Frequency of hypoglycaemia with basal insulin treatments in adults with type 1 diabetes treated with basal-bolus insulin regimens in treat-to-target trials: A narrative review.

AIM: To summarise, in a narrative review, published data on hypoglycaemia occurrence with basal insulin therapy in adults with type 1 diabetes treated with basal-bolus insulin regimens in treat-to-target randomised controlled trials. METHODS: Data were included from 21 eligible trials, which mainly used self-measured blood glucose or plasma glucose to detect hypoglycaemia. RESULTS: All-day self-measured blood glucose or plasma glucose level 2 (glucose threshold of 3.1 or 3.0 mmol/L) and level 3 (severe, requiring assistance) hypoglycaemic events were reported, respectively, by a range of 69.0%-97.5% and 0%-13.4% adults when receiving basal-bolus insulin therapy, with rates of 10.6-68.1 and 0.0-0.4 events per patient-year of exposure, respectively. Hypoglycaemia rates measured using continuous glucose monitoring (three studies) were numerically, yet consistently, higher than with either other method, except when limiting to symptomatic events. Nocturnal hypoglycaemia rates were generally less than 30% of the equivalent all-day rates. CONCLUSIONS: Differences across the studies in design (e.g., titration targets) and participant characteristics hindered comparison of hypoglycaemia rates by insulin formulation. Consequently, few trends were identified by insulin formulation, study methodology or individuals' characteristics, suggesting that further research is required to identify treatment strategies that facilitate development of individualised recommendations to lower hypoglycaemia risk. These findings are useful to understand hypoglycaemia risk with available basal insulin therapies when used in a multiple daily injection regimen, as well as to provide context for the results of ongoing and future clinical trials, including those for two once-weekly basal insulins, insulin icodec and basal insulin Fc.

Prevalence, trends, and factors associated with maternal autonomy regarding healthcare, finances, and mobility in Bangladesh: Analysis of Demographic and Health Surveys 1999-2018.

Maternal autonomy is associated with improved healthcare utilization/outcomes for mothers and babies in low- and middle-income countries. We investigated the trends in the prevalence and factors associated with maternal autonomy in Bangladesh. This cross-sectional study analyzed the Bangladesh Demographic and Health Survey for 1999-00, 2004, 2007, 2011, 2014, and 2017-18. Maternal autonomy was defined as at least one decision-making ability regarding healthcare, large household purchases, and freedom of mobility. We included 15-49-year-old mothers with at least one live-birth in the past three years. We compared the samples based on the presence of autonomy and reported the trends in prevalence (95% confidence intervals (CIs)) across the survey years. Lastly, we performed multilevel logistic regression to report prevalence odds ratios (PORs) for the associated factors. Variables investigated as potential factors included maternal age, number of children, maternal education, paternal education, current work, religion, mass media exposure, wealth quintile, place and division of residence, and survey years. The prevalence of 'any' maternal autonomy was 72.0% (95% CI: 70.5-73.5) in 1999-00 and increased to 83.8% (95% CI: 82.7-84.9) in 2017-18. In adjusted analysis, mothers with older age, higher education, work outside the home, and mass media exposure had higher odds of autonomy than their counterparts (POR > 1, p < 0.05). For instance, compared to mothers without any formal education, the odds of autonomy were significantly (p < 0.001) higher among mothers with primary (adjusted POR: 1.2, 95% CI: 1.1-1.4), secondary (adjusted POR: 1.4, 95% CI: 1.2-1.6), and college/above (adjusted POR: 1.9, 95% CI: 1.6-2.2) education. While the level of maternal autonomy has increased, a substantial proportion still do not have autonomy. Expanding educational and earning opportunities may increase maternal autonomy. Further research should investigate other ways to improve it as well.

Switching to once-weekly insulin icodec versus once-daily insulin glargine U100 in individuals with basal-bolus insulin-treated type 2 diabetes (ONWARDS 4): a phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial.

BACKGROUND: Insulin icodec (icodec) is a basal insulin analogue suitable for once-weekly dosing. ONWARDS 4 aimed to assess the efficacy and safety of once-weekly icodec compared with once-daily insulin glargine U100 (glargine U100) in individuals with long-standing type 2 diabetes on a basal-bolus regimen. METHODS: In this 26-week, phase 3a, randomised, open-label, multicentre, treat-to-target, non-inferiority trial, adults from 80 sites (outpatient clinics and hospital departments) across nine countries (Belgium, India, Italy, Japan, Mexico, the Netherlands, Romania, Russia, and the USA) with type 2 diabetes (glycated haemoglobin [HbA1c] 7·0-10·0%) were randomly assigned (1:1) to receive once-weekly icodec or once-daily glargine U100 combined with 2-4 daily bolus insulin aspart injections. The primary outcome was change in HbA1c from baseline to week 26 (non-inferiority margin of 0·3 percentage points). The primary outcome was evaluated in the full analysis set (ie, all randomly assigned participants). Safety outcomes were evaluated in the safety analysis set (ie, all participants randomly assigned who received at least one dose of trial product). This trial is registered with ClinicalTrials.gov, NCT04880850. FINDINGS: Between May 14 and Oct 29, 2021, 746 participants were screened for eligibility, of whom 582 (78%) were randomly assigned (291 [50%] to icodec treatment and 291 [50%] to glargine U100 treatment). Participants had a mean duration of type 2 diabetes of 17·1 years (SD 8·4). At week 26, estimated mean change in HbA1c was -1·16 percentage points in the icodec group (baseline 8·29%) and -1·18 percentage points in the glargine U100 group (baseline 8·31%), showing non-inferiority for icodec versus glargine U100 (estimated treatment difference 0·02 percentage points [95% CI -0·11 to 0·15], p<0·0001). Overall, 171 (59%) of 291 participants in the icodec group and 167 (57%) of 291 participants in the glargine U100 group had an adverse event. 35 serious adverse events were reported in 22 (8%) of 291 participants in the icodec group and 33 serious adverse events were reported in 25 (9%) of 291 participants receiving glargine U100. Overall, combined level 2 and level 3 hypoglycaemia rates were similar between treatment groups. No new safety concerns were identified for icodec. INTERPRETATION: In people with long-standing type 2 diabetes on a basal-bolus regimen, once-weekly icodec showed similar improvements in glycaemic control, with fewer basal insulin injections, lower bolus insulin dose, and with no increase in hypoglycaemic rates compared with once-daily glargine U100. Key strengths of this trial include the use of masked continous glucose monitoring; the high trial completion rate; and the inclusion of a large, diverse, and multinational population. Limitations include the relatively short trial duration and the open-label design. FUNDING: Novo Nordisk.

How Should Clinicians and Health Care Organizations Promote Equity in Child Abuse and Neglect Suspicion, Evaluation, and Reporting?

Victims of child abuse and neglect come from every racial, ethnic, and socioeconomic background, yet clinical evaluation, reporting to child protective services, and responses to reports inequitably harm Black children and malign families of color. Racial bias and inequity in suspicion, reporting, and substantiation of abuse and neglect and in services offered and delivered, foster care placement, and criminal prosecution are widely documented. In response, clinicians and health care organizations should promote equity by educating clinicians about racial bias, standardizing evaluation using clinical decision support tools, and working with policy makers to support prevention services. If we decide that it is ethically justifiable for clinicians to err on the side of overreporting, we must ensure fair distribution of associated benefits and harms among all children and families.

Effective Overall Glycaemic Control with Fast-Acting Insulin Aspart Across Patients with Different Baseline Characteristics: A Post Hoc Analysis of the Onset 9 Trial.

AIMS: To investigate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp) in participants with type 2 diabetes (T2D) across different subgroups. METHODS: We report on a post hoc analysis of onset 9, a 16-week trial of participants with T2D randomised to faster aspart (n = 546) or IAsp (n = 545). Participants were grouped by baseline HbA1c (< 7.0%, ≥ 7.0%), meal test bolus insulin dose (≤ 10 units [U], > 10 U to ≤ 20 U, > 20 U), body mass index (< 30 kg/m2, ≥ 30 to < 35 kg/m2, ≥ 35 kg/m2), and age (< 65 years, ≥ 65 years). Outcomes assessed were change from baseline in HbA1c and in 1-h postprandial glucose (PPG) increment, and severe or blood glucose (BG)-confirmed hypoglycaemia. RESULTS: Faster aspart provided reductions in HbA1c comparable to IAsp across all subgroups, with improved 1-h PPG control compared with IAsp in several subgroups. Faster aspart had comparable or improved rates of severe or BG-confirmed hypoglycaemia versus IAsp, particularly in participants with good glycaemic control (HbA1c < 7.0%), the elderly (≥ 65 years old), and those with insulin resistance (> 20 U meal test bolus insulin dose). CONCLUSIONS: Faster aspart provides effective overall glycaemic control, with improved early PPG control compared with IAsp across a range of patient characteristics. CLINICAL TRIAL REGISTRATION: NCT03268005.

Fast-acting insulin aspart (faster aspart) is a type of insulin used at mealtimes to reduce the spike in blood sugar resulting from that meal. Faster aspart works in the body more quickly and more effectively than insulin aspart (IAsp), the previous version of this insulin. The properties of insulins in the body can change according to certain patient characteristics. In this study, the researchers wanted to find out if there were differences between various subgroups of patients in the effectiveness and safety of faster aspart compared with IAsp in the treatment of type 2 diabetes. Data were used from a clinical trial (onset 9), in which 546 patients were treated with faster aspart and 545 were treated with IAsp. Patients were grouped by baseline glycated haemoglobin (HbA1c), meal test actual bolus insulin dose, body mass index, and age. Faster aspart provided reductions in HbA1c comparable to IAsp across all subgroups, with improved glucose control 1 hour after a meal compared with IAsp, in several subgroups. Faster aspart had comparable or improved rates of hypoglycaemia versus IAsp, particularly in participants with good glucose control, the elderly (≥ 65 years old), and those with insulin resistance. In summary, the researchers found that faster aspart provides effective overall glucose control, with improved early mealtime glucose control compared with IAsp across patients with a range of baseline characteristics.

Benefits realization management in the context of a national digital transformation initiative in English provider organizations.

BACKGROUND: The Global Digital Exemplar (GDE) Programme is a national initiative to promote digitally enabled transformation in English provider organizations. The Programme applied benefits realization management techniques to promote and demonstrate transformative outcomes. This work was part of an independent national evaluation of the GDE Programme. AIMS: We explored how benefits realization management was approached and conceptualized in the GDE Programme. METHODS: We conducted a series of 36 longitudinal case studies of provider organizations participating in the GDE Programme, 12 of which were in depth. Data collection included a combination of 628 interviews (with implementation staff in provider organizations, national programme management staff, and suppliers), 499 documents (of national and local implementation plans and lessons learned), and 190 nonparticipant observations (of national and local programme management meetings to develop insights into the broader context of benefits realization activities, tensions arising, and how these were negotiated). Data were coded drawing on a sociotechnical framework developed in related work and thematically analyzed, initially within and then across cases, with the help of NVivo 11 software. RESULTS: Most stakeholders broadly agreed with the rationale of benefits realization in the GDE Programme to show due diligence that public money was appropriately spent, and to develop an evidence base supporting the value of digitally enabled transformation. Differing national and local reporting purposes, however, created tensions. Central requirements, for progress reporting and tracking high-level benefits, had limited perceived local value and were seen to impose an unnecessary burden on provider organizations. This was accentuated by the lack of harmonization of reporting requirements to different stakeholders (which differed in content and timing). There were tensions between the desire for early evidence of outcomes and the slow processes of infrastructural change (which created problems of attribution of benefits to causes as benefits emerged gradually and over long timeframes), and also between reporting immediately visible local changes and showing how these flowed through to high level organization wide benefits (eg, in terms of health outcomes or cost savings/return on investment). The attempt to fulfill these diverging agendas and informational needs within a single reporting tool had limited success. These difficulties were mitigated by efforts to simplify reporting requirements and to support targeted collection of key national outcome measures. Although progress was hampered by an initial lack of benefits realization expertise in provider organizations, some providers subsequently retained these skills for their own change management purposes. CONCLUSIONS: There is a need to recognize the limitations and cost of benefits realization management practices in the context of healthcare digitalization where benefits may materialize over long timeframes and in unanticipated ways. Although diverse stakeholder information needs may create tensions, prior agreement about rationales for collecting information and a targeted approach to tracking local and high-level benefits may enhance local relevance, reduce perceived reporting burdens, and improve acceptance/effectiveness. A single integrated reporting mechanism is unlikely to fulfill both national and local requirements.

Basal Insulin Degludec and Glycemic Control Compared to Aspart Via Insulin Pump in Type 1 Diabetes (BIGLEAP): A Single-Center, Open-Label, Randomized, Crossover Trial.

OBJECTIVE: We compared the efficacy of the second-generation basal insulin degludec (IDeg) to that of insulin aspart via pump using continuous glucose monitoring in patients with well-controlled type 1 diabetes. METHODS: In this 40-week, single-center, randomized, crossover-controlled trial, adults with well-controlled type 1 diabetes (hemoglobin A1C of <7.5% [<58 mmol/mol]) (N = 52) who were using an insulin pump and continuous glucose monitoring were randomized to 1 of 2 treatments for a 20-week period: a single daily injection of IDeg with bolus aspart via pump or a continuous subcutaneous insulin infusion (CSII) with aspart, followed by crossover to the other treatment. The primary endpoint was time in range (70-180 mg/dL) during the final 2 weeks of each treatment period. RESULTS: Fifty-two patients were randomized and completed both treatment periods. The time in range for IDeg and CSII was 71.5% and 70.9%, respectively (P = .553). The time in level 1 hypoglycemia for the 24-hour period with IDeg and CSII was 2.19% and 1.75%, respectively (P = .065). The time in level 2 hypoglycemia for the 24-hour period with IDeg and CSII was 0.355% and 0.271%, respectively (P = .212), and the nocturnal period was 0.330% and 0.381%, respectively (P = .639). The mean standard deviation of blood glucose levels for the 24-hour period for IDeg and CSII was 52.4 mg/dL and 51.0 mg/dL, respectively (P = .294). The final hemoglobin A1C level for each treatment was 7.04% (53 mmol/mol) with IDeg, and 6.95% (52 mmol/mol) with CSII (P = .288). Adverse events were similar between treatments. CONCLUSION: We observed similar glycemic control between IDeg and insulin aspart via CSII for basal insulin coverage in patients with well-controlled type 1 diabetes.

Driving digital health transformation in hospitals: a formative qualitative evaluation of the English Global Digital Exemplar programme.

BACKGROUND: There is currently a strong drive internationally towards creating digitally advanced healthcare systems through coordinated efforts at a national level. The English Global Digital Exemplar (GDE) programme is a large-scale national health information technology change programme aiming to promote digitally-enabled transformation in secondary healthcare provider organisations by supporting relatively digitally mature provider organisations to become international centres of excellence. AIM: To qualitatively evaluate the impact of the GDE programme in promoting digital transformation in provider organisations that took part in the programme. METHODS: We conducted a series of in-depth case studies in 12 purposively selected provider organisations and a further 24 wider case studies of the remaining organisations participating in the GDE programme. Data collected included 628 interviews, non-participant observations of 190 meetings and workshops and analysis of 9 documents. We used thematic analysis aided by NVivo software and drew on sociotechnical theory to analyse the data. RESULTS: We found the GDE programme accelerated digital transformation within participating provider organisations. This acceleration was triggered by: (1) dedicated funding and the associated requirement for matched internal funding, which in turn helped to prioritise digital transformation locally; (2) governance requirements put in place by the programme that helped strengthen existing local governance and project management structures and supported the emergence of a cadre of clinical health informatics leaders locally; and (3) reputational benefits associated with being recognised as a centre of digital excellence, which facilitated organisational buy-in for digital transformation and increased negotiating power with vendors. CONCLUSION: The GDE programme has been successful in accelerating digital transformation in participating provider organisations. Large-scale digital transformation programmes in healthcare can stimulate local progress through protected funding, putting in place governance structures and leveraging reputational benefits for participating provider organisations, around a coherent vision of transformation.

Exploring the Burden of Mealtime Insulin Dosing in Adults and Children With Type 1 Diabetes.

Timely and accurate mealtime insulin dosing can be an ongoing challenge for people with type 1 diabetes. This multinational, online study aimed to explore attitudes and behaviors around mealtime insulin dosing and the impact of mealtime dose timing, particularly with regard to premeal dosing (15-20 minutes before a meal). Although the majority of surveyed participants (96%) recognized the importance of accurate mealtime bolus insulin dosing, only a small proportion (35%) reported being "very confident" in accurate bolus insulin estimation. Given the choice, the majority of participants would prefer to administer insulin immediately before or after a meal, as this timing would improve their quality of life.

Glycaemic Control in People with Diabetes Starting Treatment with Fast-Acting Insulin Aspart: a US Database Study.

INTRODUCTION: This study investigated glycaemic control in individuals with type 1 (T1D) or type 2 diabetes (T2D) 6 months after initiating fast-acting insulin aspart (faster aspart) in a real-world setting. METHODS: This was a single-arm, observational study using extracted patient data from the IBM® Explorys® database (USA) for individuals with T1D or T2D initiating faster aspart (at least one prescription of faster aspart) in the study period 1 January 2018 to 27 October 2020. Clinical characteristics, including age, body mass index, and baseline HbA1c, were extracted, as well as recorded events of hypoglycaemia. The primary endpoint was the change in HbA1c from baseline to 6 months. RESULTS: A total of 787 individuals were included; 36.6% of these individuals had T1D and 63.4% had T2D (of whom 46.9% were new users of rapid-acting insulin when initiating faster aspart [T2D new users] and 53.1% were switching from another rapid-acting insulin to faster aspart [T2D switchers]). For individuals with T1D, T2D new users, or T2D switchers, estimated mean change in HbA1c from baseline to 6 months was - 0.20% (95% CI - 0.53, 0.14; p  =  0.252), - 1.00% (95% CI -  1.34, -  0.67; p < 0.0001), and - 0.70% (95% CI - 1.06, - 0.35; p = 0.0001), respectively. In the baseline HbA1c > 8.5% subgroup, there was a significant estimated decrease in HbA1c from baseline to 6 months in individuals with T1D (-  1.2% [95% CI - 1.80, -  0.60]; p = 0.0001) or T2D (- 0.6% [95% CI - 0.92, -  0.35]; p <  0.0001). Event rates of hypoglycaemia after 12 months were 0.68, 0.38, and 0.59 events/year for individuals with T1D, T2D new users, and T2D switchers, respectively. CONCLUSION: US IBM® Explorys® data demonstrated a clinically relevant reduction in HbA1c 6 months after initiating faster aspart treatment for individuals with T2D, but not T1D overall, although patients with baseline HbA1c > 8.5% had significant HbA1c reductions regardless of diabetes type.

Interorganizational Knowledge Sharing to Establish Digital Health Learning Ecosystems: Qualitative Evaluation of a National Digital Health Transformation Program in England.

BACKGROUND: The English Global Digital Exemplar (GDE) program is one of the first concerted efforts to create a digital health learning ecosystem across a national health service. OBJECTIVE: This study aims to explore mechanisms that support or inhibit the exchange of interorganizational digital transformation knowledge. METHODS: We conducted a formative qualitative evaluation of the GDE program. We used semistructured interviews with clinical, technical, and managerial staff; national program managers and network leaders; nonparticipant observations of knowledge transfer activities through attending meetings, workshops, and conferences; and documentary analysis of policy documents. The data were thematically analyzed by drawing on a theory-informed sociotechnical coding framework. We used a mixture of deductive and inductive methods, supported by NVivo software, to facilitate coding. RESULTS: We conducted 341 one-on-one and 116 group interviews, observed 86 meetings, and analyzed 245 documents from 36 participating provider organizations. We also conducted 51 high-level interviews with policy makers and vendors; performed 77 observations of national meetings, workshops, and conferences; and analyzed 80 national documents. Formal processes put in place by the GDE program to initiate and reinforce knowledge transfer and learning have accelerated the growth of informal knowledge networking and helped establish the foundations of a learning ecosystem. However, formal networks were most effective when supported by informal networking. The benefits of networking were enhanced (and costs reduced) by geographical proximity, shared culture and context, common technological functionality, regional and strategic alignments, and professional agendas. CONCLUSIONS: Knowledge exchange is most effective when sustained through informal networking driven by the mutual benefits of sharing knowledge and convergence between group members in their organizational and technological setting and goals. Policy interventions need to enhance incentives and reduce barriers to sharing across the ecosystem, be flexible in tailoring formal interventions to emerging needs, and promote informal knowledge sharing.

Promoting inter-organisational knowledge sharing: A qualitative evaluation of England's Global Digital Exemplar and Fast Follower Programme.

BACKGROUND: The Global Digital Exemplar (GDE) Programme was designed to promote the digitisation of hospital services in England. Selected provider organisations that were reasonably digitally-mature were funded with the expectation that they would achieve internationally recognised levels of excellence and act as exemplars ('GDE sites') and share their learning with somewhat less digitally-mature Fast Follower (FF) sites. AIMS: This paper explores how partnerships between GDE and FF sites have promoted knowledge sharing and learning between organisations. METHODS: We conducted an independent qualitative longitudinal evaluation of the GDE Programme, collecting data across 36 provider organisations (including acute, mental health and speciality), 12 of which we studied as in-depth ethnographic case studies. We used a combination of semi-structured interviews with programme leads, vendors and national policy leads, non-participant observations of meetings and workshops, and analysed national and local documents. This allowed us to explore both how inter-organisational learning and knowledge sharing was planned, and how it played out in practice. Thematic qualitative analysis, combining findings from diverse data sources, was facilitated by NVivo 11 and drew on sociotechnical systems theory. RESULTS: Formally established GDE and FF partnerships were perceived to enhance learning and accelerate adoption of technologies in most pairings. They were seen to be most successful where they had encouraged, and were supported by, informal knowledge networking, driven by the mutual benefits of information sharing. Informal networking was enhanced where the benefits were maximised (for example where paired sites had implemented the same technological system) and networking costs minimised (for example by geographical proximity, prior links and institutional alignment). Although the intervention anticipated uni-directional learning between exemplar sites and 'followers', in most cases we observed a two-way flow of information, with GDEs also learning from FFs, through informal networking which also extended to other health service providers outside the Programme. The efforts of the GDE Programme to establish a learning ecosystem has enhanced the profile of shared learning within the NHS. CONCLUSIONS: Inter-organisational partnerships have produced significant gains for both follower (FF) and exemplar (GDE) sites. Formal linkages were most effective where they had facilitated, and were supported by, informal networking. Informal networking was driven by the mutual benefits of information sharing and was optimised where sites were well aligned in terms of technology, geography and culture. Misalignments that created barriers to networking between organisations in a few cases were attributed to inappropriate choice of partners. Policy makers seeking to promote learning through centrally directed mechanisms need to create a framework that enables networking and informal knowledge transfer, allowing local organisations to develop bottom-up collaboration and exchanges, where they are productive, in an organic manner.

Using Blueprints to promote interorganizational knowledge transfer in digital health initiatives-a qualitative exploration of a national change program in English hospitals.

OBJECTIVE: The Global Digital Exemplar (GDE) Program is a national attempt to accelerate digital maturity in healthcare providers through promoting knowledge transfer across the English National Health Service (NHS). "Blueprints"-documents capturing implementation experience-were intended to facilitate this knowledge transfer. Here we explore how Blueprints have been conceptualized, produced, and used to promote interorganizational knowledge transfer across the NHS. MATERIALS AND METHODS: We undertook an independent national qualitative evaluation of the GDE Program. This involved collecting data using semistructured interviews with implementation staff and clinical leaders in provider organizations, nonparticipant observation of meetings, and key documents. We also attended a range of national meetings and conferences, interviewed national program managers, and analyzed a range of policy documents. Our analysis drew on sociotechnical principles, combining deductive and inductive methods. RESULTS: Data comprised 508 interviews, 163 observed meetings, and analysis of 325 documents. We found little evidence of Blueprints being adopted in the manner originally conceived by national program managers. However, they proved effective in different ways to those planned. As well as providing a helpful initial guide to a topic, we found that Blueprints served as a method of identifying relevant expertise that paved the way for subsequent discussions and richer knowledge transfers amongst provider organizations. The primary value of Blueprinting, therefore, seemed to be its role as a networking tool. Members of different organizations came together in developing, applying, and sustaining Blueprints through bilateral conversations-in some circumstances also fostering informal communities of practice. CONCLUSIONS: Blueprints may be effective in facilitating knowledge transfer among healthcare organizations, but need to be accompanied by other evolving methods, such as site visits and other networking activities, to iteratively transfer knowledge and experience.

Glucose Variability and Time in Range in Type 2 Diabetes Treated with U-500R by Pump or Injection: CGM Findings from the VIVID Study.

Background: The EValuating U-500R Infusion Versus Injection in Type 2 Diabetes Mellitus (VIVID) study compared two methods of U-500R insulin delivery, continuous subcutaneous insulin infusion (CSII) and multiple daily injection (MDI), for 26 weeks in people with type 2 diabetes (T2D) requiring high doses of insulin. To assess glycemic variability (GV) and time in range (TIR), a subset of participants performed masked continuous glucose monitoring (CGM). Methods: VIVID participants were adults who had insulin requirements of >200 but ≤600 U/day and A1C 7.5% to 12%. Participants performed masked CGM for seven consecutive days on each of three occasions: before weeks 0 (baseline), 14, and 26. The primary objective was to compare GV between CSII and MDI groups, based on change from baseline of within-day standard deviation (SDw) of CGM glucose. Results: Of 54 participants enrolled, 41 with evaluable data were analyzed (17 and 24 in CSII and MDI groups, respectively). The CSII group had a significantly greater reduction from baseline in mean SDw of glucose (45.0 to 38.2 mg/dL [-8.1 mg/dL]) compared with the MDI group (47.0 to 45.8 [-0.4 mg/dL]; P = 0.047). TIR 70-180 mg/dL glucose increased significantly from baseline in the CSII group only, from 59.8% to 73.1% (change +12.9%, P < 0.05), but was not significantly different between groups. There were no significant between-group differences in the endpoint mean glucose or A1C. Conclusions: In the VIVID CGM substudy of U-500R in people with T2D requiring high doses of insulin, participants using CSII significantly reduced GV compared with MDI. CSII also significantly increased TIR with no difference between groups.

Cost effectiveness of SEEK: A primary care-based child maltreatment prevention model.

BACKGROUND: Funding for prevention interventions is often quite limited. Cost-related assessments are important to best allocate prevention funds. OBJECTIVES: To determine the (1) overall cost for implementing the Safe Environment for Every Kid (SEEK) model, (2) cost of implementation per child, and (3) cost per case of maltreatment averted. DESIGN: Cost-effective analysis of a randomized controlled trial. PARTICIPANTS AND SETTING: 102 pediatric providers at 18 pediatric primary care practices. 924 families with children < 6 years receiving care by those providers. METHODS: Practices and their providers were randomized to either SEEK training and implementation or usual care. Families in SEEK and control practices were recruited for evaluation. Rates of psychological and physical abuse were calculated by parent self-report 12 months following recruitment. Model costs were calculated including salaries for team members, provider time for training and booster sessions, and development and distribution of materials. RESULTS: Implementing SEEK in all 18 practices would have cost approximately $265,892 over 2.5 years; $3.59 per child per year; or $305.58 ($229.18-$381.97) to prevent one incident. Based on a very conservative cost estimate of $2779 per maltreatment incident, SEEK would save an estimated $2,151,878 in health care costs for 29,610 children. CONCLUSIONS: The SEEK model is cost saving. Cost per case of psychological and physical abuse averted were significantly lower than the short-term costs of medical and mental health care for maltreated children. SEEK model expansion has the potential to significantly decrease medical, mental health, and other related costs associated with maltreatment.

Social determinants of health, personalized medicine, and child maltreatment.

This review begins with a brief summary of the importance of child maltreatment as a major public health problem, given its prevalence and the substantial human and economic costs involved. The focus then shifts to consideration of personalized medicine and child maltreatment, including genetic and genomics factors, as well as the role of social determinants of health. Research on epigenetics related to child abuse and neglect is presented, followed by that pertaining to a few specific social factors, such as poverty, parental depression and substance use, and domestic (or intimate partner) violence. The review ends with a discussion of interventions to help address social determinants of health with brief descriptions of several model programs, and thoughts concerning the role of personalized medicine in addressing child maltreatment in the foreseeable future. IMPACT: This paper synthesizes knowledge on social determinants of health and advances in genetics and genomics related to the prevention of child maltreatment. It provides examples of model approaches to addressing the prevention of child maltreatment in primary care practices.

Formative independent evaluation of a digital change programme in the English National Health Service: study protocol for a longitudinal qualitative study.

INTRODUCTION: Many countries are launching large-scale, digitally enabled change programmes as part of efforts to improve the quality, safety and efficiency of care. We have been commissioned to conduct an independent evaluation of a major national change programme, the Global Digital Exemplar (GDE) Programme, which aims to develop exemplary digital health solutions and encourage their wider adoption by creating a learning ecosystem across English National Health Service (NHS) provider organisations. METHODS AND ANALYSIS: This theoretically informed, qualitative, longitudinal formative evaluation comprises five inter-related work packages. We will conduct a combination of 12 in-depth and 24 broader qualitative case studies in GDE sites exploring digital transformation, local learning and mechanisms of spread of knowledge within the Programme and across the wider NHS. Data will be collected through a combination of semistructured interviews with managers, implementation staff (clinical and non-clinical), vendors and policymakers, plus non-participant observations of meetings, site visits, workshops and documentary analysis of strategic local and national plans. Data will be analysed through inductive and deductive methods, beginning with in-depth case study sites and testing the findings against data from the wider sample and national stakeholders. ETHICS AND DISSEMINATION: This work is commissioned as part of a national change programme and is therefore a service evaluation. We have ethical approval from the University of Edinburgh. Results will be disseminated at six monthly intervals to national policymakers, and made available via our publicly accessible website. We will also identify lessons for the management and evaluation of large-scale evolving digital health change programmes that are of international relevance.

Technological Capabilities to Assess Digital Excellence in Hospitals in High Performing Health Care Systems: International eDelphi Exercise.

BACKGROUND: Hospitals worldwide are developing ambitious digital transformation programs as part of broader efforts to create digitally advanced health care systems. However, there is as yet no consensus on how best to characterize and assess digital excellence in hospitals. OBJECTIVE: Our aim was to develop an international agreement on a defined set of technological capabilities to assess digital excellence in hospitals. METHODS: We conducted a two-stage international modified electronic Delphi (eDelphi) consensus-building exercise, which included a qualitative analysis of free-text responses. In total, 31 international health informatics experts participated, representing clinical, academic, public, and vendor organizations. RESULTS: We identified 35 technological capabilities that indicate digital excellence in hospitals. These are divided into two categories: (a) capabilities within a hospital (n=20) and (b) capabilities enabling communication with other parts of the health and social care system, and with patients and carers (n=15). The analysis of free-text responses pointed to the importance of nontechnological aspects of digitally enabled change, including social and organizational factors. Examples included an institutional culture characterized by a willingness to transform established ways of working and openness to risk-taking. The availability of a range of skills within digitization teams, including technological, project management and business expertise, and availability of resources to support hospital staff, were also highlighted. CONCLUSIONS: We have identified a set of criteria for assessing digital excellence in hospitals. Our findings highlight the need to broaden the focus from technical functionalities to wider digital transformation capabilities.

Theoretical and methodological considerations in evaluating large-scale health information technology change programmes.

BACKGROUND: Attempts to achieve digital transformation across the health service have stimulated increasingly large-scale and more complex change programmes. These encompass a growing range of functions in multiple locations across the system and may take place over extended timeframes. This calls for new approaches to evaluate these programmes. MAIN BODY: Drawing on over a decade of conducting formative and summative evaluations of health information technologies, we here build on previous work detailing evaluation challenges and ways to tackle these. Important considerations include changing organisational, economic, political, vendor and markets necessitating tracing of evolving networks, relationships, and processes; exploring mechanisms of spread; and studying selected settings in depth to understand local tensions and priorities. CONCLUSIONS: Decision-makers need to recognise that formative evaluations, if built on solid theoretical and methodological foundations, can help to mitigate risks and help to ensure that programmes have maximum chances of success.

A Randomized Trial Evaluating the Efficacy and Safety of Fast-Acting Insulin Aspart Compared With Insulin Aspart, Both in Combination With Insulin Degludec With or Without Metformin, in Adults With Type 2 Diabetes (ONSET 9).

OBJECTIVE: To evaluate the efficacy and safety of fast-acting insulin aspart (faster aspart) compared with insulin aspart (IAsp), both with insulin degludec with or without metformin, in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen. RESEARCH DESIGN AND METHODS: This multicenter, double-blind, treat-to-target trial randomized participants to faster aspart (n = 546) or IAsp (n = 545). All available information, regardless of treatment discontinuation or use of ancillary treatment, was used for evaluation of effect. RESULTS: Noninferiority for the change from baseline in HbA1c 16 weeks after randomization (primary end point) was confirmed for faster aspart versus IAsp (estimated treatment difference [ETD] -0.04% [95% CI -0.11; 0.03]; -0.39 mmol/mol [-1.15; 0.37]; P < 0.001). Faster aspart was superior to IAsp for change from baseline in 1-h postprandial glucose (PPG) increment using a meal test (ETD -0.40 mmol/L [-0.66; -0.14]; -7.23 mg/dL [-11.92; -2.55]; P = 0.001 for superiority). Change from baseline in self-measured 1-h PPG increment for the mean over all meals favored faster aspart (ETD -0.25 mmol/L [-0.42; -0.09]); -4.58 mg/dL [-7.59; -1.57]; P = 0.003). The overall rate of treatment-emergent severe or blood glucose (BG)-confirmed hypoglycemia was statistically significantly lower for faster aspart versus IAsp (estimated treatment ratio 0.81 [95% CI 0.68; 0.97]). CONCLUSIONS: In combination with insulin degludec, faster aspart provided effective overall glycemic control, superior PPG control, and a lower rate of severe or BG-confirmed hypoglycemia versus IAsp in adults with type 2 diabetes not optimally controlled with a basal-bolus regimen.