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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.
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
3.
Diabet Med ; 36(3): 383-387, 2019 03.
Article in English | MEDLINE | ID: mdl-30307056

ABSTRACT

AIMS: To assess the impact of social deprivation, demographics and centre on HbA1c outcomes with continuous subcutaneous insulin infusion (CSII) in adults with Type 1 diabetes. METHODS: Demographic data, postcode-derived English Index of Multiple Deprivation data and 12-month average HbA1c (mmol/mol) pre- and post-CSII were collated from three diabetes centres in the north west of England, University Hospital of South Manchester (UHSM), Salford Royal Foundation Hospital (SRFT) and Manchester Royal Infirmary (MRI). Univariable and multivariable regression models explored relationships between demographics, Index of Multiple Deprivation, centre and HbA1c outcomes. RESULTS: Data were available for 693 (78%) individuals (UHSM, n = 90; SRFT, n = 112; and MRI, n = 491) of whom 59% were women. Median age at CSII start was 39 (IQR 29.5-49.0) years and median diabetes duration was 20 (11-29) years. Median Index of Multiple Deprivation was 15 193 (6313-25 727). Overall median HbA1c improved from 69 to 64 mmol/mol (8.5% to 8.0%) within the first year of CSII. In multivariable analysis, higher pre-CSII HbA1c was significantly associated with higher deprivation (P = 0.036), being female (P < 0.001), and centre (MRI; P = 0.005). Following pre-CSII HbA1c adjustment, post-CSII HbA1c or HbA1c change were not related to demographic factors and deprivation, but remained significantly related to the centre; UHSM and SRFT had larger reductions in HbA1c with CSII compared with MRI [median -7.0 (-0.6%) vs. -6.0 (-0.55%) vs. -4.5 (-0.45%) mmol/mol; P = 0.005]. CONCLUSIONS: Higher pre-CSII HbA1c levels were associated with higher deprivation and being female. CSII improves HbA1c irrespective of social deprivation and demographics. Significant differences in HbA1c improvements were observed between centres. Further work is warranted to explain these differences and minimize variation in clinical outcomes with CSII.


Subject(s)
Cultural Deprivation , Diabetes Mellitus, Type 1 , Glycated Hemoglobin/metabolism , Health Services Accessibility/statistics & numerical data , Insulin Infusion Systems , Insulin/administration & dosage , Adult , Blood Glucose/metabolism , Demography , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/epidemiology , England/epidemiology , Female , Geography , Glycated Hemoglobin/analysis , Humans , Infusions, Subcutaneous , Male , Middle Aged , Psychological Distance , Retrospective Studies , Treatment Outcome
4.
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
5.
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
6.
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
7.
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
9.
Diabet Med ; 32(5): 601-8, 2015 May.
Article in English | MEDLINE | ID: mdl-25615888

ABSTRACT

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.


Subject(s)
Ambulatory Care , Diabetes Mellitus, Type 1/drug therapy , Insulin Infusion Systems/classification , Insulin Infusion Systems/psychology , Insulin/administration & dosage , Insulin/therapeutic use , Self Care , Adult , Anxiety/epidemiology , Blood Glucose/metabolism , Cross-Over Studies , Diabetes Mellitus, Type 1/blood , Diabetes Mellitus, Type 1/psychology , Female , Humans , Hypoglycemic Agents/administration & dosage , Hypoglycemic Agents/therapeutic use , Incidence , Interview, Psychological , Male , Middle Aged , Patient Satisfaction , Psychology , Surveys and Questionnaires , Treatment Outcome
10.
Diabetes Obes Metab ; 17(5): 452-8, 2015 May.
Article in English | MEDLINE | ID: mdl-25492378

ABSTRACT

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.


Subject(s)
Diabetes Mellitus, Type 1/drug therapy , Hypoglycemic Agents/administration & dosage , Insulin Infusion Systems , Insulin/administration & dosage , Adolescent , Adult , Algorithms , Blood Glucose/metabolism , Blood Glucose Self-Monitoring/methods , Cross-Over Studies , Diabetes Mellitus, Type 1/blood , Female , Glycated Hemoglobin/metabolism , Humans , Hypoglycemia/drug therapy , Male , Middle Aged , Time Factors , Treatment Outcome
11.
Diabetes Obes Metab ; 16(6): 500-9, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24267153

ABSTRACT

Inpatient glycaemic control remains an important issue due to the increasing number of patients with diabetes admitted to hospital. Morbidity and mortality in hospital are associated with poor glucose control, and cost of hospitalization is higher compared to non-diabetes patients. Guidelines for inpatient glycaemic control in the non-critical care setting have been published. Current recommendations include basal-bolus insulin therapy, regular glucose monitoring, as well as enhancing healthcare provider's role and knowledge. In spite of growing focus, implementation in practice is limited, mainly due to increasing workload burden on staff and fear of hypoglycaemia. Advances in healthcare technology may contribute to an improvement of inpatient diabetes care. Integration of glucose measurements with healthcare records and computerized glycaemic control protocols are currently being used in some institutions. Recent interests in continuous glucose monitoring have led to studies assessing its utilization in inpatients. Automation of glucose monitoring and insulin delivery may provide a safe and efficacious tool for hospital staff to manage inpatient hyperglycaemia, whilst reducing staff workload. This review summarizes the evidence on current approaches to managing inpatient glycaemic control; its utility and limitations. We conclude by discussing the evidence from feasibility studies to date, on the potential use of closed loop in the non-critical care setting and its implication for future studies.


Subject(s)
Blood Glucose/drug effects , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/metabolism , Hyperglycemia/drug therapy , Insulin/therapeutic use , Humans , Hypoglycemic Agents/therapeutic use , Severity of Illness Index
12.
Diabetes Obes Metab ; 16(11): 1174-8, 2014 Nov.
Article in English | MEDLINE | ID: mdl-24909206

ABSTRACT

We evaluated the safety and efficacy of closed-loop therapy with meal announcement during reduction and omission of meal insulin boluses in adolescents with type 1 diabetes (T1D). Twelve adolescents with T1D [six male; mean (s.d.) age 15.9 (1.8) years; mean (s.d.) glycated haemoglobin (HbA1c) 77 (27) mmol/mol] were studied in a randomized crossover study comparing closed-loop therapy with meal announcement with conventional pump therapy over two 24-h stays at a clinical research facility. Identical meals were given on both occasions. The evening meal insulin bolus was calculated to cover half of the carbohydrate content of the meal and no bolus was delivered for lunch. Plasma glucose levels were in the target range of 3.9-10 mmol/l for a median [interquartile range (IQR)] of 74 (55,86)% of the time during closed-loop therapy with meal announcement and for 62 (49,75)% of the time during conventional therapy (p = 0.26). Median (IQR) time spent with plasma glucose levels > 10 mmol/l [23 (13,39) vs. 27 (10,50)%; p = 0.88] or < 3.9 mmol/l [1(0,4) vs. 5 (1,10)%; p = 0.24] and mean [standard deviation (SD)] glucose levels [8.0 (7.6,9.3) vs. 7.7 (6.6,10.1) mmol/l, p = 0.79] were also similar. In conclusion, these results assist home testing of closed-loop delivery with meal announcement in adolescents with poorly controlled T1D who miscalculate or miss meal insulin boluses.


Subject(s)
Blood Glucose/metabolism , Diabetes Mellitus, Type 1/drug therapy , Glycated Hemoglobin/metabolism , Hypoglycemic Agents/administration & dosage , Insulin Infusion Systems , Insulin/administration & dosage , Adolescent , Algorithms , Cross-Over Studies , Diabetes Mellitus, Type 1/blood , Female , Humans , Male , Meals , Treatment Outcome
13.
Ir J Med Sci ; 190(3): 999-1004, 2021 Aug.
Article in English | MEDLINE | ID: mdl-33231831

ABSTRACT

BACKGROUND: There is limited data on glycaemic control and cardiovascular risk factor management in newly diagnosed individuals with type 1 diabetes in the first 2 years. METHODS: Retrospective, single centre study from the North West of England, newly diagnosed with type 1 diabetes between 2014 and 2018 (n = 58). HbA1c, blood pressure, lipids and body mass index (BMI) data were collected from electronic patient records from the time of diagnosis until the end of 2 years, stratified by age 16-24 years or ≥ 25 years at presentation. RESULTS: For those aged 16-24 years (n = 31), median (IQR), HbA1c improved at 6 months from 83 (63-93) to 51.5 (46-75) mmol/mol (p = 0.001) and remained stable 6-24 months. For those ≥ 25 years (n = 27), HbA1c declined from 91 (70-107) to 65 (50-89) mmol/mol, (p < 0.01) at 6 months and declined further to 52 mmol/mol (44-70) at 24 months. At 24 months, 27.8% of all individuals had an HbA1c ≥ 69 mmol/mol. Approximately, a third met LDL (< 2 mmol/L) and total cholesterol (< 4 mmol/L) targets. A total of 58.6% of individuals were overweight/obese (BMI > 25 kg/m2) at 24 months compared to 45.8% at baseline. There were no significant blood pressure changes during the follow-up. CONCLUSIONS: In both age groups, significant improvement of HbA1c occurred within the first 6 months of diagnosis with no statistical difference between the two groups at any of the time points up to 24 months. Despite significant improvements in HbA1c, majority had levels > 53 mmol/mol at 24 months. Alongside the high incidence of obesity and dyslipidaemia, our data support the need for further intensification of therapy from diagnosis of type 1 diabetes.


Subject(s)
Diabetes Mellitus, Type 1 , Glycated Hemoglobin , Adolescent , Adult , Blood Glucose , Blood Pressure , Body Mass Index , Diabetes Mellitus, Type 1/drug therapy , Diabetes Mellitus, Type 1/epidemiology , Female , Glycated Hemoglobin/analysis , Humans , Infant , Retrospective Studies , Young Adult
14.
BMJ Open ; 11(7): e050713, 2021 07 14.
Article in English | MEDLINE | ID: mdl-34261691

ABSTRACT

INTRODUCTION: Optimising glycaemic control in type 1 diabetes (T1D) remains challenging. Flash glucose monitoring with FreeStyle Libre 2 (FSL2) is a novel alternative to the current standard of care self-monitoring of blood glucose (SMBG). No randomised controlled trials to date have explored the potential benefits of FSL2 in T1D. We aim to assess the impact of FSL2 in people with suboptimal glycaemic control T1D in comparison with SMBG. METHODS: This open-label, multicentre, randomised (via stochastic minimisation), parallel design study conducted at eight UK secondary and primary care centres will aim to recruit 180 people age ≥16 years with T1D for >1 year and glycated haemoglobin (HbA1c) 7.5%-11%. Eligible participants will be randomised to 24 weeks of FSL2 (intervention) or SMBG (control) periods, after 2-week of blinded sensor wear. Participants will be assessed virtually or in-person owing to the COVID-19 pandemic. HbA1c will be measured at baseline, 12 and 24 weeks (primary outcome). Participants will be contacted at 4 and 12 weeks for glucose optimisation. Control participants will wear a blinded sensor during the last 2 weeks. Psychosocial outcomes will be measured at baseline and 24 weeks. Secondary outcomes include sensor-based metrics, insulin doses, adverse events and self-report psychosocial measures. Utility, acceptability, expectations and experience of using FSL2 will be explored. Data on health service resource utilisation will be collected. ANALYSIS: Efficacy analyses will follow intention-to-treat principle. Outcomes will be analysed using analysis of covariance, adjusted for the baseline value of the corresponding outcome, minimisation factors and other known prognostic factors. Both within-trial and life-time economic evaluations, informed by modelling from the perspective of the National Health Service setting, will be performed. ETHICS: The study was approved by Greater Manchester West Research Ethics Committee (reference 19/NW/0081). Informed consent will be sought from all participants. TRIAL REGISTRATION NUMBER: NCT03815006. PROTOCOL VERSION: 4.0 dated 29 June 2020.


Subject(s)
COVID-19 , Diabetes Mellitus, Type 1 , Adolescent , Blood Glucose , Blood Glucose Self-Monitoring , Diabetes Mellitus, Type 1/drug therapy , Humans , Hypoglycemic Agents , Multicenter Studies as Topic , Pandemics , Randomized Controlled Trials as Topic , SARS-CoV-2 , State Medicine , United Kingdom
15.
Ir Med J ; 101(6): 177-80, 2008 Jun.
Article in English | MEDLINE | ID: mdl-18700512

ABSTRACT

We compared the glycemic and cardiovascular risk status of non-Caucasian patients with type 2 diabetes mellitus (T2DM) who recently emigrated to Ireland with a matched population of Irish patients. We identified 105 non-Caucasian patients with T2DM who recently emigrated to Ireland and compared them with 105 Irish patients with T2DM, who were matched for age, sex and duration of diabetes. Immigrants with T2DM had significantly worse initial (9.8% vs 9.1%, p<0.05) and on-going (8.3% vs 7.1, p<0.05) glycemic control and higher microalbumin to creatinine ratio compared to the Irish patients. A greater proportion of immigrants with T2DM were on insulin therapy for their diabetes. Irish patients had significantly higher fasting triglyceride concentrations compared to the immigrants (1.9+/-0.1 mmol/l vs 1.6+/-0.1 mmol/l, p<0.05). This vulnerable population of immigrants with T2DM is currently at higher risk of complications of diabetes and warrants greater attention to glycemic control and control of other risk factors.


Subject(s)
Blood Glucose , Diabetes Mellitus, Type 2/epidemiology , Emigrants and Immigrants/statistics & numerical data , Emigration and Immigration/statistics & numerical data , Adult , Case-Control Studies , Databases as Topic , Diabetes Mellitus, Type 2/physiopathology , Diabetes Mellitus, Type 2/prevention & control , Female , Humans , Ireland/epidemiology , Male , Middle Aged , Risk Factors , Time Factors , Triglycerides/blood
17.
J Clin Endocrinol Metab ; 99(6): 2225-32, 2014 Jun.
Article in English | MEDLINE | ID: mdl-24606105

ABSTRACT

CONTEXT: Discontinuation of anti-hyperglycemic oral agents and initiation of insulin is recommended in certain clinical situations for inpatients with type 2 diabetes (T2D). The effects on glucose turnover when these agents are acutely withdrawn are poorly understood and may be of importance when insulin therapy is initiated. OBJECTIVE: Our objective was to investigate alterations in glucose turnover after acute withdrawal of noninsulin therapy. DESIGN AND SETTING: This was a randomized crossover study at a clinical research facility. PARTICIPANTS: Participants included 12 insulin-naive subjects with T2D. METHODS: Subjects attended two 24-hour visits. Standard therapy was discontinued and replaced by closed-loop insulin delivery during the intervention visit. Usual anti-hyperglycemic therapy was continued during the control visit. Systemic glucose appearance (Ra) and glucose disposal (Rd) were measured using a tracer dilution technique with iv [6,6-(2)H2]glucose. RESULTS: Plasma glucose profiles during both visits were comparable (P = .48). Glucose Ra increased during the day (21.4 [19.5, 23.5] vs 18.6 [17.0, 21.6) µmol/kg/min, P = .019) and decreased overnight (9.7 [8.5, 11.4] vs 11.6 [10.3, 12.9] µmol/kg/min, P = .004) when the usual therapy was discontinued and replaced with insulin. Increased daytime glucose Rd (21.2 [19.4, 23.9] vs 18.8 [18.3, 21.7] µmol/kg/min, P = .002) and decreased overnight Rd (10.4 [9.1, 12.0] vs 11.8 [10.7, 13.7] µmol/kg/min, P = .005) were observed when the usual therapy was discontinued, whereas daytime peripheral insulin sensitivity was reduced (47.8 [24.8, 66.1] vs 62.5 [34.8, 75.8] nmol/kg/min per pmol/L, P = .034). CONCLUSION: In T2D, acute discontinuation of anti-hyperglycemic therapy and replacement with insulin increases postprandial Ra and reduces peripheral insulin sensitivity. Insulin dose initiation may need to compensate for these alterations.


Subject(s)
Blood Glucose/metabolism , Diabetes Mellitus, Type 2/drug therapy , Drug Substitution , Hypoglycemic Agents/therapeutic use , Insulin/administration & dosage , Adult , Aged , Diabetes Mellitus, Type 2/metabolism , Female , Humans , Insulin/blood , Insulin Infusion Systems , Insulin Resistance , Male , Middle Aged , Treatment Outcome , Withholding Treatment
18.
Article in English | MEDLINE | ID: mdl-24616778

ABSTRACT

UNLABELLED: Silent myocardial ischaemia (SMI), defined as objective evidence of myocardial ischaemia in the absence of symptoms, has important clinical implications for the patient with coronary artery disease. We present a dramatic case of SMI in a diabetes patient who attended annual review clinic with ST elevation myocardial infarction. His troponin was normal on admission but raised to 10.7 ng/ml (normal <0.5) when repeated the next day. His angiogram showed diffused coronary artery disease. We here discuss the implications of silent ischaemia for the patient and for the physician caring for patients with diabetes. LEARNING POINTS: Silent myocardial ischaemia (SMI) is an important clinical entity.SMI is common and occurs with increased frequency in patients with diabetes.SMI is an independent predictor of mortality.Recognition may lead to early intervention.

19.
Ir J Med Sci ; 181(4): 549-53, 2012 Dec.
Article in English | MEDLINE | ID: mdl-22467184

ABSTRACT

BACKGROUND AND METHODS: Joint diabetes renal (JDR) clinics are recommended as the appropriate model of care to manage advanced diabetic-associated renal failure. We performed a retrospective review of clinical data and records of the first 60 patients who attended our service and their follow-up at 12 months. RESULTS: Of the patients, 88 % had type 2 diabetes. At the first visit, 43 % had retinopathy, 56 % had neuropathy, 48 % had overt cardiovascular disease, 13 % had a previous history of stroke and 36 % peripheral arterial disease. Ten percent had lower limb amputation and 33 % had never previously seen a diabetologist. Fifteen percent were still on metformin despite significant renal impairment, while 43 % were on three or more different antihypertensives. Sixty-eight percent were either on an ACE inhibitor or angiotensin receptor blocker. At 12 months, a trend towards a reduction in HbA1c (7.6 ± 2.0 vs. 7.0 ± 1.6 %, p = 0.14) and systolic (159.4 ± 30.8 vs. 141.8 ± 35.5 mmHg, p = 0.13) and diastolic blood pressure (73.2 ± 9.3 vs. 69.2 ± 9.4 mmHg, p = 0.075) was observed. No significant differences were found in the lipid profile or creatinine clearance within the group. CONCLUSION: Thirty-three percent of patients with advanced diabetic nephropathy had never previously seen a diabetes consultant and a significant proportion had other diabetes-related complications. Patients with diabetic nephropathy may therefore benefit from having a multidisciplinary input at a joint diabetes renal clinic.


Subject(s)
Diabetes Complications/epidemiology , Diabetes Complications/therapy , Diabetic Nephropathies/therapy , Referral and Consultation/statistics & numerical data , Renal Insufficiency/therapy , Aged , Female , Follow-Up Studies , Health Facilities , Humans , Ireland/epidemiology , Male , Middle Aged , Prevalence , Retrospective Studies , Risk Factors , Treatment Outcome
20.
Diabetes Res Clin Pract ; 86(3): 208-12, 2009 Dec.
Article in English | MEDLINE | ID: mdl-19783061

ABSTRACT

AIMS: Executive function (EF) comprises a set of cognitive skills that controls the execution of complex activities. In the context of diabetes, this may include patients' self-monitoring and daily management of their condition. We compared two different measures of EF in a population of elderly patients with type 2 diabetes mellitus (T2DM) and studied its relationship with diabetes self-care. METHODS: Fifty patients (34 males) had EF assessed using Frontal Assessment Battery (FAB) and Executive Interview 25 (EXIT25). Diabetes self-care was assessed using the Summary of Diabetes Self-Care Activities (SDSCA) scale. Haemoglobin A1c (HbA1c), lipid levels, blood pressure and diabetes duration were recorded. RESULTS: The mean age of the patients was 67.0+/-7.5 years and mean duration of diabetes was 8.1+/-6.4 years. Mean HbA1c was 7.0+/-1.2%, and mean fasting plasma glucose, cholesterol and LDL-C were 7.0+/-1.7mM, 4.0+/-0.9mM and 2.1+/-0.7mM respectively. Mean EXIT25 score was 9.5+/-4.6 in the range of normal EF (14% had EXIT25 score>15, indicating impaired EF). Mean FAB score was 13.7+/-3.3 (48% having scores<15, indicating impaired EF), suggesting a degree of dysexecutive syndrome involving frontal lobe functions. EXIT25 score was inversely correlated with SDSCA (r=-0.3, p<0.05) but no significant correlation between FAB and SDSCA or HbA1c, diabetes duration, lipid levels and blood pressure with EXIT25, FAB or SDCSA was found. CONCLUSION: A substantial proportion of elderly patients with T2DM may have dysexecutive syndrome and impairment in EF may impact on self-care in this group.


Subject(s)
Cognition , Diabetes Mellitus, Type 2/psychology , Executive Function/physiology , Geriatric Assessment/methods , Self Care , Age of Onset , Aged , Blood Glucose/analysis , Blood Pressure , Body Mass Index , Cognition Disorders/epidemiology , Cognition Disorders/psychology , Diabetes Mellitus, Type 2/blood , Glycated Hemoglobin/analysis , Humans , Interviews as Topic , Lipids/blood , MMPI , Middle Aged
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