Developing an intervention to support dietary change for shift workers living with type 2 diabetes: A stakeholder consultation.

BACKGROUND: Shift workers, compared to day workers, are more likely to be diagnosed with type 2 diabetes (T2D). Currently, there is no tailored programme of dietary support available to either shift workers living with T2D or employers. METHODS: An intervention development consultation workshop was convened in June 2023 with the aim of evaluating potential interventions to identify those with a potential to take forward for further development. Findings from prior formative research into factors influencing dietary behaviour in shift workers with T2D were mapped to potential interventions addressing the barriers and enablers to healthy eating reported by shift workers with T2D. The findings of the Shift-Diabetes Study were presented in the context of the COM-B (Capability, Opportunity, Motivation, Behaviour) theoretical framework of behaviour change. Three interventions in turn were presented to attendees: (1) Educational resources and structured education, (2) Increasing availability and accessibility of food on a night shift and (3) Biofeedback and tailored advice. Seven workshop attendees were invited to express their thoughts, using the APEASE criteria (Affordability, Practicability, Effectiveness, Acceptability, Side-effects/Safety, Equity) to guide the discussion. The workshop was conducted online and recorded, and transcripts were thematically coded to the APEASE framework. RESULTS/CONCLUSIONS: The workshop highlighted the importance of multilevel interventions to support dietary behaviour change in this occupational group. Priority actions identified include (i) understanding barriers to 24/7 food availability, (ii) including shift workers in clinical diabetes studies and (iii) research to understand the effectiveness of continuous glucose monitoring in shift workers with T2D.

The importance of intravenous glucose tolerance test glucose stimulus for the evaluation of insulin secretion.

For 100 years, the Intravenous glucose tolerance test (IVGTT) has been used extensively in researching the pathophysiology of diabetes mellitus and AIRg-the IVGTT-induced acute insulin response to the rapid rise in circulating glucose-is a key measure of insulin secretory capacity. For an effective evaluation of AIRg, IVGTT glucose loading should be adjusted for glucose distribution volume (gVOL) to provide an invariant, trend-free immediate rise in circulating glucose (ΔG0). Body weight-based glucose loads have been widely used but whether these achieve a trend-free ΔG0 does not appear to have been investigated. By analysing variation in AIRg, ΔG0 and gVOL with a range of IVGTT loads, both observed and simulated, we explored the hypothesis that there would be an optimum anthropometry-based IVGTT load calculation that, by achieving a trend-free ΔG0, would not compromise evaluation of AIRg as an index of beta cell function. Data derived from patient and research volunteer records for 3806 IVGTT glucose and insulin profiles. Among the non-obese, as gVOL rose, weight increased disproportionately rapidly. Consequently, the IVGTT glucose load needed for an invariant ΔG0 was progressively overestimated, accounting for 47% of variation in AIRg. Among the obese, ΔG0 was trend-free yet AIRg increased by 11.6% per unit body mass index, consistent with a more proportionate increase in weight with gVOL and a hyperinsulinaemic adaptation to adiposity-associated insulin resistance. Simulations further confirmed our hypothesis by demonstrating that a body surface area-based IVGTT load calculation could provide for a more generally invariant IVGTT ΔG0.

Ward monitoring 4.0: real-time metabolic insights from continuous glucose monitoring into perioperative organ dysfunction.

The now-routine clinical deployment of continuous glucose monitoring has demonstrated benefit in real-world settings. We make the case that continuous glucose monitoring can help re-examine, at scale, the role that (stress) hyperglycaemia plays in fuelling organ dysfunction after tissue trauma. Provided robust perioperative data do emerge, well-established continuous glucose monitoring technology could soon help transform the perioperative landscape.

Assessment of the impact of a personalised nutrition intervention in impaired glucose regulation over 26 weeks: a randomised controlled trial.

Dietary interventions can reduce progression to type 2 diabetes mellitus (T2DM) in people with non-diabetic hyperglycaemia. In this study we aimed to determine the impact of a DNA-personalised nutrition intervention in people with non-diabetic hyperglycaemia over 26 weeks. ASPIRE-DNA was a pilot study. Participants were randomised into three arms to receive either (i) Control arm: standard care (NICE guidelines) (n = 51), (ii) Intervention arm: DNA-personalised dietary advice (n = 50), or (iii) Exploratory arm: DNA-personalised dietary advice via a self-guided app and wearable device (n = 46). The primary outcome was the difference in fasting plasma glucose (FPG) between the Control and Intervention arms after 6 weeks. 180 people were recruited, of whom 148 people were randomised, mean age of 59 years (SD = 11), 69% of whom were female. There was no significant difference in the FPG change between the Control and Intervention arms at 6 weeks (- 0.13 mmol/L (95% CI [- 0.37, 0.11]), p = 0.29), however, we found that a DNA-personalised dietary intervention led to a significant reduction of FPG at 26 weeks in the Intervention arm when compared to standard care (- 0.019 (SD = 0.008), p = 0.01), as did the Exploratory arm (- 0.021 (SD = 0.008), p = 0.006). HbA1c at 26 weeks was significantly reduced in the Intervention arm when compared to standard care (- 0.038 (SD = 0.018), p = 0.04). There was some evidence suggesting prevention of progression to T2DM across the groups that received a DNA-based intervention (p = 0.06). Personalisation of dietary advice based on DNA did not result in glucose changes within the first 6 weeks but was associated with significant reduction of FPG and HbA1c at 26 weeks when compared to standard care. The DNA-based diet was effective regardless of intervention type, though results should be interpreted with caution due to the low sample size. These findings suggest that DNA-based dietary guidance is an effective intervention compared to standard care, but there is still a minimum timeframe of adherence to the intervention before changes in clinical outcomes become apparent.Trial Registration: www.clinicaltrials.gov.uk Ref: NCT03702465.

The role of real-time continuous glucose monitoring in diabetes management and how it should link to integrated personalized diabetes management.

Diabetes is a complex metabolic condition that demands tailored, individualized approaches for effective management. Real-time continuous glucose monitoring (rtCGM) systems have improved in terms of design, usability and accuracy over the years and play a pivotal role in the delivery of integrated personalized diabetes management (iPDM). iPDM is a comprehensive multidisciplinary approach that combines individualized care strategies utilizing technologies and interventions and encourages the active involvement of the person with diabetes in the care provided. The use of stand-alone rtCGM and its integration with other diabetes technologies, such as hybrid automated insulin delivery, have enabled improved glycaemic and quality of life outcomes for people with diabetes. As the uptake of rtCGM and associated technologies is increasing and becoming the standard of care for people with diabetes, it is important that efforts are focused on associated goals such as reducing health inequalities in terms of access, aligning structured education with rtCGM usage, choosing the right technology based on needs and preferences, and minimizing burden while aiming for optimal glucose outcomes. Utilizing rtCGM in other settings than outpatients and in diabetes cohorts beyond type 1 and type 2 diabetes needs further exploration. This review aims to provide an overview of the role of rtCGM and how best to link rtCGM to iPDM, highlighting its role in enhancing personalized treatment strategies.

A Three-Arm Randomized Controlled Study Comparing Patient-Reported Outcomes in People With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion or Multiple Daily Injections.

BACKGROUND: The aim of this study was to compare patient-reported outcomes (PROs) in people with type 1 diabetes using either continuous subcutaneous insulin infusion (CSII) with two different insulin patch pumps or multiple daily injections (MDIs). MATERIALS AND METHODS: In this randomized three-arm study, people with type 1 diabetes on MDI therapy were included and used either MDI, the Accu-Chek Solo micropump system (Solo) or Omnipod for 26 weeks. From weeks 26 to 39, all participants used CSII with Solo. Patient-reported outcomes were assessed using the diabetes technology questionnaire (DTQ); in addition, HbA1c values were measured. RESULTS: Overall, 181 participants were randomized (61 MDI arm, 62 Solo arm, 58 Omnipod arm) and 142 completed the study. After 26 weeks in the study, the DTQ "change" score in the Solo group (105.9 [100.6-111.2]; baseline-adjusted mean [95% confidence interval]) was significantly higher than in the MDI group (94.8 [89.6-100.0]) (P = .001). The comparison between the Solo group (105.1 [99.1-111.1]) and the Omnipod group (108.7 [103.1-114.4]) showed no significant differences (P = .382). HbA1c increased by 0.2% ± 0.7% in the MDI group and decreased in both pump groups (Solo group -0.2% ± 0.8% and Omnipod group -0.1% ± 0.8%). Differences in HbA1c between the Solo group and the MDI group were significant (P = .009), but not between the Solo group and the Omnipod group (P = .896). CONCLUSIONS: This study showed that switching from MDI to CSII improves both psychosocial well-being and physiological outcomes. Furthermore, there were no substantial differences between the established and the recently released patch pump. Trial registration at www.clinicaltrials.gov is NCT03478969.

Switching from Intermittently Scanned Continuous Glucose Monitoring to Real-Time Continuous Glucose Monitoring with a Predictive Urgent Low Soon Alert Reduces Exposure to Hypoglycemia.

Differences in the effectiveness of real-time continuous glucose monitoring (rtCGM) and intermittently scanned continuous glucose monitoring (isCGM) in type 1 diabetes (T1D) are reported. The impact on percent time in range of switching from an isCGM with glucose threshold-based optional alerts only (FreeStyle Libre 2 [FSL2]) to an rtCGM (Dexcom G7) with an urgent low soon predictive alert was assessed, alongside other secondary outcomes including hemoglobin A1c (HbA1c) and other continuous glucose monitoring metrics. Adults with T1D using FSL2 were switched to Dexcom G7 for 12 weeks. HbA1c and continuous glucose data during FSL2 and Dexcom G7 use were compared. Data from 29 participants (aged 44.8 ± 16.5 years, 12 male and 17 female) were analyzed. After switching to rtCGM, participants spent less time in hypoglycemia below 3.9 mmol/L (70 mg/dL) (3.0% [1.0%, 5.0%] vs. 2.0% [1.0%, 3.0%], P = 0.006) and had higher percentage achievement of time below 3.9 mmol/L (70 mg/dL) of <4% (55.2% vs. 82.8%, P = 0.005). Coefficient of variation was lower (39.3 ± 6.6% vs. 37.2 ± 5.6%, P = 0.008). In conclusion, adults with T1D who switched from isCGM to rtCGM may benefit from reduced exposure to hypoglycemia and glycemic variability.

Increased glycemic variability in pregnant women with Roux-en-Y gastric bypass compared with sleeve gastrectomy.

INTRODUCTION: Bariatric surgery is associated with adverse pregnancy outcomes such as reduced birth weight and premature birth. One possible mechanism for this is increased glycemic variability (GV) which occurs after bariatric surgery. The objective of this study was to compare the effect of Roux-en-Y gastric bypass (RYGB) versus vertical sleeve gastrectomy (SG) on GV during pregnancy and to investigate the relationships of GV, type of bariatric surgery and maternal and neonatal outcomes. RESEARCH DESIGN AND METHODS: Fourteen pregnant women after RYGB and 14 after SG were investigated with continuous glucose monitoring in their second or third trimester in this observational study carried out as part of routine clinical care. RESULTS: Pregnant women with RYGB had similar mean interstitial glucose values but significantly increased indices of GV and a lower %time in range 3.9-7.8 mmol/L (70-140 mg/dL), compared with SG. CONCLUSIONS: Pregnant women who have undergone RYGB have greater GV during pregnancy compared with those who have undergone SG. Further research is needed to establish the relationship between GV and pregnancy outcomes to determine the preferred bariatric operation in women of reproductive age, and whether interventions to reduce GV might improve outcomes.

A narrative commentary about interoperability in medical devices and data used in diabetes therapy from an academic EU/UK/US perspective.

People living with diabetes have many medical devices available to assist with disease management. A critical aspect that must be considered is how systems for continuous glucose monitoring and insulin pumps communicate with each other and how the data generated by these devices can be downloaded, integrated, presented and used. Not only is interoperability associated with practical challenges, but also devices must adhere to all aspects of regulatory and legal frameworks. Key issues around interoperability in terms of data ownership, privacy and the limitations of interoperability include where the responsibility/liability for device and data interoperability lies and the need for standard data-sharing protocols to allow the seamless integration of data from different sources. There is a need for standardised protocols for the open and transparent handling of data and secure integration of data into electronic health records. Here, we discuss the current status of interoperability in medical devices and data used in diabetes therapy, as well as regulatory and legal issues surrounding both device and data interoperability, focusing on Europe (including the UK) and the USA. We also discuss a potential future landscape in which a clear and transparent framework for interoperability and data handling also fulfils the needs of people living with diabetes and healthcare professionals.

A Randomized Controlled Trial Assessing the Impact of Continuous Glucose Monitoring with a Predictive Hypoglycemia Alert Function on Hypoglycemia in Physical Activity for People with Type 1 Diabetes (PACE).

Background: Uptake of exercise in people with type 1 diabetes (T1D) is low despite significant health benefits. Fear of hypoglycemia is the main barrier to exercise. Continuous glucose monitoring (CGM) with predictive alarms warning of impending hypoglycemia may improve self-management of diabetes around exercise. Aim: To assess the impact of Dexcom G6 real-time CGM system with a predictive hypoglycemia alert function on the frequency, duration, and severity of hypoglycemia occurring during and after regular (≥150 min/week) physical activity in people with T1D. Methods: After 10 days of blinded run-in (Baseline), CGM was unblinded and participants randomized 1:1 to have the "urgent low soon" (ULS) alert switched "on" or "off" for 40 days. Participants then switched alerts "off" or "on," respectively, for a further 40 days. Physical activity, and carbohydrate and insulin doses were recorded. Results: Twenty-four participants (8 men, 16 women) were randomized. There was no difference in change from baseline of hypoglycemia <3.0 and <3.9 mmol/L with the ULS on or off during the 24 h after exercise. With ULS alert "on" time spent below 2.8 mmol/L compared with baseline was significantly (P = 0.04) lower than with ULS "off" in the 24 h after exercise. In mixed effects regression, timing of the exercise and baseline HbA1c independently affected risk of hypoglycemia during exercise; exercise timing also affected hypoglycemia risk after exercise. Conclusion: A CGM device with an ULS alert reduces exposure to hypoglycemia below 2.8 mmol/L overall and in the 24 h after exercise compared with a threshold alert.

Hyperglycaemia aversion in type 1 diabetes: A grounded theory study.

OBJECTIVE: Very little is known about the circumstances under which hyperglycaemia aversion develops and is maintained. The present study aimed to identify psychological factors involved in the process of hyperglycaemia aversion and to understand how it affects people's self-management of type 1 diabetes. DESIGN: Qualitative, in-depth interviews were used. METHODS: A constructivist grounded theory study, using semi-structured participant interviews, was undertaken to build a theoretical model of the process of hyperglycaemia aversion. RESULTS: Eighteen participants were interviewed. Fifteen were considered hyperglycaemia averse and included in the analysis. A theoretical model was developed to describe and explain processes involved in hyperglycaemia aversion. Many participants held very high standards for themselves and often had a strong preference for control. While some participants described anxiety associated with higher blood glucose, the most proximal driver of their approach was self-criticism and frustration associated with not meeting their own high standards for blood glucose. A number of attentional processes and beliefs, mostly related to hypoglycaemia, maintained and reinforced their blood glucose preference. Diabetes technology served as an enabler, raiser of standards, and additional critical judge of participants' hyperglycaemia aversion. CONCLUSIONS: The trans-diagnostic concept of emotional over-control is used to understand the proposed model of processes of hyperglycaemia aversion. The present study offers new insight which will aid clinicians in identifying and supporting those who may be at risk of psychological distress and harm associated with a preference for avoidance of higher blood glucose levels.

Exploration of the individual, social and environmental factors influencing dietary behaviour in shift workers with type 2 diabetes working in UK healthcare-The Shift-Diabetes Study: A qualitative study using the theoretical domains framework.

AIM: To identify factors influencing dietary behaviour in shift workers with type 2 diabetes (T2D) working in UK healthcare settings. METHODS: Semi-structured qualitative interviews based on the theoretical domains framework (TDF) were conducted with a convenience sample (n = 15) of shift workers (32-59 years) diagnosed with T2D who worked night shifts as part of a mixed shift schedule. The TDF was applied to analyse transcripts using a combined deductive framework and inductive thematic analysis approach. Identified influences were mapped to the behaviour change technique taxonomy to identify potential strategies to change dietary behaviour in this context. RESULTS: Key barriers to healthy dietary behaviours were access and cost of food available during night work (TDF domain: Environment Context and Resources). Factors identified as both enablers and barriers included: availability of staff facilities and time to take a break, (Environment Context and Resources), the physical impact of night work (Beliefs About Consequences), eating in response to stress or tiredness (Emotion), advance planning of meals/food and taking own food to work (Behavioural Regulation). Potential techniques to address these influences and improve dietary behaviour in this context include: meal planning templates, self-monitoring and biofeedback, and increasing accessibility and availability of healthier food choices during night shifts. CONCLUSIONS: The dietary behaviour of shift workers with T2D is influenced by interacting individual, socio-cultural and environmental factors. Intervention should focus on environmental restructuring and strategies that enable monitoring and meal planning.

HIV and type 2 diabetes: An evolving story.

INTRODUCTION: Diabetes is widely reported to be more common in people living with HIV (PLWH). Much of the data supporting this originated during the earlier HIV era. The perceived increased risk of type 2 diabetes is reflected in HIV clinical guidelines that recommend screening for diabetes in PLWH on anti-retroviral therapy (ART). However, international HIV clinical guidelines do not agree on the best marker of glycaemia to screen for diabetes. This stems from studies that suggest HbA1c underestimates glycaemia in PLWH. METHODS: Within this review we summarise the literature surrounding the association of HIV and type 2 diabetes and how this has changed over time. We also present the evidence on HbA1c discrepancy in PLWH. CONCLUSION: We suggest there is no basis to any international guidelines to restrict HbA1c based on HIV serostatus. We recommend, using the current evidence, that PLWH should be screened annually for diabetes in keeping with country specific guidance. Finally, we suggest future work to elucidate phenotype and natural history of type 2 diabetes in PLWH across all populations.

Speckle-Tracking Analysis of the Right and Left Heart after Peak Exercise in Healthy Subjects with Type 1 Diabetes: An Explorative Analysis of the AppEx Trial.

In eight healthy participants with Type 1 diabetes (T1D) exercise-related dynamic cardiac remodeling was analyzed by performing two-dimensional echocardiography, including deformation analysis of the left-ventricular (LV) global longitudinal strain (LV-GLS), and the deformation pattern of the left atrium (LA) and right ventricle (RV) at rest and post-peak performance on a bicycle. The feasibility echocardiographic speckle-tracking analysis was performed on eight asymptomatic participants with T1D (n = 8, male n = 5, age: 23-65 years). The obtained echocardiographic data were compared for various echocardiographic parameters at rest and post exercise. Across our participating T1D individuals no structural echocardiographic abnormalities of concern could be revealed. All participating T1D subjects showed preserved contractile reserve of the LV and no significant diastolic dysfunction. Significant differences were found for the phasic LA contractile strain pattern at rest and post exercise (p < 0.001), whereby the dynamic RV (p = 0.5839 and p = 0.7419) and LV strain pattern (p = 0.5952) did not reveal significant differences in comparison to resting conditions. This descriptive secondary outcome analysis describes preserved contractile reserve of the LV and elucidates dynamic modification of the phasic LA contractile deformation pattern in asymptomatic T1D individuals after exhaustive exercise on a bicycle.

Symptomatic benefits of testosterone treatment in patient subgroups: a systematic review, individual participant data meta-analysis, and aggregate data meta-analysis.

BACKGROUND: Testosterone replacement therapy is known to improve sexual function in men younger than 40 years with pathological hypogonadism. However, the extent to which testosterone alleviates sexual dysfunction in older men and men with obesity is unclear, despite the fact that testosterone is being increasingly prescribed to these patient populations. We aimed to evaluate whether subgroups of men with low testosterone derive any symptomatic benefit from testosterone treatment. METHODS: We did a systematic review and meta-analysis to evaluate characteristics associated with symptomatic benefit of testosterone treatment versus placebo in men aged 18 years and older with a baseline serum total testosterone concentration of less than 12 nmol/L. We searched major electronic databases (MEDLINE, Embase, Science Citation Index, and the Cochrane Central Register of Controlled Trials) and clinical trial registries for reports published in English between Jan 1, 1992, and Aug 27, 2018. Anonymised individual participant data were requested from the investigators of all identified trials. Primary (cardiovascular) outcomes from this analysis have been published previously. In this report, we present the secondary outcomes of sexual function, quality of life, and psychological outcomes at 12 months. We did a one-stage individual participant data meta-analysis with a random-effects linear regression model, and a two-stage meta-analysis integrating individual participant data with aggregated data from studies that did not provide individual participant data. This study is registered with PROSPERO, CRD42018111005. FINDINGS: 9871 citations were identified through database searches. After exclusion of duplicates and publications not meeting inclusion criteria, 225 full texts were assessed for inclusion, of which 109 publications reporting 35 primary studies (with a total 5601 participants) were included. Of these, 17 trials provided individual participant data (3431 participants; median age 67 years [IQR 60-72]; 3281 [97%] of 3380 aged ≥40 years) Compared with placebo, testosterone treatment increased 15-item International Index of Erectile Function (IIEF-15) total score (mean difference 5·52 [95% CI 3·95-7·10]; τ2=1·17; n=1412) and IIEF-15 erectile function subscore (2·14 [1·40-2·89]; τ2=0·64; n=1436), reaching the minimal clinically important difference for mild erectile dysfunction. These effects were not found to be dependent on participant age, obesity, presence of diabetes, or baseline serum total testosterone. However, absolute IIEF-15 scores reached during testosterone treatment were subject to thresholds in patient age and baseline serum total testosterone. Testosterone significantly improved Aging Males' Symptoms score, and some 12-item or 36-item Short Form Survey quality of life subscores compared with placebo, but it did not significantly improve psychological symptoms (measured by Beck Depression Inventory). INTERPRETATION: In men aged 40 years or older with baseline serum testosterone of less than 12 nmol/L, short-to-medium-term testosterone treatment could provide clinically meaningful treatment for mild erectile dysfunction, irrespective of patient age, obesity, or degree of low testosterone. However, due to more severe baseline symptoms, the absolute level of sexual function reached during testosterone treatment might be lower in older men and men with obesity. FUNDING: National Institute for Health and Care Research Health Technology Assessment Programme.

Accuracy and impact on quality of life of real-time continuous glucose monitoring in children with hyperinsulinaemic hypoglycaemia.

Objective: Continuous glucose monitoring (CGM) is the standard of care for glucose monitoring in children with diabetes, however there are limited data reporting their use in hyperinsulinaemic hypoglycaemia (HH). Here, we evaluate CGM accuracy and its impact on quality of life in children with HH. Methods: Real-time CGM (Dexcom G5 and G6) was used in children with HH aged 0-16years. Data from self-monitoring capillary blood glucose (CBG) and CGM were collected over a period of up to 28days and analysed. Quality of life was assessed by the PedsQL4.0 general module and PedsQL2.0 family impact module, completed by children and their parents/carers before and after CGM insertion. Analysis of accuracy metrics included mean absolute relative difference (MARD) and proportion of CGM values within 15, 20, and 30% or 15, 20, and 30 mg/dL of reference glucose values >100 mg/dL or ≤100 mg/dL, respectively (% 15/15, % 20/20, % 30/30). Clinical reliability was assessed with Clarke error grid (CEG) analyses. Results: Prospective longitudinal study with data analysed from 40 children. The overall MARD between reference glucose and paired CGM values (n=4,928) was 13.0% (Dexcom G5 12.8%, Dexcom G6 13.1%). The proportion of readings meeting %15/15 and %20/20 were 77.3% and 86.4%, respectively, with CEG analysis demonstrating 97.4% of all values in zones A and B. Within the hypoglycaemia range (<70 mg/dL), the median ARD was 11.4% with a sensitivity and specificity of 64.2% and 91.3%, respectively. Overall PedsQL child report at baseline and endpoint were 57.6 (50.5 - 75.8) and 87.0 (82.9 - 91.2), and for parents were 60.3 (44.8 - 66.0) and 85.3 (83.7 - 91.3), respectively (both p<0.001). Conclusion: Use of CGM for children with HH is feasible, with clinically acceptable accuracy, particularly in the hypoglycaemic range. Quality of life measures demonstrate significant improvement after CGM use. These data are important to explore use of CGM in disease indications, including neonatal and paediatric diabetes, cystic fibrosis and glycogen storage disorders.