Self monitoring of blood glucose - a survey of Diabetes UK members with type 2 diabetes who use SMBG

Background: aim - to survey members of Diabetes UK who had Type 2 diabetes and who used self monitoring of blood glucose (SMBG), to elicit their views on its usefulness in the management of their diabetes, and how they used the results. A questionnaire was developed for the Diabetes UK website. The questionnaire was posted on the Diabetes UK website until over 500 people had responded. Questions asked users to specify the benefits gained from SMBG, and how these benefits were achieved. We carried out both quantitative analysis and a thematic analysis for the open ended free-text questions.Findings: 554 participants completed the survey, of whom 289 (52.2%) were male. 20% of respondents were recently diagnosed (&lt; 6 months). Frequency of SMBG varied, with 43% of participants testing between once and four times a day and 22% testing less than once a month or for occasional periods.80% of respondents reported high satisfaction with SMBG, and reported feeling more 'in control' of their diabetes management using it. The most frequently reported use of SMBG was to make adjustments to food intake or confirm a hyperglycaemic episode.Women were significantly more likely to report feelings of guilt or self-chastisement associated with out of range readings (p = &lt; .001).Conclusion: SMBG was clearly of benefit to this group of confirmed users, who used the results to adjust diet, physical activity or medications. However many individuals (particularly women) reported feelings of anxiety and depression associated with its use.<br/

Qualitative study into quality of life issues surrounding insulin pump use in Type 1 diabetes

Currently, there is a need for qualitative research about how insulin pump therapy changes quality of life, which is significant to people with type 1 diabetes. This study aimed to elicit the experiences of current insulin pump users in order to discover the therapy\u27s benefits, downsides and effect on their quality of life. A qualitative approach was taken in order to reveal subjective experiences. This research will inform future research and assist with policy and guideline development by health care providers about pump therapy. Participants were briefly interviewed by telephone about their experiences of living with an insulin pump. Four questions were asked. These covered the benefits of pump use, effects on quality of life, whether participants experienced downsides to using a pump and any other issues participants wished to raise. In all, 80 insulin pump users participated in the study. All 80 reported experiencing benefits; insulin pump use had improved their quality of life. Key positive themes emerging from the data included greater control (45), flexibility (33), freedom (28), family effects (seven), convenience (seven) and independence (five). Key drawbacks emerging from the data included visibility— device (25), breakdown (17), visibility— skin (five) and cost (three). Participants overwhelmingly reported experiencing benefits and improvements in their quality of life associated with insulin pump use. These pump users remain on pump therapy by choice, so the benefits clearly outweigh the downsides. However, further work needs to determine if these downsides contribute to explaining why 2–4% of pump users discontinue pump use after a short period of time, or whether this is a result of other factors. Copyright © 2007 John Wiley & Sons

Impact of Chronic Sleep Disturbance for People Living With T1 Diabetes.

AIM: The aim was to explore personal experiences and to determine the impact of impaired sleep on well-being and diabetes-related activities/decision making among a cohort of people living with T1D. METHOD: Adults with T1D over the age of 18 and parents/carers of children with T1D were invited to complete an online questionnaire about their quality and quantity of sleep. Questions included impact of sleep on diabetes-related decision making, effective calculation of bolus doses, important aspects of psychosocial functioning, and frequency of waking. Diasend download data were used to objectively determine frequency of nocturnal blood glucose testing in children. RESULTS: A total of 258 parent/carer participants (n = 221 female, 85.6%) and 192 adults with T1D (n = 145, 75.5% female, age range 19 to 89 years) took part. In all, 239 parents/carers and 160 adults believed waking in the night has an impact on their usual daily functioning. Of these, 236 parents/carers and 151 (64%) adults reported the impact as negative. Chronic sleep interruption was associated with detrimental impact on mood, work, family relationships, ability to exercise regularly, ability to eat healthily, and happiness. CONCLUSION: Chronic sleep interruption is highly prevalent in adults with T1D and parents/carers of children with T1D with negative effects on daily functioning and well-being. Appropriate interventions are required to alleviate this burden of T1D, address modifiable risk factors for nocturnal hypoglycemia, and reduce the (perceived) need for nocturnal waking

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

Barriers and facilitators to taking on diabetes self-management tasks in pre-adolescent children with type 1 diabetes: a qualitative study.

BACKGROUND: When children with type 1 diabetes approach adolescence, they are encouraged to become more involved in diabetes self-management. This study explored the challenges pre-adolescent children encounter when self-managing diabetes and the factors which motivate and enable them to take on new diabetes-related tasks. A key objective was to inform the support offered to pre-adolescent children. METHODS: In-depth interviews using age-appropriate questioning with 24 children (aged 9-12 years) with type 1 diabetes. Data were analysed using an inductive, thematic approach. RESULTS: Children reported several barriers to taking on self-management tasks. As well as seeking respite from managing diabetes, children described relying on their parents to: perform the complex maths involved in working out carbohydrate content in food; calculate insulin doses if they did not use a bolus advisor; and administer injections or insert a cannula in hard-to-reach locations. Children described being motivated to take on diabetes tasks in order to: minimise the pain experienced when others administered injections; alleviate the burden on their parents; and participate independently in activities with their peers. Several also discussed being motivated to take on diabetes-management responsibilities when they started secondary school. Children described being enabled to take on new responsibilities by using strategies which limited the need to perform complex maths. These included using labels on food packaging to determine carbohydrate contents, or choosing foods with carbohydrate values they could remember. Many children discussed using bolus advisors with pre-programmed ratios and entering carbohydrate on food labels or values provided by their parents to calculate insulin doses. Several also described using mobile phones to seek advice about carbohydrate contents in food. CONCLUSIONS: Our findings highlight several barriers which deter children from taking on diabetes self-management tasks, motivators which encourage them to take on new responsibilities, and strategies and technologies which enable them to become more autonomous. To limit the need to perform complex maths, children may benefit from using bolus advisors provided they receive regular review from healthcare professionals to determine and adjust pre-programmed insulin-to-carbohydrate ratios. Education and support should be age-specific to reflect children's changing involvement in self-managing diabetes

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

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

A systematic review of models to predict recruitment to multicentre clinical trials

<p>Abstract</p> <p>Background</p> <p>Less than one third of publicly funded trials managed to recruit according to their original plan often resulting in request for additional funding and/or time extensions. The aim was to identify models which might be useful to a major public funder of randomised controlled trials when estimating likely time requirements for recruiting trial participants. The requirements of a useful model were identified as usability, based on experience, able to reflect time trends, accounting for centre recruitment and contribution to a commissioning decision.</p> <p>Methods</p> <p>A systematic review of English language articles using MEDLINE and EMBASE. Search terms included: randomised controlled trial, patient, accrual, predict, enrol, models, statistical; Bayes Theorem; Decision Theory; Monte Carlo Method and Poisson. Only studies discussing prediction of recruitment to trials using a modelling approach were included. Information was extracted from articles by one author, and checked by a second, using a pre-defined form.</p> <p>Results</p> <p>Out of 326 identified abstracts, only 8 met all the inclusion criteria. Of these 8 studies examined, there are five major classes of model discussed: the unconditional model, the conditional model, the Poisson model, Bayesian models and Monte Carlo simulation of Markov models. None of these meet all the pre-identified needs of the funder.</p> <p>Conclusions</p> <p>To meet the needs of a number of research programmes, a new model is required as a matter of importance. Any model chosen should be validated against both retrospective and prospective data, to ensure the predictions it gives are superior to those currently used.</p

Acceptability of Implantable Continuous Glucose Monitoring Sensor

Real-time continuous glucose monitoring is associated with significant benefits for diabetes management. Implantable sensors could overcome some challenges reportedly associated with device visibility, psychosocial functioning and sensor durability. A psychosocial assessment was conducted to determine acceptability and impact of an implantable continuous glucose monitoring (CGM) sensor as part of the PRECISE trial. Questionnaires were administered to participants comprising the Diabetes Distress Scale, the CGM impact scale, and bespoke device satisfaction. Fifty-one participants across the United Kingdom (n = 10) and Germany (n = 41) completed the questionnaires. Of these, 90% had T1D, 50% followed an insulin pump therapy regimen, and 45% of the participants were previous CGM users. CGM Impact Scale results show 86% (n = 44) of participants reported feeling better (14% neutral) about their diabetes control with 90% CGM naïve participants and 81% previous CGM users reporting increased confidence about their diabetes management. Furthermore, 73% (n = 37) felt more safe (27% neutral) while sleeping and 78% (n = 39) more confident (22% neutral) about avoiding serious hypoglycemia. Responses correspond with an average improvement in HbA1c from 7.51 to 7.05 ( P < .0001) over the 90 days use of the CGM. Overall, the system was rated highly on ease of use, convenience and comfort. 84% would choose to be inserted again with 93% of CGM naïve participants (86% previous CGM users) reporting minimized burden of diabetes. Implantable CGM devices are acceptable to users and are evaluated favorably. The considerable majority of participants (93% of first time users and 77% previous CGM users) would like to continue using the system to help manage their diabetes more effectivel

Home use of closed loop insulin delivery improves overnight glucose control in adults with type 1 diabetes: A four-week multicentre randomised crossover study

This is the author accepted manuscript and will be embargoed until 16/12/14. The final published version can be found here: http://www.thelancet.com/journals/landia/article/PIIS2213-8587(14)70114-7/fulltext#article_upsell.Background: We assessed whether overnight home use of automated closed loop insulin delivery (artificial pancreas) improves glucose control. Methods: We studied 24 adults with type 1 diabetes in a multicentre crossover study design comparing four weeks of overnight closed loop using a model predictive control algorithm to direct insulin delivery, with four weeks of insulin pump therapy in which participants used real-time display of continuous glucose monitoring independent of their pumps as control. Primary outcome was time when glucose was in the target range of 3•9 and 8•0mmol/l between midnight to 07:00. Analyses were by intention to treat. Trial registration ClinicalTrials.gov NCT01440140. Findings: Closed loop was utilised over median 8•3 (interquartile range 6•0, 9•6)hours on 555nights (86%). Proportion of time when overnight glucose was in target range was significantly higher during closed loop compared to control by 13•5% (95% CI, 7•3-19•7; p<0•001). Mean overnight glucose (8•2±0•9 vs. 9•0±1•3mmol/l; p=0•005) and time spent above target (44•3%±11•9 vs. 57•1%±15•6; p=0•001) were significantly lower during closed loop. Time spent below target was low and comparable [1•8%( 0•6, 3•6) vs. 2•1%(0•7, 3•9);p=0•28]. Lower mean overnight glucose was brought about by increased overnight insulin delivery [6•4 (4•5, 8•1) vs. 4•9 (3•7, 6•3)units;p<0•001) without changing the total daily insulin amount [34•5 (29•3, 48•4) vs. 35•4 (29•7, 45•2)units;p=0•32]. No severe hypoglycaemia episodes occurred during control period and two during closed loop not related to algorithm instructions. Interpretation: Unsupervised overnight closed loop at home is feasible and may improve glucose control in adults with type 1 diabetes