures of quality of life, fear of hypoglycaemia, diabetes distress, glucose monitoring satisfaction. Exploratory factor analysis assessed factor structures. Associations between INSPIRE scores and other measures, HbA1c , and technology use assessed concurrent and discriminant validity. RESULTS: Youth, adult, parent and partner measures assess positive expectancies of automated insulin delivery systems. Measures range from 17 to 22 items and are reliable (α = 0.95-0.97). Youth, adult and parent measures are unidimensional; the partner measure has a two-factor structure (perceptions of impact on partners versus the person with diabetes). Measures showed concurrent and discriminant validity. CONCLUSIONS: INSPIRE measures assessing the positive expectancies of automated insulin delivery systems for youth, adults, parents and partners have meaningful factor structures and are internally consistent. The developmentally sensitive INSPIRE measures offer added value as clinical trials test newer systems, systems become commercially available and clinicians initiate using these systems.

Parents' and healthcare professionals' experiences of care after stillbirth in low- and middle-income countries: a systematic review and meta-summary.

BACKGROUND: Stillbirth has a profound impact on women, families, and healthcare workers. The burden is highest in low- and middle-income countries (LMICs). There is need for respectful and supportive care for women, partners, and families after bereavement. OBJECTIVE: To perform a qualitative meta-summary of parents' and healthcare professionals' experiences of care after stillbirth in LMICs. SEARCH STRATEGY: Search terms were formulated by identifying all synonyms, thesaurus terms, and variations for stillbirth. Databases searched were AMED, EMBASE, MEDLINE, PsychINFO, BNI, CINAHL. SELECTION CRITERIA: Qualitative, quantitative, and mixed method studies that addressed parents' or healthcare professionals' experience of care after stillbirth in LMICs. DATA COLLECTION AND ANALYSIS: Studies were screened, and data extracted in duplicate. Data were analysed using the Sandelowski meta-summary technique that calculates frequency and intensity effect sizes (FES/IES). MAIN RESULTS: In all, 118 full texts were screened, and 34 studies from 17 countries were included. FES range was 15-68%. Most studies had IES 1.5-4.5. Women experience a broad range of manifestations of grief following stillbirth, which may not be recognised by healthcare workers or in their communities. Lack of recognition exacerbates negative experiences of stigmatisation, blame, devaluation, and loss of social status. Adequately developed health systems, with trained and supported staff, are best equipped to provide the support and information that women want after stillbirth. CONCLUSIONS: Basic interventions could have an immediate impact on the experiences of women and their families after stillbirth. Examples include public education to reduce stigma, promoting the respectful maternity care agenda, and investigating stillbirth appropriately. TWEETABLE ABSTRACT: Reducing stigma, promoting respectful care and investigating stillbirth have a positive impact after stillbirth for women and families in LMICs.

Experiences of closed-loop insulin delivery among pregnant women with Type 1 diabetes.

AIMS: To explore the experiences of pregnant women with Type 1 diabetes, and the relationships between perceptions of glucose control, attitudes to technology and glycaemic responses with regard to closed-loop insulin delivery. METHODS: We recruited 16 pregnant women with Type 1 diabetes [mean ± sd age 34.1 ± 4.6 years, duration of diabetes 23.6 ± 7.2 years, baseline HbA1c 51±5 mmol/mol (6.8 ± 0.6%)] to a randomized crossover trial of sensor-augmented pump therapy vs automated closed-loop therapy. Questionnaires (Diabetes Technology Questionnaire, Hypoglycaemia Fear Survey) were completed before and after each intervention, with qualitative interviews at baseline and follow-up. RESULTS: Women described the benefits and burdens of closed-loop systems during pregnancy. Feelings of improved glucose control, excitement and empowerment were counterbalanced by concerns about device visibility, obsessive data checking and diminished attentiveness to hyper- and hypoglycaemia symptoms. Responding to questionnaires, eight participants felt less worry about overnight hypoglycaemia and that diabetes 'did not run their lives'; however, five reported that closed-loop increased time thinking about diabetes, and three felt it made sleep and preventing hyperglycaemia more problematic. Women slightly overestimated their glycaemic response to closed-loop therapy. Most became more positive in their technology attitudes throughout pregnancy. Women with more positive technology attitudes had higher degrees of overestimation, and poorer levels of glycaemic control. CONCLUSIONS: Women displayed complex psychosocial responses to closed-loop therapy in pregnancy. Perceptions of glycaemic response may diverge from biomedical data.

Development of an acceptable and feasible self-management group for children, young people and families living with Type 1 diabetes.

AIMS: This study developed an acceptable and feasible self-management intervention that addresses the self-identified needs of children and young people with Type 1 diabetes and their parents. METHODS: Phase 1 reviewed previous interventions and interviewed the clinical team, young people and families. Phase 2 ran three age-matched focus groups with 11 families of children aged 8-16 years. Feedback was used to modify the workshop. Phase 3 evaluated feasibility of delivery, as well as the effects on metabolic control, quality of life and fear of hypoglycaemia, measured at baseline and 1-3 months post intervention. RESULTS: Eighty-nine families were invited to take part. Twenty-two (25%) participated in seven pilot groups (median age of young people 10 years, 36% girls). The intervention comprised a developmentally appropriate workshop for young people and parents addressing: (1) blood glucose control, (2) the potential impact of long-term high HbA1c , (3) the effects of 'hypos' and 'hypers', (4) self-management techniques and (5) talking confidently to people about diabetes. Participants were enthusiastic and positive about the workshop and would recommend it to others. Young people liked sharing ideas and meeting others with diabetes, while parents enjoyed listening to their children talk about their diabetes knowledge. CONCLUSIONS: Families living with Type 1 diabetes participated in developing a self-management group intervention. Although we demonstrated acceptability and feasibility, the pilot study results do not support the development of a randomized control trial to evaluate the effectiveness in improving HbA1c .

Home Use of an Artificial Beta Cell in Type 1 Diabetes.

BACKGROUND: The feasibility, safety, and efficacy of prolonged use of an artificial beta cell (closed-loop insulin-delivery system) in the home setting have not been established. METHODS: In two multicenter, crossover, randomized, controlled studies conducted under free-living home conditions, we compared closed-loop insulin delivery with sensor-augmented pump therapy in 58 patients with type 1 diabetes. The closed-loop system was used day and night by 33 adults and overnight by 25 children and adolescents. Participants used the closed-loop system for a 12-week period and sensor-augmented pump therapy (control) for a similar period. The primary end point was the proportion of time that the glucose level was between 70 mg and 180 mg per deciliter for adults and between 70 mg and 145 mg per deciliter for children and adolescents. RESULTS: Among adults, the proportion of time that the glucose level was in the target range was 11.0 percentage points (95% confidence interval [CI], 8.1 to 13.8) greater with the use of the closed-loop system day and night than with control therapy (P<0.001). The mean glucose level was lower during the closed-loop phase than during the control phase (difference, -11 mg per deciliter; 95% CI, -17 to -6; P<0.001), as were the area under the curve for the period when the glucose level was less than 63 mg per deciliter (39% lower; 95% CI, 24 to 51; P<0.001) and the mean glycated hemoglobin level (difference, -0.3%; 95% CI, -0.5 to -0.1; P=0.002). Among children and adolescents, the proportion of time with the nighttime glucose level in the target range was higher during the closed-loop phase than during the control phase (by 24.7 percentage points; 95% CI, 20.6 to 28.7; P<0.001), and the mean nighttime glucose level was lower (difference, -29 mg per deciliter; 95% CI, -39 to -20; P<0.001). The area under the curve for the period in which the day-and-night glucose levels were less than 63 mg per deciliter was lower by 42% (95% CI, 4 to 65; P=0.03). Three severe hypoglycemic episodes occurred during the closed-loop phase when the closed-loop system was not in use. CONCLUSIONS: Among patients with type 1 diabetes, 12-week use of a closed-loop system, as compared with sensor-augmented pump therapy, improved glucose control, reduced hypoglycemia, and, in adults, resulted in a lower glycated hemoglobin level. (Funded by the JDRF and others; AP@home04 and APCam08 ClinicalTrials.gov numbers, NCT01961622 and NCT01778348.).

A decade in diabetes specialist services, 2000 to 2011, in England: the views of consultant diabetologists and diabetes specialist nurses amidst persistent healthcare delivery change.

AIMS: To assess the impact of continual major National Health Service reorganization on commissioning, organizational and delivery arrangements for secondary care diabetes services. To explore how consultant diabetologists and diabetes specialist nurses perceive the issues facing diabetes specialist services in 2011 and how these have changed in the preceding decade. METHODS: We used a longitudinal case study approach that combined quantitative and qualitative methods. Five locations in England were purposively selected to represent the wider diabetes specialist community, and seven semi-structured interviews were conducted. Interviews were recorded, transcribed verbatim and analysed using Framework analysis. Findings were compared with and contrasted to results from national quantitative surveys of diabetes specialist services undertaken in 2000 and 2006. RESULTS: Clinicians viewed positively the expertise and commitment of multidisciplinary teams and their ability to adapt to new situations. Negative perceptions persisted throughout the decade, relating to the continual change that threatens to dismantle relationships and services which had taken many years to establish. Lack of resources, inadequate manpower planning and poor access to psychological support for people with diabetes remained constant themes from 2000 to 2011. CONCLUSIONS: A willingness to innovate and work differently to improve services was identified; however, clinicians must be supported through organizational changes to ensure people with diabetes receive high-quality care. The disruptive nature of organizational change was a recurrent theme throughout the decade. Periods of stability must exist within commissioning to allow relationships, which are key to integration, to be maintained and permit service improvements to develop.

Parents' experiences of managing their child's diabetes using an insulin pump: a qualitative study.

AIMS: Continuous subcutaneous insulin infusion delivered via a pump is increasingly recommended for younger children with Type 1 diabetes. Our aims were: to understand the impact on parents who care for young children using insulin pumps; to help interpret psychological outcomes reported in quantitative research; and to inform provision of support to future parents. METHODS: We conducted in-depth interviews with 19 parents of children (aged ≤ 12 years) with Type 1 diabetes who used an insulin pump. Data were analysed thematically. RESULTS: Parents reported multiple benefits from using insulin pumps, including: no longer having to administer painful injections; fewer restrictions on the frequency, timing and carbohydrate contents of snacks and meals; and improvements in family life and their child's glycaemic control. Parents liked and felt less anxious about using bolus calculators to determine insulin doses; however, parents also described undertaking additional and unanticipated work to manage their child's diabetes using a pump. This included performing more blood glucose tests to calculate insulin doses for snacks and to address their concerns that the pump increased their child's risk of hypoglycaemia. Some parents reported doing additional blood glucose checks because they could adjust pump settings to better manage hypo- and hyperglycaemia. CONCLUSIONS: Parents liked and perceived benefits for their child and themselves from using an insulin pump; however, parents would benefit from being made aware of the additional work involved in using a pump and also from education and support to address concerns about hypoglycaemia. Better measures to evaluate parents' experiences are also recommended.

Psychosocial aspects of closed- and open-loop insulin delivery: closing the loop in adults with Type 1 diabetes in the home setting.

AIMS: To explore the psychosocial experiences of closed-loop technology and to compare ratings of closed- and open-loop technology for adults with Type 1 diabetes taking part in a randomized crossover study. METHODS: Adults (aged > 18 years) on insulin pump therapy were recruited to receive a first phase of either real-time continuous glucose monitoring with overnight closed-loop or real-time continuous glucose monitoring alone (open-loop) followed by a second phase of the alternative treatment in random order, at home for 4 weeks, unsupervised. Participants were invited to share their views in semi-structured interviews. The impact of the closed-loop technology, positive and negative aspects of living with the device overnight, along with the hopes and anxieties of the participants, were explored. RESULTS: The participants in the trial were 24 adults with a mean (sd) age of 43 (12) years, of whom 54% were men. The mean (range) interview duration was 26 (12-46) min. Content and thematic analysis showed the following key positive themes: improved blood glucose control (n = 16); reassurance/reduced worry (n = 16); improved overnight control leading to improved daily functioning and diabetes control (n = 16); and improved sleep (n = 8). The key negative themes were: technical difficulties (n = 24); intrusiveness of alarms (n = 13); and size of equipment (n = 7). Of the 24 participant, 20 would recommend the closed-loop technology. CONCLUSIONS: Closed-loop therapy has positive effects when it works in freeing participants from the demands of self-management. The downside was technical difficulties, particularly concerning the pump and 'connectivity', which it is hoped will improve. Future research should continue to explore the acceptability of the closed-loop system as a realistic therapy option, taking account of user concerns as new systems are designed. Failure to do this may reduce the eventual utility of new systems.

Challenges of optimizing glycaemic control in children with Type 1 diabetes: a qualitative study of parents' experiences and views.

AIMS: To explore the difficulties parents encounter in trying to achieve clinically recommended blood glucose levels and how they could be better supported to optimize their child's glycaemic control. METHODS: In-depth interviews were conducted with 54 parents of children with Type 1 diabetes (≤ 12 years). Data were analysed thematically. RESULTS: Parents described being reluctant and finding it difficult to keep their child's blood glucose levels consistently within clinically recommended ranges. As well as worrying about their child's ability to detect/report hypoglycaemia, parents highlighted a multitude of factors that had an impact on their child's blood glucose levels and over which they could exercise little control. These included: leaving their child with other caregivers who could not be trusted to detect hypoglycaemia; difficulties remotely monitoring and regulating their child's food consumption and activity; and physical and social changes accompanying childhood development. Most parents used two sets of blood glucose targets, with clinically recommended targets employed when their child was in their immediate care and higher targets when in the care of others. Parents described health professionals as lacking understanding of the difficulties they encountered keeping blood glucose within target ranges and needing more empathetic, tailored and realistic advice. CONCLUSION: It is not parents' fear of hypoglycaemia in isolation that leads to decisions to raise their child's blood glucose but, rather, parental fear in conjunction with other factors and considerations. Hence, to improve diabetes management in children, these factors may need to be addressed; for instance, by training others in diabetes management and using new technologies. Changes to consultations are also recommended.

Unsupervised home use of an overnight closed-loop system over 3-4 weeks: a pooled analysis of randomized controlled studies in adults and adolescents with type 1 diabetes.

AIMS: To compare overnight closed-loop and sensor-augmented pump therapy in patients with type 1 diabetes by combining data collected during free-living unsupervised randomized crossover home studies. METHODS: A total of 40 participants with type 1 diabetes, of whom 24 were adults [mean ± standard deviation (s.d.) age 43 ± 12 years and glycated haemoglobin (HbA1c) 8.0 ± 0.9%] and 16 were adolescents (mean ± s.d. age 15.6 ± 3.6 years and HbA1c 8.1 ± 0.8%), underwent two periods of sensor-augmented pump therapy in the home setting, in combination with or without an overnight closed-loop insulin delivery system that uses a model predictive control algorithm to direct insulin delivery. The order of the two interventions was random; each period lasted 4 weeks in adults and 3 weeks in adolescents. The primary outcome was time during which sensor glucose readings were in the target range of 3.9-8.0 mmol/l. RESULTS: The proportion of time when sensor glucose was in the target range (3.9-8.0 mmol/l) overnight (between 24:00 and 08:00 hours) was 18.5% greater during closed-loop insulin delivery than during sensor-augmented therapy (p < 0.001). Closed-loop therapy significantly reduced mean overnight glucose levels by 0.9 mmol/l (p < 0.001), with no difference in glycaemic variability, as measured by the standard deviation of sensor glucose. Time spent above the target range was reduced (p = 0.001), as was time spent in hypoglycaemia (<3.9 mmol/l; p = 0.014) during closed-loop therapy. Lower mean overnight glucose levels during closed-loop therapy were brought about by increased overnight insulin delivery (p < 0.001) without changes to the total daily delivery (p = 0.84). CONCLUSION: Overnight closed-loop insulin therapy at home in adults and adolescents with type 1 diabetes is feasible, showing improvements in glucose control and reducing the risk of nocturnal hypoglycaemia.

Perceptions and experiences of using automated bolus advisors amongst people with type 1 diabetes: a longitudinal qualitative investigation.

AIMS: We explored people's reasons for, and experiences of, using bolus advisors to determine insulin doses; and, their likes/dislikes of this technology. SUBJECTS AND METHODS: 42 people with type 1 diabetes who had received instruction in use of bolus advisors during a structured education course were interviewed post-course and 6 months later. Data were analysed thematically. RESULTS: Participants who considered themselves to have poor mathematical skills highlighted a gratitude for, and heavy reliance on, advisors. Others liked and chose to use advisors because they saved time and effort calculating doses and/or had a data storage facility. Follow-up interviews highlighted that, by virtue of no longer calculating their doses, participants could become deskilled and increasingly dependent on advisors. Some forgot what their mealtime ratios were; others reported a misperception that, because they were pre-programmed during courses, these parameters never needed changing. Use of data storage facilities could hinder effective review of blood glucose data and some participants reported an adverse impact on glycaemic control. DISCUSSION: While participants liked and perceived benefits to using advisors, there may be unintended consequences to giving people access to this technology. To promote effective use, on-going input and education from trained health professionals may be necessary.

Alcohol health literacy in young adults with type 1 diabetes and its impact on diabetes management.

AIMS: To investigate the knowledge of alcohol and carbohydrate content of commonly consumed alcoholic drinks among young adults with Type 1 diabetes and to explore alcohol consumption while identifying diabetes self-management strategies used to minimize alcohol-associated risk. METHOD: We conducted an open-access, multiple-choice web survey to investigate knowledge of alcohol and carbohydrate content of typical alcoholic drinks using images. Respondents to the survey also recorded their current alcohol consumption and diabetes self-management strategies when drinking. RESULTS: A total of 547 people aged 18-30 years responded to the survey (341 women; 192 men; mean (sd) age 24.5 (3.7) years), of whom 365 (66.7%) drank alcohol. In all, 84 (32.9%) women and 31 (22.6%) men scored higher than the cut-off score for increased-risk drinking. Knowledge accuracy of alcohol units was poor: only 7.3% (n = 40) correctly identified the alcohol content of six or more out of 10 drinks. Knowledge of carbohydrate content was also poor: no respondent correctly identified the carbohydrate content of six or more out of 10 drinks. Various and inconsistent strategies to minimize alcohol-associated risk were reported. CONCLUSIONS: Alcohol consumption was common among the survey respondents, but knowledge of alcohol and carbohydrate content was poor. Greater alcohol-related health literacy is required to minimize alcohol-associated risk. Further research should help develop effective strategies to improve health literacy and support safe drinking for young adults with Type 1 diabetes.

Kaleidoscope model of diabetes care: time for a rethink?

National Audit Data highlight persistent sub-optimum control among increasing numbers of people living with diabetes, with severe consequences for the individual and the NHS. The aim of the present review was to introduce a new cohesive, holistic model of care, tailored to individual needs to support optimum diabetes outcomes. This model of diabetes is necessary in order to understand the driving forces behind behaviour and their impact on diabetes management. Feelings (an emotional state or reaction) and beliefs (an acceptance that something is true or real) are fundamental behavioural drivers and influence diabetes self-management choices. Individually, these explain some of the complexities of behaviour and, collectively, they impact on personal motivation (rationale/desire to act) to achieve a specific outcome. Inevitably, they independently affect diabetes self-management and the environment in which individuals live. A model of care that proposes the encompassing of environment, intrinsic thought and therapy regimens to provide tailored, personalized healthcare should support enhanced diabetes self-management and outcomes from diagnosis. The Kaleidoscope model of care could be deliverable in routine care, incorporating each of the influences on diabetes self-management, and should benefit both individuals with diabetes and healthcare professionals.

Are current clinical trials in diabetes addressing important issues in diabetes care?

AIMS/HYPOTHESIS: Clinical trials assessing interventions for treating and preventing diabetes mellitus and its complications are needed to inform evidence-based practice. To examine whether current studies adequately address these needs, we conducted a descriptive analysis of diabetes-related trials registered with ClinicalTrials.gov from 2007 to 2010. METHODS: From a dataset including 96,346 studies registered in ClinicalTrials.gov downloaded on 27 September, 2010, a subset of 2,484 interventional trials was created by selecting trials with disease condition terms relevant to diabetes. RESULTS: Of the diabetes-related trials, 74.8% had a primarily therapeutic purpose while 10% were preventive. Listed interventions included drugs (63.1%) and behavioural (11.7%). Most trials were designed to enrol ≤ 500 (91.1%) or ≤ 100 (58.6%) participants, with mean/median times to completion of 1.8/1.4 years. Small percentages of trials targeted persons aged ≤ 18 years (3.7%) or ≥ 65 years (0.6%), while 30.8% excluded patients >65 years and the majority excluded those >75 years. Funding sources included industry (50.9%), NIH (7.5%) or other, with most being single-centre trials of other sponsorship (37.7%) or industry-funded multicentre studies (27.4%). A small number of trials (1.4%) listed primary outcomes including mortality or clinically significant cardiovascular complications. The distribution of trials by global region and US state does not correlate with prevalence of diabetes. CONCLUSIONS/INTERPRETATION: The majority of diabetes-related trials include small numbers of participants, exclude those at the extremes of age, are of short duration, involve drug therapy rather than preventive or non-drug interventions and do not focus upon significant cardiovascular outcomes. Recently registered diabetes trials may not sufficiently address important diabetes care issues or involve affected populations.

Alcohol-associated risks for young adults with Type 1 diabetes: a narrative review.

AIM: To undertake a narrative review of the impact and pattern of alcohol consumption in young adults with Type 1 diabetes. DATA SOURCES: MEDLINE, EMBASE, PsycINFO, The Cochrane Library, Web of Science, meeting abstracts of the European Association for the Study of Diabetes, the American Diabetes Association and Diabetes UK, Current Controlled Trials, ClinicalTrials.gov, UK Clinical Research Network, scrutiny of bibliographies of retrieved papers and contact with experts in the field. INCLUSION CRITERIA: relevant studies of any design of alcohol consumption and young adults with Type 1 diabetes (age 14-25 years) were included. The key outcomes were the quantity, pattern and impact of alcohol consumption, the effect on diabetes control and the effect of interventions to minimize the risks of alcohol for this population. RESULTS: Six articles and two conference abstracts met the inclusion criteria. There were six cross-sectional studies, one qualitative study and one within-subjects design study. Quality of studies was variable. Alcohol use amongst young adults with Type 1 diabetes was reported to be common and potentially harmful. There was a paucity of evidence on interventions to minimize the risks of alcohol in this target group. CONCLUSIONS: Research is required to understand the social context of alcohol consumption in this population with a view to developing appropriate interventions to minimize the risks associated with its use.

Optimising the management of primary breast cancer in older women - a report of a multi-disciplinary study day.

PURPOSE: The objectives of the study day were to (i) develop an in-depth understanding around the biology and treatment options; (ii) explore the specific physical and psychosocial needs and consideration including patients perspective; and (iii) gain insight into the development of a dedicated, holistic and multi-disciplinary clinic service and the importance of supporting research, for older women with primary breast cancer. DESIGN: The format included presentations (with lectures from external and local faculty, and short research papers from Nottingham) with a number of interactive discussions, and sharing of patients' experience. RESULTS: Four sessions were held covering (i) pathological features, (ii) role of radiotherapy and adjuvant chemotherapy, (iii) role of surgery, geriatric assessment and quality of life issues, and (iv) challenges in running research trials. CONCLUSIONS: A dedicated and joint team approach is required to improve clinical service and support research, in order to optimise the management of primary breast cancer in older women.

Self-monitoring of blood glucose in type 2 diabetes: systematic review.

OBJECTIVES: To examine whether or not self-monitoring of blood glucose (SMBG) is worthwhile, in terms of glycaemic control, hypoglycaemia, quality of life (QoL) and cost per quality-adjusted life-year (QALY), in people with type 2 diabetes (T2DM) who were not treated with insulin or who were on basal insulin in combination with oral agents. DATA SOURCES: Literature searched included systematic reviews published since 1996, and a systematic review and meta-analyses of randomised controlled trials (RCTs) identified from the reviews, and from searches for more recent trials, along with review of qualitative and economic studies. Search strategies were limited to the English language and to articles published since 1996, and included: databases searched from 1996 to April 2009 - The Cochrane Library, MEDLINE, EMBASE, PsycINFO, Web of Science - limited to meeting abstracts; and websites. REVIEW METHODS: The intervention was self-testing of blood glucose with a meter and test strips. Studies included adult patients with T2DM on any oral treatment or combination of regimens, including lifestyle, oral agents or once-daily basal insulin. Existing systematic reviews of SMBG were summarised and results compared. Evidence synthesis of all of the studies meeting the inclusion criteria was carried out using a narrative review. Data were analysed by outcome and subgroups. HbA1c data from RCTs were summarised using a meta-analysis. Heterogeneity was calculated using the chi-squared and I2 methods. The following analyses were carried out: SMBG compared to self-monitoring of urine glucose, SMBG versus no SMBG, more intensive SMBG versus less intensive SMBG, and more intensive SMBG versus no SMBG. Available qualitative data gained from in-depth interview studies, repeated interviews, and questionnaire and survey data were summarised. RESULTS: The review identified 30 RCTs, although few were of high quality. Ten trials comparing SMBG with no SMBG showed statistically significant reduction in HbA1C of 0.21%, which may not be considered clinically significant. A similar, though not statistically significant difference, was shown where SMBG with education was compared to SMBG without education or feedback. RCTs showed no consistent effect on hypoglycaemic episodes and no impact on medication changes. Review of cost-effectiveness studies showed that costs of SMBG per annum vary considerably (10-259 pounds). Although some studies assert that SMBG may lead to savings in health-care costs which may offset the costs of testing, the best analysis to date (DiGEM - Diabetes Glycaemic Education and Monitoring) concluded that SMBG was not cost-effective. Qualitative studies revealed that there was a lack of education in how to interpret and use the data from SMBG, and that failure to act on the results was common. CONCLUSIONS: The evidence suggested that SMBG is of limited clinical effectiveness in improving glycaemic control in people with T2DM on oral agents, or diet alone, and is therefore unlikely to be cost-effective. SMBG may lead to improved glycaemic control only in the context of appropriate education - both for patients and health-care professionals - on how to respond to the data, in terms of lifestyle and treatment adjustment. Also, SMBG may be more effective if patients are able to self-adjust drug treatment. Further research is required on the type of education and feedback that are most helpful, characteristics of patients benefiting most from SMBG, optimal timing and frequency of SMBG, and the circumstances under which SMBG causes anxiety and/or depression.