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User designed Automated Insulin Delivery systems (AID), termed Do-It-Yourself (DIY) AID include; AndroidAPS, OpenAPS and Loop. These unregulated systems provide challenges for healthcare providers worldwide, with potential legal and ethical barriers to supporting their use. We performed a scoping review of the currently available literature surrounding DIY AID systems, specifically to highlight the evidence available to facilitate healthcare providers to support persons with diabetes who may benefit from DIY AID. Studies relating to DIY AID systems were searched in Embase, Medline, Web of Science, Scopus, Proquest and Cochrane library until 31st December 2021. Publications were screened through title and abstract to identify study type and AID system type described. A thematic synthesis methodology was used for analysis of studies of DIY AID use due to the heterogeneity in study designs (case reports, qualitative, cross-sectional and cohort studies), with similarity in outcome themes. Following implementation of the search strategy, 38 relevant full texts were identified; comprising 12 case reports, 9 qualitative studies and 17 cohort studies, and data was also available from 24 relevant conference abstracts. No randomized studies were identified. Common themes were identified in the outcomes across the studies; glycemic variability, safety, quality of life, healthcare provider attitudes and social media. There is extensive real-world data, but a lack of randomized control trial evidence supporting DIY AID system use, due to the user-driven, unregulated nature of these systems. Healthcare providers report a lack of understanding surrounding, and confidence in supporting, DIY AID despite impressive observational and user self-reported improvements in glycemic variability, without any reported safety compromises.

This volume contains lectures on leading-edge research in methods and tools for use in computer system engineering; at the 4th International School on Engineering Trustworthy Software Systems, SETSS 2018, held in April 2018 at Southwest University in Chongqing, China. The five chapters in this volume provide an overview of research in the frontier of theories, methods, and tools for software modelling, design, and verification. The topics covered in these chapter include Software Verification with Whiley, Learning Büchi Automata and Its Applications, Security in IoT Applications, Programming in Z3, and The Impact of Alan Turing: Formal Methods and Beyond. The volume provides a useful resource for postgraduate students, resarchers, academics, and engineers in industry, who are interested in theory, methods, and tools for the development of trustworthy software.

Islet transplantation is an established clinical procedure for select patients with type 1 diabetes and severe hypoglycemia to stabilize glycemic control. Post-transplant, substantial beta cell mass is lost, necessitating multiple donors to maintain euglycemia. A potential strategy to augment islet engraftment is the co-transplantation of islets with multipotent mesenchymal stem cells to capitalize upon their pro-angiogenic and anti-inflammatory properties. Herein, we examine the in vitro and in vivo effect of co-culturing murine islets with human adipose-derived mesenchymal stem cells (Ad-MSCs). Islets co-cultured with Ad-MSCs for 48 hours had decreased cell death, superior viability as measured by membrane integrity, improved glucose stimulated insulin secretion and reduced apoptosis compared to control islets. These observations were recapitulated with human islets, albeit tested in a limited capacity. Recipients of marginal mouse islet mass grafts, co-transplanted with Ad-MSCs without a co-culture period, did not reverse to normoglycemia as efficiently as islets alone. However, utilizing a 48-hour co-culture period, marginal mouse islets grafts with Ad-MSCs achieved a superior percent euglycemia rate when compared to islets cultured and transplanted alone. A co-culture period of human islets with human Ad-MSCs may have a clinical benefit improving engraftment outcomes.

Islet transplantation (ITx) is advancing rapidly, with clinical trials of stem cell derived islets demonstrating short-term insulin independence. However, long-term insulin independence may still require multiple infusions. We examined the effects of sequential ITx on portal venous pressure and factors influencing acute pressure changes across 693 intraportal ITx procedures in 298 adults (44% M); who received up to 5 procedures, at the University of Alberta Hospital over 24 years. We assessed acute portal pressure changes per infusion, using linear mixed-effects models to compare sequential pre-infusion pressures to baseline and assess relationships between pressure changes and packed cell volume (PCV), purity, islet dose (IE/kg) and estimated total liver volume (eTLV). Portal pressure transiently increased, similarly, after each infusion by an overall median 2.0 mmHg (IQR 1.0,4.0). PCV exhibited the strongest relationship with change in pressure, with1mmHg increase per 1 mL of PCV, when adjusted for other parameters (Coefficient = 1.0 [95%CI 0.81,1.21];p < 0.0001). Conversely, higher purity and larger eTLV were associated with smaller increases in pressure. A significant interaction term indicated that the effect that PCV has on pressure change may be moderated at higher purities. Our work provides insights from deceased-donor intraportal ITx that can inform the design of future clinical protocols for ITx.

User designed Automated Insulin Delivery systems (AID), termed Do-It-Yourself (DIY) AID include; AndroidAPS, OpenAPS and Loop. These unregulated systems provide challenges for healthcare providers worldwide, with potential legal and ethical barriers to supporting their use. We performed a scoping review of the currently available literature surrounding DIY AID systems, specifically to highlight the evidence available to facilitate healthcare providers to support persons with diabetes who may benefit from DIY AID. Studies relating to DIY AID systems were searched in Embase, Medline, Web of Science, Scopus, Proquest and Cochrane library until 31.sup.st December 2021. Publications were screened through title and abstract to identify study type and AID system type described. A thematic synthesis methodology was used for analysis of studies of DIY AID use due to the heterogeneity in study designs (case reports, qualitative, cross-sectional and cohort studies), with similarity in outcome themes. Following implementation of the search strategy, 38 relevant full texts were identified; comprising 12 case reports, 9 qualitative studies and 17 cohort studies, and data was also available from 24 relevant conference abstracts. No randomized studies were identified. Common themes were identified in the outcomes across the studies; glycemic variability, safety, quality of life, healthcare provider attitudes and social media. There is extensive real-world data, but a lack of randomized control trial evidence supporting DIY AID system use, due to the user-driven, unregulated nature of these systems. Healthcare providers report a lack of understanding surrounding, and confidence in supporting, DIY AID despite impressive observational and user self-reported improvements in glycemic variability, without any reported safety compromises.

Background Pre-operative fasting leads to insulin resistance and increased metabolic stress in non-diabetic patients. Consumption of a carbohydrate drink may alleviate these deleterious effects. Patients with diabetes mellitus represent over 15% of the surgical population, yet concerns over hyperglycemia and aspiration have excluded patients with diabetes mellitus from studies assessing the utility of pre-operative carbohydrate drinks. Objective To assess for a clinically significant increase in pre-operative blood glucose concentration (defined as >2 mmol/L) in patients with diabetes consuming a pre-operative carbohydrate drink. Methods A prospective observational non-inferiority cohort study of 106 subjects with diabetes mellitus was undertaken to assess the effect of consuming a pre-operative carbohydrate drink in surgical patients. All patients with diabetes mellitus undergoing surgery (including but not limited to cardiac, neurologic, urologic, and general surgical procedures) were enrolled. Subjects were instructed to consume two carbohydrate-rich drinks, one before sleeping the evening prior to surgery and another on the day of surgery. Results In total, 43% of subjects were fully compliant with the pre-operative carbohydrate drink regimen. There were no significant differences between the fully compliant and non-compliant subjects with respect to baseline characteristics. Consumption of a pre-operative carbohydrate drink was determined to be non-inferior to fasting in terms of pre-operative blood glucose concentration (absolute difference 0.23 mmol/L, 95% CI: −1.00 to 1.45 mmol/L, p non-inferiority  < 0.01). Neither group was found to be superior in terms of pre-operative blood glucose concentration, hyperglycemia, or length of stay. Conclusions These findings function as a step toward ensuring pre-operative carbohydrate drinks are safe in patients with diabetes undergoing surgery.

Five-Year Follow-Up After Clinical Islet Transplantation Edmond A. Ryan 1 , Breay W. Paty 1 , Peter A. Senior 1 , David Bigam 2 , Eman Alfadhli 1 , Norman M. Kneteman 2 , Jonathan R.T. Lakey 2 and A.M. James Shapiro 2 1 Department of Medicine, Clinical Islet Transplant Program, University of Alberta and Capital Health, Edmonton, Alberta, Canada 2 Department of Surgery, Clinical Islet Transplant Program, University of Alberta and Capital Health, Edmonton, Alberta, Canada Address correspondence and reprint requests to Edmond A. Ryan, Clinical Islet Transplant Program, 2000 College Plaza, 8215 112th St., Edmonton, Alberta, Canada T6G 2C8. E-mail: edmond.ryan{at}ualberta.ca Abstract Islet transplantation can restore endogenous β-cell function to subjects with type 1 diabetes. Sixty-five patients received an islet transplant in Edmonton as of 1 November 2004. Their mean age was 42.9 ± 1.2 years, their mean duration of diabetes was 27.1 ± 1.3 years, and 57% were women. The main indication was problematic hypoglycemia. Forty-four patients completed the islet transplant as defined by insulin independence, and three further patients received >16,000 islet equivalents (IE)/kg but remained on insulin and are deemed complete. Those who became insulin independent received a total of 799,912 ± 30,220 IE (11,910 ± 469 IE/kg). Five subjects became insulin independent after one transplant. Fifty-two patients had two transplants, and 11 subjects had three transplants. In the completed patients, 5-year follow-up reveals that the majority (∼80%) have C-peptide present post–islet transplant, but only a minority (∼10%) maintain insulin independence. The median duration of insulin independence was 15 months (interquartile range 6.2–25.5). The HbA 1c (A1C) level was well controlled in those off insulin (6.4% [6.1–6.7]) and in those back on insulin but C-peptide positive (6.7% [5.9–7.5]) and higher in those who lost all graft function (9.0% [6.7–9.3]) ( P < 0.05). Those who resumed insulin therapy did not appear more insulin resistant compared with those off insulin and required half their pretransplant daily dose of insulin but had a lower increment of C-peptide to a standard meal challenge (0.44 ± 0.06 vs. 0.76 ± 0.06 nmol/l, P < 0.001). The Hypoglycemic score and lability index both improved significantly posttransplant. In the 128 procedures performed, bleeding occurred in 15 and branch portal vein thrombosis in 5 subjects. Complications of immunosuppressive therapy included mouth ulcers, diarrhea, anemia, and ovarian cysts. Of the 47 completed patients, 4 required retinal laser photocoagulation or vitrectomy and 5 patients with microalbuminuria developed macroproteinuria. The need for multiple antihypertensive medications increased from 6% pretransplant to 42% posttransplant, while the use of statin therapy increased from 23 to 83% posttransplant. There was no change in the neurothesiometer scores pre- versus posttransplant. In conclusion, islet transplantation can relieve glucose instability and problems with hypoglycemia. C-peptide secretion was maintained in the majority of subjects for up to 5 years, although most reverted to using some insulin. The results, though promising, still point to the need for further progress in the availability of transplantable islets, improving islet engraftment, preserving islet function, and reducing toxic immunosuppression. CBC, complete blood count CMV, cytomegalovirus HOMA, homeostasis model assessment HYPO score, Hypoglycemic score LI, lability index LFT, liver function test PRA, panel reactive antibody Footnotes Accepted April 13, 2005. Received February 18, 2005. DIABETES

Aim. This study compares the usefulness of Montreal Cognitive Assessment (MoCA) to Standardized Mini-Mental Status Exam (SMMSE) for diagnosing mild cognitive impairment (MCI) in Type 2 diabetes mellitus (DM) population. Methods. This prospective pilot study enrolled 30 community dwelling adults with Type 2 DM aged 50 years and above. Subjects were assessed using both the SMMSE and MoCA for MCI. In all subjects, depression and dementia were ruled out using the DSM IV criteria, and a functional assessment was done. MCI was diagnosed using the standard test, the European consortium criteria. Sensitivity and specificity analysis, positive and negative predictive values, likelihood ratios and Kappa statistic were calculated. Results. In comparison to consortium criteria, the sensitivity and specificity of MoCA were 67% and 93% in identifying individuals with MCI, and SMMSE were 13% and 93%, respectively. The positive and negative predictive values for MoCA were 84% and 56%, and for SMMSE were 66% and 51%, respectively. Kappa statistics showed moderate agreement between MoCA and consortium criteria (kappa = 0.4) and a low agreement between SMMSE and consortium criteria (kappa = 0.07). Conclusion. In this pilot study, MoCA appears to be a better screening tool than SMMSE for MCI in the diabetic population.

Abstract Background Indeterminate glycemia (INDET) and impaired glucose tolerance (IGT) are independently associated with cystic fibrosis-related diabetes (CFRD) risk. We determined whether patients meeting both criteria have increased risk of diabetes in 2 separate adult cohorts. Methods The Montreal Cystic Fibrosis Cohort (MCFC; n = 293 baseline and 198 for prospective analysis excluding subjects identified with incident CFRD at baseline) and the Lyon cystic fibrosis cohort [Determination of the Predictive Factors in the Reversibility or the Aggravation in the Disorders of the Glucose Metabolism in Cystic Fibrosis Patients (DIAMUCO); n = 144/105] are prospective observational cohorts. Results In the MCFC and DIAMUCO cohorts, mean age was 25.5 ± 7.7 and 25.0 ± 8.6 years; body mass index, 21.7 ± 3.0 and 20.2 ± 2.2 kg/m2; percentage of forced expiratory volume expired in 1 sec, 73.2 ± 22.1 and 62.5 ± 21.9; and follow-up, 6.9 ± 3.8 and 2.4 ± 1.2 years, respectively. In the MCFC cohort, the IGT only and combined INDET and IGT (INDET + IGT) groups had greater risk of CFRD (P = 0.0109). In the DIAMUCO cohort, there was lower diabetes-free survival in the INDET + IGT group (P = 0.0105). In both cohorts, CFRD risk ranged from 17% in normal glucose tolerance patients up to 42% to 56% in patients with INDET + IGT. Conclusion Patients who meet combined criteria have a higher risk of developing diabetes probably justifying closer follow-up.