Katharine Barnard

The prevalence of co-morbid depression in adults with Type 1 diabetes: systematic literature review

Aim  To review the literature estimating the cross‐sectional prevalence of clinical depression in adults with Type 1 diabetes.

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.).

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.

Not all roads lead to Rome-a review of quality of life measurement in adults with diabetes.

Aims  Quality of life (QoL) is recognized widely as an important health outcome in diabetes, where the burden of self‐management places great demands on the individual. However, the concept of QoL remains ambiguous and poorly defined. The aim of our review is to clarify the measurement of QoL in terms of conceptualization, terminology and psychometric properties, to review the instruments that have been used most frequently to assess QoL in diabetes research and make recommendations for how to select measures appropriately.

Fear of hypoglycaemia in parents of young children with type 1 diabetes: a systematic review

BackgroundMany children with type 1 diabetes have poor glycaemic control. Since the Diabetes Control and Complications Trial (DCCT) showed that tighter control reduces complication rates, there has been more emphasis on intensified insulin therapy. We know that patients and families are afraid of hypoglycaemia. We hypothesised that fear of hypoglycaemia might take precedence over concern about long-term complications, and that behaviour to avoid hypoglycaemia might be at the cost of poorer control, and aimed to evaluate the effectiveness of any interventions designed to prevent that. The objective of this review was to systematically review studies concerning the extent and consequences of fear of hypoglycaemia in parents of children under 12 years of age with type 1 diabetes, and interventions to reduce it.MethodsData Sources: MEDLINE, EMBASE, PsycINFO, The Cochrane Library, Web of Science, meeting abstracts of EASD, ADA and Diabetes UK, Current Controlled Trials, ClinicalTrials.gov, UK CRN, scrutiny of bibliographies of retrieved papers and contact with experts in the field.Inclusions: Relevant studies of any design of parents of children under 12 years of age with Type 1 diabetes were included. The key outcomes were the extent and impact of fear, hypoglycaemia avoidance behaviour in parents due to parental fear of hypoglycaemia in their children, the effect on diabetes control, and the impact of interventions to reduce this fear and hypoglycaemia avoidance behaviour.ResultsEight articles from six studies met the inclusion criteria. All were cross sectional studies and most were of good quality. Parental fear of hypoglycaemia, anxiety and depression were reported to be common. There was a paucity of evidence on behaviour to avoid hypoglycaemia, but there were some suggestions that higher than desirable blood glucose levels might be permitted in order to avoid hypoglycaemia. No studies reporting interventions to reduce parental fear of hypoglycaemia were found.ConclusionsThe evidence base was limited. Parents of children with Type 1 diabetes reported considerable parental fear of hypoglycaemia, affecting both parental health and quality of life. There is some suggestion that hypoglycaemia avoidance behaviours by parents might adversely affect glycaemic control. Trials of interventions to reduce parental anxiety and hypoglycaemia avoidance behaviour are needed. We suggest that there should be a trial of structured education for parents of young children with Type 1 diabetes.

Home use of closed-loop insulin delivery for overnight glucose control in adults with type 1 diabetes: a 4-week, multicentre, randomised crossover study.

BACKGROUND Closed-loop insulin delivery is a promising option to improve glycaemic control and reduce the risk of hypoglycaemia. We aimed to assess whether overnight home use of automated closed-loop insulin delivery would improve glucose control. METHODS We did this open-label, multicentre, randomised controlled, crossover study between Dec 1, 2012, and Dec 23, 2014, recruiting patients from three centres in the UK. Patients aged 18 years or older with type 1 diabetes were randomly assigned to receive 4 weeks of overnight closed-loop insulin delivery (using a model-predictive control algorithm to direct insulin delivery), then 4 weeks of insulin pump therapy (in which participants used real-time display of continuous glucose monitoring independent of their pumps as control), or vice versa. Allocation to initial treatment group was by computer-generated permuted block randomisation. Each treatment period was separated by a 3-4 week washout period. The primary outcome was time spent in the target glucose range of 3·9-8·0 mmol/L between 0000 h and 0700 h. Analyses were by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01440140. FINDINGS We randomly assigned 25 participants to initial treatment in either the closed-loop group or the control group, patients were later crossed over into the other group; one patient from the closed-loop group withdrew consent after randomisation, and data for 24 patients were analysed. Closed loop was used over a median of 8·3 h (IQR 6·0-9·6) on 555 (86%) of 644 nights. The proportion of time when overnight glucose was in target range was significantly higher during the closed-loop period compared to during the control period (mean difference between groups 13·5%, 95% CI 7·3-19·7; p=0·0002). We noted no severe hypoglycaemic episodes during the control period compared with two episodes during the closed-loop period; these episodes were not related to closed-loop algorithm instructions. INTERPRETATION Unsupervised overnight closed-loop insulin delivery at home is feasible and could improve glucose control in adults with type 1 diabetes. FUNDING Diabetes UK.

Systematic literature review: quality of life associated with insulin pump use in Type 1 diabetes.

Aim  To review systematically the published literature addressing whether continuous subcutaneous insulin infusion (CSII) provides any quality of life benefits to people with Type 1 diabetes.

Closing the loop overnight at home setting: psychosocial impact for adolescents with type 1 diabetes and their parents

Objective To explore the experiences of adolescents with type 1 diabetes mellitus (T1DM) and their parents taking part in an overnight closed loop study at home, using qualitative and quantitative research methods. Research design and methods Adolescents aged 12–18 years on insulin pump therapy were recruited to a pilot closed loop study in the home setting. Following training on the use of a study insulin pump and continuous glucose monitoring (CGM), participants were randomized to receive either real-time CGM combined with overnight closed loop or real-time CGM alone followed by the alternative treatment for an additional 21 days with a 2–3-week washout period in between study arms. Semistructured interviews were performed to explore participants’ perceptions of the impact of the closed loop technology. At study entry and again at the end of each 21-day crossover arm of the trial, participants completed the Diabetes Technology Questionnaire (DTQ) and Hypoglycemia Fear Survey (HFS; also completed by parents). Results 15 adolescents and 13 parents were interviewed. Key positive themes included reassurance/peace of mind, confidence, ‘time off’ from diabetes demands, safety, and improved diabetes control. Key negative themes included difficulties with calibration, alarms, and size of the devices. DTQ results reflected these findings. HFS scores were mixed. Conclusions Closed loop insulin delivery represents cutting-edge technology in the treatment of T1DM. Results indicate that the psychological and physical benefits of the closed loop system outweighed the practical challenges reported. Further research from longitudinal studies is required to determine the long-term psychosocial benefit of the closed loop technology.

Antidepressant Medication as a Risk Factor for Type 2 Diabetes and Impaired Glucose Regulation: Systematic review

OBJECTIVE Antidepressant use has risen sharply over recent years. Recent concerns that antidepressants may adversely affect glucose metabolism require investigation. Our aim was to assess the risk of type 2 diabetes associated with antidepressants through a systematic review. RESEARCH DESIGN AND METHODS Data sources were MEDLINE, Embase, PsycINFO, The Cochrane Library, Web of Science, meeting abstracts of the European Association for the Study of Diabetes, American Diabetes Association, and Diabetes UK, Current Controlled Trials, ClinicalTrials.gov, U.K. Clinical Research Network, scrutiny of bibliographies of retrieved articles, and contact with relevant experts. Relevant studies of antidepressant effects were included. Key outcomes were diabetes incidence and change in blood glucose (fasting and random). RESULTS Three systemic reviews and 22 studies met the inclusion criteria. Research designs included 1 case series and 21 observational studies comprising 4 cross-sectional, 5 case-control, and 12 cohort studies. There was evidence that antidepressant use is associated with type 2 diabetes. Causality is not established, but rather, the picture is confused, with some antidepressants linked to worsening glucose control, particularly with higher doses and longer duration, others linked with improved control, and yet more with mixed results. The more recent, larger studies, however, suggest a modest effect. Study quality was variable. CONCLUSIONS Although evidence exists that antidepressant use may be an independent risk factor for type 2 diabetes, long-term prospective studies of the effects of individual antidepressants rather than class effects are required. Heightened alertness to potential risks is necessary until these are complete.

Use of an Automated Bolus Calculator Reduces Fear of Hypoglycemia and Improves Confidence in Dosage Accuracy in Patients with Type 1 Diabetes Mellitus Treated with Multiple Daily Insulin Injections

Background: Many patients do not intensify their insulin regimens. It is believed that lack of adherence may be largely due to fear of hypoglycemia. We hypothesized that utilization of an automated bolus calculator (bolus advisor) might reduce fear of hypoglycemia and encourage patients to achieve improved glycemic control. Method: We surveyed 1,412 type 1 diabetes mellitus (T1DM) patients treated with multiple daily insulin injection therapy at 270 hospitals in the United Kingdom and Republic of Ireland to assess their attitudes and behaviors regarding insulin therapy after use of a bolus advisor (Accu-Chek® Aviva Expert blood glucose meter and bolus advisor system, Roche Diagnostics). The device automatically calculates bolus dosages based on current blood glucose values, anticipated meal intake, and other parameters. Results: Five hundred eighty-eight T1DM patients responded to the survey. Respondents were predominantly female, age <1 to 70 years, with diabetes duration of <1 to >15 years. Respondents had 4–12 weeks prior experience using the bolus advisor. 76.7% of respondents indicated current bolus advisor use to calculate insulin boluses for meals/snacks always or quite often. 52.0% of respondents indicated that fear of hypoglycemia was reduced (39.0%) or significantly reduced (13.0%). 78.8% indicated that confidence in the insulin dose calculation improved (50.8%) or significantly improved (28.0%). 89.3% indicated that the bolus advisor made bolus calculation easy or very easy compared with manual calculation. Conclusions: Most patients felt that using the bolus advisor was easier than manual bolus calculation, improved their confidence in the accuracy of their bolus dosage, and reduced their fear of hypoglycemia. Randomized trials are needed to confirm these perceptions and determine whether bolus advisor use improves clinical outcomes.