Suboptimal Glycemic Control Research Articles

Adolescents' Experiences of Using a Smartphone Application Hosting a Closed-loop Algorithm to Manage Type 1 Diabetes in Everyday Life: Qualitative Study.

Background:Closed-loop technology may help address health disparities experienced by adolescents, who are more likely to have suboptimal glycemic control than other age groups and, because of their age, find diabetes self-management particularly challenging. The CamAPS FX closed-loop has sought to address accessibility and usability issues reported by users of previous prototype systems. It comprises small components and a smartphone app used to: announce meal-time boluses, adjust (“boost” or “ease-off”) closed-loop insulin delivery, customize alarms, and review/share data. We explored how using the CamAPS FX platform influences adolescents’ self-management practices and everyday lives.Methods:Eighteen adolescents were interviewed after having ≥6 months experience using the closed-loop platform. Data were analyzed thematically.Results:Participants reported feeling less burdened and shackled by diabetes because closed-loop components were easier to carry/wear, finger-pricks were not required, the smartphone app provided a discreet and less stigmatizing way of managing diabetes in public, and they were able to customize alarms. Participants also reported checking and reviewing data more regularly, because they did so when using the smartphone for other reasons. Some reported challenges in school settings where use of personal phones was restricted. Participants highlighted how self-management practices were improved because they could easily review glucose data and adjust closed-loop insulin delivery using the “boost” and “ease-off” functions. Some described how using the system resulted in them forgetting about diabetes and neglecting certain tasks.Conclusions:A closed-loop system with small components and control algorithm on a smartphone app can enhance usability and acceptability for adolescents and may help address the health-related disparities experienced by this age group. However, challenges can arise from using a medical app on a device which doubles as a smartphone.Trial registration:Closed Loop From Onset in Type 1 Diabetes (CLOuD); NCT02871089; https://clinicaltrials.gov/ct2/show/NCT02871089

Effect of a New Formulation of Nutraceuticals as an Add-On to Metformin Monotherapy for Patients with Type 2 Diabetes and Suboptimal Glycemic Control: A Randomized Controlled Trial.

The aim of the study was to evaluate the overall biohumoral and metabolic effects of a 12-week add-on therapy consisting of a new nutraceutical formulation (BHC) based on berberine, hesperidin, and chromium picolinate in type 2 diabetes mellitus (T2D) patients with suboptimal glycemic compensation receiving metformin. After 12 weeks, participants in the group receiving metformin plus BHC, compared to the group receiving metformin only, saw a significant improvement in their glucose profile, in terms of both glycated hemoglobin (HbA1c) and fasting blood glucose (FBG). Their FBG dropped from 145 ± 20 mg/dL to 128 ± 23 mg/dL (p < 0.01), a decrease of 11.7% compared with the baseline. This decrease differed significantly from the situation in the control arm (p < 0.05). HbA1c decreased by 7.5% from the baseline, from 53.5 ± 4.3 mmol/mol to 49.5 ± 5.1 mmol/mol (p < 0.01), in the group given BHC, while no difference was seen in the control group. Advanced glycation end products (AGEs) and malondialdehyde (MDA) were found to be significantly reduced (p < 0.01) only in the BHC group, from 9.34 ± 7.61 μg/mL to 6.75 ± 6.13 μg/mL, and from 1.7 ± 0.15 μmol/L to 1.4 ± 0.25 μmol/L, respectively. In patients with T2D taking metformin with suboptimal glycemic compensation, adding BHC for 3 months significantly improved glucose control in terms of FBG and HbA1c, and had a positive effect on the lipid peroxidation profile, as indicated by a decrease in AGEs and MDA.

Driving Distance and Glycemic Control in Patients with Insulin-Treated Diabetes Mellitus

Context: Driving distance to health-care facilities has been associated with suboptimal glycemic control in patients with diabetes. The data pertaining to the driving burden on patients with diabetes in Saudi Arabia is lacking. Aims: This study aims to assess the driving distance to healthcare facilities and the glycemic control of patients with insulin-treated diabetes mellitus (ITDM) in Saudi Arabia. Setting and Design: This study is part of the diabetes and driving study–a cross-sectional project conducted on individuals with ITDM in Saudi Arabia. Materials and Methods: Data collection was performed from August 2016 to February 2017 from the designated clinics every alternate day, for 4-h intervals. We included men aged more than 18 years, with at least 1 year of follow-up with the clinic, and using a car as the main mode of transportation. Results: A total of 429 individuals were included in the study, they were mostly from Riyadh (95.3%, n = 409) with an average age of 49.54 ± 15.20 years. The distance driven was on average 32.09 ± 115.23 km. The average duration of diabetes was 14.36 ± 8.44 years. Most (80.4%; n = 345) had uncontrolled diabetes and were almost equally distributed between those driving

Characteristics of pregnant women with diabetes using injectable glucose-lowering drugs in the EVOLVE study

Aims To examine clinical parameters, glycemic control, folic acid supplementation, and the presence of other chronic diseases during early pregnancy in the EVOLVE study population (women with pre-existing diabetes treated with injectable glucose-lowering drugs). Methods Cross-sectional baseline evaluation of EVOLVE: an international, multicenter, non-interventional study investigating the safety of injectable glucose-lowering drugs in pregnant women with pre-existing type 1 (T1D) or type 2 diabetes (T2D). Data were collected at enrollment visit interviews before gestational week 16. Results In total, 2383 women from 17 mainly European countries were enrolled in the study: 2122 with T1D and 261 with T2D; mean age was 31 and 33 years, and duration of diabetes was 15 and 6 years, respectively. For women with T1D or T2D, 63% and 75%, respectively, received basal and rapid-acting insulin, 36% and 3% rapid-acting insulin only, 0.7% and 14.0% basal insulin only, 0.2% and 5.4% premix insulin, 0.0% and 1.2% injectable glucagon-like peptide-1 receptor agonist treatment without insulin. In women with T1D or T2D, respectively, during early pregnancy, 59% and 62% had HbA1c <7.0% (53 mmol/mol); 16% and 36% reported not taking folic acid before or during early pregnancy. Overall, >40% of women had ≥1 chronic concomitant condition (predominantly thyroid disease or hypertension). Retinopathy was the most commonly reported diabetic complication. The most commonly reported previous pregnancy complication was miscarriage. Conclusions Baseline data from this large multinational population of women with pre-existing diabetes indicate that sub-optimal glycemic control, poor pregnancy planning, and chronic concomitant conditions were common in early pregnancy.

142-OR: Health Care Coverage and Access and Associations with Glycemic Control in Young Adults with Youth-Onset Diabetes: The SEARCH for Diabetes in Youth and TODAY Studies

Background: Young adults with diabetes face transitions in health care (provider, insurance, costs) and commonly have suboptimal glycemic control. We explored healthcare coverage and access to care and their associations with HbA1c, by diabetes type. Methods: In the SEARCH (T1D and T2D) and TODAY (T2D) studies, interviewer-administered surveys collected data on health care coverage at study visits (2017-2019). The associations between healthcare coverage or access and HbA1c were examined separately in T1D and T2D. Results: A total of 1374 participants, mean age 25 years, completed the survey. Mean HbA1c was similar in T1D and T2D for those with public insurance, but higher in T1D with no insurance. Having health insurance and a usual place for diabetes care were associated with lower HbA1c for T1D participants but not for those with T2D (Table). Participants from states with Medicaid eligibility expansion were more likely to have health insurance for T1D: 99% with vs. 91% without expansion; and T2D: 93% with vs. 75% without expansion. Conclusion: Having healthcare coverage and access was associated with better glycemic control for young adults with T1D, but not T2D. Medicaid eligibility expansion was associated with having health insurance. Examining how healthcare access factors affect self-care differently in T1D and T2D is essential. Disclosure C. Pihoker: None. J. Divers: None. P. Zhang: None. D. M. Nathan: None. K. Drews: None. D. Dabelea: None. P. Zeitler: Consultant; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Daiichi Sankyo, Eli Lilly and Company, Janssen Research & Development, LLC, Merck & Co., Inc. B. H. Braffett: None. T. Songer: Employee; Spouse/Partner; Boehringer Ingelheim Pharmaceuticals, Inc. W. H. Herman: Advisory Panel; Spouse/Partner; Rhythm Pharmaceuticals, Inc., Consultant; Self; RTI International, Other Relationship; Self; American Diabetes Association, American Diabetes Association, American Diabetes Association, International Diabetes Federation, Merck Sharp & Dohme Corp., National Committee for Quality Assurance, National Institute of Diabetes and Digestive and Kidney Diseases, Special Government Employee, Research Support; Spouse/Partner; Nestle. M. Tung: None. S. Kuo: None. A. Bellatorre: None. E. M. Isganaitis: None. E. T. Jensen: None.

1272-PUB: Improving Hemoglobin A1c and Treatment Satisfaction of Elderly Adults with Type 2 Diabetes Mellitus Using the Omnipod System and Continuous Glucose Monitoring

With the increasing prevalence of type 2 diabetes mellitus (T2DM) around the world, along with a population that is living longer, there is a need to provide elderly patients with technological advances in the management of diabetes mellitus. The use of continuous subcutaneous insulin infusion (CSII) and continuous glucose monitors (CGM) have been seen as a potential challenge for elderly patients with T2DM. We undertook an observational analysis of three elderly male patients with T2DM and a mean age of 70.7 years (range, 66-74 years) who were previously treated with multiple daily injections (MDI) of insulin yet had suboptimal glycemic control and transitioned to tubeless CSII systems along with a CGM. By implementing the use of the tubeless CSII (Omnipod® System) and CGM, elderly patients were able to improve overall glycemic control after three months by decreasing hemoglobin A1c, increasing time in range, and decreasing total daily dose of insulin. Outcomes are reported below. Improvements continued after six months of use and all patients reported that they are very satisfied with their current treatment. With proper patient education and consistent follow-up, all patients were able to independently manage their devices at home and have been able to minimize incidences of hypoglycemia. Disclosure R. Rida: None. A. J. Manzano: None.

1065-P: Glycemic Trend at One Year in a Longitudinal Nationwide Study on Real-World Outcomes of Type 2 Diabetes in India (LANDMARC)

Glycemic change from baseline to 1-year was examined during the first year of LANDMARC, a 3-year prospective observational study (CTRI/2017/05/008452), which included patients with type 2 diabetes (T2D) taking ≥2 antihyperglycemic medications (with/without glycemic control). Out of 6236 patients (mean baseline values - age: 52.1 years, T2D duration: 8.6 years and A1C: 8.05%) enrolled, 5654 completed 1-year follow-up visit. All glycemic parameters improved significantly (p<0.0001) from baseline (A1C: -0.45% [1.53]; FPG: -12.17 mg/dL [53.33]; and PPG -17.61 mg/dL [76.49] (Table). Among A1C subgroups, the number of patients in the 7-7.9% group increased whereas those in other A1C subgroups (with high A1C) decreased; however, only 20% achieved optimum glycemic control (A1C<7%) (Table). Subgroups with cardiovascular risk factors, microvascular and macrovascular complications had suboptimal glycemic control (A1C>7%). In the first year of the LANDMARC study, though there was marked improvement in all glycemic parameters, a large majority of the patients remained uncontrolled, emphasizing the need for optimum diabetes management in India.View largeDownload slideView largeDownload slide DisclosureS. Joshi: Advisory Panel; Self; Abbott, AstraZeneca, Biocon, Franco Indian, Glenmark, Lupin, Marico, Roche, Twinhealth, Zydus, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Merck Sharp & Dohme Corp., Novartis Pharmaceuticals Corporation, Novo Nordisk, Sanofi, Serdia Pharmaceuticals (India) Pvt. Ltd. R. Ghosh: Employee; Self; Sanofi. S. Krishnan: Employee; Self; Sanofi. A. Nair: Employee; Self; Sanofi. S. Mohanasundaram: Employee; Self; Sanofi. S. K. Menon: Employee; Self; Sanofi. V. Salvi: Employee; Self; Sanofi. D. Chodankar: Employee; Self; Sanofi. C. Trivedi: None. S. Wangnoo: None. A. H. Zargar: None. A. K. Das: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk, Roche Pharma, Sanofi. N. Rais: None. K. Kumar: Advisory Panel; Self; Sanofi-Aventis. A. Mithal: Advisory Panel; Self; Eris Lifesciences Limited, Consultant; Self; Glenmark Pharmaceuticals Limited, Lupin Pharmaceuticals, Inc., USV Private Limited, Speaker’s Bureau; Self; Abbott, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Intas Pharmaceuticals Ltd., Novo Nordisk, Sanofi. S. Kalra: Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk, Sanofi. A. Unnikrishnan: Advisory Panel; Self; Sanofi-Aventis, Other Relationship; Self; Novo Nordisk A/S, Speaker’s Bureau; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Lilly Diabetes. H. Thacker: None. B. Sethi: None. S. Chowdhury: None.FundingSanofi

541-P: Social and Biological Risk Factors Threaten Hispanics/Latinos with Type 2 Diabetes, Now at Risk for COVID-19

Hispanics/Latinos have disproportionately poor health outcomes from type 2 diabetes (T2D) and now emerging health threats like COVID-19. Mil Familias is a longitudinal observational cohort study enrolling Hispanic/Latino families with T2D, building a unique real-world dataset of genetic, biological, behavioral, psychosocial, and environmental determinants of health. This analysis showed that this cohort has biological and social risk factors for poor health outcomes from diabetes and emerging health threats.Interim analyses were conducted on the first 158 enrollees (64% female, age 57.6 years, 129 with T2D). In T2D subjects, sub-optimal glycemic control, obesity and uncontrolled blood pressure were common, increasing risk from T2D and COVID-19. Further, validated assessments of social determinants of health reveal inadequate health insurance coverage and low levels of: income, educational attainment, acculturation, trust in physicians, and confidence in their literacy-numeracy skills.Hispanic/Latino adults, especially women, with T2D in the Mil Familias cohort have a cluster of social as well as biological risk factors that make them vulnerable from T2D and new threats like COVID-19. The novel Mil Familias dataset sheds timely light on important social as well as biological risk factors for both communicable and non-communicable disease.View largeDownload slideView largeDownload slide DisclosureN. M. Glantz: Research Support; Self; Abbott, Eli Lilly and Company. R. Paczkowski: Employee; Self; Eli Lilly and Company, Employee; Spouse/Partner; Amgen Inc., Stock/Shareholder; Self; Eli Lilly and Company, Stock/Shareholder; Spouse/Partner; Amgen Inc. A. J. Larez: Research Support; Self; Abbott, Eli Lilly and Company. F. Gelsey: Employee; Self; Eli Lilly and Company, Stock/Shareholder; Self; Eli Lilly and Company. B. Yang: Research Support; Self; Abbott, Eli Lilly and Company. B. D. Benneyworth: Employee; Self; Eli Lilly and Company. D. Kerr: Advisory Panel; Self; Novo Nordisk, Sanofi-Aventis, Research Support; Self; Abbott Diabetes, Elsevier, Lilly Diabetes, Stock/Shareholder; Self; Glooko, Inc.

646-P: Efficacy and Safety of Evogliptin plus Metformin Added to Insulin Therapy in Elderly Indian Patients with Type 2 Diabetes

Objective: The combination of evogliptin plus metformin and insulin has known to be effective for the treatment of type 2 diabetes (T2D). However, longitudinal efficacy and safety for elderly patients have not been established. Here, we evaluated whether Evogliptin plus metformin added to insulin therapy safely improved glycemic control for T2D patients older than 65 years of age. Method: Thirty two T2D patients (male/female 20/12; age 76.2± 6.3 years, HbA1c 8.4±0.8%, DOD 6.9±2.1 years) who were administrated insulin were recruited and Evogliptin (5 mg) plus Metformin (500 mg) was added to their treatment regimen. Before and 6 months after adding Lira, we assessed metabolic parameters and the data from CGM. Result: Six months after adding evogliptin plus metformin, HbA1c ( from 8.4±0.8% to 7.2±1.2%; P=0.003) and body weight ( from 62.8±8.3 kg to 61.2±4.6 kg, P=0.006) were significantly improved despite the daily dose ( from 58.5±11.2 IU/day to 45.63±14.4 IU/day, P=0.005) and number of insulin injections per day being reduced. CGM analysis revealed that SD and ≥180 mg/dL AUC were significantly decreased and hypoglycemic events were not increased. Furthermore, 22% of patients with suboptimal glycemic control (A1C&amp;gt;7%) achieved a composite outcome consisting of improvement in A1C, weight loss and insulin dose reduction. Conclusion: These results suggest that the administration of evogliptin plus metformin could safely improve glycemic control and reduce body weight in elderly patients with T2DM undergoing insulin therapy. The reduction of glucose fluctuation and number of insulin injections may improve the quality of life of elderly T2D patients, especially those who require social support. Disclosure S. Guha: None. R. Ranjan: None. A. Gaurav: None. P. Ranjan: None.

Visit Content Analysis: Doctor-Patient Communication in Patients with Type 2 Diabetes.

The primary care visit is an important opportunity to discuss and modify diabetes management. To gain insight into doctor-patient communication during primary care visits among English and Spanish speaking patients with type 2 diabetes and suboptimal glycemic control (HbA1c > 7%). We conducted a quantitative content analysis of audiotaped primary care visits in 2 patient cohorts. In Study 1 (31 English-speaking patients), we examined factors associated with management changes, and in Study 2 (20 Spanish-speaking patients and their Spanish-speaking providers), we examined the association of question asking with HbA1c control. This study was conducted between November 2017 and January 2020 across 8 primary care practices within Kaiser Permanente Northern California. In Study 1, the only factor significantly associated with a diabetes management change was patient identification of diabetes as a priority prior to the visit (91.7% had a management change vs 52.6% of patients who did not identify diabetes as a priority; p = 0.02). In Study 2, patients with poorer glycemic control (HbA1c ≥ 10.0) asked significantly fewer questions (3.4 ± 1.8 vs 10.7 ± 6.9 questions per 15 minutes; p = 0.004). Overall, despite receiving primary care from language-concordant providers, Spanish-speaking Study 2 patients asked fewer questions than English-speaking Study 1 patients (4.5 ± 2.9 vs 7.5 ± 3.7 questions per 15 minutes, respectively; p = 0.004). Our results highlight 2 potential strategies (preparing patients for their visits through identifying priorities and learning how to ask more questions during visits) for improving diabetes primary care.

219-OR: Impact Of Inpen Smart Insulin Pen Use on Real-World Glycemic and Insulin Dosing Outcomes in Individuals with Poorly Controlled Diabetes

Background: Smart insulin pens that track the timing and amount of insulin administration, communicate with phone apps that provide bolus calculators and integrate CGM data are emerging as important technology for users of multiple daily injections (MDI) therapy, as they can improve glycemic outcomes and be more cost-effective compared to some standards of care.1,2 Early real-world outcomes of InPen™ smart insulin pen users were assessed in the present study. Methods: Deidentified CGM-derived data from N=1736 individuals before and up to 90 days after starting InPen use between Jan. 2018 to Oct. 2020 were evaluated. Glycemic outcomes including mean sensor glucose (SG), glucose management indicator (GMI), and percentage of time spent between 70-180mg/dL (TIR), &amp;gt;180mg/dL (TAR) and &amp;lt;70mg/dL (TBR) ranges were determined and analyzed (Wilcoxon signed-rank test). Results: Compared to pre-InPen use, individuals (N=423) with suboptimal baseline glycemic control (GMI &amp;gt;8.0%) had increased TIR (+2.3%, 0.6h/day); and reduced GMI (-0.1%), SG (-4.3mg/dL) and TAR (-2.4%); with no change in TBR. Those with poorest glycemic control at baseline (GMI &amp;gt;9.5, N=106) had TIR that improved by +5.0% (1.2h/day), GMI by -0.4%, SG by -14.9mg/dL, and TAR by -5.1% (-1.2h/day), with no change in TBR. From the first month to 90-days post-InPen use, average daily insulin bolus frequency decreased (from 3.7 to 3.6/day and 3.3 to 3.2/day, respectively, for each group) and total rapid acting daily dose of insulin increased (from 26.29 to 27.19 u/day and 27.57 to 29.24 u/day, respectively, for each group). All results were significant at p&amp;lt;0.05. Discussion: These data show that InPen use is associated with improved glycemic control and increased doses of bolus insulin in users with poor glycemic control. 1. Jendle J, Ericsson Å, Gundgaard J, et al. Diabetes Ther. 2020; doi: 10.1007/s13300-020-00980-1. 2. Adolfsson P, Hartvig NV, Kaas A, rt al. Diabetes Technol Ther;2020;22:709-718. Disclosure R. Vigersky: Employee; Self; Medtronic. M. Smith: Employee; Self; Companion Medical, Medtronic. S. Thanasekaran: Employee; Self; Companion Medical, Medtronic. A. Gaetano: Employee; Self; Companion Medical, Medtronic. G. Im: Employee; Self; Companion Medical, Medtronic. T. L. Cordero: Employee; Self; Medtronic. J. Macleod: Employee; Self; Companion Medical, Medtronic.

814-P: Clinical Factors Impacting Glycemic Control in Young Adults with Type 1 Diabetes at Transition to Adult Clinical Care

Young adults (YA) with type 1 diabetes (T1D) transfer from pediatric to adult diabetes care during a time when many of them experience suboptimal glycemic control. To determine the factors impacting glycemic control in YA transitioning to adult care, we conducted a retrospective study of YA (age 17-30 years) with T1D establishing care at an adult tertiary diabetes-only clinic. Demographic, clinical characteristics, A1c at first visit, use of insulin pump or continuous glucose monitor (CGM), referral center, and insurance information were collected from the electronic medical record. Among 329 YA with T1D (55% female, 75% white, 40% on CGM, 55% on insulin pump), average age of transition was 23±3 years and mean A1c at first visit was 8.5±1.6%. We divided YA by A1c at first visit as ≤7.5% (n=96) and A1c≥8.5% (n=130). Patients with better glycemic control (A1c < 7.5% at first visit) were older and had more private insurance. Patients with better glycemic control also used more diabetes technology (59% vs. 43% on pump, 51% vs. 35% on CGM). In our cohort, older age at transfer, use of diabetes technology, referral center and private insurance status were associated with better glycemic control at first visit in adult care. These factors may be important for adult clinicians to consider when assessing YA with T1D at their first visit to develop a tailored diabetes self-management plan.View largeDownload slideView largeDownload slide DisclosureK. Flint: None. M. Bennetti: None. A. Atakov-castillo: None. E. Toschi: Consultant; Self; Medtronic.FundingSteven M. and Joyce E. Tadler Charitable Trust

418-P: Adults with T1D, Neuropathy, and Depressive Symptoms Are in Need of Clinical Intervention

Prolonged T1D and suboptimal glycemic control contributes to diabetic peripheral neuropathy, which may occur with impairing psychological symptoms. This study examined the association between neuropathy and depressive symptoms in adults with T1D.Neuropathy was assessed using the Michigan Neuropathy Screening Instrument history and physical assessment (clinical scores >2 indicate neuropathy) in the Coronary Artery Calcification in Type 1 Diabetes (CACTI) Study. Depressive symptoms were assessed by the Beck Depression Inventory (BDI-II; scores >14 indicate clinically elevations).Neuropathy was detected in 22% of participants with T1D (N=364; 55% female; age=51±9 years; T1D duration=38±9 years) and elevated depressive symptoms in 10%. Participants with neuropathy were older and had longer T1D duration and higher BDI-II scores; they were more likely to have elevated depressive symptoms. In logistic regression models adjusted for age, sex, T1D duration, and A1C, neuropathy was associated with a 7-fold increased odds of elevated depressive symptoms (OR [95% CI] = 7.5 [3.1-17.9, p<0.0001). It is well known that significant pain and depression result in functional impairment across various domains of daily life. Interventions to reduce clinically elevated depressive symptoms and promote adaptive coping in adults with T1D with neuropathy are largely absent, and critically needed.View largeDownload slideView largeDownload slide DisclosureS. E. Wetter: None. K. A. Driscoll: None. J. K. Snell-bergeon: Stock/Shareholder; Self; GlaxoSmithKline plc.FundingNational Institutes of Health (R01HL113029)

Effect of Dapagliflozin on Myocardial Insulin Sensitivity and Perfusion: Rationale and Design of The DAPAHEART Trial.

IntroductionSodium-glucose co-transporter-2 (SGLT-2) inhibitors have been shown to have beneficial effects on various cardiovascular (CV) outcomes in patients with type 2 diabetes (T2D) in primary prevention and in those with a high CV risk profile. However, the mechanism(s) responsible for these CV benefits remain elusive and unexplained. The aim of the DAPAHEART study will be to demonstrate that treatment with SGLT-2 inhibitors is associated with greater myocardial insulin sensitivity in patients with T2D, and to determine whether this improvement can be attributed to a decrease in whole-body (and tissue-specific) insulin resistance and to increased myocardial perfusion and/or glucose uptake. We will also determine whether there is an appreciable degree of improvement in myocardial-wall conditions subtended by affected and non-affected coronary vessels, and if this relates to changes in left ventricular function.MethodsThe DAPAHEART trial will be a phase III, single-center, randomized, two-arm, parallel-group, double-blind, placebo-controlled study. A cohort of 52 T2D patients with stable coronary artery disease (without any previous history of myocardial infarction, with or without previous percutaneous coronary intervention), with suboptimal glycemic control (glycated hemoglobin [HbA1c] 7–8.5%) on their current standard of care anti-hyperglycemic regimen, will be randomized in a 1:1 ratio to dapagliflozin or placebo. The primary outcome is to detect changes in myocardial glucose uptake from baseline to 4 weeks after treatment initiation. The main secondary outcome will be changes in myocardial blood flow, as measured by 13N-ammonia positron emission tomography/computed tomography (PET/CT). Other outcomes include cardiac function, glucose uptake in skeletal muscle, adipose tissue, liver, brain and kidney, as assessed by fluorodeoxyglucose (FDG) PET-CT imaging during hyperinsulinemic-euglycemic clamp; pericardial, subcutaneous and visceral fat, and browning as observed on CT images during FDG PET-CT studies; systemic insulin sensitivity, as assessed by hyperinsulinemic-euglycemic clamp, glycemic control, urinary glucose output; and microbiota modification.DiscussionSGLT-2 inhibitors, in addition to their insulin-independent plasma glucose-lowering effect, are able to directly (substrate availability, fuel utilization, insulin sensitivity) as well as indirectly (cardiac after-load reduction, decreased risk factors for heart failure) affect myocardial functions. Our study will provide novel insights into how these drugs exert CV protection in a diabetic population.Trial registrationEudraCT No. 2016-003614-27; ClinicalTrials.gov Identifier: NCT03313752.Supplementary InformationThe online version contains supplementary material available at 10.1007/s13300-021-01083-1.

Characteristics and treatment patterns of patients with type 2 diabetes in Lebanon: the DISCOVER study.

Lebanon is part of the global DISCOVER study, a global, noninterventional, multicentre, prospective study with 3-years of follow-up. The aim of this study is to describe real-world clinical practice in terms of type 2 diabetes mellitus (T2DM) disease management and treatment patterns within Lebanon. Baseline demographic and clinical parameters were captured on a standardized case report form, according to routine clinical practice at each clinical site. We recruited 348 patients. At the initiation of second-line therapy, mean duration of diabetes was 6.7 [standard deviation (SD) 6.5] years; mean HbA1c and fasting plasma glucose levels were 8.5% (SD 1.6%) and 178.7 (SD 56.5) mg/dL respectively. Almost half the patients were hypertensive (45.1%) or had dyslipidaemia (48.6%). Metformin monotherapy was used as first-line therapy in 56.9% of the patients and upfront dual therapy in 25%. The primary reason for changing firstline therapy was poor glycaemic control. The main factors in choosing the second-line therapy were efficacy, tolerability and hypoglycaemia. Clinical inertia was evident in this cohort of patients as they had suboptimal glycaemic control at the time of enrolment and the initiation of second-line therapy. Treatment intensification is required to reduce diabetes-related adverse outcomes.

Association of Self-Efficacy, Transition Readiness and Diabetes Distress With Glycemic Control in Adolescents With Type 1 Diabetes Preparing to Transition to Adult Care

ObjectivesAdolescence and emerging adulthood are associated with inadequate medical follow up, suboptimal glycemic control and higher risk for adverse outcomes. Our aim in this study was to determine whether self-efficacy, transition readiness or diabetes distress is associated with glycemic control (glycated hemoglobin [A1C]) among adolescents with type 1 diabetes (T1D) preparing to transition to adult care. MethodsWe conducted a cross-sectional study of adolescents (age 17 years) with T1D followed at the Montreal Children’s Hospital Diabetes Clinic 1 year before transferring to adult care. Participants completed validated questionnaires on self-efficacy (Self-Efficacy for Diabetes Self-Management Measure [SEDM], score 1 to 10), transition readiness (Am I ON TRAC? For Adult Care questionnaire [TRAC], score ≥8 indicates readiness) and diabetes distress (Diabetes Distress Scale for Adults with Type 1 Diabetes [T1-DDS], score ≥3 indicates distress). The primary outcome was A1C (%) 1 year before transfer. We examined associations of self-efficacy, transition readiness and diabetes distress with A1C using multivariate linear and logistic regression models adjusted for sex, age at diagnosis and socioeconomic status. ResultsOf 74 adolescents with T1D (29 males, 39.1%), 27 (36.4%) had suboptimal glycemic control (A1C ≥9.0%). Less than half were transition-ready (TRAC questionnaire score ≥8) and 14% had diabetes distress (T1-DDS score ≥3). SEDM was not associated with A1C. Adolescents considered ready for transition were less likely to have suboptimal glycemic control (odds ratio, 0.30; 95% confidence interval, 0.09 to 0.99), whereas adolescents with diabetes distress were more likely to have suboptimal glycemic control (odds ratio, 6.24; 95% confidence interval, 1.06 to 36.75). ConclusionsImproving health-care transition within pediatric care should focus on both transition readiness and diabetes distress to help improve adolescents’ glycemic control and prepare them for adult care.

Abbott FreeStyle Libre Versus Dexcom G6: Detecting Disorders of Carbohydrate Metabolism in a Youthful Non-Diabetic Cohort Pilot Study

Objective: Disorders of aging develop decades prior to emerging according to evidence in the literature. Early detection and actionable intervention have tremendous potential to prevent, delay, or even reverse the onset of disease. Individual carbohydrate metabolism data inform interventions to address the progression of underlying disorders of carbohydrate metabolism. Continuous glucose monitoring (CGM) devices can be harnessed to reveal suboptimal glycemic control. In the present study, two CGM devices were used to screen for carbohydrate metabolic dysfunction in 14 individuals without a history of type 2 diabetes. Methods: The two CGM devices used in this prospective cohort study were the Abbott FreeStyle Libre and Dexcom G6. Participants concurrently wore both devices for 30 days and were instructed to maintain their usual dietary habits for the duration of the study. The optimal glucose range was defined as 70–120 mg/dL. Glucose data were compiled and analyzed to screen for metabolic abnormalities. Results: 14 non-diabetic individuals were enrolled in this study. The cohort was 50% female with ages ranging from 22–46 years (mean=31.4 years). Out of the 14 participants, 100% showed glycemic abnormalities, including hypoglycemia and hyperglycemia. Across the cohort, the Abbott FreeStyle Libre and Dexcom G6 detected fasting and postprandial values between 40–237 mg/dL and 40–279 mg/dL, respectively. Both CGM devices detected glucose values <70 mg/dL and >120 mg/dL in all 14 participants. The amount of time each participant spent outside the optimal glucose range was variable. Using the Abbott FreeStyle Libre, the mean percent of time that participant glucose values measured <70 mg/dL and >120 mg/dL were 9.1% and 4.8%, respectively. Using the Dexcom G6, the mean percent of time that participant glucose values measured <70 mg/dL and >120 mg/dL were 1.4% and 19.2%, respectively. Discussion: Using CGM devices, we discovered that these 14 non-diabetic individuals exhibit suboptimal glycemic control, as demonstrated by blood glucose measurements falling outside 70–120 mg/dL for all participants. In addition, the Abbott FreeStyle Libre detected fasting hypoglycemia and reactive hypoglycemic responses more often than the Dexcom G6, while the Dexcom G6 detected more postprandial hyperglycemia than the Abbott FreeStyle Libre. It is plausible that the recommended device placement contributed to these differences, with the Abbott FreeStyle Libre on the tricep and Dexcom G6 on the abdomen. These findings support the utility of CGM devices as screening tools to detect and predict disorders of carbohydrate metabolism and warrant further investigation into the variation between CGM device measurements.

Can placental growth factors explain birthweight variation in offspring of women with type 1 diabetes?

Maternal hyperglycaemia alone does not explain the incidence of large offspring amongst women with type 1 diabetes. The objective of the study was to determine if there is an association between placental function, as measured by angiogenic factors, and offspring birthweight z score in women with type 1 diabetes. This cohort study included samples from 157 Continuous Glucose Monitoring in Pregnant Women with Type 1 Diabetes (CONCEPTT) trial participants. Correlations were estimated between birthweight z score and placental growth factor (PlGF) and soluble fms-like tyrosine kinase (sFlt-1) levels measured at baseline and at 24 and 34weeks of gestation. Linear regression was used to assess the relationship between birthweight z score and placental health, as measured by PlGF and sFlt-1/PlGF ratio, stratified by glycaemic status (continuous glucose monitoring and HbA1c measures) and adjusted for potential confounders of maternal BMI, smoking and weight gain. Higher PlGF levels and lower sFlt-1/PlGF ratios represent healthy placentas, while lower PlGF levels and higher sFlt-1/PlGF ratios represent unhealthy placentas. Among CONCEPTT participants, the slopes relating PlGF levels to birthweight z scores differed according to maternal glycaemia at 34weeks of gestation (p = 0.003). With optimal maternal glycaemia (HbA1c < 48mmol/mol [6.5%]/ or continuous glucose monitoring time above range ≤ 30%), birthweight z scores were reduced towards zero (normal weight) with increasing PlGF values (representing a healthy placenta), and increased with decreasing PlGF values. With suboptimal glycaemic status (HbA1c ≥ 48mmol/mol [6.5%] or time above range > 30%), increasing PlGF values were associated with heavier infants. Those with a healthy placenta (PlGF > 100) and suboptimal glycaemic control had a higher mean z score (2.45) than those with an unhealthy placenta (mean z score = 1.86). Similar relationships were seen when using sFlt-1/PlGF ratio as a marker for a healthy vs unhealthy placenta. In women with type 1 diabetes, infant birthweight is influenced by both glycaemic status and placental function. In women with suboptimal glycaemia, infant birthweight was heavier when placentas were healthy. Suboptimal placental function should be considered in the setting of suboptimal glycaemia and apparently 'normal' birthweight.

Suboptimal glycemic control and prevalence of diabetes-related complications in Kenyan population with diabetes: cohort analysis of the seventh wave of the International Diabetes Management Practices Study (IDMPS)

• The 7th wave of the IDMPS is an international, multicenter, non-interventional, cross-sectional, observational study aimed at assessment of current practices in the management of both T1DM and T2DM in 24 countries in Africa, Eurasia, Middle East, and South Asia. It was conducted as a continuation of the previous waves of the IDMPS and data was collected during the period of January to September 2016 • At the time of the study, target HbA1c of <7.0% was reportedly achieved in only 36.6% of subjects with T2DM • The two most cited reasons for not attaining HbA1c targets in insulinized subjects were – lack of appropriate titration of insulin dose and lack of experience among patients in the management of their insulin dose • Diabetes-related complications were reported by 34.6% subjects overall with a predominance of microvascular complications over macrovascular complications. • This study highlights that the achievement of glycemic target in Kenyan subjects with T2DM is suboptimal and further investigations are required to formulate effective health policies to improve rates of glycemic target attainment in Kenya. To identify real-life medical practices in the management of diabetes mellitus (DM) in the Kenyan population. Kenyan subjects with DM were recruited as part of the 7 th wave of the International Diabetes Management and Practices Study in between September and October 2016. Data on demographics; medical history; glycemic control; concomitant anti-diabetic therapy; and hypoglycemic episodes were analyzed using descriptive statistics. Analysis of subjects with type 2 DM (T2DM), representing 96.7% (n/N: 187/194) of evaluable subjects, is presented. Target HbA1c achievement rate and average HbA1c at last measurement were 36.6% (n/N: 68/187) and 8.2% (66 mmol/mol), respectively. Microvascular complications were prevalent in 35.3% (n=65) of subjects, most frequently as neuropathy (n=41, 21.5%) and microalbuminuria (n=27, 14.1%). Most common comorbidities were dyslipidemia (n=125, 73.5%) and hypertension (n=123, 65.8%). Oral antidiabetic drugs, either alone (n=120, 64.2%) or in combination with insulin (n=48, 25.7%), were the preferred treatment. Inability in reaching glycemic targets in insulinized subjects were mostly attributed to lack of appropriate dose titration and lack of experience in management of dose. The achievement of glycemic target in Kenyan subjects with T2DM is suboptimal. Further investigations are required to formulate effective health policies to improve rates of glycemic target attainment in Kenya.

Effect of Acute Stress Glycemic Control and Long-Term Glycemic Control on the Incidence of Post-Operative Infection in Diabetics Undergoing Cardiac Surgery.

ObjectivePost-operative infection after cardiac surgery causes prolonged hospital stay and increased mortality. In patients with diabetes, peri-operative and pre-operative glycemic control have been associated with increased risk of post-operative infection. Saudi Arabia is the 7th highest country in the world for the prevalence of diabetes. In our surgical population the incidence of diabetes is 77%. We were aware of a high incidence of post-operative infections in our institution. The aim of this work was to assess how peri-operative and pre-operative glycemic control was related to the six-week incidence of post-operative infection.MethodWe retrospectively collected data for 174 adult patients with diabetes undergoing cardiac surgery between January 2017 and June 2019. For group analysis of peri-operative glycemic control, a mean value of ≤10 mmol/l was categorized as optimal control and a mean value of >10 mmol/l as sub-optimal control. The admission glucose value, the maximum glucose value and glycosylated hemoglobin A1c (HbA1c) were separately recorded. Admission HbA1c was used for optimal long-term control group (HbA1c ≤ 7%) and sub-optimal long-term control group (HbA1c > 7%).ResultsOf the 174 patients 60 (34%) developed infection in the six-week post-operative period. No statistically significant difference in infections was seen in the optimal peri-operative control group (n = 24, 14%) compared to sub-optimal peri-operative control group (n = 36, 21%; p = 0.113). However, patients with infection had a significantly higher mean glucose (10.4 mmol/l versus 9.9 mmol/l, p = 0.0316) than no infection.Grouping according to their HbA1c: well controlled group (41, 24.0%) and poor control group (130, 76.0%) showed no difference in infections. However, patients with lower HbA1c had better glycemic control as measured by: initial glucose (r = 0.52, p=<0.001); mean peri-operative glucose (r = 0.45, p=<0.001); maximum recorded glucose (r = 0.41, p=<0.001).ConclusionThe majority of our patients presented with sub-optimal long-term glycemic control which we linked to poor stress glycemic control perioperatively. Patients with post-operative infections had higher mean peri-operative blood glucose. With the high incidence of diabetes in Saudi Arabia we have demonstrated the importance of good pre-operative assessment which allows tighter peri-operative glycemic control to reduce post-operative morbidity.