T2D Duration Research Articles

1167-P: Burden of Cardiorenal Complications (CRCs) in T2D: Take Care of Me Programme

Rationale: CRCs are known to be key determinants of patient outcomes in T2D; however, the burden of undiagnosed CRCs in unselected T2D population remains unclear, particularly in low-to-middle income countries (LMICs) . ‘Take CaRe of Me’ (TCOM) programme aims to determine the global burden and treatment patterns of CRCs in people with T2D without prior history of cardiovascular (CV) and renal disease. Methods: TCOM programme records data in a cloud based repository after being reported by primary care physicians on albuminuria, eGFR, CV risk, echocardiography and treatment patterns in adults with T2D and no CRCs at index visit for early identification of CRCs. We present a descriptive analysis (up to Dec 2021) of baseline cardiorenal factors from 6 LMICs. Results: We recruited 11335 adults (mean [±SD] age, 54.8±11.4 yrs; 57.9% women, mean T2D duration, 9.8±8.0 yrs) . Mean HbA1c was 8.3±2.2% (65.8% with HbA1c >7%) . Individuals with moderate-to-high renal risk (per urine albumin-creatinine ratio) ranged from 24.8% (Mexico) to 45.1% (Philippines) and with high/very high CV risk (per ESC 2019) ranged from 31.6% (Philippines) to 45.0% (Egypt) (Table) . Discussion: There is high burden of unrecognized CRCs in T2D in real-world setting, with >35% having moderate-to-high renal and high/very high CV risks. Our results point at the unmet need for early diagnosis, risk factor management and use of cardiorenoprotective glucose lowering drugs. Disclosure K.Khunti: Consultant; Abbott, Amgen Inc., AstraZeneca, Bayer AG, Berlin-Chemie AG, Boehringer Ingelheim International GmbH, Lilly, Merck Sharp & Dohme Corp., Napp Pharmaceuticals Limited, Novartis AG, Novo Nordisk, Roche Diabetes Care, Sanofi-Aventis Deutschland GmbH, Servier Laboratories, Research Support; AstraZeneca, Boehringer Ingelheim International GmbH, Lilly, Merck Sharp & Dohme Corp., Novartis AG, Novo Nordisk, Sanofi-Aventis Deutschland GmbH. A.I.Silva: Employee; AstraZeneca. F.Surmont: Employee; AstraZeneca. H.Vasnawala: None. E.Vazquez-mendez: None. P.Fenici: Employee; AstraZeneca. S.Goncalves: None. H.L.Heerspink: Consultant; AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Chinook Therapeutics Inc., CSL Behring, Gilead Sciences, Inc., Goldfinch Bio, Inc., Janssen Research & Development, LLC, Mitsubishi Tanabe Pharma Corporation, Mundipharma, Traveere Pharmaceuticals, Research Support; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk A/S. S.Joshi: Advisory Panel; Abbott, Boehringer Ingelheim International GmbH, Dr. Reddy’s Laboratories Ltd., Eli Lilly and Company, Novo Nordisk, Roche Diabetes Care, Consultant; Biocon, Glenmark Pharmaceuticals, Sanofi, USV Private Limited. M.N.Kosiborod: Advisory Panel; Amgen Inc., Applied Therapeutics, Bayer AG, Eli Lilly and Company, ESPERION Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Pharmacosmos A/S, Sanofi, Vifor Pharma Management Ltd., Consultant; Alnylam Pharmaceuticals, Inc., Other Relationship; AstraZeneca, Boehringer Ingelheim International GmbH, Novo Nordisk. C.S.Lam: Other Relationship; Prosciento Inc, Radcliffe Group Ltd., Roche Diagnostics, Sanofi, Siemens Healthcare Diagnostics, Abbott, Actelion, Amgen, AnaCardio , Applied Therapeutics, AstraZeneca, Bayer, Boehringer, Boston Scientific, Cytokinetics, Darma., EchoNous, Impulse Dynamics, Ionis Pharma, Janssen R&D, Medscape/WebM, Us2.ai. A.Nicolucci: Board Member; AstraZeneca, Research Support; Novo Nordisk, PIKDARE S.p.A., Sanofi, Shionogi & Co., Ltd., Swedish Orphan Biovitrum AB, Speaker's Bureau; Eli Lilly and Company. L.Ramirez: Employee; AstraZeneca. Funding TCoM study was funded by AstraZeneca International

715-P: Tirzepatide as Monotherapy Improved Markers of Beta-Cell Function and Insulin Sensitivity in People with Type 2 Diabetes (SURPASS-1)

Tirzepatide (TZP) , a novel dual GIP/GLP-1 receptor agonist, led to greater HbA1c, fasting serum glucose and body weight reductions vs. placebo (PBO) in people with early T2D (baseline mean T2D duration 4.7 y and 54% no prior diabetes medications) from the 40-wk SURPASS-1 trial. In a Phase 2b trial, TZP also improved β-cell function and insulin sensitivity (IS) vs. PBO and selective GLP-1 receptor agonist, dulaglutide 1.5 mg. Similarly, in SURPASS-1, TZP improved β-cell function, as indicated by a 75-80% increase in HOMA2-B, and insulin resistance, as indicated by a 2-12% decrease in fasting insulin and 8-20% decrease in HOMA2-IR. In this analysis, we aimed to explore changes in additional biomarkers of β-cell function and IS after TZP monotherapy (5, and 15 mg) . At 40 wks, proinsulin/C-peptide ratios, a marker of insulin processing, β-cell stress and β-cell function improved with decrease by 47-49% with TZP vs. -0.1% with PBO (p<0.001, all doses) (Table) . Fasting proinsulin decreased by 49-55% with TZP vs. no change with PBO (p<0.001, all doses) . Decreases in fasting C-peptide by 3-9% with TZP did not differ vs. PBO. TZP vs. PBO improved biomarkers of IS evidenced by increases in adiponectin (16-23% vs. -0.2%; p≤0.028, all doses) and IGFBP-2 (38-70% vs. 4.1%; p<0.001, all doses) . As a monotherapy for early T2D, TZP achieved significant improvement in markers of β-cell function and IS. Disclosure C.Lee: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. H.Mao: Employee; Eli Lilly and Company. V.Thieu: None. M.K.Thomas: Employee; Eli Lilly and Company, Stock/Shareholder; Eli Lilly and Company. Funding Eli Lilly and Company

Preoperative Prediction of Body Mass Index of Patients with Type 2 Diabetes at 1 Year After Laparoscopic Sleeve Gastrectomy: Cross-Sectional Study.

Background: Very few models predict weight loss among type 2 diabetes mellitus (T2D) patients after laparoscopic sleeve gastrectomy (LSG). This retrospective study undertook such a task. Materials and Methods: We identified all patients >18 years old with T2D who underwent primary LSG at our institution and had complete data. The training set comprised 107 patients operated upon during the period April 2011 to June 2014; the validation set comprised 134 patients operated upon during the successive chronological period, July 2014 to December 2015. Sex, age, presurgery BMI, T2D duration, number of T2D medications, insulin use, hypertension, and dyslipidemia were utilized as independent predictors of 1-year BMI. We employed regression analysis, and assessed the goodness of fit and "Residuals versus Fits" plot. Paired sample t-tests compared the observed and predicted BMI at 1 year. Results: The model comprised preoperative BMI (β = 0.757, P = 0.026) + age (β = 0.142, P < 0.0001) with adjusted R2 of 0.581 (P < 0.0001), and goodness of fit showed an unbiased model with accurate prediction. The equation was: BMI value 1 year after LSG = 1.777 + 0.614 × presurgery BMI (kg/m2) +0.106 × age (years). For validation, the equation exhibited an adjusted R2 0.550 (P < 0.0001), and the goodness of fit indicated an unbiased model. The BMI predicted by the model fell within -3.78 BMI points to +2.42 points of the observed 1-year BMI. Pairwise difference between the mean 1-year observed and predicted BMI was not significant (-0.41 kg/m2, P = 0.225). Conclusions: This predictive model estimates the BMI 1 year after LSG. The model comprises preoperative BMI and age. It allows the forecast of patients' BMI after surgery, hence setting realistic expectations which are critical for patient satisfaction after bariatric surgery. An attainable target motivates the patient to achieve it.

Assessment of Type II Diabetes Patients' Caregivers' Burnout Level: A Cross-Sectional Study in Taif, Saudi Arabia.

BackgroundDiabetes mellitus type II (T2D) is a chronic condition that requires significant change in the family behavior and is associated with psychosocial conflicts for both patients and their family environment. The aim of this study is to assess burnout among relatives caring for patients with T2D.MethodsThis cross-sectional study with random sampling was conducted on 501 caregivers of patients with T2D between April and September 2021 at Prince Mansour armed forces hospital in Taif city, Saudi Arabia. Data collection tool was a modified version of the caregiver stress self-assessment questionnaire. Data analysis was then carried out using t-test and chi-square test (SPSS v20).ResultsThe mean patient age was 64.4+12.0 years, female predominant with longstanding T2D. Metformin was the most prescribed T2D medication. The caregivers’ mean age was 34.9+12.4 years, male predominant, and around 45% of them report low level of education and income; 63.9% of the caregivers report little to no stress. Compared with caregivers with mild/moderate stress and moderate/severe stress, caregivers with little to no stress were more likely to be younger in age (P <0.001), male (P = 0.464), single (P = 0.035), patient’s offspring (P = 0.490), caring for T2D patients with younger age (P = 0.058) and shorter T2D duration (P = 0.074), patients who were less likely to use a wheelchair (P = 0.008), patients who were less likely to be prescribed a complex insulin regimen and with better glycemic control parameters (both P >0.05), and patients with higher HDL level (P = 0.037).ConclusionThere were no correlations between the caregivers’ levels of stress and the T2D patients’ HbA1c levels. There was a significant positive correlation between a caregiver’s stress score and the caregiver’s age. Future studies are needed to assess other caregivers’ parameters and their relation to metabolic control of T2D patients.

An Innovative, Paradigm-Shifting Lifestyle Intervention to Reduce Glucose Excursions With the Use of Continuous Glucose Monitoring to Educate, Motivate, and Activate Adults With Newly Diagnosed Type 2 Diabetes: Pilot Feasibility Study.

BackgroundType 2 diabetes (T2D) is a growing epidemic in the United States, and metabolic control has not been improved over the last 10 years. Glycemic excursion minimization (GEM) is an alternative lifestyle treatment option focused on reducing postnutrient glucose excursions rather than reducing weight. GEM has been proven to be superior to routine care when delivered face to face, and equivalent or superior to conventional weight loss therapy, but it has not been evaluated among patients newly diagnosed with T2D or in a self-administered format.ObjectiveThis pilot study evaluated the feasibility of a self-administered version of GEM, augmented with continuous glucose monitoring (CGM), to improve metabolic control (hemoglobin A1c [HbA1c]) while diminishing or delaying the need for diabetes medications in adults recently diagnosed with T2D. These primary objectives were hypothesized to be achieved by reducing carbohydrate intake and increasing physical activity to diminish CGM glucose excursions, leading to the secondary benefits of an increase in diabetes empowerment and reduced diabetes distress, depressive symptoms, and BMI.MethodsGEM was self-administered by 17 adults recently diagnosed with T2D (mean age 52 years, SD 11.6 years; mean T2D duration 3.9 months, SD 2.5 months; mean HbA1c levels 8.0%, SD 1.6%; 40% female; 33.3% non-White), with the aid of a 4-chapter pocket guide and diary, automated motivational text messaging, and feedback from an activity monitor, along with CGM and supplies for the 6-week intervention and the 3-month follow-up. Treatment was initiated with one telephone call reviewing the use of the technology and 3 days later with a second call reviewing the use of the GEM pocket guide and intervention.ResultsAt 3-month follow-up, 67% of the participants’ diabetes was in remission (HbA1c levels <6.5%), and only one participant started taking diabetes medication. Participants demonstrated a significant reduction in HbA1c levels (–1.8%; P<.001). Participants also experienced significant reductions in high-glycemic-load carbohydrates routinely consumed, CGM readings that were >140 mg/dL, diabetes distress, depressive symptoms, and BMI. Participants felt that use of the CGM was the most significant single element of the intervention.ConclusionsGEM augmented with CGM feedback may be an effective initial intervention for adults newly diagnosed with T2D. A self-administered version of GEM may provide primary care physicians and patients with a new tool to help people recently diagnosed with T2D achieve remission independent of medication and without weight loss as the primary focus. Future research is needed with a larger and more diverse sample.

Obstructive sleep apnea is not associated with diabetic retinopathy in diabetes: a prospective case-control study.

Diabetic retinopathy (DR) is the most common ocular complication of type 2 diabetes mellitus (T2D) and is associated with diabetes duration, glycemic control, and hypertension (HTN). Obstructive sleep apnea (OSA) is frequent in T2D and isassociated with poor glycemic control. However, it is unclear if there is an association between OSA and DR. This study aimed to assess whetheror not the presence of OSA inpatients with T2D was associated with DR. In this prospective case-control study, consecutivepatients with DM attending the ophthalmology clinics were recruited to include patients with DR (cases) and without DR (controls). OSA was diagnosed by attended polysomnography (PSG). Blood pressure and a fasting morning blood sample, including glycosylated hemoglobin (HbA1c), were recorded. Patients were matched for age, body mass index (BMI), gender, and T2D duration. Thirty diabetic patients with DR were matched with 30 controls. In all patients, the prevalence of moderate-to-severe OSA was 57%. In the logistic regression analysis, DR was associated with increased HbA1c (OR 2.63, 95% CI 1.35-5.16, p = 0.004) but not with any PSG parameter. In the DR group, PSG parameters were not associated with the severity of ocular disease (non-proliferative, proliferative, presence/absence of macular edema). The proliferative aspect of DR was correlated with age (p = 0.017). DR occurred more frequently in uncontrolled diabetes compared to well-controlled diabetes (80% vs 38%, p = 0.029). Inpatients with T2D, the presence of DR is not associated with OSA, but with poorly controlled T2D.

1041-P: Diabetes Complications among Patients from Metropolitan vs. Non-metropolitan Cities in India: One-Year Results of LANDMARC

Data on complications in patients with diabetes from Indian metropolitan and non-metropolitan cities are unavailable. Hence, macro- and microvascular complications during the first year of LANDMARC, a 3-year nationwide prospective observational study (CTRI/2017/05/008452), were evaluated in patients from metropolitan versus non-metropolitan cities. LANDMARC included patients with T2D who were on ≥2 antihyperglycemic medications. Of the total 6236 patients, 2378 and 3858 were from metropolitan and non-metropolitan cities, respectively. Age, T2D duration, and baseline A1C were similar across groups (Table). At 1-year, microvascular complications were significantly higher in those from non-metropolitan than metropolitan cities (19.08% vs. 10.89%; P<0.0001) (Table). Neuropathy was the most common microvascular complication reported in both the groups. Among macrovascular complications reported, acute coronary syndrome and heart failure were the most common and were significantly higher in participants from non-metropolitan cities (Table). The present, first-of-its-kind, data from India demonstrates that patients from non-metropolitan cities may have higher complications, particularly microvascular. The LANDMARC results elicit patterns of disease progression among patients with T2D.View largeDownload slideView largeDownload slide DisclosureS. Kalra: Speaker’s Bureau; Self; Eli Lilly and Company, Novo Nordisk, Sanofi. 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. S. 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. 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. K. Kumar: Advisory Panel; Self; Sanofi-Aventis. 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

1087-P: Therapy Trends at One Year in the Longitudinal LANDMARC Study on Real-World Outcomes in Type 2 Diabetes Patients in India

Therapy patterns were examined across various subgroups during the first year of LANDMARC, a 3-year prospective observational study (CTRI/2017/05/008452) that included patients with T2D on ≥2 antihyperglycemic medications. 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. Therapeutic management was at the discretion of the treating physician. At the end of the first year, the proportion of patients taking insulin + OAD increased (baseline: 24%; 1-year: 30.7%); while, those taking only OADs decreased (baseline: 74.4%; 1-year: 67.3%). Biguanides and sulfonylureas were the most commonly used OAD classes, the highest increase in use was seen for DPP4 inhibitors (baseline: 48.9%; 1-year: 58.7%). Overall, at 1-year, glycemic parameters improved significantly (p≤0.001); HbA1c improved more in the insulin versus insulin naïve subgroup (p<0.0001) (Table); but no statistical difference was noted in those who received >3 versus ≤3 OADs. All glycemic parameters improved in those receiving basal or premix insulins. Overall, 1-year data indicate that timely initiation of insulin may play an important role in improving glycemic parameters.View largeDownload slideView largeDownload slide DisclosureH. Thacker: None. 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. S. 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. 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. K. Kumar: Advisory Panel; Self; Sanofi-Aventis. B. Sethi: None. S. Chowdhury: None.FundingSanofi

Hepatic steatosis indices as predictors of vitamin D3 deficiency in patients with NAFLD associated with type 2 diabetes

Background. Recently, vitamin D3 deficiency is considered one of the factors associated with the development of non-alcoholic fatty liver disease (NAFLD). The aim was to evaluate steatosis indices and metabolic parameters in NAFLD depending on vitamin D3 status. Methods. According to the recommendations of the European Society of Endocrinology, all patients were divided into 3 groups: group 1 — with an optimal level of vitamin D3 (30 ng/mL); group 2 — vitamin D3 insufficiency (21–29 ng/mL) and group 3 — vitamin D3 deficiency (< 20 ng/mL). Results. The study included 126 T2D patients with NAFLD diagnosed with ultrasound. The highest hepatic steatosis (HSI) and fatty liver (FLI) index values were diagnosed in vitamin D3 deficiency as compared to optimal group (HSI — 43.34 ± 6.59 vs. 39.67 ± 4.37; P = 0.032 and FLI — 79.21 ± 19.61 vs. 64.96 ± 17.72; P = 0.007). Triglyceride and glucose index (TyG) also were insignificantly elevated parallel to vitamin D3 status worsened (P = 0.175). In multivariate logistic regression analysis all steatosis indices were independent from transaminases activity, body mass index (BMI) and T2D duration associated with vitamin D3 deficiency. Conclusions. Hepatic steatosis indices (HSI, FLI and TyG) independently from anthropometric parameters and transaminase activity associated with D3 deficiency in NAFLD patients

Incident Type 2 Diabetes Duration and Cancer Risk: A Prospective Study in Two US Cohorts.

The influence of type 2 diabetes mellitus (T2D) duration on cancer incidence remains poorly understood. We prospectively followed for cancer incidence 113429 women in the Nurses' Health Study (1978-2014) and 45604 men in the Health Professionals Follow-up Study (1988-2014) who were free of diabetes and cancer at baseline. Cancer incidences were ascertained by review of medical records. In the multivariable-adjusted model incident, T2D was associated with higher risk of cancers in the colorectum, lung, pancreas, esophagus, liver, thyroid, breast, and endometrium. The pooled hazard ratios (HRs) ranged from 1.21 (95% confidence interval [CI] = 1.06 to 1.38) for colorectal cancer to 3.39 (95% CI = 2.24 to 5.12) for liver cancer. For both composite cancer outcomes and individual cancers, the elevated risks did not further increase after 8 years of T2D duration. The hazard ratio for total cancer was 1.28 (95% CI = 1.17 to 1.40) for T2D duration of 4.1-6.0 years, 1.37 (95% CI = 1.25 to 1.50) for 6.1-8.0 years, 1.21 (95% CI = 1.09 to 1.35) for 8.1-10.0 years, and 1.04 (95% CI = 0.95 to 1.14) after 15.0 years. In a cross-sectional analysis, a higher level of plasma C-peptide was found among participants with prevalent T2D of up to 8 years than those without T2D, whereas a higher level of HbA1c was found for those with prevalent T2D of up to 15 years. Incident T2D was associated with higher cancer risk, which peaked at approximately 8 years after diabetes diagnosis. Similar duration-dependent pattern was observed for plasma C-peptide. Our findings support a role of hyperinsulinemia in cancer development.

Prevalence and Impact of Weight Self Stigmatization on Type II Diabetes Glycemic and Cardiovascular Markers Control.

Patients with Type II Diabetes (T2D) are at high risk for developing serious diabetes related complications. The primary study goal was to assess the weight stigma among our T2D patients and its relation to various diabetes and cardiovascular related markers. A cross-sectional study was carried out for adult T2D patients whom had a routine clinic visit between the period of May-August, 2019. Validated Weight Self Stigma (WSS) Questionnaire was used and those with a total score of >30 points were considered at increased risk of stigmatization. Study included a total of 663 T2D patients with a mean age of 57.3±22.0 years, mostly female with long standing diabetes and a mean BMI in the overweight range. About 45.6% of the sample were considered to have high risk for self-stigmatization. Compared to those whom considered to have low risk for self-stigmatization, those who were high risk were mostly female (p 0.046), have longer T2D duration (p 0.161), higher BMI and higher systolic blood pressure (p<0.001 and 0.006), lower diastolic blood pressure (p 0.004), higher resting heart rate (p 0.002), more likely to be divorced (p 0.046), higher educational level and income (both p<0.001), have retinopathy and neuropathy (p<0.001 and 0.009) and exercise more than 150 min/week if physically active (p<0.001). High risk self-stigmatization was highly prevalent among T2D patients' sample. It was also associated with worsening in some of the measured cardiovascular markers and having more microvascular complications despite the comparable HbA1c and lipid profiles.

1037-P: Efficacy and Safety of Fast-Acting Insulin Aspart in Adults with T2D with Different Insulin Requirements

A previous post-hoc analysis of the 26-week onset 2 trial indicated that with insulin glargine the effect of fast-acting insulin aspart (FA) vs. insulin aspart (IAsp) on PPG increment (meal test) was larger for subjects on high bolus insulin doses in bolus-naïve adults with T2D (duration ≥6 mo). This post-hoc analysis of the 16-week onset 9 trial aimed to confirm this and explore efficacy and safety of FA vs. IAsp, both with insulin degludec, in bolus-experienced adults with T2D (duration ≥10 yrs) by insulin requirement. Participants were divided by meal test bolus dose at baseline: ≤10 U (n=303), 10-20 U (n=518) or &amp;gt;20 U (n=270). Baseline characteristics were similar across subgroups; except for BMI and daily insulin dose, which increased with meal test dose (Table). Change from baseline in HbA1c 16 weeks post randomization was similar for FA vs. IAsp across subgroups. There was a trend in favor of FA vs. IAsp for change from baseline in PPG increments (meal test), but treatment differences did not depend on subgroup. There was a trend towards lower rates of severe or blood glucose-confirmed hypoglycemia with higher insulin doses at meal test, with a benefit for FA vs. IAsp in the &amp;gt;20 U subgroup. Treatment difference (FA vs. IAsp) in change from baseline in PPG increments was unaffected by bolus insulin dose; however hypoglycemia risk may be lower with FA vs. IAsp in adults with long-standing T2D and high bolus insulin requirements. Disclosure W. Lane: Research Support; Self; AstraZeneca, Gilead, Mylan, Sanofi, Tolerion, vTv. Other Relationship; Self; Dexcom, Insulet, Novo Nordisk. M. Ekelund: Employee; Self; Novo Nordisk. Stock/Shareholder; Self; Novo Nordisk. Stock/Shareholder; Spouse/Partner; Novo Nordisk. Ó. Thórisdóttir: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. E. Jódar: Other Relationship; Self; Elli Lilly &amp; Co, Novo Nordisk, MSD, Lilly, Janssen, Pfizer, AstraZeneca, Sanofi, UCB, Amgen, FAES, Shire, Mundipharma, Novartis. A. Oviedo: None. N. Rathor: Employee; Self; Novo Nordisk. P. Senior: Research Support; Self; Allergan, Novo Nordisk. G. Sesti: Advisory Panel; Self; Servier, Mylan, Novo Nordisk, Boehringer Ingelheim, Lilly, AstraZeneca, MSD, Sanofi, Amgem, Novartis, GSK. Speaker’s Bureau; Self; Novo Nordisk, Servier, MSD, Boehringer Ingelheim, Lilly, AstraZeneca, L-Nutra, Theras, Sanofi, Mundipharma, Omikron, Novartis. E. Franek: Advisory Panel; Self; Novartis AG. Speaker’s Bureau; Self; AstraZeneca, Bioton, Eli Lilly and Company. Other Relationship; Self; Boehringer Ingelheim, Novo Nordisk. Funding Novo Nordisk

147-OR: Long-Term Effect of GLP-1 on Pancreas Endocrine Function after Gastric Bypass in Individuals with and without Diabetes Remission

The contribution of GLP-1 on glucose control after gastric bypass (GBP) is not fully elucidated. Hypotheses: The improvement in β-cell glucose sensitivity (BCGS) to oral glucose after GBP is GLP-1 mediated, weight loss independent, and varies according to diabetes (T2D) remission status; The administration of exendin 9-39 (EX9), a GLP-1 receptor blocker, has minimal effect on blood glucose. Methods: Patients with T2D (n=29) underwent a 75 g OGTT prior to and at 3, 12 and 24 months (M) after GBP. Glucose, insulin secretion rates (ISR), BCGS, and glucagon were measured with and without EX9. The cohort was retrospectively divided into 3 groups based on T2D remission status determined at the latest study time point (24 or 12M): remitters (REM, n=5), persistent T2D (P-T2D, n=8), impaired (IGT, n=16). Results: Prior to GBP, patients were 42.9±8.3y old, had a BMI of 42.4±4.6 kg/m2, 7.7±7.3 y known T2D duration, an HbA1c of 7.8±1.1% (35% on insulin) and an HOMA-IR of 11.5±5.8. Both magnitude and temporal increases in BCGS varied according to remission status: greater (up to 6.5 fold, p&amp;lt;0.03) and sustained in REM, variable in IGT (∼3 fold, p&amp;lt;0.01), minimal and only transient (3M, p=0.014) in P-T2D. These differences were not explained by weight-loss since it did not differ between the 3 groups at any time. EX9 reversed the effect of GBP on ISR at 3, 12 and 24M (p&amp;lt;0.003); it further enhanced the rise in post-prandial glucagon, but this effect was only significant at 3M (p=0.005). Both effects varied in magnitude overtime and by remission status. Glucose improved after GBP, as expected; EX9 decreased glucose levels at 3M in the whole cohort (p&amp;lt;0.001), but had no effect on glucose at 12 and 24M. EX9 increased significantly, albeit minimally, glucose at 120 and/or 180 minutes during the OGTT in REM and IGT, but not in P-T2D. Conclusions: Our data suggest that the effect of endogenous GLP-1 on pancreatic endocrine function and glucose varies with time and according to remission status after GBP. Disclosure M.A. Prasad: None. A. Shah: None. V.M. Mark: None. N. Nair: None. J.J. Holst: Advisory Panel; Self; AstraZeneca, Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Zealand Pharma A/S. Other Relationship; Spouse/Partner; Antag Therapeutics. Funding National Institutes of Health (R01DK67561, DK007559, P30DK26687, UL1RR024156, UL1TR000040, F32DK113747)

947-P: Semaglutide Added to Treatment or Changed from Other GLP-1 Receptor Agonist in Type 2 Diabetes: A Study to Evaluate Real-World Effectiveness

Objective: To evaluate real-world clinical outcomes of semaglutide on glycemic control and weight as an add-on to treatment or changed-on from other GLP-1 in patients with T2D who initiate treatment. Patients and Methods: To better understand the effectiveness of semaglutide on clinical outcomes in a real-world setting, this retrospective cohort study included eligible patients were at least 18 years old with uncontrolled T2D (HbA1c 6.5-11%) receiving stable therapy that initiated subcutaneous semaglutide 0.5 or 1.0 mg once weekly added to their therapy or after a change from other GLP-1. Primary endpoint was change from baseline in glycated Hb (HbA1c) and confirmatory secondary endpoint was change from baseline in body weight, both at week 24. Semaglutide was initiated as part of their diabetes therapy based in clinical practice. Results: in this study, were included 147 patients had a mean age of 60.3 ± 10.1 years, T2D duration of 14.0 ± 7.4 years, and baseline A1C of 8.3 ± 1.34%. Seventy-five were naïve in treatment with GLP-1 and seventy-four received previously another GLP-1 (liraglutide 1.8 mg daily or dulaglutide 1.5 mg once weekly). At 6 months follow-up, 145 patients who remained on-treatment showed an A1C reduction of 1.2 ± 1.15% (p&amp;lt;0.05), A1C lowering was seen in both groups: a reduction de 1.8±1.8% (p &amp;lt; 0.05) in patients that received GLP for first time and 0.6± 1.0%(p&amp;lt; 0.05) in group prior use of GLP-1. Mean weight reduction was 5.1 ± 4.6 kg (p &amp;lt; 0.001) in the group initiated GLP-1 for first time and 2.1±4.0 kg (p&amp;lt;0.01) in group that changed from another GLP-1. Four patients presented gastrointestinal adverse events to retire the treatment, all of them in the group that never had been treated with GLP-1. Conclusion: In this real-world study, patients initiating semaglutide had significant reductions in HbA1c and weight. The effect was reached whether patients received GLP-1 for the first time or if a change had been made from another GLP-1. Disclosure J. Ferrer-García: None. R. Albalat Galera: None. L. Arribas: None. M. Tolosa Torrens: None. A. Sánchez Lorente: None. A.J. Portilla: None. A. Artero: None. C. Sánchez-Juan: None.

30-OR: Empagliflozin Delays Need for Insulin Initiation in Patients with Type 2 Diabetes and Cardiovascular Disease: Findings from EMPA-REG OUTCOME

Insulin in T2D is associated with hypoglycemia and weight gain, requires training, can be expensive, and is generally not preferred by patients. Reducing insulin needs is attractive to both patients and practitioners. In EMPA-REG OUTCOME, 7020 patients were treated with empagliflozin (EMPA) 10, 25 mg, or placebo (PBO). Median follow-up was 3.1 yrs. After the first 12 weeks, changes in background glucose-lowering therapy were permitted. We assessed treatment effects of pooled EMPA vs. PBO on time to new initiation of insulin among insulin-naïve patients and time to total daily insulin dose increase by &amp;gt;20% among insulin-treated patients. In 3633 (52%) insulin-naïve patients, EMPA reduced need for insulin use vs. PBO by 54% (11.1% vs. 22.3%; HR 0.46 [0.39-0.54]), adjusted for key covariates (Figure). In 3387 (48%) patients using insulin at baseline, EMPA reduced need for a &amp;gt;20% increase in insulin dose by 57% (19.1% vs. 36.8%; HR 0.43 [0.37-0.49]). Reductions in incident insulin use was most pronounced in patients within 5 yrs of T2D diagnosis (HR 0.31 [0.21-0.45]) compared with T2D duration of &amp;gt;5-10 yrs (0.42 [0.31-0.59]) or &amp;gt;10 yrs (0.56 [0.44-0.71); P&amp;lt;sub&amp;gt;interaction =0.03. In patients with T2D and CVD, EMPA markedly and durably delays the need for insulin initiation, more so in those recently diagnosed, and reduces need for large dose increases in those already using insulin. Disclosure M. Vaduganathan: Advisory Panel; Self; Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Relypsa, Inc. Consultant; Self; Amgen, AstraZeneca, Baxter. N. Sattar: Advisory Panel; Self; Amgen, AstraZeneca, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Novo Nordisk A/S, Pfizer Inc., Sanofi. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc. D.H. Fitchett: Consultant; Self; AstraZeneca, Boehringer Ingelheim International GmbH. Speaker’s Bureau; Self; Lilly Diabetes. Other Relationship; Self; Novo Nordisk Inc. A. Ofstad: Employee; Self; Boehringer Ingelheim International GmbH. M. Brueckmann: Employee; Self; Boehringer Ingelheim International GmbH. J.T. George: Employee; Self; Boehringer Ingelheim International GmbH. S. Verma: Advisory Panel; Self; Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim (Canada) Ltd., Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck &amp; Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Amgen, AstraZeneca, Bayer AG, Boehringer Ingelheim International GmbH, Bristol-Myers Squibb, Janssen Pharmaceuticals, Inc., Merck &amp; Co., Inc. Other Relationship; Self; AstraZeneca, AstraZeneca, Bayer AG, Boehringer Ingelheim (Canada) Ltd., Boehringer Ingelheim International GmbH, Eli Lilly and Company, Eli Lilly and Company, EOCI Pharmacomm, Janssen Pharmaceuticals, Inc., Merck &amp; Co., Inc., Novartis Pharmaceuticals Canada Inc., Novo Nordisk A/S, Novo Nordisk A/S, Sanofi, Sanofi, Sun Pharmaceuticals, Toronto Knowledge Translation Working Group. M. Mattheus: None. C. Wanner: Advisory Panel; Self; Eli Lilly and Company, Merck &amp; Co., Inc., Mundipharma International. Consultant; Self; Boehringer Ingelheim (Canada) Ltd., Sanofi Genzyme. Speaker’s Bureau; Self; AstraZeneca. Other Relationship; Self; Boehringer Ingelheim International GmbH. S.E. Inzucchi: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lexicon Pharmaceuticals, Inc., Novo Nordisk A/S, Sanofi. Consultant; Self; Abbott, Merck &amp; Co., Inc., vTv Therapeutics. B. Zinman: Advisory Panel; Self; Abbott, Boehringer Ingelheim International GmbH, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Merck Sharp &amp; Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis. J. Butler: Consultant; Self; Amgen, Array BioPharma, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Bristol-Myers Squibb, CVRx, G3 Pharmaceuticals, Innolife Co., Ltd., Janssen Pharmaceuticals, Inc., Luitpold Pharmaceuticals, Inc., Medtronic, Merck &amp; Co., Inc., Novartis Pharmaceuticals Corporation, Relypsa, Inc., VIfor. Funding Boehringer Ingelheim and Eli Lilly and Company Diabetes Alliance

1112-P: Does Background T2D Therapy Modify the Benefits of Dapagliflozin in Heart Failure? Analysis of the DAPA-HF Trial

Background: At present, dapagliflozin (dapa) is typically used as a 2nd-line glucose-lowering medication (GLM) in T2D, often added to metformin. In DAPA-HF, dapa improved clinical outcomes vs. placebo in patients (pts) with HF and reduced ejection fraction (HFrEF), with or without T2D. We examined whether these benefits varied by background GLM in the T2D cohort, including in drug naïve pts and in pts not on metformin. Methods: The primary outcome was a composite of worsening HF (hospitalization or urgent visit requiring IV therapy) or cardiovascular death. The effect of dapa vs. placebo was examined using Cox proportional hazards models. Results: Of the 2139 T2D pts, 1596 (75%) were treated with GLM: metformin (48%), insulin (25%), sulfonylurea (21%), DPP-4 inhibitor (14%) and GLP-1 agonist (1%). Drug-naïve pts had a lower A1c (6.9%±1.2 vs. 7.5%±1.6; P&amp;lt;0.001) and shorter T2D duration (median 5.5 vs. 103 months; P&amp;lt;0.001). Those not using metformin had a lower eGFR (61 vs. 66; P&amp;lt;0.001). The effect of dapa on the primary outcome was consistent in the drug-naïve vs. pts receiving GLM (HR 0.86 [95%CI 0.60-1.23] vs. 0.72 [0.58-0.88]; P-interaction=0.39) and across GLM classes, including those using vs. not using metformin (HR 0.67 [0.51-0.88] vs. 0.81 [0.64-1.03]; P-interaction=0.30). Conclusion: In DAPA-HF, dapa improved outcomes irrespective of use/no use of GLM or by type of GLM used in pts with T2D and HFrEF. Disclosure K. Docherty: Speaker’s Bureau; Self; Eli Lilly and Company. Other Relationship; Self; AstraZeneca. S.E. Inzucchi: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim International GmbH, Lexicon Pharmaceuticals, Inc., Novo Nordisk A/S, Sanofi. Consultant; Self; Abbott, Merck &amp; Co., Inc., vTv Therapeutics. M.N. Kosiborod: Consultant; Self; Amarin Corporation, Amgen, Applied Therapeutics, AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Eisai Inc., Eli Lilly and Company, GlaxoSmithKline plc., Glytec, Intarcia Therapeutics, Janssen Scientific Affairs, LLC., Merck &amp; Co., Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Inc., Sanofi US, Vifor Pharma Group. Research Support; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc. L. Kober: Speaker’s Bureau; Self; AstraZeneca, Novartis AG. Other Relationship; Self; AstraZeneca. A. Langkilde: Employee; Self; AstraZeneca. Stock/Shareholder; Self; AstraZeneca. F. Martinez: Board Member; Self; AstraZeneca, Novartis Pharmaceuticals Corporation. O. Bengtsson: Employee; Self; AstraZeneca. D.L. DeMets: Consultant; Self; Actelion Pharmaceuticals US, Inc., AstraZeneca, Boston Scientific, Bristol-Myers Squibb, DalCor Pharmaceuticals, Intercept Pharmaceuticals, Inc., Medtronic. M. Sjöstrand: Employee; Self; AstraZeneca. M.S. Sabatine: Consultant; Self; Amgen, AstraZeneca, Bristol-Myers Squibb, CVS Caremark, DalCor Pharmaceuticals, Dyrnamix Inc., Esperion Therapeutics, Inc., IFM Therapeutics, Intarcia Therapeutics, Ionis Pharmaceuticals, Inc., Medicines Company, MedImmune, Merck &amp; Co., Inc. Research Support; Self; Amgen, AstraZeneca, Bayer U.S., Daiichi Sankyo, Eisai Inc., Intarcia Therapeutics, Janssen Research and Development, Medicines Company, MedImmune, Merck &amp; Co., Inc., Novartis AG, Pfizer Inc., Quark Pharmaceuticals. S. Solomon: Consultant; Self; AstraZeneca, Theracos, Inc. Research Support; Self; AstraZeneca, Theracos, Inc. P. Jhund: Advisory Panel; Self; Cytokinetics Inc. Research Support; Self; Boehringer Ingelheim International GmbH. Speaker’s Bureau; Self; Novartis AG. Other Relationship; Self; AstraZeneca. J.J. McMurray: Other Relationship; Self; AbbVie Inc., Alnylam Pharmaceuticals, Amgen, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Bristol-Myers Squibb, Cardurion, GlaxoSmithKline plc., Novartis Pharmaceuticals Corporation, Theracos, Inc.

1038-P: Insulin Glargine 300 U/ml (Gla-300) vs. First-Generation Standard-of-Care Basal Insulin Analogs (SOC-BI) in Insulin-Naïve Patients with Type 2 Diabetes (T2D): Impact of Renal Function on the Outcomes of the Randomized Pragmatic Real-Life Achieve Control S

In the 12-month ACHIEVE Control study, significantly more insulin-naive patients with T2D treated with Gla-300 vs. SOC-BI (glargine 100 U/mL or detemir) achieved the primary composite endpoint of individualized HEDIS A1c target attainment at 6 months without documented symptomatic (≤70 mg/dL) or severe hypoglycemia. This post-hoc analysis explored outcomes in subgroups with estimated glomerular filtration rate (eGFR) of &amp;lt;60, 60 to &amp;lt;90, and ≥90 mL/min/1.73 m2. Patients with eGFR &amp;lt;60 mL/min/1.73 m2 were older and had longer T2D duration. Within each eGFR subgroup, baseline characteristics were generally balanced between treatment groups. Within subgroups, odds ratios for clinical outcomes generally showed trends favoring Gla-300 vs. SOC-BI, consistent with the overall study population (Figure). In patients with eGFR &amp;lt;60 mL/min/1.73 m2, the odds ratio point estimates for absence of documented symptomatic (≤70 mg/dL and &amp;lt;54 mg/dL) or severe hypoglycemia at 6 and 12 months strongly favored Gla-300 (&amp;gt;1.40). The results suggest a potential benefit of Gla-300 vs. SOC-BI for avoiding hypoglycemia in patients with compromised renal function that warrants further evaluation in prospective studies. Disclosure L. Meneghini: Advisory Panel; Self; Novo Nordisk Inc., Sanofi US. Consultant; Self; Applied Therapeutics, Sanofi US. A. Cheng: Advisory Panel; Self; Abbott, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Boehringer Ingelheim International GmbH, Eli Lilly and Company, HLS Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Medtronic, Merck &amp; Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Applied Therapeutics, Sanofi. Speaker’s Bureau; Self; Abbott, AstraZeneca, Boehringer Ingelheim (Canada) Ltd., Boehringer Ingelheim International GmbH, Eli Lilly and Company, Insulet Corporation, Janssen Pharmaceuticals, Inc., mdBriefCase, Medtronic, Merck &amp; Co., Inc., Merck Sharp &amp; Dohme Corp., Novo Nordisk A/S, Sanofi. P. Evenou: Employee; Self; Sanofi. J. Gill: Other Relationship; Self; Sanofi US. A. Mohamed: None. G.E. Umpierrez: None. Funding Sanofi US

Impact of disease duration and β-cell reserve on the efficacy of switching to iGlarLixi in adults with type 2 diabetes on glucagon-like peptide-1 receptor agonist therapy: Exploratory analyses from the LixiLan-G trial.

AimTo evaluate the efficacy of iGlarLixi by C‐peptide levels and duration of diabetes in an exploratory analysis of the LixiLan‐G study.MethodsLixiLan‐G was a 26‐week, randomized, open‐label study in adults with type diabetes (T2D) inadequately controlled while on a glucagon‐like peptide‐1 receptor agonist (GLP‐1 RA), with metformin, with or without pioglitazone and/or a sodium‐glucose co‐transporter‐2 inhibitor. This analysis investigated the efficacy of switching to iGlarLixi by fasting baseline quartile C‐peptide levels and baseline quartile of duration of T2D compared with continued GLP‐1 RA use.ResultsChange in glycated hemoglobin (HbA1c) from baseline to week 26 was significantly greater with iGlarLixi compared with continued GLP‐1 RAs across all fasting C‐peptide quartiles (−1.00% to −1.06% vs. –0.23% to −0.54% range, respectively) and irrespective of all T2D duration quartiles (−0.94% to −1.07% vs. –0.25% to −0.50% range). A significantly greater proportion of participants in the iGlarLixi arm achieved an HbA1c of <7% across all C‐peptide quartiles (51%‐73% range) than in the GLP‐1 RA arm (19%‐32% range). The greatest reductions in HbA1c in participants receiving iGlarLixi were observed in those with the shortest duration of disease, although consistently greater than reductions observed with continued GLP‐1 RAs. Reductions in HbA1c were comparable across C‐peptide quartiles within the iGlarLixi arm.ConclusionsThe results of this study suggest that iGlarLixi is an effective treatment option, irrespective of C‐peptide levels or duration of diabetes, in adults with insufficiently controlled T2D receiving GLP‐1 RAs.

MON-612 Vitamin D and Its Relation to Type II Diabetes Control and Complications

Vitamin D and its Relation to Type II Diabetes Control and ComplicationsBackground:Type II diabetes (T2D) prevalence in Saudi Arabia is among the highest in the MENA region according to the recent International Diabetes Federation published statistics. Recent study suggested that around 54% of the screened T2D patients have vitamin D deficiency. Our aim is to assess the prevalence of vitamin D deficiency and its relation to glycemic control and T2D related complications.Methods:We conducted a cross-sectional study at the Diabetes Center, Taif, Saudi Arabia for T2D patients whom age > 18 years and were seen in the clinic between Aug2015-Jan2017 and agreed to participate. We excluded those with gestational diabetes and type I diabetes. Baseline characteristics and measurement were obtained by the participated physician. Laboratory data was collected from the patient’s EMR. We considered those whom have vitamin D level below 30 (ng/ml) to be deficient.Result:A total of 228 patients with a mean age of 59.1 + 12.5 years, diabetes duration of 10.6 + 8.8 years, BMI of 33.4 + 6.2 kg/m2, heart rate 81.6 + 12.5, systolic BP 130.8 + 19.6, diastolic BP 75.4 + 9.9, fasting glucose 9.4 + 9.5 mmol/l, HbA1c 8.0 + 2.1%, vitamin D 23.2 + 12.3 ng/ml, serum creatinine 73.8 + 22.2, total cholesterol 4.5 + 1.1, LDL 2.7 + 0.9, triglyceride 1.6 + 0.8.76.3% of the screened patients had vitamin D deficiency. Compared to those with vitamin D deficiency, those with normal vitamin D level less likely to have hypertension (P 0.521), to be male (P 0.028), to have microalbuminuria (P 0.331), and to be diagnosed with neuropathy and retinopathy (P 0.431 and 0.185 respectively). Also those with normal vitamin D were older (P 0.537),has shorter T2D duration (P 0.231), higher BMI (P 0.097), lower pulse rate (P 0.127), lower SBP (P 0.228), higher DBP (P 0.275), lower HbA1c (P 0.027), lower FBG (P 0.093), lower serum creatinine (P 0.039), and lower total cholesterol and LDL (P 0.497 and 0.404 respectively) when compared to those with vitamin D deficiency.Adjusting for age, gender, diabetes duration, BMI, SBP, DBP, vitamin D supplements and dosage, there was non-significant correlation between HbA1c and vitamin D level.Conclusion:Vitamin D deficiency is highly prevalent among our sample of T2D patients. In the non-adjusted modules, vitamin D deficiency were non-significantly associated with more microvascular complications and worse measured cardiovascular markers. Also, T2D patients with vitamin D deficiency had significantly higher HbA1c which were non-significant when adjusted for related variables.

¡Sí, Yo Puedo Vivir Sano con Diabetes! A Self-Management Randomized Controlled Pilot Trial for Low-Income Adults with Type 2 Diabetes in Mexico City.

BackgroundType 2 diabetes (T2D) is a worldwide epidemic and a leading cause of death in Mexico, with a prevalence of 15.9%, and >70% of diagnosed adults have poor glycemic control [glycated hemoglobin (HbA1c) >7.5%]. We developed a diabetes self-management education program contextualized to the study population, including dietary preferences, health literacy, and health system.ObjectivesWe aimed to evaluate the efficacy of a self-management + text message program (¡Sí, Yo Puedo Vivir Sano con Diabetes!) on primary (HbA1c), and secondary behavioral (self-management), clinical, and psychosocial outcomes in adults with T2D in Mexico City.MethodsParticipants were recruited at public primary healthcare centers (Seguro Popular), and randomly allocated to treatment (n = 26) or wait-list control groups (n = 21) with data collected at 3 and 6 mo. The program included 7 weekly sessions and 6 mo of daily text/picture messages. Descriptive statistics and a generalized linear mixed model with intent-to-treat analysis were calculated.ResultsParticipants were 55.5 ± 8.8 y of age (mean ± SD), 68% female, 88.6% overweight/obese, and 57% lived in food-insecure households. Mean ± SD T2D duration was 11.9 ± 7.8 y and HbA1c was 9.2% ± 1.5%. There was 89% attendance at sessions and 6.4% attrition across both groups at 6 mo. Group-by-time effects were seen in self-monitoring of blood glucose (P < 0.01) and diabetes self-efficacy (P < 0.04); and a trend for lower HbA1c was seen in the intervention group at 6 mo (P = 0.11). Significant improvements in dietary behavior (P < 0.01) were demonstrated in the intervention group over time, but this did not reach statistical significance compared with the control group.ConclusionsThe program was associated with clinically significant improvements in T2D self-management, self-efficacy, and HbA1c over time. Thus, T2D self-management skills, including diet, were improved in a vulnerable metropolitan population.This trial was registered at clinicaltrials.gov as NCT03159299.