Publications by authors named "Pratik Choudhary"

101 Publications

Individual, healthcare professional and system-level barriers and facilitators to initiation and adherence to injectable therapies for type 2 diabetes: A systematic review and meta-ethnography.

Diabet Med 2021 Aug 25:e14678. Epub 2021 Aug 25.

Leicester Research Centre, University of Leicester, Leicester, UK.

Aims: To review and synthesise the contemporary qualitative evidence, relating to the individual, healthcare professional and system-level barriers and facilitators to injectable therapies in people with type 2 diabetes, and evaluate (using an intersectional approach to explore the diverse perspectives of different identities) whether views have changed with treatment and guideline advancements.

Methods: A meta-ethnography approach used. Eight databases searched from the years 2006 (GLP-1 analogues introduced) to February 2021. Study selection (using a pre-defined inclusion criteria), quality appraisal and data extraction, conducted independently by two reviewers.

Results: Screened 7143 abstracts, assessed 93 full-text papers for eligibility and included 42 studies-using data from 818 individuals with type 2 diabetes and 160 healthcare professionals. Studies covered a diverse range of views from healthcare professionals and individuals, including those relating to older adults and people from ethnic migrant backgrounds, and 10 studies rated moderate to strong research value. Key themes abstracted: barriers (physical/psychological/social) and facilitators (motivation/capability/opportunity).

Conclusions: The first synthesis of contemporary qualitative data to adopt an intersectionality approach and explore diverse views relating to barriers and facilitators that influence engagement with injectable treatments for type 2 diabetes. A model is presented to help patients, health practitioners and policy makers identify barriers and facilitators and understand the complex interplay of physical, psychological and social factors involved when prescribing injectable therapies. Despite advances in injectable treatments and guidelines, findings highlight the many barriers that still exist and show how strongly held culturally-specific health beliefs of people from diverse socio-economic and ethnic backgrounds can become substantial obstacles to treatment.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/dme.14678DOI Listing
August 2021

The Challenge of Sustainable Access to Telemonitoring Tools for People with Diabetes in Europe: Lessons from COVID-19 and Beyond.

Diabetes Ther 2021 Sep 14;12(9):2311-2327. Epub 2021 Aug 14.

Danish Centre for Health Economics (DaCHE), Faculty of Health Sciences, University of Southern Denmark, Odense, Denmark.

Telemedicine in diabetes care has been evolving over several years, particularly since the advent of cloud-connected technologies for diabetes management, such as glucose monitoring devices, including continuous glucose monitoring (CGM) systems, that facilitate sharing of glucose data between people with diabetes and their healthcare professionals in near-real time. Extreme social distancing and shielding in place for vulnerable patients during the COVID-19 pandemic has created both the challenge and the opportunity to provide care at a distance on a large scale. Available evidence suggests that glucose control has in fact improved during this period for people with diabetes who are able to use CGM devices for remote glucose monitoring. The development of telemedicine as part of the standard of care in diabetes faces significant challenges in the European context, particularly in terms of providing consistent and effective care at a distance to large populations of patients while using robust systems that can be supported by large regional and national healthcare services. These challenges include a fragmented approach to healthcare technology assessment and reimbursement, lack of eHealth education and literacy, particularly amongst healthcare professionals, lack of data integration, as well as concerns about electronic health records, patient consent and privacy. Here we review the benefits of and challenges to wider application of telemedicine and telemonitoring in the post-pandemic future, with the aim to ensure that the value of these eHealth services is provided to patients, healthcare providers and health systems.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s13300-021-01132-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8363869PMC
September 2021

Toward an Optimal Definition of Hypoglycemia with Continuous Glucose Monitoring.

Comput Methods Programs Biomed 2021 Sep 27;209:106303. Epub 2021 Jul 27.

Department of Diabetes, School of Life Course Sciences, King's College London, UK; Department of Diabetes, University of Leicester, UK. Electronic address:

Background And Objective: As continuous glucose monitoring (CGM) becomes common in research and clinical practice, there is a need to understand how CGM-based hypoglycemia relates to hypoglycemia episodes defined conventionally as patient reported hypoglycemia (PRH). Data show that CGM identify many episodes of low interstitial glucose (LIG) that are not experienced by patients, and so the aim of this study is to use different PRH simulations to optimize CGM parameters of threshold (h) and duration (d) to provide the best PRH detection performance.

Methods: The algorithm uses particle Markov chain Monte Carlo optimization to identify the optimal h and d which maximize an objective function for detecting PRH. We tested our algorithm by creating three different cases of PRH simulations.

Results: We added three types of simulated PRH events to 10 weeks of anonymized CGM data from 96 type 1 diabetes people to see if the algorithm can detect the optimal parameters set out in the simulations. In simulation 1, we changed the locations of PRHs with respect to LIG episodes in the CGM signal to simulate random optimal LIG parameters for every individual. In simulation 2, the PRHs are CGM glucose <3.9 mmol/L followed by at least 20 min of rise > 0.11 mmol/L/min. Simulation 3 is like simulation 2 but with glucose threshold of 3.0 mmol/L. The median [interquartile range] of deviation between the optimized (found by the algorithm) and the optimal (known) h and d are -0.07% [-0.4, 1.9] and -1.3% [-5.9, 6.8], respectively across the subjects for simulation 1. The mean [min max] of the optimized LIG parameters are h = 3.8 [3.7, 3.8] mmol/L and d = 12 [10, 14] min for simulation 2 and they are h = 3.0 [2.9, 3] mmol/L and d = 10 [8, 14] min for simulation 3 across a 10-fold cross validation.

Conclusions: This work demonstrates the feasibility of the algorithm to find the best-fit definition of CGM-based hypoglycemia for PRH detection. In a prospective clinical study collecting CGM and PRH, the current algorithm will be used to optimize the definition of hypoglycemia with respect to PRH with the ambition of using the resulted definition as a surrogate for PRH in clinical practice.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.cmpb.2021.106303DOI Listing
September 2021

The impact of islet mass, number of transplants, and time between transplants on graft function in a national islet transplant program.

Am J Transplant 2021 Aug 5. Epub 2021 Aug 5.

Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK.

The UK islet allotransplant program is nationally funded to deliver one or two transplants over 12 months to individuals with type 1 diabetes and recurrent severe hypoglycemia. Analyses were undertaken 10 years after program inception to evaluate associations between transplanted mass; single versus two transplants; time between two transplants and graft survival (stimulated C-peptide >50 pmol/L) and function. In total, 84 islet transplant recipients were studied. Uninterrupted graft survival over 12 months was attained in 23 (68%) single and 47 (94%) (p = .002) two transplant recipients (separated by [median (IQR)] 6 (3-8) months). 64% recipients of one or two transplants with uninterrupted function at 12 months sustained graft function at 6 years. Total transplanted mass was associated with Mixed Meal Tolerance Test stimulated C-peptide at 12 months (p < .01). Despite 1.9-fold greater transplanted mass in recipients of two versus one islet infusion (12 218 [9291-15 417] vs. 6442 [5156-7639] IEQ/kg; p < .0001), stimulated C-peptide was not significantly higher. Shorter time between transplants was associated with greater insulin dose reduction at 12 months (beta -0.35; p = .02). Graft survival over the first 12 months was greater in recipients of two versus one islet transplant in the UK program, although function at 1 and 6 years was comparable. Minimizing the interval between 2 islet infusions may maximize cumulative impact on graft function.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/ajt.16785DOI Listing
August 2021

Telemonitoring, Telemedicine and Time in Range During the Pandemic: Paradigm Change for Diabetes Risk Management in the Post-COVID Future.

Diabetes Ther 2021 Sep 2;12(9):2289-2310. Epub 2021 Aug 2.

Abbott Diabetes Care, Wiesbaden, Germany.

People with diabetes are at greater risk for negative outcomes from COVID-19. Though this risk is multifactorial, poor glycaemic control before and during admission to hospital for COVID-19 is likely to contribute to the increased risk. The COVID-19 pandemic and restrictions on mobility and interaction can also be expected to impact on daily glucose management of people with diabetes. Telemonitoring of glucose metrics has been widely used during the pandemic in people with diabetes, including adults and children with T1D, allowing an exploration of the impact of COVID-19 inside and outside the hospital setting on glycaemic control. To date, 27 studies including 69,294 individuals with T1D have reported the effect of glycaemic control during the COVID-19 pandemic. Despite restricted access to diabetes clinics, glycaemic control has not deteriorated for 25/27 cohorts and improved in 23/27 study groups. Significantly, time in range (TIR) 70-180 mg/dL (3.9-10 mmol/L) increased across 19/27 cohorts with a median 3.3% (- 6.0% to 11.2%) change. Thirty per cent of the cohorts with TIR data reported an average clinically significant TIR improvement of 5% or more, possibly as a consequence of more accurate glucose monitoring and improved connectivity through telemedicine. Periodic consultations using telemedicine enables care of people with diabetes while limiting the need for in-person attendance at diabetes clinics. Reports that sustained hyperglycaemia and early-stage diabetic ketoacidosis may go untreated because of the lockdown and concerns about potential exposure to the risk of infection argue for wider access to glucose telemonitoring. Therefore, in this paper we have critically reviewed reports concerning use of telemonitoring in the acute hospitalized setting as well as during daily diabetes management. Furthermore, we discuss the indications and implications of adopting telemonitoring and telemedicine in the present challenging time, as well as their potential for the future.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s13300-021-01114-xDOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8327601PMC
September 2021

Design of clinical trials to assess diabetes treatment: Minimum duration of continuous glucose monitoring data to estimate time-in-ranges with the desired precision.

Diabetes Obes Metab 2021 Jul 1. Epub 2021 Jul 1.

Department of Information Engineering, University of Padova, Padova, Italy.

Aim: To compute the uncertainty of time-in-ranges, such as time in range (TIR), time in tight range (TITR), time below range (TBR) and time above range (TAR), to evaluate glucose control and to determine the minimum duration of a trial to achieve the desired precision.

Materials And Methods: Four formulas for the aforementioned time-in-ranges were obtained by estimating the equation's parameters on a training set extracted from study A (226 subjects, ~180 days, 5-minute Dexcom G4 Platinum sensor). The formulas were then validated on the remaining data. We also illustrate how to adjust the parameters for sensors with different sampling rates. Finally, we used study B (45 subjects, ~365 days, 15-minute Abbott Freestyle Libre sensor) to further validate our results.

Results: Our approach was effective in predicting the uncertainty when time-in-ranges are estimated using n days of continuous glucose monitoring (CGM), matching the variability observed in the data. As an example, monitoring a population with TIR = 70%, TITR = 50%, TBR = 5% and TAR = 25% for 30 days warrants a precision of ±3.50%, ±3.68%, ±1.33% and ±3.66%, respectively.

Conclusions: The presented approach can be used to both compute the uncertainty of time-in-ranges and determine the minimum duration of a trial to achieve the desired precision. An online tool to facilitate its implementation is made freely available to the clinical investigator.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/dom.14483DOI Listing
July 2021

Does nocturnal hypoglycaemia really improve quality of life?

Diabetologia 2021 Aug 20;64(8):1893-1894. Epub 2021 May 20.

Department of Psychology, University of Southern Denmark, Odense, Denmark.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s00125-021-05475-7DOI Listing
August 2021

A real-world study of user characteristics, safety and efficacy of open-source closed-loop systems and Medtronic 670G.

Diabetes Obes Metab 2021 08 9;23(8):1989-1994. Epub 2021 Jun 9.

Department of Diabetes, School of Life Course Sciences, King's College London, London, UK.

We report a real-world evaluation of the first commercially approved automated insulin delivery (AID) system, MiniMed 670G (670G), and open source-automated insulin delivery (OS-AID) systems. This was undertaken as a retrospective observational study in adults with type 1 diabetes using AID systems for 6 months or longer in a publicly funded health service using clinically validated data. Sixty-eight adults (38 670G, 30 OS-AID systems) were included. OS-AID system users were younger, had a shorter diabetes duration and a higher education status. OS-AID systems displayed a significantly better change in HbA1c (median -0.9% [-0.4%, -1.1%] vs. -0.1% [IQR -0.7%, 0.2%], P = .004) and time in range 3.9-10 mmol/L (mean 78.5%, SD ± 12.0% vs. 68.2% ± 14.7%, P = .024) compared with 670G. Both systems showed minimal hypoglycaemia, with OS-AID systems revealing significantly improved secondary outcomes of mean glucose and percentage of time more than 10 mmol/L, with a higher percentage of time of less than 3 mmol/L. OS-AID system users displayed improved glycaemic outcomes with no clinical safety concerns compared with 670G, although higher weight-adjusted insulin dose and weight gain were noted. The study highlights key differences in OS-AID system user characteristics that are important for interpreting real-world findings from recent OS-AID system studies.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/dom.14439DOI Listing
August 2021

Impact of Carbohydrate Counting Error on Glycemic Control in Open-Loop Management of Type 1 Diabetes: Quantitative Assessment Through an in silico Trial.

J Diabetes Sci Technol 2021 May 12:19322968211012392. Epub 2021 May 12.

Department of Information Engineering, University of Padova, Padova, Italy.

Background: In the management of type 1 diabetes (T1D), systematic and random errors in carb-counting can have an adverse effect on glycemic control. In this study, we performed an in silico trial aiming at quantifying the impact of different levels of carb-counting error on glycemic control.

Methods: The T1D patient decision simulator was used to simulate 7-day glycemic profiles of 100 adults using open-loop therapy. The simulation was repeated for different values of systematic and random carb-counting errors, generated with Gaussian distribution varying the error mean from -10% to +10% and standard deviation (SD) from 0% to 50%. The effect of the error was evaluated by computing the difference of time inside (∆TIR), above (∆TAR) and below (∆TBR) the target glycemic range (70-180mg/dl) compared to the reference case, that is, absence of error. Finally, 3 linear regression models were developed to mathematically describe how error mean and SD variations result in ∆TIR, ∆TAR, and ∆TBR changes.

Results: Random errors globally deteriorate the glycemic control; systematic underestimations lead to, on average, up to 5.2% more TAR than the reference case, while systematic overestimation results in up to 0.8% more TBR. The different time in range metrics were linearly related with error mean and SD (>0.95), with slopes of , for ∆TIR, , for ∆TAR, and , for ∆TBR.

Conclusions: The quantification of carb-counting error impact performed in this work may be useful understanding causes of glycemic variability and the impact of possible therapy adjustments or behavior changes in different glucose metrics.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/19322968211012392DOI Listing
May 2021

Hypoglycaemia detection and prediction techniques: A systematic review on the latest developments.

Diabetes Metab Res Rev 2021 Mar 15:e3449. Epub 2021 Mar 15.

Department of Endocrinology, Diabetes, Nutrition, Montpellier University Hospital, Montpellier, France.

The main objective of diabetes control is to correct hyperglycaemia while avoiding hypoglycaemia, especially in insulin-treated patients. Fear of hypoglycaemia is a hurdle to effective correction of hyperglycaemia because it promotes under-dosing of insulin. Strategies to minimise hypoglycaemia include education and training for improved hypoglycaemia awareness and the development of technologies to allow their early detection and thus minimise their occurrence. Patients with impaired hypoglycaemia awareness would benefit the most from these technologies. The purpose of this systematic review is to review currently available or in-development technologies that support detection of hypoglycaemia or hypoglycaemia risk, and identify gaps in the research. Nanomaterial use in sensors is a promising strategy to increase the accuracy of continuous glucose monitoring devices for low glucose values. Hypoglycaemia is associated with changes on vital signs, so electrocardiogram and encephalogram could also be used to detect hypoglycaemia. Accuracy improvements through multivariable measures can make already marketed galvanic skin response devices a good noninvasive alternative. Breath volatile organic compounds can be detected by dogs and devices and alert patients at hypoglycaemia onset, while near-infrared spectroscopy can also be used as a hypoglycaemia alarms. Finally, one of the main directions of research are deep learning algorithms to analyse continuous glucose monitoring data and provide earlier and more accurate prediction of hypoglycaemia. Current developments for early identification of hypoglycaemia risk combine improvements of available 'needle-type' enzymatic glucose sensors and noninvasive alternatives. Patient usability will be essential to demonstrate to allow their implementation for daily use in diabetes management.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/dmrr.3449DOI Listing
March 2021

Letter to the editor.

Diabet Med 2021 Jul 3;38(7):e14546. Epub 2021 Mar 3.

Leicester Diabetes Centre, University of Leicester, Leicester, UK.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/dme.14546DOI Listing
July 2021

Protocol for a cluster randomised controlled trial of the DAFNE (Dose Adjustment For Normal Eating) intervention compared with 5x1 DAFNE: a lifelong approach to promote effective self-management in adults with type 1 diabetes.

BMJ Open 2021 01 18;11(1):e040438. Epub 2021 Jan 18.

Northumbria Healthcare NHS Foundation Trust, North Shields, UK.

Introduction: The successful treatment of type 1 diabetes (T1D) requires those affected to employ insulin therapy to maintain their blood glucose levels as close to normal to avoid complications in the long-term. The Dose Adjustment For Normal Eating (DAFNE) intervention is a group education course designed to help adults with T1D develop and sustain the complex self-management skills needed to adjust insulin in everyday life. It leads to improved glucose levels in the short term (manifest by falls in glycated haemoglobin, HbA1c), reduced rates of hypoglycaemia and sustained improvements in quality of life but overall glucose levels remain well above national targets. The DAFNE intervention is a development of DAFNE designed to incorporate behavioural change techniques, technology and longer-term structured support from healthcare professionals (HCPs).

Methods And Analysis: A pragmatic cluster randomised controlled trial in adults with T1D, delivered in diabetes centres in National Health Service secondary care hospitals in the UK. Centres will be randomised on a 1:1 basis to standard DAFNE or DAFNE. Primary clinical outcome is the change in HbA1c and the primary endpoint is HbA1c at 12 months, in those entering the trial with HbA1c >7.5% (58 mmol/mol), and HbA1c at 6 months is the secondary endpoint. Sample size is 662 participants (approximately 47 per centre); 92% power to detect a 0.5% difference in the primary outcome of HbA1c between treatment groups. The trial also measures rates of hypoglycaemia, psychological outcomes, an economic evaluation and process evaluation.

Ethics And Dissemination: Ethics approval was granted by South West-Exeter Research Ethics Committee (REC ref: 18/SW/0100) on 14 May 2018. The results of the trial will be published in a National Institute for Health Research monograph and relevant high-impact journals.

Trial Registration Number: ISRCTN42908016.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1136/bmjopen-2020-040438DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7813353PMC
January 2021

The psychopathology of recurrent diabetic ketoacidosis: A case-control study.

Diabet Med 2021 Jul 8;38(7):e14505. Epub 2021 Jan 8.

Diabetes, Psychiatry and Psychology Research Group, Institute of Psychiatry, Psychology and Neuroscience, King's College London, London, UK.

Background: Despite its poor prognosis, the psychological factors associated with recurrent diabetic ketoacidosis are poorly understood. In people with type 1 diabetes, we assessed for psychopathology in those with and without recurrent diabetic ketoacidosis (DKA).

Method: The design was a case-control study. Cases were defined as people with two or more DKA episodes in a 12-month period (recurrent DKA). Cases and controls were matched for gender and age. We compared groups for scores on Beck's Anxiety Inventory (BAI), Beck's Depression Inventory II, Difficulty in Emotion Regulation Scale (DERS), Experiences in Close Relationships-Revised, Standardised Assessment of Personality-Abbreviated Scale (SAPAS), Interpersonal Problem Inventory, Eating Disorder Examination Questionnaire and Problem Areas in Diabetes (PAID) using unpaired t-tests or Mann-Whitney U tests for parametric and non-parametric data, respectively. Correction was made for multiple testing.

Results: In all, 23 cases and 23 controls were recruited with mean age 31.0 (11.4) years and 65.2% were men. Cases had higher HbA levels than controls (101.1 (23.2) vs. 85.7 (21.7) mmol/mol, (p = 0.02)). Compared to controls, people with recurrent DKA had higher scores on the BAI (p = 0.004), PAID (p = 0.004), DERS (p = 0.001) and SAPAS (p < 0.001). Sixteen of 23 (69.6%) cases screened positive for a personality disorder compared to 6 of 23 (26.1%) controls.

Conclusions: People with recurrent DKA have elevated levels of anxiety and diabetes distress, greater difficulty with emotion regulation and personality dysfunction compared to matched controls.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/dme.14505DOI Listing
July 2021

Restoration of Hypoglycemia Awareness Alters Brain Activity in Type 1 Diabetes.

Diabetes Care 2021 02 16;44(2):533-540. Epub 2020 Dec 16.

Department of Diabetes, School of Life Course Sciences, King's College London, London, U.K.

Objective: Impaired awareness of hypoglycemia (IAH) in type 1 diabetes (T1D) is a major risk factor for severe hypoglycemia (SH) and is associated with atypical responses to hypoglycemia in brain regions involved in arousal, decision making, and memory. Whether restoration of hypoglycemia awareness alters these responses is unknown. We sought to investigate the impact of awareness restoration on brain responses to hypoglycemia.

Research Design And Methods: Twelve adults with T1D and IAH underwent pseudocontinuous arterial spin labeling functional MRI during a hypoglycemic clamp (5-2.6 mmol/L) before and after a hypoglycemia avoidance program of structured education (Dose Adjustment for Normal Eating), specialist support, and sensor-augmented pump therapy (Medtronic MiniMed 640G). Hypoglycemic cerebral blood flow (CBF) responses were compared pre- and postintervention using predefined region-of-interest analysis of the thalamus, anterior cingulate cortex (ACC), orbitofrontal cortex (OFC), and hippocampus.

Results: Postintervention, Gold and Clarke scores fell (6.0 ± 1.0 to 4.0 ± 1.6, = 0.0002, and 5.7 ± 1.7 to 3.4 ± 1.8, = 0.0008, respectively), SH rates reduced (1.5 ± 2 to 0.3 ± 0.5 episodes per year, = 0.03), hypoglycemic symptom scores increased (18.8 ± 6.3 to 27.3 ± 12.7, = 0.02), and epinephrine responses did not change ( = 0.2). Postintervention, hypoglycemia induced greater increases in ACC CBF ( = 0.01, peak voxel coordinates [6, 40, -2]), while thalamic and OFC activity did not change.

Conclusions: Increased blood flow is seen within brain pathways involved in internal self-awareness and decision making (ACC) after restoration of hypoglycemia awareness, suggesting partial recovery of brain responses lost in IAH. Resistance of frontothalamic networks, involved in arousal and emotion processing, may explain why not all individuals with IAH achieve awareness restoration with education and technology alone.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.2337/dc20-1250DOI Listing
February 2021

Hybrid closed-loop therapy: Where are we in 2021?

Diabetes Obes Metab 2021 03 20;23(3):655-660. Epub 2020 Dec 20.

Paediatric Department, Southport and Ormskirk NHS Trust, Southport, UK.

Hybrid closed-loop systems are characterized by the coexistence of algorithm-driven automated insulin delivery combined with manual mealtime boluses. Used correctly, these insulin delivery systems offer better glucose control and reduced risk of hypoglycaemia and represent the most advanced form of insulin delivery available for people with type 1 diabetes. The aim of this paper was to compare the currently available commercial hybrid closed-loop systems in the UK: the Medtronic 670G/780G, Tandem t:slim X2 Control IQ and CamAPS FX systems. The Medtronic 670G/780G systems use Guardian 3 sensor (7-day use, two to four calibrations per day), while Tandem and CamAPS systems use the calibration-free Dexcom G6 sensor (10 days). The CamAPS system is available as an android app, whereas the other two systems have the algorithm embedded in the insulin pump. During pivotal studies, depending on the study population and baseline glycated haemoglobin level, these systems achieve a time spent in the target range 3.9 to 10 mmol/L (70 to 180 mg/dL) of 65% to 76% with low burden of hypoglycaemia. All three systems allow a higher glucose target for announced exercise, while the Tandem system offers an additional night-time tighter target. The CamAPS system offers fully customizable glucose targets and is the only system licensed for use during pregnancy. Additional education is required for both users and healthcare professionals to harness the best performance from these systems as well as to troubleshoot when "automode exits" occur. We provide consensus recommendations to develop pragmatic pathways to guide patients, clinicians and commissioners in making informed decisions on the appropriate use of the diabetes technology.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/dom.14273DOI Listing
March 2021

Disordered eating in women with type 1 diabetes: Continuous glucose monitoring reveals the complex interactions of glycaemia, self-care behaviour and emotion.

Diabet Med 2021 02 23;38(2):e14446. Epub 2020 Nov 23.

Diabetes Research Group, King's College London, Weston Education Centre, London, UK.

Objectives: Glycaemia in people with type 1 diabetes and disordered eating is not well characterised. We explored the glycaemia, self-care behaviour and emotional state of women with type 1 diabetes and disordered eating.

Research Design And Methods: In all, 13 women with and 10 without disordered eating and type 1 diabetes participated in this case-control study. We used a mixed-methods approach with a 7-day blinded continuous glucose monitoring and real-time record of non-prompted capillary glucose (CG), emotion, activity and physical symptoms on a diabetes diary using a smartphone application (mySugr®). We compared groups using Mann-Whitney U test or Fisher's exact test. We conducted thematic analyses of free-text diary entries (NVivo®) and quantitative analysis of emotion/symptom tags.

Results: People with type 1 diabetes and disordered eating spent longer time above range in level 2 hyperglycaemia (>13.9 mmol/L, Median [interquartile range]: 21% [16,60] vs 5% [2,17], p = 0.015). They had lower time in range and similar time below range compared to those without disordered eating. The standard deviation of CG was significantly higher in the disordered eating group (4.7 mmol/L [4.5, 6.1] vs 3 [2.8, 3.2], p = 0.018). The median of the percentage of rising sensor glucose trends was three times higher in the disordered eating group. They also had higher negative emotional and physical symptoms associated with high blood glucose (>15 mmol/L).

Conclusions: Disordered eating has a significant impact on the glycaemia and emotion of a person with type 1 diabetes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/dme.14446DOI Listing
February 2021

A practical approach to the clinical challenges in initiation of basal insulin therapy in people with type 2 diabetes.

Diabetes Metab Res Rev 2021 Sep 1;37(6):e3418. Epub 2020 Dec 1.

Department of Endocrinology and Metabolic Diseases, Università Campus Bio-Medico, Rome, Italy.

Initiating insulin therapy with a basal insulin analogue has become a standard of care in the treatment of type 2 diabetes mellitus (T2DM). Despite increasing choices in pharmacological approaches, intensified glucose monitoring and improvements in quality of care, many patients do not achieve the desired level of glycaemic control. Although insulin therapy, when optimized, can help patients reach their glycaemic goals, there are barriers to treatment initiation on both the side of the patient and provider. Providers experience barriers based on their perceptions of patients' capabilities and concerns. They may lack the confidence to solve the practical problems of insulin therapy and avoid decisions they perceive as risky for their patients. In this study, we review recommendations for basal insulin initiation, focussing on glycaemic targets, titration, monitoring, and combination therapy with non-insulin anti-hyperglycaemic medications. We provide practical advice on how to address some of the key problems encountered in everyday clinical practice and give recommendations where there are gaps in knowledge or guidelines. We also discuss common challenges faced by people with T2DM, such as weight gain and hypoglycaemia, and how providers can address and overcome them.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1002/dmrr.3418DOI Listing
September 2021

An analytical approach to determine the optimal duration of continuous glucose monitoring data required to reliably estimate time in hypoglycemia.

Sci Rep 2020 10 23;10(1):18180. Epub 2020 Oct 23.

Department of Information Engineering, University of Padova, 35131, Padova, Italy.

Diabetes is a chronic metabolic disease that causes blood glucose (BG) concentration to make dangerous excursions outside its physiological range. Measuring the fraction of time spent by BG outside this range, and, specifically, the time-below-range (TBR), is a clinically common way to quantify the effectiveness of therapies. TBR is estimated from data recorded by continuous glucose monitoring (CGM) sensors, but the duration of CGM recording guaranteeing a reliable indicator is under debate in the literature. Here we framed the problem as random variable estimation problem and studied the convergence of the estimator, deriving a formula that links the TBR estimation error variance with the CGM recording length. Validation is performed on CGM data of 148 subjects with type-1-diabetes. First, we show the ability of the formula to predict the uncertainty of the TBR estimate in a single patient, using patient-specific parameters; then, we prove its applicability on population data, without the need of parameters individualization. The approach can be straightforwardly extended to other similar metrics, such as time-in-range and time-above-range, widely adopted by clinicians. This strengthens its potential utility in diabetes research, e.g., in the design of those clinical trials where minimal CGM monitoring duration is crucial in cost-effectiveness terms.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1038/s41598-020-75079-5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7584616PMC
October 2020

Autoreactive T cell profiles are altered following allogeneic islet transplantation with alemtuzumab induction and re-emerging phenotype is associated with graft function.

Am J Transplant 2021 03 19;21(3):1027-1038. Epub 2020 Sep 19.

Department of Immunobiology, Faculty of Life Sciences & Medicine, King's College London, London, UK.

Islet transplantation is an effective therapy for life-threatening hypoglycemia, but graft function gradually declines over time in many recipients. We characterized islet-specific T cells in recipients within an islet transplant program favoring alemtuzumab (ATZ) lymphodepleting induction and examined associations with graft function. Fifty-eight recipients were studied: 23 pretransplant and 40 posttransplant (including 5 with pretransplant phenotyping). The proportion with islet-specific T cell responses was not significantly different over time (pre-Tx: 59%; 1-6 m posttransplant: 38%; 7-12 m: 44%; 13-24 m: 47%; and >24 m: 45%). However, phenotype shifted significantly, with IFN-γ-dominated response in the pretransplant group replaced by IL-10-dominated response in the 1-6 m posttransplant group, reverting to predominantly IFN-γ-oriented response in the >24 m group. Clustering analysis of posttransplant responses revealed two main agglomerations, characterized by IFN-γ and IL-10 phenotypes, respectively. IL-10-oriented posttransplant response was associated with relatively low graft function. Recipients within the IL-10 cluster had a significant decline in C-peptide levels in the period preceding the IL-10 response, but stable graft function following the response. In contrast, an IFN-γ response was associated with subsequently decreased C-peptide. Islet transplantation favoring ATZ induction is associated with an initial altered islet-specific T cell phenotype but reversion toward pretransplant profiles over time. Posttransplant autoreactive T cell phenotype may be a predictor of subsequent graft function.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/ajt.16285DOI Listing
March 2021

Characterization of pre-transplant psychosocial burden in an integrated national islet transplant program.

Islets 2020 03 20;12(2):21-31. Epub 2020 Aug 20.

School of Psychology, Deakin University , Geelong, Australia.

The psychological burden experienced by people with diabetes prior to islet transplantation is recognized but has not been studied comprehensively, especially in relation to glycemia. Therefore, we conducted a rigorous pre-operative psychosocial profile of UK islet transplant recipients, and compared groups with higher/lower HbA1 c to test the null hypothesis that pre-transplant hypoglycemia awareness and psychosocial burden would not be related to baseline HbA1 c in this high-risk cohort. Pre-transplant, recipients (n = 44) completed validated hypoglycemia awareness questionnaires and generic/diabetes-specific measures of psychological traits and states. Scores were compared in groups, dichotomized by HbA1 c (≤8% versus >8%). Participants were aged (mean±SD) 53 ± 10 years; 64% were women; with HbA1 c 8.3 ± 1.7%. Median rate of severe hypoglycemia over the preceding 12 months was 13 events/person-year and 90% had impaired awareness of hypoglycemia (Gold/Clarke score ≥4). Participants had elevated fear of hypoglycemia (HFS-II Worry), impaired diabetes-specific quality of life (DQoL) and low generic health status (SF-36; EQ-5D). One quarter reported scores indicating likely anxiety/depression (HAD). Dispositional optimism (LOT-R) and generalized self-efficacy (GSE) were within published 'norms.' Despite negative perceptions of diabetes (including low personal control), participants were confident that islet transplantation would help (BIPQ). Hypoglycemia awareness and psychosocial profile were comparable in lower (n = 24) and higher (n = 20) HbA1 c groups. Islet transplant candidates report sub-optimal generic psychological states (anxiety/depressive symptoms), health status and diabetes-specific psychological states (fear of hypoglycemia, diabetes-specific quality of life). While their generic psychological traits (optimism, self-efficacy) are comparable with the general population, they are highly optimistic about forthcoming transplant. HbA1 c is not a proxy measure of psychosocial burden, which requires the use of validated questionnaires to systematically identify those who may benefit most from psychological assessment and support.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1080/19382014.2020.1736740DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7527016PMC
March 2020

Type 1 diabetes and fasting in Ramadan: time to rethink classification of risk?

Lancet Diabetes Endocrinol 2020 08;8(8):656-658

Department of Diabetes, School of Life Course Sciences, King's College London, London SE1 7EH, UK; Institute of Diabetes, Endocrinology and Obesity, King's Health Partners, London, UK.

View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1016/S2213-8587(20)30219-9DOI Listing
August 2020

Donor insulin use predicts beta-cell function after islet transplantation.

Diabetes Obes Metab 2020 10 14;22(10):1874-1879. Epub 2020 Jun 14.

Faculty of Medicine, Biology and Health, University of Manchester, Manchester, UK.

Insulin is routinely used to manage hyperglycaemia in organ donors and during the peri-transplant period in islet transplant recipients. However, it is unknown whether donor insulin use (DIU) predicts beta-cell dysfunction after islet transplantation. We reviewed data from the UK Transplant Registry and the UK Islet Transplant Consortium; all first-time transplants during 2008-2016 were included. Linear regression models determined associations between DIU, median and coefficient of variation (CV) peri-transplant glucose levels and 3-month islet graft function. In 91 islet cell transplant recipients, DIU was associated with lower islet function assessed by BETA-2 scores (β [SE] -3.5 [1.5], P = .02), higher 3-month post-transplant HbA1c levels (5.4 [2.6] mmol/mol, P = .04) and lower fasting C-peptide levels (-107.9 [46.1] pmol/l, P = .02). Glucose at 10 512 time points was recorded during the first 5 days peri-transplant: the median (IQR) daily glucose level was 7.9 (7.0-8.9) mmol/L and glucose CV was 28% (21%-35%). Neither median glucose levels nor glucose CV predicted outcomes post-transplantation. Data on DIU predicts beta-cell dysfunction 3 months after islet transplantation and could help improve donor selection and transplant outcomes.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1111/dom.14088DOI Listing
October 2020

Predicting Factors Associated with Hypoglycemia Reduction with Automated Predictive Insulin Suspension in Patients at High Risk of Severe Hypoglycemia: An Analysis from the SMILE Randomized Trial.

Diabetes Technol Ther 2020 09;22(9):681-685

Medtronic International Trading Sàrl, Tolochenaz, Switzerland.

This analysis from the SMILE randomized study was performed to identify predictive factors associated with the greatest reductions in hypoglycemia with the Medtronic MiniMed™ 640G Suspend before low feature in adults with type 1 diabetes at high risk of severe hypoglycemia. Clinical and treatment-related factors associated with decreased sensor hypoglycemia (SH) were identified in participants from the intervention arm by univariate and multivariate analyses. The reduction in SH events <54 mg/dL (<3.0 mmol/L) in the intervention group was significantly ( < 0.0001) associated with the baseline mean number of sensor hypoglycemic events (MNSHE) <54 mg/dL. When excluding continuous glucose monitoring (CGM) factors not readily available (MNSHE, duration of SH events, area under the curve, mean amplitude of glycemic excursions), only the baseline mean time spent <54 mg/dL was found to be a significant independent predictor factor ( < 0.0001). Baseline HbA1, mean self-monitoring of blood glucose (SMBG), and coefficient of variation of SMBG were significant, although weak, predictors in the absence of any CGM data. The greatest reductions in SH events achieved with the MiniMed 640G system with the Suspend before low feature were seen in participants with higher baseline MNSHE. Measuring these (usually uncollected) events can be a useful tool to predict hypoglycemia reduction. ClinicalTrials.gov Registration Identifier NCT02733991.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1089/dia.2019.0495DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7478192PMC
September 2020

Correction to: InRange: Comparison of the Second-Generation Basal Insulin Analogues Glargine 300 U/mL and Degludec 100 U/mL in Persons with Type 1 Diabetes Using Continuous Glucose Monitoring-Study Design.

Diabetes Ther 2020 Jul;11(7):1607-1608

International Diabetes Center at Park Nicollet, Minneapolis, USA.

In the original publication, the timing of baseline CGM assessment was incorrectly stated in the text in two instances; it is correct in Fig. 1.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1007/s13300-020-00820-2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7324444PMC
July 2020

Baseline Glucose Variability and Interweek Variability Affects the Time to Stability of Continuous Glucose Monitoring-Derived Glycemic Indices.

Diabetes Technol Ther 2020 12 14;22(12):937-942. Epub 2020 May 14.

Department of Diabetes, King's College Hospital, London, United Kingdom.

To study the effect of baseline glucose variability (GV) on the time to stability and interweek variability (IWV) of continuous glucose monitoring (CGM)-derived glycemic indices. Anonymized CGM data (median duration 32 weeks, ≥70% data coverage) of 85 adults with type 1 diabetes; age (41 ± 12 years), 66.3% women, HbA1c (7.5% ± 1.2%, 58 mmol/mol) were analyzed. We evaluated the time to stability, that is, the minimum duration of data that provided a close ( ≥ 0.9) correlation with data taken across the whole sampling period and IWV. We also evaluated the impact of baseline variability on the time to stability. For the whole data set, all indices achieved stability ( ≥ 0.9) by 9 weeks (range 5-9). Time to stability progressively increased from the lowest quartile to the highest quartile of baseline coefficient of variation (CV). Time above range (TAR) and time below range (TBR) had higher IWV than time in range (TIR) (%CV: TIR-16%, TAR-31%, TBR-62%). Baseline GV and IWV of indices affect the time to stability of glycemic indices. We recommend a minimum of 9 weeks of data to represent long-term CGM data.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1089/dia.2020.0011DOI Listing
December 2020

Differentiating Hypoglycemia Awareness Status from Hypoglycemia Experience in Tools for Measuring Impaired Awareness of Hypoglycemia.

Diabetes Technol Ther 2020 07;22(7):541-545

Department of Diabetes, School of Life Course Sciences, King's College London, London, United Kingdom.

Developing technologies in real-time continuous glucose monitoring (CGM) are successfully reducing severe hypoglycemia (SH) in trials and clinical practice. Their impact on impaired awareness of hypoglycemia, a major risk factor for SH, is uncertain. The present study examined two scales for assessing hypoglycemia awareness status, the Gold score and the eight-item Minimally Modified Clarke Hypoglycemia Survey (MMCHS), commonly used in trials of CGM, in Portuguese-speaking adults with type 1 diabetes and conducted an exploratory factor analysis on MMCHS. A bifactorial structure in MMCHS was revealed, with a clear distinction between items that measure SH experience and those that measure hypoglycemia awareness status. The latter is associated with the same risk for SH as the Gold score. We conclude that improvement in awareness scores by the MMCHS may reflect only a reduction in SH with no restoration of endogenous awareness, making the current literature consistent in evidence that CGM does not improve endogenous awareness and nonsensor supported protection from SH. This has implications for risk of SH when CGM is not being worn.
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1089/dia.2020.0034DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7336879PMC
July 2020

A systematic review of the effect of prior hypoglycaemia on cognitive function in type 1 diabetes.

Ther Adv Endocrinol Metab 2020 14;11:2042018820906017. Epub 2020 Feb 14.

Department of Diabetes, King's College Hospital, London, UK.

Background: The effect of prior hypoglycaemia on cognitive function in type 1 diabetes is an important unresolved clinical question. In this systematic review, we aimed to summarize the studies exploring the impact of prior hypoglycaemia on any aspect of cognitive function in type 1 diabetes.

Methods: We used a multidatabase search platform Healthcare Database Advanced Search to search Medline, PubMed, EMBASE, EMCARE, CINAHL, PsycINFO, BNI, HMIC, and AMED from inception until 1 May 2019. We included studies on type 1 diabetes of any age. The outcome measure was any aspect of cognitive function.

Results: The 62 studies identified were grouped as severe hypoglycaemia (SH) in childhood (⩽18 years) and adult-onset (>18 years) diabetes, nonsevere hypoglycaemia (NSH) and nocturnal hypoglycaemia (NH). SH in early childhood-onset diabetes, especially seizures and coma, was associated with poorer memory (verbal and visuospatial), as well as verbal intelligence. Among adult-onset diabetes, SH was associated with poorer cognitive performance in the older age (>55 years) group only. Early late exposure to SH had a significant association with cognitive dysfunction (CD). NSH and NH did not have any significant association with CD, while impaired awareness of hypoglycaemia was associated with poorer memory and cognitive-processing speeds.

Conclusion: The effect of SH on cognitive function is age dependent. Exposure to SH in early childhood (<10 years) and older age groups (>55 years) was associated with a moderate effect on the decrease in cognitive function in type 1 diabetes [PROSPERO ID: CRD42019141321].
View Article and Find Full Text PDF

Download full-text PDF

Source
http://dx.doi.org/10.1177/2042018820906017DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7025428PMC
February 2020
-->