Periodontitis and cardiovascular risk factors in subjects with and without type 1 diabetes: A cross sectional analysis.

AIMS: This cross-sectional analysis explored the relationships between periodontal disease (PD) and subclinical CVD in a cohort of patients with type 1 diabetes and non-diabetic controls. METHODS: Data were collected from adults enrolled in the Coronary Artery Calcification in Type 1 Diabetes (CACTI) study or enrolled through the Barbara Davis Center for Diabetes Adult Clinic. A clinical periodontal exam measured attachment loss and probing depth. Brachial artery distensibility (brachD), carotid intima-media thickness (cIMT), and pulse wave velocity (PWV) were assessed as measures of subclinical cardiovascular structure and function. RESULTS: 144 participants with T1D and 148 non-diabetics were enrolled. Compared to non-diabetic controls, T1D participants had a higher probing depth (2.6 mm vs. 2.5 mm; p = 0.04), higher attachment loss (2.7 mm vs. 2.4 mm; p < 0.01), lower brachD (mean 5.8 vs. 6.4 mmHg; p < 0.01), a higher cIMT (mean 0.68 vs. 0.64 mm; p < 0.01), and a higher PWV (mean 8.3 vs. 7.8 m/s; p < 0.01). There were no significant associations between PD and CVD metrics. CONCLUSIONS: Periodontal and cardiovascular health was worse in participants with T1D compared to non-diabetics. No significant associations between PD measures and CVD were identified.

Comparison of Graft Outcomes Reusing Original Intermediate-Term Cold Storage Solution for Entire Corneal Donor Storage Period With Exchanged Fresh Storage Solution After Donor Preparation in the Cornea Preservation Time Study.

PURPOSE: The purpose of this study was to evaluate outcomes of Descemet stripping automated endothelial keratoplasty comparing exchange with fresh intermediate-term cold storage solution after lenticule preparation versus reuse of the original solution in the Cornea Preservation Time Study. METHODS: In the Cornea Preservation Time Study, 508 donor corneas had lenticules prepared by the eye bank with fresh solution exchange (Fresh group) and 283 with reuse of the original solution (Original group). Storage time for all donors was ≤11 days. Graft success rates, central endothelial cell loss at 3 years, and frequency of positive donor rim cultures were compared between the 2 groups. RESULTS: The 3-year graft success rate (95% confidence interval) was 93.4% (90.7%-95.3%) in the Fresh group and 95.2% (91.8%-97.2%) in the Original group (adjusted hazard ratio for graft failure = 0.64, 95% confidence interval, 0.33-1.24, P = 0.19). The mean percentage endothelial cell loss was significantly greater in the Fresh group versus Original group (45% ± 22% vs. 38% ± 20%, respectively, P = 0.004). Cultures were positive in 4 (1.5%) of 267 donor rims (3 fungal and 1 bacterial) in the Fresh group and in 4 (2.5%) of 158 in the Original group ( P = 0.57). There were 2 postoperative infections in the Original group and none in the Fresh group. CONCLUSIONS: The use of the original intermediate-term cold storage solution did not reduce the 3-year graft success rate compared with exchanging with fresh solution after lenticule preparation for Descemet stripping automated endothelial keratoplasty, while the frequency of positive donor rim cultures did not significantly differ between groups.

Impact of Temporary Glycemic Target Use in the Hybrid and Advanced Hybrid Closed-Loop Systems.

The Medtronic advanced hybrid closed-loop (AHCL) and MiniMed™ 670G hybrid closed-loop (HCL) systems provide the option to temporarily increase the glucose target to 150 mg/dL (8.3 mmol/L). This analysis investigated the efficacy of the AHCL compared with that of the HCL after the use of this setting. Data from 60 participants in the Fuzzy Logic Automated Insulin Regulation (FLAIR) study were used to compare the AHCL and HCL systems after the use of the temporary target (TT), and during analogous periods where this setting was not used. Differences in time in range 70-180 mg/dL between the systems were similar after the use of the TT setting and during analogous non-TT periods (interaction P = 0.87). Similar trends were observed for mean glucose, percentage time >180 mg/dL, and percentage time >250 mg/dL. Differences between AHCL and HCL systems were similar after the use of the TT setting compared with those of non-TT periods. ClinicalTrials.gov NCT03040414.

A Comparison of Postprandial Glucose Control in the Medtronic Advanced Hybrid Closed-Loop System Versus 670G.

Background: We recently reported that use of an "advanced" hybrid closed-loop system reduced hyperglycemia without increasing hypoglycemia compared to a first-generation system. The aim of this analysis was to evaluate whether this improved performance was specifically related to better mealtime glycemic control. Methods: We conducted a secondary analysis of postprandial glycemic control in an open-label, multinational, randomized crossover trial of 112 participants with type 1 diabetes, aged 14-29, of the Medtronic MiniMed™ 670G hybrid closed-loop system (670G) versus the Medtronic advanced hybrid closed-loop (AHCL) system, for 12 weeks each. We compared glycemic and insulin delivery metrics over a 3 h horizon across all meals to assess system performance and outcomes. Results: Overall meal size and premeal insulin on board were similar during run-in and between 670G and AHCL arms. Compared with 670G arm, premeal, peak, and mean glucose levels were numerically lower in the AHCL arm (167 ± 23, 231 ± 23, and 177 ± 20 mg/dL vs. 175 ± 23, 235 ± 23, and 180 ± 19 mg/dL, respectively), with a trend to lower hyperglycemia level 2 in AHCL arm. Adjusting for premeal glucose level, all postmeal outcomes between 670G and AHCL were statistically similar. Prandial insulin delivery also was similar in both treatment arms (21 ± 9 vs. 23 ± 10 U), with a shift in basal/bolus ratio from 28%/71% in 670G arm to 20%/80% in AHCL arm. Conclusions: Reduced hyperglycemia with AHCL compared to 670G was not related to early postprandial glycemic excursions after adjusting for premeal glucose level (<3 h after meal), but likely to later (>3 h) postprandial or overnight improvements. Further refinements to mealtime bolus algorithms and strategies may more optimally control prandial glycemic excursions.

Discontinued Use of the Loop Insulin Dosing System: A Mixed-Methods Investigation.

Background: Loop is an open-source automated insulin dosing system that allows users unrivaled control over system settings that affect future glucose prediction. Thousands use Loop, but little is known about those who discontinue. Methods: In a large observational study, 874 Loop participants completed surveys and provided glycemic data, 46 (5.3%) of those self-identified as discontinuing Loop use during the observation window, 45 completed a discontinued use survey, 22 provided system settings data, and 19 participated in semistructured interviews about their discontinuation. Qualitative data were transcribed, coded, and analyzed. Results: Older age and not trusting Loop were associated with discontinued use, although no other demographic or clinical characteristics were significant correlates. The most endorsed reasons were "I decided to try something else" (27.8%) followed by "It just didn't help as much as I thought it would" (22.2%). Qualitative analyses revealed prominent themes centered upon mental and emotional burden and adjusting settings. Other reasons for discontinued use included fear of disapproval of Loop use from diabetes provider, barriers to acquiring component devices, a desire to try new/different technologies, concerns that Loop could not accommodate specific exercise or low insulin dose regimens, and worry about Loop use during pregnancy. It was noted that burdens might be alleviated by enhanced technical assistance and expert guidance. Conclusions: Although the majority of individuals in the Loop observational study continued use, those who discontinued reported similar challenges. Technical support and education specific to setting calculations could expand Loop benefits, alleviate burden, and support sustained use among new Loop users. Clinical Trial Registration: clinicaltrials.gov (NCT03838900).

Lived Experience of Advanced Hybrid Closed-Loop Versus Hybrid Closed-Loop: Patient-Reported Outcomes and Perspectives.

This article reports on the lived experience of Medtronic advanced hybrid closed-loop (AHCL) in comparison to first generation hybrid closed-loop (HCL) in a randomized, open-label, two-period crossover trial. Patient-reported outcome (PROs) measures were administered before randomization and at the end of each study period in 113 adolescents and young adults with type 1 diabetes. Glucose monitoring satisfaction subscales for emotional burden and behavioral burden improved significantly (P < 0.01) over time with use of AHCL versus HCL and co-occurred with glycemic improvements (reduced percent time above 180 mg/dL during the day and no change in % time less than 54 mg/dL across 24 h) and greater time in Auto Mode. PROs, including distress, technology attitudes, and hypoglycemia confidence, were not different. AHCL use was associated with improved glucose monitoring satisfaction. Satisfaction was greater in those participants who had more appreciable glycemic benefit and stayed in Auto Mode more often. Clinical Trial Registration number: NCT03040414.

Improvement in A1c Levels in Early Adulthood in the T1D Exchange: Impact of Racial, Socioeconomic, and Clinical Factors.

CONTEXT: Glycemic control in adolescents with type 1 diabetes is poor; yet, it typically improves during early adulthood. Factors related to improvement of glycemic control are unclear. OBJECTIVE: This work examines how demographic and clinical variables may affect trajectories of glycemic control over time. METHODS: This retrospective, observational study comprised 1775 participants ages 18 to 30 years at enrollment in the T1D Exchange clinic registry. Latent class trajectory modeling was used to determine subgroups following a similar glycated hemoglobin A1c (HbA1c) trajectory over time. RESULTS: Five distinct trajectories of HbA1c classes were identified: "low-decline" and "moderate-decline" groups had low or moderate HbA1c with a gradual decline, the "high-stable" group had high HbA1c and remained stable, and the "very high-rapid decline" and "very high-slow decline" groups had very high HbA1c with rapid or gradual decline. Compared with the "high-stable" group, the "low-decline" and "moderate-decline" groups were more likely to be male (P = .009), White non-Hispanic (P = .02), nonsmokers (P < .001), check self-monitoring blood glucose (SMBG) more frequently (P < .001), and have higher education (P < .001), lower body mass index (P = .02), and lower daily insulin dose (P < .001). Compared with the "very high-rapid decline" and "very high-slow decline" groups, the "low-decline" and "moderate-decline" groups were more likely to be male (P = .02), have higher education (P < .001), use insulin pumps (P = .01), be nonsmokers (P < .001), and have a higher number of SMBG checks per day at enrollment (P < .001). CONCLUSION: We determined 5 distinct patterns of glycemic control from early adulthood into adulthood. Further evaluation into the modifiable factors associated with a declining HbA1c trajectory would aid in the development of targeted interventions.

A comparison of two hybrid closed-loop systems in adolescents and young adults with type 1 diabetes (FLAIR): a multicentre, randomised, crossover trial.

BACKGROUND: Management of type 1 diabetes is challenging. We compared outcomes using a commercially available hybrid closed-loop system versus a new investigational system with features potentially useful for adolescents and young adults with type 1 diabetes. METHODS: In this multinational, randomised, crossover trial (Fuzzy Logic Automated Insulin Regulation [FLAIR]), individuals aged 14-29 years old, with a clinical diagnosis of type 1 diabetes with a duration of at least 1 year, using either an insulin pump or multiple daily insulin injections, and glycated haemoglobin (HbA1c) levels of 7·0-11·0% (53-97 mmol/mol) were recruited from seven academic-based endocrinology practices, four in the USA, and one each in Germany, Israel, and Slovenia. After a run-in period to teach participants how to use the study pump and continuous glucose monitor, participants were randomly assigned (1:1) using a computer-generated sequence, with a permuted block design (block sizes of two and four), stratified by baseline HbA1c and use of a personal MiniMed 670G system (Medtronic) at enrolment, to either use of a MiniMed 670G hybrid closed-loop system (670G) or the investigational advanced hybrid closed-loop system (Medtronic) for the first 12-week period, and then participants were crossed over with no washout period, to the other group for use for another 12 weeks. Masking was not possible due to the nature of the systems used. The coprimary outcomes, measured with continuous glucose monitoring, were proportion of time that glucose levels were above 180 mg/dL (>10·0 mmol/L) during 0600 h to 2359 h (ie, daytime), tested for superiority, and proportion of time that glucose levels were below 54 mg/dL (<3·0 mmol/L) calculated over a full 24-h period, tested for non-inferiority (non-inferiority margin 2%). Analysis was by intention to treat. Safety was assessed in all participants randomly assigned to treatment. This trial is registered with ClinicalTrials.gov, NCT03040414, and is now complete. FINDINGS: Between June 3 and Aug 22, 2019, 113 individuals were enrolled into the trial. Mean age was 19 years (SD 4) and 70 (62%) of 113 participants were female. Mean proportion of time with daytime glucose levels above 180 mg/dL (>10·0 mmol/L) was 42% (SD 13) at baseline, 37% (9) during use of the 670G system, and 34% (9) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -3·00% [95% CI -3·97 to -2·04]; p<0·0001). Mean 24-h proportion of time with glucose levels below 54 mg/dL (<3·0 mmol/L) was 0·46% (SD 0·42) at baseline, 0·50% (0·35) during use of the 670G system, and 0·46% (0·33) during use of the advanced hybrid closed-loop system (mean difference [advanced hybrid closed-loop system minus 670G system] -0·06% [95% CI -0·11 to -0·02]; p<0·0001 for non-inferiority). One severe hypoglycaemic event occurred in the advanced hybrid closed-loop system group, determined to be unrelated to study treatment, and none occurred in the 670G group. INTERPRETATION: Hyperglycaemia was reduced without increasing hypoglycaemia in adolescents and young adults with type 1 diabetes using the investigational advanced hybrid closed-loop system compared with the commercially available MiniMed 670G system. Testing an advanced hybrid closed-loop system in populations that are underserved due to socioeconomic factors and testing during pregnancy and in individuals with impaired awareness of hypoglycaemia would advance the effective use of this technology FUNDING: National Institute of Diabetes and Digestive and Kidney Diseases.

A Real-World Prospective Study of the Safety and Effectiveness of the Loop Open Source Automated Insulin Delivery System.

Objective: To evaluate the safety and effectiveness of the Loop Do-It-Yourself automated insulin delivery system. Research Design and Methods: A prospective real-world observational study was conducted, which included 558 adults and children (age range 1-71 years, mean HbA1c 6.8% ± 1.0%) who initiated Loop either on their own or with community-developed resources and provided data for 6 months. Results: Mean time-in-range 70-180 mg/dL (TIR) increased from 67% ± 16% at baseline (before starting Loop) to 73% ± 13% during the 6 months (mean change from baseline 6.6%, 95% confidence interval [CI] 5.9%-7.4%; P < 0.001). TIR increased in both adults and children, across the full range of baseline HbA1c, and in participants with both high- and moderate-income levels. Median time <54 mg/dL was 0.40% at baseline and changed by -0.05% (95% CI -0.09% to -0.03%, P < 0.001). Mean HbA1c was 6.8% ± 1.0% at baseline and decreased to 6.5% ± 0.8% after 6 months (mean difference = -0.33%, 95% CI -0.40% to -0.26%, P < 0.001). The incidence rate of reported severe hypoglycemia events was 18.7 per 100 person-years, a reduction from the incidence rate of 181 per 100 person-years during the 3 months before the study. Among the 481 users providing Loop data at 6 months, median continuous glucose monitoring use was 96% (interquartile range [IQR] 91%-98%) and median time Loop modulating basal insulin was at least 83% (IQR 73%-88%). Conclusions: The Loop open source system can be initiated with community-developed resources and used safely and effectively by adults and children with type 1 diabetes.

Attitudes of U.S. Hispanic and non-Hispanic women toward congenital CMV prevention behaviors: a cross sectional study.

BACKGROUND: Congenital cytomegalovirus (CMV) infection is the most common intrauterine infection. The only way to protect against congenital CMV infection is to practice CMV prevention behaviors. CMV seroprevalence rates are high in Hispanic women. It is unknown whether communication strategies should differ by ethnicity. The purpose of this study was to understand differences between U.S. Hispanic and non-Hispanic women's attitudes toward CMV prevention behaviors and examine the relationship between perceived subjective norms and these attitudes. METHODS: This was a cross-sectional study using an online panel. Participants were U.S. women of childbearing age. The dependent variable was attitude toward practicing CMV prevention behaviors, specifically avoiding sharing cups, food, and utensils with a child and not kissing a child on the lips. RESULTS: Among 818 women (50% Hispanic), 16.8% of Hispanic women and 9.7% of non-Hispanic women (p = 0.002) reported familiarity with CMV. Attitudes toward CMV prevention through avoiding sharing behaviors (M Hispanic = 5.55 vs. M non-Hispanic  = 5.20; p = 0.002) and not kissing a child on the lips (M Hispanic = 4.80 vs. M non-Hispanic = 4.21; p = 0.001) were positive for both ethnicities, but higher for Hispanic women. Hispanic women (M = 5.11) reported higher perceived behavioral control for avoiding kissing a child on the lips than non-Hispanic women (M = 4.63; p = 0.001). Hispanic women who were U.S. born or spoke English primarily more frequently kissed a child on the lips or engaged in sharing behaviors. Additionally, those who spoke Spanish mostly held more positive attitudes toward not kissing on the lips. Significant predictors for more positive attitudes toward CMV prevention behaviors were associated with perceived subjective norms, perceived behavioral control and pre-survey participation in risk behaviors. CONCLUSIONS: Hispanic women have more positive attitudes toward CMV prevention behaviors than non-Hispanic women, however in regression models other factors are more important predictors of positive attitudes than ethnicity. In developing strategies to encourage women to practice CMV prevention behaviors, a focus on further understanding and increasing subjective norms and perceived control over those behaviors may be warranted.