Lower TIR Research Articles

Predicting the Risk of Adverse Neonatal Outcomes in Women With Insulin-Treated Diabetes: Is It Time for a Pregnancy-Specific Glycemic Risk Index (GRI)?

The Glycemia Risk Index (GRI) describes the quality of glycemic control, emphasizing extreme hypoglycemia and hyperglycemia more than less extreme values. However, a pregnancy-specific GRI (pGRI), tailored to the tighter target glucose range required during pregnancy, has not been established. We retrospectively evaluated clinical, metabolic, and Continuous Glucose Monitoring (CGM) data across pregnancy in women with insulin-treated diabetes, managed between September 2021 and March 2024 at the University Hospital of Pisa. First and second levels of hyperglycemia (TAR1: 140-180 mg/dL, TAR2: >180 mg/dL) and hypoglycemia (TBR1: 63-54 mg/dL, TBR2: <54 mg/dL) were used to calculate the pGRI at each trimester. Logistic regression analysis investigated the association between pGRI and risk of at least one adverse neonatal outcome (among preterm delivery, macrosomia, large for gestational age, small for gestational age, neonatal hypoglycemia, neonatal jaundice, and neonatal intensive care unit admission). Of 45 pregnant women, 25 (56%) experienced at least one adverse neonatal outcome. In the third trimester, women with adverse outcomes had significantly higher total TAR (26 [12-32]% vs 10 [4-23]%, P = .018) and lower TIR (71 [64-83]% vs 88 [75-92]%, P = .007). Specifically, the difference was notable in TAR2 (6 [2-15]% vs 1 [0-4]%, P = .004), whereas TAR1 was comparable between the 2 groups. Accordingly, third trimester pGRI was higher in women with adverse neonatal outcomes (38 [18-49]% vs 18 [10-31]%, P = .013) and, at logistic regression, slightly but significantly increased the risk of adverse neonatal outcomes (1.044 [1.004-1.086], P = .024). Pregnant women with insulin-treated diabetes reporting adverse neonatal outcomes spent more time in hyperglycemia, particularly in extreme hyperglycemia. Therefore, the level of hyperglycemia should always be assessed during pregnancy. The pGRI, emphasizing extreme hyperglycemia, may be a novel comprehensive tool for assessing the risk of adverse neonatal outcomes.

Nocturnal Glucose Profile According to Timing of Dinner Rapid Insulin and Basal and Rapid Insulin Type: An Insulclock® Connected Insulin Cap-Based Real-World Study.

A study to assess the glucose levels of people with type 1 diabetes (T1D) overnight, based on the insulin type and timing. A real-world, retrospective study of T1D, using multiple daily insulin injections. Continuous glucose monitoring and insulin injection data were collected for ten hours after dinner using the Insulclock® connected cap. Meal events were identified using the ROC detection methodology. The timing of the rapid insulin, second injections, and the type of insulin analogs used, were evaluated. The nocturnal profiles (n = 775, 49 subjects) were analyzed. A higher glucose AUC of over 180 mg/dL was observed in subjects with delayed injections (number; %; mg/dL × h): -45-15 min (n = 136; 17.5%, 175.9 ± 271.0); -15-0 min (n = 231; 29.8%, 164.0 ± 2 37.1); 0 + 45 min (n = 408; 52.6%, 203.6 ± 260.9), (p = 0.049). The use of ultrarapid insulin (FiAsp®) (URI) vs. rapid insulin (RI) analogs was associated with less hypoglycemia events (7.1 vs. 13.6%; p = 0.005) and TBR70 (1.7 ± 6.9 vs. 4.6 ± 13.9%; p = 0.003). Users of glargine U300 vs. degludec had a higher TIR (70.7 vs. 58.5%) (adjusted R-squared: 0.22, p < 0.001). The use of a correction injection (n = 144, 18.6%) was associated with a higher number of hypoglycemia events (18.1 vs. 9.5%; p = 0.003), TBR70 (5.5 ± 14.2 vs. 3.0 ± 11.1%; p = 0.003), a glucose AUC of over 180 mg/dL (226.1 ± 257.8 vs. 178.0 ± 255.3 mg/dL × h; p = 0.001), and a lower TIR (56.0 ± 27.4 vs. 62.7 ± 29.6 mg/dL × h; p = 0.004). The dinner rapid insulin timing, insulin type, and the use of correction injections affect the nocturnal glucose profile in T1D.

Higher fibre and lower carbohydrate intake are associated with favourable CGM metrics in a cross-sectional cohort of 470 individuals with type 1 diabetes

Aims/hypothesisThe aim of this work was to investigate the association between macronutrient intakes and continuous glucose monitoring (CGM) metrics in individuals with type 1 diabetes.MethodsIn 470 individuals with type 1 diabetes of the GUTDM1 cohort (65% female, median age 40 [IQR 28–53] years, median diabetes duration 15 [IQR 6–29] years), we used logistic regression to establish associations between macronutrient intakes and the CGM metrics time in range (TIR, time spent between 3.9–10.0 mmol/l blood glucose, optimally set at ≥70%) and time below range (TBR, <3.9 mmol/l blood glucose, optimally set at <4%). ORs were expressed per 1 SD intake of nutrient and were adjusted for other macronutrient intakes, age, sex, socioeconomic status, BMI, duration of type 1 diabetes, pump use, insulin dose and alcohol intake.ResultsThe median (IQR) TIR was 67 (51–80)% and TBR was 2 (1–4)%; the mean ± SD energy intake was 6879±2001 kJ, fat intake 75±31 g, carbohydrate intake 162±63 g, fibre intake 20±9 g and protein intake 70±24 g. A higher fibre intake and a lower carbohydrate intake were associated with higher odds of having a TIR≥70% (OR [95% CI] 1.64 [1.22, 2.24] and 0.67 [0.51, 0.87], respectively), whereas solely a higher carbohydrate intake was associated with TBR<4% (OR 1.34 [95% CI 1.02, 1.78]).Conclusions/interpretationA higher fibre intake is independently associated with a higher TIR. A higher carbohydrate intake is associated with less time spent in hypoglycaemia, a lower TIR and a higher time above range. These findings warrant confirmatory (interventional) investigations and may impact current nutritional guidelines for type 1 diabetes.Graphical

Glucose Targets Using Continuous Glucose Monitoring Metrics in Older Adults With Diabetes: Are We There Yet?

The older population is increasing worldwide and up to 30% of older adults have diabetes. Older adults with diabetes are at risk of glucose-related acute and chronic complications. Recently, mostly in type 1 diabetes (T1D), continuous glucose monitoring (CGM) devices have proven beneficial in improving time in range (TIR glucose, 70-180 mg/dL or glucose 3.9-10 mmol/L), glycated hemoglobin (HbA1c), and in lowering hypoglycemia (time below range [TBR] glucose <70 mg/dL or glucose <3.9 mmol/L). The international consensus group formulated CGM glycemic targets relating to older adults with diabetes based on very limited data. Their recommendations, based on expert opinion, were aimed at mitigating hypoglycemia in all older adults. However, older adults with diabetes are a heterogeneous group, ranging from healthy to very complex frail individuals based on chronological, biological, and functional aging. Recent clinical trial and real-world data, mostly from healthy older adults with T1D, demonstrated that older adults often achieve CGM targets, including TIR recommended for non-vulnerable groups, but less often meet the recommended TBR <1%. Existing data also support that hypoglycemia avoidance may be more strongly related to minimization of glucose variability (coefficient of variation [CV]) rather than lower TIR. Very limited data are available for glucose goals in older adults adjusted for the complexity of their health status. Herein, we review the bidirectional associations between glucose and health status in older adults with diabetes; use of diabetes technologies, and their impact on glucose control; discuss current guidelines; and propose a new set of CGM targets for older adults with insulin-treated diabetes that are individualized for health and living status.

Is It Time to Move Beyond TIR to TITR? Real-World Data from Over 20,000 Users of Continuous Glucose Monitoring in Patients with Type 1 and Type 2 Diabetes.

The growing use of continuous glucose monitoring (CGM) has been supported by expert consensus and clinical guidelines on glycemic management in diabetes with time in range (TIR 70-180 mg/dL) representing a key CGM-derived glucose metric. Time in tight range (TITR) has also been proposed for clinical use, spanning largely normal glucose levels of 70-140 mg/dL. However, keeping such narrow glucose ranges can be challenging, and understanding the factors modulating TITR can help achieve these tight glycemic targets. Our real-life study aimed to evaluate the relationship between average glucose (AG) and TIR/TITR in a large cohort (n = 22,006) of CGM users, divided into four groups: self-identified as having type 1 diabetes (T1D) treated with insulin using multiple daily injections (MDI) or pumps; type 2 diabetes (T2D) on MDI or insulin pumps; T2D on basal insulin only; and T2D not on insulin treatment. The T2D groups, regardless of treatment type, displayed the highest TIR and TITR values, associated with lowest glycemic variability measured as glucose coefficient of variation (CV; 23-30%). The T1D group showed the lowest TIR and TITR, associated with the highest CVs (36-38%). Overall, higher CV was associated with lower TIR and TITR for AG values below 180 and 140 mg/dL, respectively, with the reverse holding true for AG values above these thresholds. The discordance between AG and TIR/TITR was less pronounced in T2D compared with T1D, attributed to lower CV in the former group. It was also observed that TITR has advantages over TIR for assessing glycemia status and progress toward more stringent A1C, particularly when approaching normal glucose levels. The data detail how CV affects the AG relationship with TIR/TITR, which has implications for CGM interpretation. In many instances TITR, rather than TIR, may be preferable to employ once AG falls below 140 mg/dL and near-normal glucose levels are required clinically.

1313-P: The Prevalences of NAFLD and Liver Fibrosis Are High in Individuals with Type 1 Diabetes and Increase with Disease Progression

Introduction: Approximately 30% of the global population has nonalcoholic fatty liver disease (NAFLD). This can result in nonalcoholic steatohepatitis (NASH) and liver fibrosis (2% in general population). NAFLD with fibrosis increases overall morbidity and mortality significantly. T2D increases the risk of fibrosis progression in NAFLD, but little is known about NAFLD in T1D. Therefore, the aim of this study was to assess the prevalence of NAFLD and liver fibrosis in T1D. Methods: In this cross-sectional study 453 individuals with T1D were included for analyses (41.0 ±14years old, 64% female, HbA1c 55.6 ±12mmol/mol, median T1D duration 14 [IQR: 6-29] years. Participants underwent a FibroScan® to assess liver stiffness, with a cut-off of 238 dB/m for steatosis and 7.0 kPa for fibrosis. Data analyses was performed in R studio, using a Students T- or Mann-Whitney U test, as appropriate. Results: Prevalence of liver steatosis was 29.5% and fibrosis was 7.7%. Steatosis was significantly higher in individuals with longer T1D duration (median:15 [IQR:7-25] vs. 23 [9-33] years), higher 24-hour insulin dose (34 [24-47] vs. 46 [33-62] units), higher BMI (mean 24.3±SD 3.5 vs. 27.9±4.6 kg/m2), higher CRP levels (1.0 [0.5-2.1] vs. 1.6 [0.8, 3.7] mg/L), higher triglyceride levels (0.6±0.3 vs. 0.8±0.5 mmol/L) and lower TIR (67 [51-82] vs. 62 [48-75] %). Presence of fibrosis was associated with a longer duration of T1D (16 [7-27] vs. 30 [20-39] years) a higher 24-hour insulin (36.0 [26-50] vs. 42 [34-63] units), higher BMI (25.1±4.1 vs. 27.8±4.6 kg/m2), higher CRP levels (1.2 [0.6-2.4] vs 1.5 [0.8-3.9] mg/L) and lower TIR (67 [51, 8] vs. 58 [46, 71] %). Conclusion: The prevalence of NAFLD and liver fibrosis was 7.7% in individuals with T1D. Duration of T1D, markers of insulin resistance, glycemic control and inflammation are likely contributors to this high prevalence and more attention should be paid to this possible complication. Disclosure C. Fuhri Snethage: None. A.S. Meijnikman: None. P. de Groen: None. C. Callender: None. E. Rampanelli: None. C.B. Brouwer: None. D. van Raalte: Consultant; Boehringer Ingelheim and Eli Lilly Alliance, AstraZeneca, Merck &amp; Co., Inc. Research Support; Boehringer Ingelheim and Eli Lilly Alliance, AstraZeneca, Merck &amp; Co., Inc. M. Nieuwdorp: Advisory Panel; caelus health. N. Hanssen: Research Support; Novo Nordisk. Consultant; Novo Nordisk. Funding DNF DON Grant 2020 (2020.10.002)

1119-P: Improved Glycemic Control with Less Effort during Real-World MiniMed 780G Advanced Hybrid Closed-Loop (AHCL) System Use by Children with T1D

Objective: To evaluate real-world glycemic outcomes and insulin delivery based on TIR (70-180mg/dL) before and after MiniMed™ 780G system use by children with T1D. Methods: MiniMed™ 780G system data from 2,516 users aged ≤15 years (from Europe, the Middle East and Africa) who provided assent, were uploaded between Aug 2020 and Jun 2022. For users with ≥10 days of sensor glucose (SG) data, glycemic outcomes (e.g., SG, time in SG ranges and glucose management indicator [GMI]), insulin delivered, and use of the 100mg/dL* glucose target and 2hrs active insulin time (recommended settings) were summarized and stratified by baseline TIR quartiles. Results: After AHCL initiation, overall glycemic control (GMI) improved and TIR increased in all TIR quartiles, with increased system-initiated insulin (auto basal and auto correction) delivery and fewer user-initiated boluses (Figure). Greater recommended settings use was associated with a higher TIR (4th quartile) and less recommended settings use was associated with a lower TIR (1st quartile). Conclusion: Children with T1D using the MiniMed™ 780G system had improved glycemic control evidenced by increased TIR with less effort (i.e., fewer user-initiated boluses). Glycemic control was improved across the spectrum of users and use of recommended settings enhanced outcomes. Disclosure J.Mcvean: Employee; Medtronic. A.Arrieta: Employee; Medtronic. T.L.Cordero: Employee; Medtronic. J.Castañeda: Employee; Medtronic. O.Cohen: Employee; Medtronic.

663-P: Dynamic Real-Time Relationships among Glucose and Cognitive Performance in Diverse Adults with T1D

Introduction: Blood glucose (BG) regulation is linked to cognitive performance among people with diabetes. Most studies are cross-sectional and limited to adults with T2D. Pairing continuous glucose monitoring (CGM) with ambulatory cognitive tests, we examined real-time bidirectional associations between BG and cognition in everyday life among adults with T1D. Methods: Participants wore a blinded CGM for 10-14 days and completed ambulatory cognitive tests 5-6 times daily. Using dynamic structural equation modeling, we evaluated within-person bidirectional relationships between BG and cognition over sequential 3-hr periods. BG metrics included mean BG, time in range (TIR; 70-180 mg/dL), % time in low (50-69 mg/dL), high (181-250 mg/dL) and very high BG (&amp;gt;250 mg/dL), and coefficient of variation (CV). Cognitive variables included processing speed and sustained attention. Results: Among 182 adults with T1D (40±14 yrs, 46% male, 41% Latino, 29% White, 15% Black), greater mean BG (beta=0.03), lower TIR (beta=-0.03), and more time in high (beta=0.03) and very high BG (beta=0.03) predicted slower processing speed 3 hrs later (ps&amp;lt;.05); no BG metric predicted sustained attention ability. Surprisingly, slower processing speed predicted lower mean BG (beta=-0.05), more TIR (beta=0.04) and less time in high (beta=-0.01) and very high BG (beta=-0.04) over the next 3 hrs. Reduced sustained attention predicted more time in very high BG (beta=-0.01) and lower CV (beta=0.03) (ps&amp;lt;0.05). Conclusion: Our findings suggest that poorer BG regulation negatively influences processing speed over short time frames. Slower processing speed predicted subsequent improvements in CGM metrics, suggesting that individuals may take steps to correct BG when experiencing cognitive effects of poor BG regulation. These short-term relationships illuminate opportunities for in-the-moment interventions. Disclosure C.J.Hoogendoorn: None. D.Spruijt-metz: None. E.Pyatak: Research Support; Abbott Diabetes. J.S.Gonzalez: Consultant; Virta Health Corp. R.Hernandez: None. S.Schneider: None. A.L.Peters: Advisory Panel; Abbott Diabetes, Medscape, Novo Nordisk, Vertex Pharmaceuticals Incorporated, Zealand Pharma A/S, Research Support; Abbott Diabetes, Dexcom, Inc., Insulet Corporation, Stock/Shareholder; Omada Health, Inc., Livongo. J.P.Crandall: Research Support; Abbott. G.Crespo-ramos: None. H.Jin: None. L.T.Pham: None. S.Agarwal: Advisory Panel; Medtronic, Consultant; Beta Bionics, Inc., Research Support; Abbott Diabetes, Dexcom, Inc. Funding National Institutes of Health (R01DK121298, P30DK020541, P30DK111022)

Fear of hyperglycemia in parents of children with type 1 diabetes mellitus - a multi-center multi-national study.

Study aims: (1) developing and validating a novel questionnaire for measuring fear of hyperglycemia among parents of children with type 1 diabetes (T1D) - the Hyperglycemia Fear Survey - Parent version (FoHyper-P); (2) investigating correlations between parental fear of hyperglycemia and objective measures of glycemic control. A multi-center, multi-national study of 152 parents of children with T1D was conducted in three large diabetes clinics from Israel, Poland, and Greece. Inclusion criteria were parents of children aged 6-16 years, at least 6 months from diagnosis, at least 3 months of CGM use and parental involvement in care. Parents filled the FoHyper-P and the Hypoglycemia Fear Survey - Parent Version (HFS-P). Patient data were obtained via electronic medical records and informative questionnaires. Bonferroni correction was performed to counteract multiple comparisons. Significant strong-moderate correlations were found between FoHyper-P and HFS-P including total questionnaires scoring (r=0.747, PBonf. <0.001), worries subscales (r=0.735, PBonf <0.001), and behavior subscales (r=0.532, PBonf <0.001). Using linear regression models we found a positive association between the worry subscale and HbA1C. Weak correlations (P<0.05, not significant after Bonferroni correction) were found between time in range, time above range and parental fear of hyperglycemia as well as between worry subscales and a higher HbA1C in the past year, percent of hyperglycemia and lower TIR. The FoHyper-P is a novel, validated tool for assessing parental fear of hyperglycemia. Integrating it into clinical practice addresses an underestimated aspect of parental diabetes management, enabling better care for children with T1D.

The association between time in the glucose target range and abnormal ankle-brachial index: a cross-sectional analysis

BackgroundTime in range (TIR), a novel proxy measure of glucose control, is found closely related to diabetic microangiopathy and some other chronic complications, but the correlation between TIR and lower limb angiopathy has not been studied yet. Our purpose is to explore the relationship between TIR and abnormal ankle-brachial index(ABI) in type 2 diabetes.MethodsWe retrospectively collected patients’ information from the database and performed cross-sectional analysis. A total of 405 type 2 diabetes patients were enrolled in this study. ABI was measured and patients were stratified into low, normal, and high groups according to ≤ 0.9, > 0.9 and < 1.3, ≥ 1.3 ABI values. All patients underwent continuous glucose monitoring(CGM), and TIR was defined as the percentage of time in which glucose was in the range of 3.9–10 mmol/L during a 24-h period. Correlations between TIR and abnormal ABI were analyzed using Spearman analysis. And logistic regression was used to explore whether TIR is an independent risk factor for abnormal ABI.ResultsThe overall prevalence of abnormal ABI was 20.2% (low 4.9% and high 15.3%). TIR was lower in patients with abnormal ABI values (P = 0.009). The prevalence of abnormal ABI decreased with increasing quartiles of TIR (P = 0.026). Abnormal ABI was negatively correlated with TIR and positively correlated with hypertension, age, diabetes duration, UREA, Scr, ACR, TAR, MBG, and M values (P < 0.05). The logistic regression revealed a significant association between TIR and abnormal ABI, while HbA1C and blood glucose variability measures had no explicit correlation with abnormal ABI. Additionally, there was a significant difference in LDL between the low and high ABI groups (P = 0.009), and in Scr between normal and low groups (P = 0.007). And there were significant differences in TIR (P = 0.003), age (P = 0.023), UREA (P = 0.006), ACR (P = 0.004), TAR (P = 0.015), and MBG (P = 0.014) between normal and high ABI groups, and in diabetes duration between both normal and low (P = 0.023) and normal and high (P = 0.006) groups.ConclusionsIn type 2 diabetes patients, abnormal ABI is associated with lower TIR, and the correlation is stronger than that with HbA1C. Therefore, the role of TIR should be emphasized in the evaluation of lower limb vascular diseases.

Increased Glycemic Variability Evaluated by Continuous Glucose Monitoring is Associated with Osteoporosis in Type 2 Diabetic Patients

BackgroundSubjects with type 2 diabetes mellitus (T2DM) are susceptible to osteoporosis. This study was conducted to evaluate the association between glycemic variability evaluated by continuous glucose monitoring (CGM) and osteoporosis in type 2 diabetic patient.MethodsA total of 362 type 2 diabetic subjects who underwent bone mineral density (BMD) measurement and were monitored by a CGM system from Jan 2019 to May 2020 were enrolled in this cross-sectional study. Glycemic variability was calculated with the Easy GV software, including 24-hour mean blood glucose (24-h MBG), the standard deviation of 24-h MBG (SDBG), coefficient of variation (CV), mean amplitude of glycemic excursions (MAGE), and time in range between 3.9 and 10.0 mmol/L (TIR). Other potential influence factors for osteoporosis were also examined.ResultsBased on the T-scores of BMD measurement, there were 190 patients with normal bone mass, 132 patients with osteopenia and 40 patients with osteoporosis. T2DM patients with osteoporosis showed a higher 24-h MBG, SDBG, CV, and MAGE, but a lower TIR (all p < 0.05). Multivariate logistic regression analysis revealed that age, female gender, body mass index (BMI), low-density lipoprotein cholesterol (LDL-C), serum uric acid (SUA) and MAGE independently contribute to osteoporosis, and corresponding odds ratio [95% confidence interval (CI)] was 1.129 (1.072-1.190), 4.215 (1.613-11.012), 0.801 (0.712-0.901), 2.743 (1.385-5.431), 0.993 (0.988-0.999), and 1.380 (1.026-1.857), respectively. Further receiver operating characteristic analysis with Youden index indicated that the area under the curve and its 95% CI were 0.673 and 0.604-0.742, with the optimal cut-off value of MAGE predicting osteoporosis being 4.31 mmol/L.ConclusionIn addition to conventional influence factors including age, female gender, BMI, LDL-C and SUA, increased glycemic variability assessed by MAGE is associated with osteoporosis in type 2 diabetic patients.

Time in range, especially overnight time in range, is associated with sudomotor dysfunction in patients with type 1 diabetes

BackgroundTime in range (TIR) is advocated as key metric of glycemic control and is reported to be associated with microvascular complications of diabetes. Sudomotor dysfunction is among the earliest detectable diabetic peripheral neuropathy (DPN). We set about to research the relationship between TIR including overnight TIR and sudomotor function detected by SUDOSCAN with the intention of exploring the correlation of TIR including overnight TIR and early DPN in type 1 diabetes (T1D).Methods95 patients with T1D were enrolled. TIR including nocturnal TIR of 3.9–10.0 mmol/L was evaluated with CGM. SUDOSCAN measured feet electrochemical skin conductance (FESC) and sudomotor dysfunction was defined as average FESC < 60µS. Logistic regressions were applied to examine the independent association of TIR and overnight TIR with sudomotor function.ResultsThe overall prevalence of sudomotor dysfunction was 28.42%. Patients with sudomotor dysfunction had significantly lower TIR for the whole recorded phase and for nighttime. The sudomotor dysfunction prevalence progressively declined with the ascending tertiles of TIR and nocturnal TIR (P for trend < 0.05). Correlation analysis showed that the relationship between nocturnal TIR and FESC was stronger than that between TIR and FESC with correlation coefficients were respectively 0.362 and 0.356 (P < 0.001). Finally, logistic regression analysis indicated the independently negative relation between TIR and nocturnal TIR and sudomotor dysfunction (P < 0.05), and the correlation between nocturnal TIR and sudomotor dysfunction was more statistically significant.ConclusionsTIR is negatively correlated with sudomotor dysfunction in T1D independent of HbA1c. Furthermore, decreased nocturnal TIR is more closely related to the impaired function of sudomotor nerves in sweat glands.

Development and validation of a scale to measure diabetes burnout

IntroductionThe aim of this study is to establish reliability and validity of the Diabetes Burnout Scale (DBS) among adults with type 1 diabetes (T1D). MethodsWe used a multi-stage, mixed methods approach to developing the DBS. First, the research team identified twenty-eight candidate items through a review of the literature and 117 qualitative narratives from adults living with T1D. Next, items were revised based on the expert (n = 20) and individual with T1D (n = 10) feedback. The resulting 18-item DBS measure along with validated measures of diabetes distress, depressive symptoms, and questions related to diabetes outcomes (i.e., last reported hemoglobin A1c [HbA1c] and Time-in-Range [TiR]) were completed by 1099 adults with T1D across the U.S. The sample was randomly divided into two subsets (n1 = 561, n2 = 538) for exploratory and confirmatory factor analyses (EFA/CFA) to determine the underlying structure of the DBS. Regression analyses examined the relationships of the DBS with self-reported glycemic control and socio-demographic characteristics. ResultsBased on the EFA three factors are identified and the DBS demonstrated strong internal consistency with Cronbach alphas (≥0.80). The validation and confirmatory analysis for the structure of the DBS provided consistent results with EFA. Higher burnout (overall DBS) was positively associated with diabetes distress (b = 0.74; p < 0.01) and depressive symptoms (b = 0.61; p < 0.01). Overall DBS, however was the strongest predictor for poorer HbA1c (r2 = 0.19; p < 0.01) and lower TiR (r2 = 0.17; p < 0.01) compared to diabetes distress and depressive symptoms. ConclusionThe 12-item DBS is a reliable and valid scale to measure diabetes burnout in adults with diabetes. The results provide a weak to strong degree of association between the validated DBS scale, T1-DDS and PHQ-8. The DBS can contribute to advancement of diabetes science by measuring diabetes burnout and informing clinical interventions to improve psychosocial care in individuals with diabetes.

Maintaining Blood Glucose Levels in Range (70-150 mg/dL) is Difficult in COVID-19 Compared to Non-COVID-19 ICU Patients-A Retrospective Analysis.

Beta cell dysfunction is suggested in patients with COVID-19 infections. Poor glycemic control in ICU is associated with poor patient outcomes. This is a single center, retrospective analysis of 562 patients in an intensive care unit from 1 March to 30 April 2020. We review the time in range (70–150 mg/dL) spent by critically ill COVID-19 patients and non-COVID-19 patients, along with the daily insulin use. Ninety-three in the COVID-19 cohort and 469 in the non-COVID-19 cohort were compared for percentage of blood glucose TIR (70–150 mg/dL) and average daily insulin use. The COVID-19 cohort spent significantly less TIR (70–150 mg/dL) compared to the non-COVID-19 cohort (44.4% vs. 68.5%). Daily average insulin use in the COVID-19 cohort was higher (8.37 units versus 6.17 units). ICU COVID-19 patients spent less time in range (70–150 mg/dL) and required higher daily insulin dose. A higher requirement for ventilator and days on ventilator was associated with a lower TIR. Mortality was lower for COVID-19 patients who achieved a higher TIR.

539-P: Time in Glucose Target Range Indicates the Risk of DPN in Chinese Type 1 Diabetes Patients

Objective: Previous studies have indicated that in addition to poor glycemic control, glucose variability, obesity and hypertension may also have impacts on DPN in T2DM patients. Not much researches have been taken on T1DM patients. Our study aims to use the data derived from CGMs to assess the association between DPN and glucose variety as well as to find out the potential risk factors for DPN among T1DM patients. Methods: In this cross-sectional study, a total of 116 type 1 diabetes inpatients were recruited. Patients age range from 14 to 75 years old. All patients were screened for DPN and then divided into 2 groups, DPN and non-DPN group. A 3-day CGMs was conducted on each patient. Information regarding BMI, smoking and drinking habits, medical history were collected from the patients’ medical record book. Results: 1. Among the type 1 diabetes patients enrolled in our study, the average age is 47.8 years old, with a known diabetes duration of 9.56 years. 40 (34.48%) presented with DPN. The prevalence of DPN increased steadily with increasing duration of diabetes, from 12.1% in those diagnosed diabetes within 5 years to 53.7% in those have diabetes longer than 10 years. 2. Compared with the control group, DPN patients are older, have longer duration, higher BMI, waist circumstance, HbA1c, GA and lower TIR (p&amp;lt;0.05). The prevalence of hypertension, carotid artery plaque, current drinking and smoking were higher in DPN group (p &amp;lt; 0.05). Meanwhile, glucose variability, evaluated by SD and MAGE; insulin function are comparable between two groups(p&amp;lt;0.05) 3. Multivariate logistic regression analysis showed that TIR quartiles(Q1: &amp;gt;71%; Q2: 56-71%; Q3: 41-56%; Q4≤41%) (OR 2.18, CI 1.35-3.51, p =0.001) and duration (OR 1.17, CI 1.08-1.27, p &amp;lt;0.001)were significantly correlating with DPN. Discussion: In T1DM patients, glycemic variability is not a risk factor for DPN. TIR is a significantly independent risk factor for DPN. Components of the metabolic syndrome may also play an important role in the development of DPN. Disclosure W. Shen: None. F. Liu: None.

82-LB: Including Continuous Glucose Monitoring (CGM) to Provide Personalized Glycemic Profiles as Part of a Pilot Worksite Health Screening

Incorporating CGM into worksite health screenings may help employees gain insight into their glycemic patterns. This observational study piloted a voluntary health screening at a large employer that included 10 days of blinded Dexcom G6 CGM wear. At enrollment, HbA1c values and participants’ reports were used to assign diabetes status. Participants and their primary care providers received summaries of their CGM-based glucose profiles. A total of 207 participants (mean (sd) age = 50.7 (10), 84% female, 15% African American, 15% Hispanic, 56% obese) enrolled in the screening from April through August 2019, and 85% (175) wore the CGM for ≥4 days. HbA1c identified 7 and 24 participants with previously undiagnosed T2D and prediabetes, respectively. The final diabetes prevalence was 61 (35%) with T2D, 5 (3%) with T1D, 35 (20%) with prediabetes, and 74 (42%) with no diabetes. Among those with T2D, 27 (44%) met consensus-based goals for TIR. The Table shows CGM-based metrics from health screening participants compared to Shah’s (2019) normative sensor glucose data of people without diabetes. Those with prediabetes had higher mean glucose and lower TIR than the normative sample. Health screenings that include blinded CGM provide personalized feedback regarding glycemic patterns, even among people without known diabetes. Disclosure I.J. Klein: Consultant; Self; Dexcom, Inc. M. Crawford: Employee; Self; Dexcom, Inc. G.J. Norman: Employee; Self; Dexcom, Inc. K.C. Hames: Employee; Self; Dexcom, Inc. J.I. Justus: None. S. Treadwell: Employee; Self; Dexcom, Inc. T.M. Combee: None. S. Kinzler: Research Support; Self; Dexcom, Inc. J. Welsh: Employee; Self; CSL Behring. M. Johnson: Employee; Self; Dexcom, Inc.

P1372PRE-DIALYSIS HAEMOGLOBIN TARGET ATTAINMENT AND POST-DIALYSIS OUTCOMES IN PERSONS WITH RENAL ANAEMIA: A NATIONWIDE STUDY

Abstract Background and Aims Attaining the narrow hemoglobin range (10-12 g/dL) recommended by current ERBP renal anemia guidelines may be difficult, and whether this leads to better outcomes is not well known. This study aimed to identify patient and clinical factors associated with difficulties in maintaining hemoglobin target ranges in routine non-dialysis nephrologist care. We also evaluated whether adherence to ERBP hemoglobin recommendations during pre-dialysis care predicted early post-dialysis outcomes. Method Observational study from the Swedish Renal Registry including all patients with non-dialysis dependent CKD stages 3b-5 developing renal anemia or initiating treatment (iron, ESA or both) between 2012-2016. Through multinomial logistic regression with clustered variance, we identified clinical conditions associated to serum hemoglobin values outside the ERBP recommended range (&amp;lt;10 and &amp;gt;12 g/dL) throughout all recorded patient visits until death, dialysis or end of follow-up. For those who initiated dialysis, we calculated the proportion of patient-time in which hemoglobin was maintained within range (time in range [TIR]). We then explored associations between TIR and subsequent one-year risk of death or MACE (composite of death caused by CVD and non-fatal MI, stroke, heart failure) with Cox proportional hazards regression. Results A total 8106 patients with CKD 3b-5 developed incident anemia in Sweden during 2012-2016, contributing with 37422 nephrology visits during median 2 years of follow up. In multinomial logistic regression, being a man and having received iron or higher ESA doses was associated with hemoglobin values outside target range. Patients with CKD 3b and 4, ongoing transplant, history of CVD, or with higher serum calcium and albumin levels had higher odds of maintaining hemoglobin values above range. Conversely, recent bleeding or transfusions, nephrosclerosis, inflammation (CRP&amp;gt;5 mg/dl), and higher phosphate levels increased the odds of having hemoglobin values below range. A total 2435 patients initiated maintenance dialysis during the study period. Of those, 327 died and 701 developed MACE during the subsequent year. Their median TIR during their pre-dialysis period was 44% (IQR: 34-50). On a continuous scale (FIGURE), we observed worse outcomes for patients with poor guideline recommendation adherence (low percentage TIR), although the association was judged weak. On a categorical scale, patients that spent more than 40% of their pre-dialysis TIR had lower hazards of death (0.57, 95% CI 0.41-0.80) and MACE (0.67, 95% CI, 0.54-0.84) compared to those with &amp;lt;44% TIR. Conclusion This nationwide study reports that greater adherence to ERBP anemia guidelines during pre-dialysis care, using existing conventional therapeutic approaches, is associated with better post-dialysis outcomes. Whether active interaction by healthcare practitioners affected the observed relationship needs to be further explored.

Associations between A1C and Continuous Glucose Monitoring–Derived Glycemic Parameters

The percentage of continuous glucose monitoring (CGM)-derived sensor glucose (SG) values in the 70-180 mg/dL range (time in range [TIR]) is an important outcome for patients and their clinicians; however, consensus TIR goals are lacking. This study aimed to characterize associations between CGM-derived glycemic metrics and A1C in 4 clinical trials: DIAMOND Phase 1 (N=104), DIAMOND Phase 2 (N=69), REPLACE-BG (N=216), and HypoDE (N=141). Each study lasted ≥24 weeks, used current-generation CGM systems (Dexcom, Inc.), and included comparisons of central-lab end-of-study A1C to CGM data during the preceding 3 mo. Data from 530 adults with diabetes (455 type 1) were analyzed. The Figure shows mean SG (MSG), TIR, time &amp;lt;70, &amp;lt;54, and &amp;gt;250 mg/dL for individuals in 6 A1C bins. Higher A1C bins were associated with higher MSG and lower TIR; lower A1C bins were associated with lower MSG and higher TIR. For subjects with A1C &amp;lt;7.0%, median TIR was 72%, with 90% of subjects having TIR &amp;gt;57%. Median time with SG &amp;lt;54 mg/dL was &amp;lt;20 min/day for all A1C bins, but median time with SG &amp;gt;250 mg/dL increased from 0.6 h/day to 6.7 h/day across bins. For subjects with A1C ≥8.0%, median TIR was 44%, with 90% of the subjects having TIR &amp;lt;59%. In CGM users, low A1C values can be achieved with minimal additional exposure to very low SG values. The observed associations between TIR and A1C may help clinicians and patients establish appropriate TIR goals. Disclosure P. Calhoun: Employee; Self; Dexcom, Inc.. Stock/Shareholder; Self; Dexcom, Inc.T. Johnson: Employee; Self; Dexcom, Inc.J. Welsh: Employee; Self; Dexcom, Inc.. Stock/Shareholder; Self; Dexcom, Inc., Medtronic. T.C. Walker: Employee; Self; Dexcom, Inc.D.A. Price: Employee; Self; Dexcom, Inc..

The clinical evaluation of International Normalized Ratio variability and control in conventional oral anticoagulant administration by use of the variance growth rate

The time in target International Normalized Ratio (INR) range (TIR) is used to assess the control and intensity of oral anticoagulation, but it does not measure variation in the INR. The value of assessing INR variability by use of the variance growth rate (VGR) as a predictor of events was investigated in patients treated with warfarin. Three different methods of VGR determination (A, B1, and B2) together with the TIR were studied. MethodA measures both INR variability and control, but methodsB1 and B2 measure variability only. The VGR and TIR were determined over three time periods: overall follow-up to an event, and 6months and 3months before an event. Six hundred and sixty-one control patients were matched to 158 cases (bleeding, thromboembolism, or death). With all VGR methods, the risk of an event was greater in unstable patients at 6months before an event than in stable patients. MethodA demonstrated the greatest risk 3months before an event in the unstable VGR group as compared with the stable group (odds ratio3.3, 95% confidence interval1.9-5.7, P<0.005). The risk of an event was 1.9 times greater in patients with a low TIR (<39%) than in those with a high TIR (>80%) in the 3-month period (P=0.02). Risk of bleeding was significantly greater in the 3-month period in patients with unstable VGR, with the greatest risk found with method B2 (P<0.01). Patients with unstable anticoagulation have a significantly increased risk of 'clinical events' at 3 and 6months before an event. The VGR can be incorporated into computer-dosage programs, and may offer additional safety when oral anticoagulation is monitored.