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1.
Diabet Med ; 40(9): e15126, 2023 09.
Article in English | MEDLINE | ID: mdl-37171467

ABSTRACT

AIMS: Use of the CamAPS FX hybrid closed loop (CL) system is associated with improved time in range and glycated haemoglobin A1c across the age span, but little is known about its effects on patient-reported outcomes (PROs). METHODS: This open-label, randomized, multi-site study compared CamAPS FX to sensor-augmented pump (SAP) in a sample of older adults (≥60 years) with type 1 diabetes (T1D). Thirty-five older adults completed PROs surveys at the start of the study and after each period of 16 weeks using either CL or SAP. At the end of the study, 19 participated in interviews about their experiences with CL. RESULTS: Results examining the 16 weeks of CL use showed that the overall Diabetes Distress Scale score and two subscales (powerlessness and physician distress) improved significantly along with trust on the Glucose Monitoring Satisfaction Survey. User experience interview responses were consistent in noting benefits of 'improved glycaemic control' and 'worrying less about diabetes'. CONCLUSION: In this sample of older adults with T1D who have previously shown glycaemic benefit, there are indicators of improved PROs and subjective user experience benefits.


Subject(s)
Diabetes Mellitus, Type 1 , Aged , Humans , Blood Glucose , Blood Glucose Self-Monitoring/methods , Diabetes Mellitus, Type 1/drug therapy , Hypoglycemic Agents/therapeutic use , Insulin/therapeutic use , Insulin Infusion Systems , Treatment Outcome , Middle Aged
2.
Chronic Illn ; 18(4): 742-756, 2022 12.
Article in English | MEDLINE | ID: mdl-33472409

ABSTRACT

OBJECTIVES: Type 1 diabetes can have life-shattering consequences for adolescents and parents. A closed-loop system is a cutting-edge technology which automatically regulates glucose to reduce the burden of diabetes management. We explored adolescents' and parents' experiences of using this technology to understand how it affects their biographies and everyday lives. METHODS: In-depth interviews with 18 adolescents newly diagnosed with type 1 diabetes and 21 parents after ≥12 months experience using closed-loop technology. Data were analysed thematically. RESULTS: Participants reported very few disruptions to their lives when using a closed-loop. Reports of family conflict were minimal as the closed-loop enabled dietary flexibility and glucose levels to be checked effortlessly. Adolescents described doing 'normal' activities without worrying about high/low glucose, and parents reported allowing them to do so unsupervised because the closed-loop would regulate their glucose and keep them safe. Some adolescents expressed concerns about the visibility of components and, to avoid stigma, described curtailing activities such as swimming. Participants described how the closed-loop enabled adolescents to be in control of, or create distance from, diabetes. DISCUSSION: The closed-loop has life-enhancing consequences for both adolescents and parents and helps to reduce the biographical disruption of type 1 diabetes in this age group.


Subject(s)
Diabetes Mellitus, Type 1 , Adolescent , Humans , Diabetes Mellitus, Type 1/therapy , Insulin Infusion Systems , Blood Glucose Self-Monitoring , Blood Glucose/analysis , Parents , Insulin/therapeutic use , Hypoglycemic Agents/therapeutic use
3.
BMC Pediatr ; 21(1): 160, 2021 04 04.
Article in English | MEDLINE | ID: mdl-33814007

ABSTRACT

AIMS: To synthesise the qualitative evidence on parents' experiences of caring for a child aged ≤8 years with type 1 diabetes to identify: the challenges they encounter; their views about support received; ways in which support could be improved; and, directions for future research. METHODS: We searched Medline, EMBASE, CINAHL, PsycINFO and Web of Science databases to identify qualitative studies reporting parents' views and experiences of caring for a child with type 1 diabetes aged ≤8 years. Key analytical themes were identified using thematic synthesis. RESULTS: Fourteen studies were included. The synthesis resulted in the generation of two overarching themes. Monopolisation of life describes the all-encompassing impact diabetes could have on parents due to the constant worry they experienced and the perceived need for vigilance. It describes how parents' caring responsibilities could affect their wellbeing, relationships and finances, and how a lack of trusted sources of childcare and a desire to enable a 'normal' childhood constrained personal choices and activities. However, use of diabetes technologies could lessen some of these burdens. Experiences of professional and informal support describes how encounters with healthcare professionals, while generally perceived as helpful, could lead to frustration and anxiety, and how connecting with other parents caring for a child with type 1 diabetes provided valued emotional and practical support. CONCLUSIONS: This synthesis outlines the challenges parents encounter, their views about support received and ways in which support might be improved. It also highlights significant limitations in the current literature and points to important areas for future research, including how sociodemographic factors and use of newer diabetes technologies influence parents' diabetes management practices and experiences. PROSPERO: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42019128710.


Subject(s)
Diabetes Mellitus, Type 1 , Child , Diabetes Mellitus, Type 1/therapy , Family Relations , Health Personnel , Humans , Parents , Qualitative Research
4.
Nutr Bull ; 46(1): 52-59, 2021 Mar.
Article in English | MEDLINE | ID: mdl-33776583

ABSTRACT

With an increasing prevalence of diabetes worldwide, effective dietary strategies for blood glucose control are crucial. As carbohydrates make up approximately 50% of the diet, it is neither practical nor advisable to avoid them altogether. Most of the carbohydrate in the diet is derived from starch, found in potatoes, pasta, rice and bread. These foods are often processed in some way before consumption, yet little is known about the effects processing, such as chilling and reheating, has on the glycaemic response, particularly when the food is consumed in the context of a mixed meal. This article introduces the SPUD project, a BBSRC DRINC-funded initiative. Taking the potato as the model carbohydrate, this project will investigate, via in vitro and in vivo studies, the effects of domestic food processing techniques on the glycaemic response. A final study, utilising intrinsically labelled potato and a dual stable isotope methodology, will model glucose flux data to determine the underlying mechanisms of action.

6.
Diabet Med ; 37(6): 1023-1029, 2020 06.
Article in English | MEDLINE | ID: mdl-31943318

ABSTRACT

AIM: Clinicians mediate access to new technologies. Consequently, their views on specific devices may influence user access to diabetes technology in mainstream care. As yet, little is known about clinicians' views about closed-loop systems. This qualitative study explored clinicians' views on the likely impacts of future closed-loop systems in mainstream diabetes care in England. METHODS: We conducted interviews with 36 clinicians from a range of professional backgrounds in five hospital outpatient clinics (two adult, two pregnancy, one paediatric) in England to explore possible consequences of closed-loop systems for users and clinicians. Data analysis utilized a framework approach. RESULTS: Clinicians reported a range of expected benefits for future users, including improved glucose control and quality of life. Expected burdens included continued need for manual input and the risk of losing basic self-care skills. In terms of future clinical workloads, three clinicians emphasized only positive impacts, seven emphasized both positive and negative impacts, and 17 mentioned only negative impacts. Our most prominent finding, expressed by 24 clinicians, was that closed-loop systems would generate initial challenges due to the need for staff training, user education and support, and new analytical capacities, alongside existing intra-clinic variations in technological experience. CONCLUSIONS: Clinicians recognize the value of closed-loop systems in terms of health benefits, but also identify a range of concerns for both users and healthcare staff, which could impact negatively on user access. Future implementation efforts should address these concerns by providing training and support for healthcare teams, taking varied technological expertise into account.


Subject(s)
Attitude of Health Personnel , Blood Glucose Self-Monitoring , Diabetes Mellitus/drug therapy , Hypoglycemic Agents/administration & dosage , Infusion Pumps, Implantable , Insulin Infusion Systems , Insulin/administration & dosage , Monitoring, Ambulatory , Algorithms , England , Humans , Nurses , Nutritionists , Physicians , Qualitative Research
7.
Diabet Med ; 37(6): 1030-1037, 2020 06.
Article in English | MEDLINE | ID: mdl-31989684

ABSTRACT

AIM: To explore health professionals' views about who would benefit from using a closed-loop system and who should be prioritized for access to the technology in routine clinical care. METHODS: Health professionals (n = 22) delivering the Closed Loop from Onset in type 1 Diabetes (CLOuD) trial were interviewed after they had ≥ 6 months' experience supporting participants using a closed-loop system. Data were analysed thematically. RESULTS: Interviewees described holding strong assumptions about the types of people who would use the technology effectively prior to the trial. Interviewees described changing their views as a result of observing individuals engaging with the closed-loop system in ways they had not anticipated. This included educated, technologically competent individuals who over-interacted with the system in ways which could compromise glycaemic control. Other individuals, who health professionals assumed would struggle to understand and use the technology, were reported to have benefitted from it because they stood back and allowed the system to operate without interference. Interviewees concluded that individual, family and psychological attributes cannot be used as pre-selection criteria and, ideally, all individuals should be given the chance to try the technology. However, it was recognized that clinical guidelines will be needed to inform difficult decisions about treatment allocation (and withdrawal), with young children and infants being considered priority groups. CONCLUSIONS: To ensure fair and equitable access to closed-loop systems, prejudicial assumptions held by health professionals may need to be addressed. To support their decision-making, clinical guidelines need to be made available in a timely manner.


Subject(s)
Attitude of Health Personnel , Diabetes Mellitus, Type 1/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin/administration & dosage , Nurses , Patient Selection , Physicians , Blood Glucose Self-Monitoring , Health Care Rationing , Humans , Infusion Pumps, Implantable , Insulin Infusion Systems , Monitoring, Ambulatory , Qualitative Research , Randomized Controlled Trials as Topic
8.
Br J Hosp Med (Lond) ; 80(11): 665-669, 2019 Nov 02.
Article in English | MEDLINE | ID: mdl-31707881

ABSTRACT

The prevalence of diabetes in the inpatient setting is increasing, and suboptimal glucose control in hospital is associated with increased morbidity and mortality. Attaining the recommended glucose levels is challenging with standard insulin therapy. Hypoglycaemia and hyperglycaemia are common and diabetes management in hospital can be a considerable workload burden for health-care professionals. Fully automated insulin delivery (closed-loop) has been shown to be safe, and achieves superior glucose control than standard insulin therapy in the hospital, including in those patients receiving haemodialysis and enteral or parenteral nutrition where glucose control can be particularly challenging. Evidence that the improved glucose control achieved using closed-loop systems can translate into improved clinical outcomes for patients is key to support widespread adoption of this technology. The closed-loop approach has the potential to provide a paradigm shift in the management of inpatient diabetes, particularly in the most challenging inpatient populations, and may reduce staff work burden and the health-care costs associated with inpatient diabetes.


Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Hyperglycemia/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin Infusion Systems , Insulin/administration & dosage , Adult , Child , Critical Care , Enteral Nutrition , Equipment Design , Hospitalization , Humans , Parenteral Nutrition , Patient Satisfaction , Renal Dialysis , Terminal Care
10.
AJOB Empir Bioeth ; 10(2): 100-112, 2019.
Article in English | MEDLINE | ID: mdl-30986113

ABSTRACT

Increasing ethical attention and debate is focusing on whether individuals who take part in clinical trials should be given access to post-trial care. However, the main focus of this debate has been upon drug trials undertaken in low-income settings. To broaden this debate, we report findings from interviews with individuals (n = 24) who participated in a clinical trial of a closed-loop system, which is a medical device under development for people with type 1 diabetes that automatically adjusts blood glucose to help keep it within clinically recommended ranges. Individuals were recruited from UK sites and interviewed following trial close-out, at which point the closed-loop had been withdrawn. While individuals were stoical and accepting of the requirement to return the closed-loop, they also conveyed varying degrees of distress. Many described having relaxed diabetes management practices while using the closed-loop and having become deskilled as a consequence, which made reverting back to pre-trial regimens challenging. Participants also described unanticipated consequences arising from using a closed-loop. As well as deskilling, these included experiencing psychological and emotional benefits that could not be sustained after the closed-loop had been withdrawn and participants reevaluating their pre- and post-trial life in light of having used a closed-loop and now perceiving this life much more negatively. Participants also voiced frustrations about experiencing better blood glucose control using a closed-loop and then having to revert to using what they now saw as antiquated and imprecise self-management tools. We use these findings to argue that ethical debates about post-trial provisioning need to be broadened to consider potential psychological and emotional harms, and not just clinical harms, that may result from withdrawal of investigated treatments. We also suggest that individuals may benefit from information about potential nonclinical harms to help make informed decisions about trial participation.


Subject(s)
Blood Glucose Self-Monitoring/instrumentation , Diabetes Mellitus, Type 1/drug therapy , Insulin Infusion Systems , Research Subjects/psychology , Self-Management/methods , Withholding Treatment , Adolescent , Adult , Aged , Anxiety , Blood Glucose/metabolism , Blood Glucose Self-Monitoring/psychology , Diabetes Mellitus, Type 1/blood , Female , Health Services Accessibility , Humans , Insulin Infusion Systems/psychology , Interviews as Topic , Male , Middle Aged , Motivation , Psychological Distress , Qualitative Research , Self-Management/psychology , Young Adult
11.
Diabet Med ; 36(12): 1711-1714, 2019 12.
Article in English | MEDLINE | ID: mdl-31002426

ABSTRACT

BACKGROUND: Glucose management for people with diabetes approaching the end of life can be very challenging. The aim is to balance a minimally invasive approach with avoidance of symptomatic hypo- and hyperglycaemia. CASE REPORT: We present a case of a hospitalized individual whose glucose was managed with closed-loop insulin delivery within a randomized controlled trial setting during a period of terminal illness. During the time in which closed-loop insulin delivery was used, glucose control was safe, with no glucose-related harm. The mean ± sd sensor glucose for this individual was 11.3 ± 4.3 mmol/l, percentage of time spent in target glucose range between 6 and 15 mmol/l was 70.5%, time spent in hypoglycaemia was 2.0% and time spent in significant hyperglycaemia >20 mmol/l was 2.6%. CONCLUSION: Closed-loop systems can accommodate personalized glucose targets and highly variable insulin requirements. Factory-calibrated continuous glucose sensors and insulin pump therapy are less intrusive than finger-stick glucose measurements and insulin injections, respectively. Closed-loop systems may provide a safer and less burdensome approach to glucose management towards the end of life.


Subject(s)
Insulin Infusion Systems , Insulin/administration & dosage , Terminal Care/methods , Blood Glucose/analysis , Diabetes Mellitus, Type 2/blood , Diabetes Mellitus, Type 2/drug therapy , Fatal Outcome , Female , Humans
12.
Diabet Med ; 36(3): 279-286, 2019 03.
Article in English | MEDLINE | ID: mdl-30183096

ABSTRACT

The artificial pancreas is now a viable treatment option for people with Type 1 diabetes and has demonstrated improved glycaemic outcomes while also reducing the onus of self-management of Type 1 diabetes. Closed-loop glucose-responsive insulin delivery guided by real-time sensor glucose readings can accommodate highly variable day-to-day insulin requirements and reduce the hypoglycaemia risk observed with tight glycaemic control in Type 1 diabetes. In 2011, the James Lind Alliance research priorities for Type 1 diabetes were produced and priority 3 was to establish whether an artificial pancreas (closed-loop system) for Type 1 diabetes is effective. This review focuses on the progress that has been made in the evolution of closed-loop systems as an effective treatment option for Type 1 diabetes. Development of closed-loop systems has advanced from feasibility evaluations in highly supervised settings over short periods, to clinical studies in free-living, unsupervised conditions lasting several months. The approval in the USA of the first hybrid closed-loop system (MiniMed® 670G pump, Medtronic, Northridge, CA, USA) in 2016 for use in Type 1 diabetes reflects these advancements. We discuss the evidence from clinical studies that closed-loop systems are effective with improved glycaemic outcomes, reduced hypoglycaemia and had positive end-user acceptance in children, adolescents, adults and pregnant women with Type 1 diabetes. We also present the outlook for future closed-loop systems in the treatment of Type 1 diabetes and identify the challenges facing the wide-spread clinical adoption of this technology.


Subject(s)
Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/drug therapy , Insulin Infusion Systems , Insulin/administration & dosage , Pancreas, Artificial , Adolescent , Adult , Blood Glucose/analysis , Blood Glucose/drug effects , Blood Glucose Self-Monitoring/adverse effects , Blood Glucose Self-Monitoring/instrumentation , Blood Glucose Self-Monitoring/methods , Child , Female , Humans , Insulin Infusion Systems/adverse effects , Insulin Infusion Systems/standards , Pancreas, Artificial/adverse effects , Pancreas, Artificial/standards , Pregnancy , Pregnancy in Diabetics/blood , Pregnancy in Diabetics/drug therapy , Treatment Outcome
13.
Diabet Med ; 36(6): 753-760, 2019 06.
Article in English | MEDLINE | ID: mdl-30575114

ABSTRACT

AIMS: We explored whether, how and why moving onto and using a hybrid day-and-night closed-loop system affected people's food choices and dietary practices to better understand the impact of this technology on everyday life and inform recommendations for training and support given to future users. METHODS: Twenty-four adults, adolescents and parents were interviewed before commencing use of the closed-loop system and following its 3-month use. Data were analysed thematically and longitudinally. RESULTS: While participants described preparing and/or eating similar meals to those consumed prior to using a closed-loop, many described feeling more normal and less burdened by diabetes in dietary situations. Individuals also noted how the use of this technology could lead to deskilling (less precise carbohydrate counting) and less healthy eating (increased snacking and portion sizes and consumption of fatty, energy-dense foods) because of the perceived ability of the system to deal with errors in carbohydrate counting and address small rises in blood glucose without a corrective dose needing to be administered. CONCLUSIONS: While there may be quality-of-life benefits to using a closed-loop, individuals might benefit from additional nutritional and behavioural education to help promote healthy eating. Refresher training in carbohydrate counting may also be necessary to help ensure that users are able to undertake diabetes management in situations where the technology might fail or that they take a break from using it.


Subject(s)
Blood Glucose/metabolism , Diabetes Mellitus, Type 1 , Feeding Behavior/physiology , Food Preferences , Insulin Infusion Systems , Insulin/administration & dosage , Adolescent , Adult , Blood Glucose/analysis , Blood Glucose Self-Monitoring/psychology , Blood Glucose Self-Monitoring/statistics & numerical data , Choice Behavior , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/epidemiology , Diet/statistics & numerical data , Female , Food Preferences/psychology , Humans , Insulin Infusion Systems/psychology , Insulin Infusion Systems/statistics & numerical data , Longitudinal Studies , Male , Middle Aged , Parents/psychology , Qualitative Research , Quality of Life , Surveys and Questionnaires , Young Adult
14.
BMC Endocr Disord ; 18(1): 12, 2018 Feb 20.
Article in English | MEDLINE | ID: mdl-29458348

ABSTRACT

BACKGROUND: Continuous glucose monitoring (CGM) enables users to view real-time interstitial glucose readings and provides information on the direction and rate of change of blood glucose levels. Users can also access historical data to inform treatment decisions. While the clinical and psychological benefits of CGM are well established, little is known about how individuals use CGM to inform diabetes self-management. We explored participants' experiences of using CGM in order to provide recommendations for supporting individuals to make optimal use of this technology. METHODS: In-depth interviews (n = 24) with adults, adolescents and parents who had used CGM for ≥4 weeks; data were analysed thematically. RESULTS: Participants found CGM an empowering tool because they could access blood glucose data effortlessly, and trend arrows enabled them to see whether blood glucose was rising or dropping and at what speed. This predicative information aided short-term lifestyle planning and enabled individuals to take action to prevent hypoglycaemia and hyperglycaemia. Having easy access to blood glucose data on a continuous basis also allowed participants to develop a better understanding of how insulin, activity and food impacted on blood glucose. This understanding was described as motivating individuals to make dietary changes and break cycles of over-treating hypoglycaemia and hyperglycaemia. Participants also described how historical CGM data provided a more nuanced picture of blood glucose control than was possible with blood glucose self-monitoring and, hence, better information to inform changes to background insulin doses and mealtime ratios. However, while participants expressed confidence making immediate adjustments to insulin and lifestyle to address impending hypoglycaemia and hypoglycaemia, most described needing and expecting health professionals to interpret historical CGM data and determine changes to background insulin doses and mealtime ratios. While alarms could reinforce a sense of hypoglycaemic safety, some individuals expressed ambivalent views, especially those who perceived alarms as signalling personal failure to achieve optimal glycaemic control. CONCLUSIONS: CGM can be an empowering and motivational tool which enables participants to fine-tune and optimize their blood glucose control. However, individuals may benefit from psycho-social education, training and/or technological support to make optimal use of CGM data and use alarms appropriately.


Subject(s)
Blood Glucose Self-Monitoring/methods , Caregivers/psychology , Diabetes Mellitus, Type 1/blood , Glycated Hemoglobin/analysis , Hyperglycemia/prevention & control , Hypoglycemia/prevention & control , Parents/psychology , Self-Management , Adolescent , Adult , Aged , Diabetes Mellitus, Type 1/psychology , Female , Follow-Up Studies , Humans , Male , Middle Aged , Qualitative Research , Quality of Life , Young Adult
15.
Diabet Med ; 35(3): 347-351, 2018 03.
Article in English | MEDLINE | ID: mdl-28755444

ABSTRACT

AIM: To compare bolus insulin delivery patterns during closed-loop home studies in adults with suboptimally [HbA1c 58-86 mmol/mol (7.5%-10%)] and well-controlled [58 mmol/mol (< 7.5%)] Type 1 diabetes. METHODS: Retrospective analysis of daytime and night-time insulin delivery during home use of closed-loop over 4 weeks. Daytime and night-time controller effort, defined as amount of insulin delivered by closed-loop relative to usual basal insulin delivery, and daytime bolus effort, defined as total bolus insulin delivery relative to total daytime insulin delivery were compared between both cohorts. Correlation analysis was performed between individual bolus behaviour (bolus effort and frequency) and daytime controller efforts, and proportion of time spent within and below sensor glucose target range. RESULTS: Individuals with suboptimally controlled Type 1 diabetes had significantly lower bolus effort (P = 0.038) and daily bolus frequency (P < 0.001) compared with those with well-controlled diabetes. Controller effort during both daytime (P = 0.007) and night-time (P = 0.005) were significantly higher for those with suboptimally controlled Type 1 diabetes. Time when glucose was within the target range (3.9-10.0 mmol/L) during daytime correlated positively with bolus effort (r = 0.37, P = 0.016) and bolus frequency (r = 0.33, P = 0.037). Time when glucose was below the target range during daytime was comparable in both groups (P = 0.36), and did not correlate significantly with bolus effort (r = 0.28, P = 0.066) or bolus frequency (r = -0.21, P = 0.19). CONCLUSION: More frequent bolusing and higher proportion of insulin delivered as bolus during hybrid closed-loop use correlated positively with time glucose was in target range. This emphasises the need for user input and educational support to benefit from this novel therapeutic modality.


Subject(s)
Blood Glucose/metabolism , Diabetes Mellitus, Type 1/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin/administration & dosage , Adult , Diabetes Mellitus, Type 1/blood , Female , Glycated Hemoglobin/metabolism , Home Care Services , Humans , Insulin Infusion Systems , Male , Retrospective Studies
16.
Diabet Med ; 35(4): 460-471, 2018 04.
Article in English | MEDLINE | ID: mdl-29266376

ABSTRACT

Emerging evidence shows that suboptimal glycaemic control is associated with increased morbidity and length of stay in hospital. Various guidelines for safe and effective inpatient glycaemic control in the non-critical care setting have been published. In spite of this, implementation in practice remains limited because of the increasing number of people with diabetes admitted to hospital and staff work burden. The use of technology in the outpatient setting has led to improved glycaemic outcomes and quality of life for people with diabetes. There remains an unmet need for technology utilisation in inpatient hyperglycaemia management in the non-critical care setting. Novel technologies have the potential to provide benefits in diabetes care in hospital by improving efficacy, safety and efficiency. Rapid analysis of glucose measurements by point-of-care devices help facilitate clinical decision-making and therapy adjustment in the hospital setting. Glucose treatment data integration with computerized glucose management systems underpins the effective use of decision support systems and may streamline clinical staff workflow. Continuous glucose monitoring and automation of insulin delivery through closed-loop systems may provide a safe and efficacious tool for hospital staff to manage inpatient hyperglycaemia whilst reducing staff workload. This review summarizes the evidence with regard to technological methods to manage inpatient glycaemic control, their limitations and the future outlook, as well as potential strategies by healthcare organizations such as the National Health Service to mediate the adoption, procurement and use of diabetes technologies in the hospital setting.


Subject(s)
Biomedical Technology/statistics & numerical data , Diabetes Mellitus, Type 1/prevention & control , Diabetes Mellitus, Type 2/prevention & control , Hospitalization , Hyperglycemia/prevention & control , Blood Glucose/metabolism , Blood Glucose Self-Monitoring/instrumentation , Blood Glucose Self-Monitoring/methods , Decision Support Systems, Clinical , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 2/blood , Electronic Health Records , Equipment and Supplies Utilization , Humans , Hypoglycemic Agents/administration & dosage , Insulin Infusion Systems , Inventions/statistics & numerical data , Point-of-Care Systems/statistics & numerical data , State Medicine
17.
Diabet Med ; 34(10): 1461-1469, 2017 10.
Article in English | MEDLINE | ID: mdl-28631849

ABSTRACT

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.


Subject(s)
Blood Glucose/analysis , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/drug therapy , Insulin Infusion Systems , Insulin/administration & dosage , Pregnancy in Diabetics/blood , Pregnancy in Diabetics/drug therapy , Adolescent , Adult , Biosensing Techniques/instrumentation , Biosensing Techniques/methods , Blood Glucose/drug effects , Blood Glucose Self-Monitoring/instrumentation , Blood Glucose Self-Monitoring/methods , Cross-Over Studies , Female , Humans , Middle Aged , Patient Satisfaction , Pregnancy , Surveys and Questionnaires , Young Adult
18.
N Engl J Med ; 373(22): 2129-2140, 2015 Nov 26.
Article in English | MEDLINE | ID: mdl-26379095

ABSTRACT

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.).


Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Hypoglycemic Agents/adverse effects , Insulin Infusion Systems , Insulin/adverse effects , Adolescent , Adult , Algorithms , Child , Cross-Over Studies , Diabetes Mellitus, Type 1/blood , Equipment Design , Female , Glycated Hemoglobin/analysis , Humans , Hypoglycemia/chemically induced , Hypoglycemic Agents/administration & dosage , Infusion Pumps, Implantable , Insulin/administration & dosage , Insulin Infusion Systems/adverse effects , Male , Middle Aged
19.
Diabetes Obes Metab ; 17(12): 1173-9, 2015 Dec.
Article in English | MEDLINE | ID: mdl-26257323

ABSTRACT

AIMS: To evaluate safety, efficacy and glucose turnover during closed-loop with meal announcement using reduced prandial insulin boluses in adolescents with type 1 diabetes (T1D). METHODS: We conducted a randomized crossover study comparing closed-loop therapy with standard prandial insulin boluses versus closed-loop therapy with prandial boluses reduced by 25%. Eight adolescents with T1D [3 males; mean (standard deviation) age 15.9 (1.5) years, glycated haemoglobin 74 (17) mmol/mol; median (interquartile range) total daily dose 0.9 (0.7, 1.1) IU/kg/day] were studied on two 36-h-long visits. In random order, subjects received closed-loop therapy with either standard or reduced insulin boluses administered with main meals (50-80 g carbohydrates) but not with snacks (15-30 g carbohydrates). Stable-label tracer dilution methodology measured total glucose appearance (Ra_total) and glucose disposal (Rd). RESULTS: The median (interquartile range) time spent in target (3.9-10 mmol/l) was similar between the two interventions [74 (66, 84)% vs 80 (65, 96)%; p = 0.87] as was time spent above 10 mmol/l [21.8 (16.3, 33.5)% vs 18.0 (4.1, 34.2)%; p = 0.87] and below 3.9 mmol/l [0 (0, 1.5)% vs 0 (0, 1.8)%; p = 0.88]. Mean plasma glucose was identical during the two interventions [8.4 (0.9) mmol/l; p = 0.98]. Hypoglycaemia occurred once 1.5 h post-meal during closed-loop therapy with standard bolus. Overall insulin delivery was lower with reduced prandial boluses [61.9 (55.2, 75.0) vs 72.5 (63.6, 80.3) IU; p = 0.01] and resulted in lower mean plasma insulin concentration [186 (171, 260) vs 252 (198, 336) pmol/l; p = 0.002]. Lower plasma insulin was also documented overnight [160 (136, 192) vs 191 (133, 252) pmol/l; p = 0.01, pooled nights]. Ra_total was similar [26.3 (21.9, 28.0) vs 25.4 (21.0, 29.2) µmol/kg/min; p = 0.19] during the two interventions as was Rd [25.8 (21.0, 26.9) vs 25.2 (21.2, 28.8) µmol/kg/min; p = 0.46]. CONCLUSIONS: A 25% reduction in prandial boluses during closed-loop therapy maintains similar glucose control in adolescents with T1D whilst lowering overall plasma insulin levels. It remains unclear whether closed-loop therapy with a 25% reduction in prandial boluses would prevent postprandial hypoglycaemia.


Subject(s)
Blood Glucose/analysis , Diabetes Mellitus, Type 1/drug therapy , Hypoglycemia/prevention & control , Hypoglycemic Agents/administration & dosage , Insulin Infusion Systems , Insulin/administration & dosage , Monitoring, Physiologic , Adolescent , Algorithms , Cross-Over Studies , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/metabolism , Drug Administration Schedule , England/epidemiology , Female , Glycemic Load , Humans , Hyperinsulinism/chemically induced , Hyperinsulinism/epidemiology , Hyperinsulinism/prevention & control , Hypoglycemia/chemically induced , Hypoglycemia/epidemiology , Hypoglycemic Agents/adverse effects , Hypoglycemic Agents/blood , Hypoglycemic Agents/therapeutic use , Injections, Subcutaneous , Insulin/adverse effects , Insulin/blood , Insulin/therapeutic use , Insulin Resistance , Male , Meals , Risk
20.
Diabet Med ; 32(8): 987-92, 2015 Aug.
Article in English | MEDLINE | ID: mdl-25819473

ABSTRACT

The development and clinical testing of closed-loop systems (the artificial pancreas) is underpinned by advances in continuous glucose monitoring and benefits from concerted academic and industry collaborative efforts. This review describes the progress of the Artificial Pancreas Project at the University of Cambridge from 2006 to 2014. Initial studies under controlled laboratory conditions, designed to collect representative safety and performance data, were followed by short to medium free-living unsupervised outpatient studies demonstrating the safety and efficacy of closed-loop insulin delivery using a model predictive control algorithm. Accompanying investigations included assessment of the psychosocial impact and key factors affecting glucose control such as insulin kinetics and glucose absorption. Translation to other disease conditions such as critical illness and Type 2 diabetes took place. It is concluded that innovation of iteratively enhanced closed-loop systems will provide tangible means to improve outcomes and quality of life in people with Type 1 diabetes and their families in the next decade.


Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 2/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin Infusion Systems , Insulin/administration & dosage , Pancreas, Artificial , Algorithms , Blood Glucose/metabolism , Blood Glucose Self-Monitoring , Diabetes Mellitus, Type 1/metabolism , Diabetes Mellitus, Type 2/metabolism , Humans
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