Lower estimated insulin sensitivity was associated with risk for hyperfiltration over time, whereas increased albumin excretion was associated with hyperglycemia in youth-onset T2DM.

Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets. RESEARCH DESIGN AND METHODSThis single-arm, multicenter, prospective study enrolled 112 children (age 6-13.9 years) and 129 adults (age 14-70 years). A 2-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA 1c and percent time in sensor glucose range 70-180 mg/dL ("time in range"). RESULTSA total of 235 participants (98% of enrolled, including 111 children and 124 adults) completed the study. HbA 1c was significantly reduced in children by 0.71% (7.8 mmol/mol) (mean ± SD: 7.67 ± 0.95% to 6.99 ± 0.63% [60 ± 10.4 mmol/mol to 53 ± 6.9 mmol/mol], P < 0.0001) and in adults by 0.38% (4.2 mmol/mol) (7.16 ± 0.86% to 6.78 ± 0.68% [55 ± 9.4 mmol/mol to 51 ± 7.4 mmol/mol], P < 0.0001). Time in range was improved from standard therapy by 15.6 ± 11.5% or 3.7 h/day in children and 9.3 ± 11.8% or 2.2 h/day in adults (both P < 0.0001). This was accomplished with a reduction in time in hypoglycemia <70 mg/dL among adults (median [interquartile range]: 2.00% [0.63, 4.06] to 1.09% [0.46, 1.75], P < 0.0001), while this parameter remained the same in children. There were three severe hypoglycemia events not attributable to automated insulin delivery malfunction and one diabetic ketoacidosis event from an infusion site failure. CONCLUSIONSThis tubeless automated insulin delivery system was safe and allowed participants to significantly improve HbA 1c levels and time in target glucose range with a very low occurrence of hypoglycemia.

<b>Objective:</b> Advances in diabetes technology have transformed the treatment paradigm for type 1 diabetes, yet the burden of disease is significant. We report on a pivotal, safety study of the first tubeless, on-body automated insulin delivery system with customizable glycemic targets. <p><b>Research Design and Methods: </b>This single-arm, multicenter, prospective study enrolled 112 children (6-13.9 years) and 129 adults (14-70 years). A two-week standard therapy phase (usual insulin regimen) was followed by 3 months of automated insulin delivery. Primary safety outcomes were incidence of severe hypoglycemia and diabetic ketoacidosis. Primary effectiveness outcomes were change in HbA1c and percent time in sensor glucose range 70-180mg/dL. </p> <p><b>Results: </b>235 participants (98% of enrolled: 111 children, 124 adults) completed the study. HbA1c was significantly reduced in children by 0.71% (7.8mmol/mol) (mean±standard deviation: 7.67±0.95% to 6.99±0.63%, 60±10.4mmol/mol to 53±6.9mmol/mol, <i>p</i><0.0001) and in adults by 0.38% (4.2mmol/mol) (7.16±0.86% to 6.78±0.68%, 55±9.4mmol/mol to 51±7.4mmol/mol, <i>p</i><0.0001). Time in range was improved from standard therapy by 15.6±11.5% or 3.7 hours/day in children and 9.3±11.8% or 2.2 hours/day in adults (both <i>p</i><0.0001). This was accomplished with a reduction in time in hypoglycemia <70mg/dL among adults (median (interquartile range): 2.00% (0.63, 4.06) to 1.09% (0.46, 1.75), <i>p</i><0.0001), while this parameter remained the same in children. There were 3 severe hypoglycemia events not attributable to automated insulin delivery malfunction and 1 diabetic ketoacidosis event from an infusion site failure.<a></a><a></a></p> <p><b>Conclusions: </b>This tubeless automated insulin delivery system was safe, and allowed participants to significantly improve HbA1c levels and time in target glucose range with a very low occurrence of hypoglycemia.<br> </p>

To evaluate the contemporary prevalence of diabetic peripheral neuropathy (DPN) in participants with type 1 diabetes in the T1D Exchange Clinic Registry throughout the U.S. RESEARCH DESIGN AND METHODSDPN was assessed with the Michigan Neuropathy Screening Instrument Questionnaire (MNSIQ) in adults with ‡5 years of type 1 diabetes duration. A score of ‡4 defined DPN. Associations of demographic, clinical, and laboratory factors with DPN were assessed. RESULTSAmong 5,936 T1D Exchange participants (mean 6 SD age 39 6 18 years, median type 1 diabetes duration 18 years [interquartile range 11, 31], 55% female, 88% non-Hispanic white, mean glycated hemoglobin [HbA 1c ] 8.1 6 1.6% [65.3 6 17.5 mmol/mol]), DPN prevalence was 11%. Compared with those without DPN, DPN participants were older, had higher HbA 1c , had longer duration of diabetes, were more likely to be female, and were less likely to have a college education and private insurance (all P < 0.001). DPN participants also were more likely to have cardiovascular disease (CVD) (P < 0.001), worse CVD risk factors of smoking (P 5 0.008), hypertriglyceridemia (P 5 0.002), higher BMI (P 5 0.009), retinopathy (P 5 0.004), reduced estimated glomerular filtration rate (P 5 0.02), and Charcot neuroarthropathy (P 5 0.002). There were no differences in insulin pump or continuous glucose monitor use, although DPN participants were more likely to have had severe hypoglycemia (P 5 0.04) and/or diabetic ketoacidosis (P < 0.001) in the past 3 months. CONCLUSIONSThe prevalence of DPN in this national cohort with type 1 diabetes is lower than in prior published reports but is reflective of current clinical care practices. These data also highlight that nonglycemic risk factors, such as CVD risk factors, severe hypoglycemia, diabetic ketoacidosis, and lower socioeconomic status, may also play a role in DPN development.Diabetic neuropathy is a prevalent complication in patients with diabetes and a major cause of morbidity and mortality (1). Among the various forms of diabetic neuropathy, distal symmetric polyneuropathy (DPN) and diabetic autonomic neuropathies are by far the most studied (1).

Repeat Fundus Exam (N=367) Sex (% Female) 452 (64.6%) 236 (64.3%) Race/ Ethnicity Hispanic 278 (39.7%) 146 (39.7%) Non-Hispanic Black 227 (32.5%) 126 (34.3%) Non-Hispanic White 143 (20.5%) 71 (19.3%) Other 51 (7.3%) 24 (6.5%) Age at baseline (years) 14.0 (± 2.0) 13.7 (± 2.0) Diabetes Duration (years) 4.9 (± 1.5) 4.9 (± 1.5) Mean BMI (kg/m 2 ) 34.9 (± 7.6) 34.7 (± 7.8) Mean HbA1c (%) 6.0 (± 0.7) 6.0 (± 0.8) Blood Pressure Mean Systolic BP (mm Hg) 113.2 (± 10.9) 112.6 (± 10.7) Mean Diastolic BP (mm Hg) 66.7 (± 8.2) 66.6 (± 8.1) Cholesterol Mean LDL (mg/dL) 85 (± 24.8) 84 (± 24.2) Mean HDL (mg/dL) 38.7 (± 8.6) 38.7 (± 8.8) Mean Triglycerides (mg/dL) 93.5 [27/0, 823.0] 89 [30.0, 623.0] Mean Fasting C-Peptide (ng/mL) 3.6 [0.9, 11.1] 3.5 [0.9, 9.6] Mean Fasting Glucose (mg/dL) 103.0 [70.0, 269.0] 103 [70.0, 210.0] Comorbidities (%) Hypertension 132 (18.8%) 69 (18.8%) ACR ≥30mg/g 54 (7.7%) 28 (7.6%) ACR ≥300mg/g 10 (1.4%) 7 (1.9%) Medications (%) History of any hypertensive medication 32 (4.6%) 22 (6.0%) History of any lipid lowering medication 6 (0.8%) 5 (1.4%) Ever Smoked (%) 27 (3.8%) 9 (2.5%) Data are mean (± std), median [IQR], or n (%).