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Purpose of Review: While preliminary evidence for use of real-time continuous glucose monitoring (rtCGM) in the hospital setting is encouraging, challenges with currently available devices and technology will need to be overcome as part of real-world integration. This paper reviews the current evidence and guidelines regarding use of rtCGM in the hospital and suggests a practical approach to implementation. Recent Findings: There is now a considerable body of real-world evidence on the benefits of reducing dysglycemia in the hospital using both traditional point-of-care (POC) glucose testing and rtCGM. Benefits of rtCGM include decreased frequency of hypo- and hyperglycemia with reduced need of frequent POC checks and it is both feasible and well-accepted by nursing staff and providers. Summary: If expansion to additional sites is to be considered, practical solutions will need to be offered. Recommendations for an operational workflow and tools are described to guide implementation in the non-ICU setting. Further testing in randomized controlled trials and real-world dissemination and implementation designs is needed, together with industry and technology collaborations, to further streamline the integration into health systems. [ABSTRACT FROM AUTHOR]

Aims: Insulin efsitora alfa (efsitora) is a once‐weekly basal insulin. This review describes the study design and rationale of the efsitora phase 3 Once Weekly (QW) Insulin Therapy (QWINT) clinical development programme, including the five trials, QWINT‐1 through QWINT‐5. Materials and Methods: The five trials included insulin‐naïve adults (QWINT‐1 and ‐2) with type 2 diabetes (T2D), adults with T2D previously treated with basal insulin (QWINT‐3 and ‐4), and QWINT‐5 in adults with type 1 diabetes. All five trials were designed as multicentre, randomized, controlled, open‐label, treat‐to‐target studies to investigate the efficacy and safety of efsitora versus active once‐daily basal insulin comparators (insulin glargine U100 or insulin degludec U100). The primary objective of each trial is to compare the change in HbA1c from baseline to week 26 or 52 between efsitora and the active comparator. The key secondary objectives include change in fasting glucose, insulin dose and continuous glucose monitoring variables, and patient‐reported outcome questionnaires. Conclusions: The QWINT development programme includes a racially and geographically diverse population to provide important information regarding the efficacy and safety of efsitora and its clinical management of people with diabetes. [ABSTRACT FROM AUTHOR]

OBJECTIVE This cluster (clinic-level) randomized controlled trial (RCT) compared medical assistant (MA) health coaching (MAC) with usual care (UC) among at-risk adults with type 2 diabetes in two diverse real-world primary care environments: a federally qualified health center (FQHC; Neighborhood Healthcare) and a large nonprofit private insurance--based health system (Scripps Health). RESEARCH DESIGN AND METHODS A total of 600 adults with type 2 diabetes who met one or more of the following criteria in the last 90 days were enrolled: HbA1c ≥8% and/or LDL cholesterol ≥100 mg/dL and/or systolic blood pressure (SBP) ≥140 mmHg. Participants at MAC clinics received in-person and telephone self-management support from a specially trained MA health coach for 12 months. Electronic medical records were used to examine clinical outcomes in the overall sample. Behavioral and psychosocial outcomes were evaluated in a subsample (n = 300). RESULTS All clinical outcomes improved significantly over 1 year in the overall sample (P < 0.001). The reduction in HbA1c was significantly greater in the MAC versus UC group (unstandardized Binteraction = -0.06; P = 0.002). A significant time by group by site interaction also showed that MAC resulted in greater improvements in LDL cholesterol than UC at Neighborhood Healthcare relative to Scripps Health (Binteraction = -1.78 vs. 1.49; P < 0.05). No other statistically significant effects were observed. CONCLUSIONS This was the first large-scale pragmatic RCT supporting the real-world effectiveness of MAC for type 2 diabetes in U.S. primary care settings. Findings suggest that this team-based approach may be particularly effective in improving diabetes outcomes in FQHC settings. [ABSTRACT FROM AUTHOR]

OBJECTIVE: This post hoc analysis assessed continuous glucose monitoring (CGM)–based metrics and hypoglycemia duration with once-weekly insulin icodec versus once-daily basal insulin analogs in insulin-experienced individuals with long-standing type 2 diabetes from two 26-week phase 3a trials (ONWARDS 2 and ONWARDS 4). RESEARCH DESIGN AND METHODS: Time in range (TIR) (3.9–10.0 mmol/L), time above range (TAR) (>10.0 mmol/L), and time below range (TBR) (<3.9 mmol/L and <3.0 mmol/L) were assessed during three CGM time periods (switch [weeks 0–4], end of treatment [weeks 22–26], and follow-up [weeks 27–31]) for icodec versus comparators (ONWARDS 2, insulin degludec [basal regimen]; ONWARDS 4, insulin glargine U100 [basal-bolus regimen]) using double-blind CGM data. CGM-derived hypoglycemic episode duration (<3.9 mmol/L) was assessed. RESULTS: In both trials, there were no statistically significant differences in TIR, TAR, or TBR (<3.0 mmol/L) for icodec versus comparators across all time periods. In the end-of-treatment period, mean TIR was 63.1% (icodec) vs. 59.5% (degludec) in ONWARDS 2 and 66.9% (icodec) vs. 66.4% (glargine U100) in ONWARDS 4. Mean TBR <3.9 mmol/L and <3.0 mmol/L remained within recommended targets (<4% and <1%, respectively) across time periods and treatment arms. Hypoglycemic episode duration (<3.9 mmol/L) was comparable across time periods and treatment arms (median duration ≤40 min). CONCLUSIONS: In insulin-experienced participants with long-standing type 2 diabetes, CGM-based TIR, TAR, and CGM-derived hypoglycemia duration (<3.9 mmol/L) were comparable for icodec and once-daily basal insulin analogs during all time periods. TBR remained within recommended targets. [ABSTRACT FROM AUTHOR]

Type 2 diabetes disproportionately impacts ethnic minorities and individuals from low socioeconomic status. Diabetes self-management education and support has been shown to improve clinical outcomes in these populations, and mobile health (mHealth) interventions can reduce barriers to access. Dulce Digital-Me (DD-Me) was developed to integrate adaptive mHealth technologies to enhance self-management and reduce disparities in the high-risk, underserved Hispanic population. The objective of the present study was to evaluate reach, adoption, and implementation of an mHealth diabetes self-management education and support intervention in this underrepresented population. The present analysis is a multimethod process evaluation using the Reach , Effectiveness, Adoption , Implementation, and Maintenance (RE-AIM) framework. The study was effective in reaching a sample that was representative of the intended population; only modest but significant differences were observed in sex and age. The DD-Me health coach (HC) cited several important facilitators of intervention adoption , including outreach frequency and personalization, and the automated HC report. Implementation fidelity was high, with participants receiving >90% of intended interventions. Participants who received DD-Me with support from a HC were most engaged, suggesting utility and acceptability of integrating HCs with mHealth interventions. Perceptions of implementation among study participants were positive and consistent across study arms. This evaluation revealed the target population was successfully reached and engaged in the digital health interventions, which was implemented with high fidelity. Further studies should evaluate the efficacy and maintenance of the study following the RE-AIM model to determine whether this intervention warrants expansion to additional settings and populations. [ABSTRACT FROM AUTHOR]

Background: Multimorbidity frequently co-occurs with behavioral health concerns and leads to increased healthcare costs and reduced quality and quantity of life. Unplanned readmissions are a primary driver of high healthcare costs. Objective: We tested the effectiveness of a culturally appropriate care transitions program for Latino adults with multiple cardiometabolic conditions and behavioral health concerns in reducing hospital utilization and improving patient-reported outcomes. Design: Randomized, controlled, single-blind parallel-groups. Participants: Hispanic/Latino adults (N=536; 75% of those screened and eligible; M=62.3 years (SD=13.9); 48% women; 73% born in Mexico) with multiple chronic cardiometabolic conditions and at least one behavioral health concern (e.g., depression symptoms, alcohol misuse) hospitalized at a hospital that serves a large, mostly Hispanic/Latino, low-income population. Interventions: Usual care (UC) involved best-practice discharge processes (e.g., discharge instructions, assistance with appointments). Mi Puente ("My Bridge"; MP) was a culturally appropriate program of UC plus inpatient and telephone encounters with a behavioral health nurse and community mentor team who addressed participants' social, medical, and behavioral health needs. Main Measures: The primary outcome was 30- and 180-day readmissions (inpatient, emergency, and observation visits). Patient-reported outcomes (quality of life, patient activation) and healthcare use were also examined. Key Results: In intention-to-treat models, the MP group evidenced a higher rate of recurrent hospitalization (15.9%) versus UC (9.4%) (OR=1.91 (95% CI 1.09, 3.33)), and a greater number of recurrent hospitalizations (M=0.20 (SD=0.49) MP versus 0.12 (SD=0.45) UC; P=0.02) at 30 days. Similar trends were observed at 180 days. Both groups showed improved patient-reported outcomes, with no advantage in the Mi Puente group. Results were similar in per protocol analyses. Conclusions: In this at-risk population, the MP group experienced increased hospital utilization and did not demonstrate an advantage in improved patient-reported outcomes, relative to UC. Possible reasons for these unexpected findings are discussed. Trial Registration: ClinicalTrials.gov Identifier: NCT02723019. Registered on 30 March 2016. [ABSTRACT FROM AUTHOR]

Aim: To describe the phase 3a ONWARDS clinical development programme investigating insulin icodec (icodec), a once‐weekly basal insulin, including the design and rationale for each of the ONWARDS 1–6 trials. Materials and Methods: Six randomized controlled trials have been initiated in adults with type 2 diabetes (T2D) (insulin‐naive: ONWARDS 1, 3 and 5; previously insulin‐treated: ONWARDS 2 and 4) and type 1 diabetes (T1D) (ONWARDS 6). Each trial will investigate icodec use in a unique clinical scenario, with consideration of long‐term safety and varied comparator treatments (insulin glargine U100 or U300 or insulin degludec). ONWARDS 5 will incorporate real‐world elements and a digital dose titration solution to guide icodec dosing. The primary objective for each of the trials is to compare the change in HbA1c from baseline to week 26 or week 52 between icodec and comparator arms. Secondary objectives include investigating other glycaemic control and safety parameters, such as fasting glucose, time in glycaemic range and hypoglycaemia. Patient‐reported outcomes will assess treatment satisfaction. Conclusions: The ONWARDS 1–6 trials will evaluate the efficacy and safety of once‐weekly icodec compared with currently available daily basal insulin analogues in T2D and T1D. These trials will generate comprehensive evidence of icodec use in diverse populations across the spectrum of diabetes progression and treatment experience. [ABSTRACT FROM AUTHOR]

Keywords: insulin analogues; insulin therapy; type 2 diabetes EN insulin analogues insulin therapy type 2 diabetes 332 336 5 01/11/22 20220201 NES 220201 PEER REVIEW The peer review history for this article is available at https://publons.com/publon/10.1111/dom.14564. Risk of hypoglycaemia with insulin degludec versus insulin glargine U300 in insulin-treated patients with type 2 diabetes: the randomised, head-to-head CONCLUDE trial. HbA1c levels and rates of hypoglycemia with insulin degludec U200 and insulin glargine U300 stratified by estimated renal function in people with type 2 diabetes: a post hoc analysis from the CONCLUDE trial. [Extracted from the article]

Team-based models that use medical assistants (MAs) to provide self-management support for adults with type 2 diabetes (T2D) have not been pragmatically tested in diverse samples. This cluster-randomized controlled trial compares MA health coaching with usual care in adults with T2D and poor clinical control ("MAC Trial"). The purpose was to conduct a multi-method process evaluation of the MAC Trial using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Reach was assessed by calculating the proportion of enrolled participants out of the eligible pool and examining representativeness of those enrolled. Key informant interviews documented adoption by MA Health Coaches. We examined implementation from the research and patient perspectives by evaluating protocol adherence and the Patient Perceptions of Chronic Illness Care (PACIC-SF) measure, respectively. Findings indicate that the MAC Trial was efficient and effective in reaching patients who were representative of the target population. The acceptance rate among those approached for health coaching was high (87%). Both MA Health Coaches reported high satisfaction with the program and high levels of confidence in their role. The intervention was well-implemented, as evidenced by the protocol adherence rate of 79%; however, statistically significant changes in PACIC-SF scores were not observed. Overall, if found to be effective in improving clinical and patient-reported outcomes, the MAC model holds potential for wider-scale implementation given its successful adoption and implementation and demonstrated ability to reach patients with poorly controlled T2D who are at-risk for diabetes complications in diverse primary care settings. [ABSTRACT FROM AUTHOR]

Background: By 2034, the number of US individuals with diabetes is predicted to increase from 23.7 to 44.1 million, and annual diabetes-related spending is expected to grow from $113 to $336 billion. Up to 55% of US Hispanics born in the year 2000 are expected to develop diabetes during their lifetime. Poor healthcare access and cultural barriers prevent optimal care, adherence, and clinical benefit, placing Hispanics at disproportionate risk for costly diabetes complications. Mobile technology is increasingly prevalent in all populations and can circumvent such barriers. Our group developed Dulce Digital, an educational text messaging program that improved glycemic control relative to usual care. Dulce Digital-Me (DD-Me) has been tailored to a participant's individual needs with a greater focus on health behavior change.Methods: This is a three-arm, parallel group, randomized trial with equal allocation ratio enrolling Hispanic adults with low income and poorly managed type 2 diabetes (N = 414) from a San Diego County Federally Qualified Health Center. Participants are randomized to receive Dulce Digital, Dulce Digital-Me-Automated, or Dulce Digital-Me-Telephonic. The DD-Me groups include Dulce Digital components plus personalized goal-setting and feedback delivered via algorithm-driven automated text messaging (DD-Me-Automated) or by the care team health coach (DD-Me-Telephonic) over a 12-month follow-up period. The study will examine the comparative effectiveness of the three groups in improving diabetes clinical control [HbA1c, primary outcome; low-density lipoprotein cholesterol (LDL-C), and systolic blood pressure (SBP)] and patient-provider communication and patient adherence (i.e., medication, self-management tasks) over 12 months and will examine cost-effectiveness of the three interventions.Discussion: Our comparative evaluation of three mHealth approaches will elucidate how technology can be integrated most effectively and efficiently within primary care-based chronic care model approaches to reduce diabetes disparities in Hispanics and will assess two modes of personalized messaging delivery (i.e., automated messaging vs. telephonic by health coach) to inform cost and acceptability.Trial Registration: NCT03130699-All items from the WHO Trial Registration data set are available in https://clinicaltrials.gov/ct2/show/study/NCT03130699 . [ABSTRACT FROM AUTHOR]

Team-based models that use medical assistants (MAs) to provide self-management support for adults with type 2 diabetes (T2D) have not been pragmatically tested in diverse samples. This cluster-randomized controlled trial compares MA health coaching with usual care in adults with T2D and poor clinical control ("MAC Trial"). The purpose was to conduct a multi-method process evaluation of the MAC Trial using the Reach, Effectiveness, Adoption, Implementation, and Maintenance framework. Reach was assessed by calculating the proportion of enrolled participants out of the eligible pool and examining representativeness of those enrolled. Key informant interviews documented adoption by MA Health Coaches. We examined implementation from the research and patient perspectives by evaluating protocol adherence and the Patient Perceptions of Chronic Illness Care (PACIC-SF) measure, respectively. Findings indicate that the MAC Trial was efficient and effective in reaching patients who were representative of the target population. The acceptance rate among those approached for health coaching was high (87%). Both MA Health Coaches reported high satisfaction with the program and high levels of confidence in their role. The intervention was well-implemented, as evidenced by the protocol adherence rate of 79%; however, statistically significant changes in PACIC-SF scores were not observed. Overall, if found to be effective in improving clinical and patient-reported outcomes, the MAC model holds potential for wider-scale implementation given its successful adoption and implementation and demonstrated ability to reach patients with poorly controlled T2D who are at-risk for diabetes complications in diverse primary care settings. [ABSTRACT FROM AUTHOR]

Objective: To explore the effect of discontinuing continuous glucose monitoring (CGM) after 8 months of CGM use in adults with type 2 diabetes treated with basal without bolus insulin.Research Design and Methods: This multicenter trial had an initial randomization to either real-time CGM or blood glucose monitoring (BGM) for 8 months followed by 6 months in which the BGM group continued to use BGM (n = 57) and the CGM group was randomly reassigned either to continue CGM (n = 53) or discontinue CGM with resumption of BGM for glucose monitoring (n = 53).Results: In the group that discontinued CGM, mean time in range (TIR) 70-180 mg/dL, which improved from 38% before initiating CGM to 62% after 8 months of CGM, decreased after discontinuing CGM to 50% at 14 months (mean change from 8 to 14 months -12% [95% CI -21% to -3%], P = 0.01). In the group that continued CGM use, little change was found in TIR from 8 to 14 months (baseline 44%, 8 months 56%, 14 months 57%, mean change from 8 to 14 months 1% [95% CI -11% to 12%], P = 0.89). Comparing the two groups at 14 months, the adjusted treatment group difference in mean TIR was -6% (95% CI -16% to 4%, P = 0.20).Conclusions: In adults with type 2 diabetes treated with basal insulin who had been using real-time CGM for 8 months, discontinuing CGM resulted in a loss of about one-half of the initial gain in TIR that had been achieved during CGM use. [ABSTRACT FROM AUTHOR]

Importance: Continuous glucose monitoring (CGM) has been shown to be beneficial for adults with type 2 diabetes using intensive insulin therapy, but its use in type 2 diabetes treated with basal insulin without prandial insulin has not been well studied.Objective: To determine the effectiveness of CGM in adults with type 2 diabetes treated with basal insulin without prandial insulin in primary care practices.Design, Setting, and Participants: This randomized clinical trial was conducted at 15 centers in the US (enrollment from July 30, 2018, to October 30, 2019; follow-up completed July 7, 2020) and included adults with type 2 diabetes receiving their diabetes care from a primary care clinician and treated with 1 or 2 daily injections of long- or intermediate-acting basal insulin without prandial insulin, with or without noninsulin glucose-lowering medications.Interventions: Random assignment 2:1 to CGM (n = 116) or traditional blood glucose meter (BGM) monitoring (n = 59).Main Outcomes and Measures: The primary outcome was hemoglobin A1c (HbA1c) level at 8 months. Key secondary outcomes were CGM-measured time in target glucose range of 70 to 180 mg/dL, time with glucose level at greater than 250 mg/dL, and mean glucose level at 8 months.Results: Among 175 randomized participants (mean [SD] age, 57 [9] years; 88 women [50%]; 92 racial/ethnic minority individuals [53%]; mean [SD] baseline HbA1c level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA1c level decreased from 9.1% at baseline to 8.0% at 8 months in the CGM group and from 9.0% to 8.4% in the BGM group (adjusted difference, -0.4% [95% CI, -0.8% to -0.1%]; P = .02). In the CGM group, compared with the BGM group, the mean percentage of CGM-measured time in the target glucose range of 70 to 180 mg/dL was 59% vs 43% (adjusted difference, 15% [95% CI, 8% to 23%]; P < .001), the mean percentage of time at greater than 250 mg/dL was 11% vs 27% (adjusted difference, -16% [95% CI, -21% to -11%]; P < .001), and the means of the mean glucose values were 179 mg/dL vs 206 mg/dL (adjusted difference, -26 mg/dL [95% CI, -41 to -12]; P < .001). Severe hypoglycemic events occurred in 1 participant (1%) in the CGM group and in 1 (2%) in the BGM group.Conclusions and Relevance: Among adults with poorly controlled type 2 diabetes treated with basal insulin without prandial insulin, continuous glucose monitoring, as compared with blood glucose meter monitoring, resulted in significantly lower HbA1c levels at 8 months.Trial Registration: ClinicalTrials.gov Identifier: NCT03566693. [ABSTRACT FROM AUTHOR]

Aims: The ability to differentiate patient populations with type 2 diabetes at high risk of severe hypoglycaemia could impact clinical decision making. The aim of this study was to develop a risk score, using patient characteristics, that could differentiate between populations with higher and lower 2‐year risk of severe hypoglycaemia among individuals at increased risk of cardiovascular disease. Materials and methods: Two models were developed for the risk score based on data from the DEVOTE cardiovascular outcomes trials. The first, a data‐driven machine‐learning model, used stepwise regression with bidirectional elimination to identify risk factors for severe hypoglycaemia. The second, a risk score based on known clinical risk factors accessible in clinical practice identified from the data‐driven model, included: insulin treatment regimen; diabetes duration; sex; age; and glycated haemoglobin, all at baseline. Both the data‐driven model and simple risk score were evaluated for discrimination, calibration and generalizability using data from DEVOTE, and were validated against the external LEADER cardiovascular outcomes trial dataset. Results: Both the data‐driven model and the simple risk score discriminated between patients at higher and lower hypoglycaemia risk, and performed similarly well based on the time‐dependent area under the curve index (0.63 and 0.66, respectively) over a 2‐year time horizon. Conclusions: Both the data‐driven model and the simple hypoglycaemia risk score were able to discriminate between patients at higher and lower risk of severe hypoglycaemia, the latter doing so using easily accessible clinical data. The implementation of such a tool (http://www.hyporiskscore.com/) may facilitate improved recognition of, and education about, severe hypoglycaemia risk, potentially improving patient care. [ABSTRACT FROM AUTHOR]

Aims: To undertake a post‐hoc analysis, utilizing a hypoglycaemia risk score based on DEVOTE trial data, to investigate if a high risk of severe hypoglycaemia was associated with an increased risk of cardiovascular events, and whether reduced rates of severe hypoglycaemia in patients identified as having the highest risk affected the risk of cardiovascular outcomes. Materials and Methods: The DEVOTE population was divided into quartiles according to patients' individual hypoglycaemia risk scores. For each quartile, the observed incidence and rate of severe hypoglycaemia, major adverse cardiovascular event (MACE) and all‐cause mortality were determined to investigate whether those with the highest risk of hypoglycaemia were also at the greatest risk of MACE and all‐cause mortality. In addition, treatment differences within each risk quartile [insulin degludec (degludec) vs. insulin glargine 100 units/mL (glargine U100)] in terms of severe hypoglycaemia, MACE and all‐cause mortality were investigated. Results: Patients with the highest risk scores had the highest rates of severe hypoglycaemia, MACE and all‐cause mortality. Treatment ratios between degludec and glargine U100 in the highest risk quartile were 95% confidence interval (CI) 0.56 (0.39; 0.80) (severe hypoglycaemia), 95% CI 0.76 (0.58; 0.99) (MACE) and 95% CI 0.77 (0.55; 1.07) (all‐cause mortality). Conclusions: The risk score demonstrated that a high risk of severe hypoglycaemia was associated with a high incidence of MACE and all‐cause mortality and that, in this high‐risk group, those treated with degludec had a lower incidence of MACE. These observations support the hypothesis that hypoglycaemia is a risk factor for cardiovascular events. [ABSTRACT FROM AUTHOR]

Despite significant treatment advances, diabetes outcomes remain suboptimal and health care costs continue to rise. There are limited data on the feasibility and financial implications of integrating a diabetes-specific care team in the primary care setting (ie, where the majority of diabetes is treated). This pragmatic quality improvement project investigated whether a cardiometabolic care team intervention (CMC-TI) could achieve greater improvements in clinical, behavioral, and cost outcomes compared to usual diabetes care in a large primary care group in Southern California. Over 12 months, n = 236 CMC-TI and n = 239 usual care patients with type 1 or 2 diabetes were identified using the electronic medical record. In the CMC-TI group, a registered nurse (RN)/certified diabetes educator care manager, medical assistant health coach, and RN depression care manager utilized electronic medical record-based risk stratification reports, standardized decision-support tools, live and remote tailored treatments, and coaching to manage care. Results indicated that the CMC-TI group achieved greater improvements in glycemic and lipid control, diabetes self-management behaviors, and emotional distress over 1 year compared with the usual care group (all P < .05). The CMC-TI group also had a significant 12.6% reduction in total health care costs compared to a 51.7% increase in the usual care group during the same period and inclusive of CMC-TI program costs. Patients and providers reported high satisfaction with CMC-TI. These findings highlight that team-based care management interventions that utilize nurses, medical assistant health coaches, and behavioral specialists to support diabetes patients can help primary care practices achieve value-based targets of improved health, cost, and patient experience. [ABSTRACT FROM AUTHOR]

Objective: The current standard for hospital glucose management is point-of-care (POC) testing. We conducted a randomized controlled trial of real-time continuous glucose monitoring (RT-CGM) compared with POC in a non-intensive care unit (ICU) hospital setting.Research Design and Methods: A total of 110 adults with type 2 diabetes on a non-ICU floor received RT-CGM with Dexcom G6 versus usual care (UC). RT-CGM data were wirelessly transmitted from the bedside. Hospital telemetry monitored RT-CGM data and notified bedside nursing of glucose alerts and trends. Standardized protocols were used for interventions.Results: The RT-CGM group demonstrated significantly lower mean glucose (M∆ = -18.5 mg/dL) and percentage of time in hyperglycemia >250 mg/dL (-11.41%) and higher time in range 70-250 mg/dL (+11.26%) compared with UC (P values <0.05). Percentage of time in hypoglycemia was very low.Conclusions: RT-CGM can be used successfully in community-based hospital non-ICU settings to improve glucose management. Continuously streaming glucose readings may truly be the fifth vital sign. [ABSTRACT FROM AUTHOR]

Importance: Continuous glucose monitoring (CGM) provides real-time assessment of glucose levels and may be beneficial in reducing hypoglycemia in older adults with type 1 diabetes.Objective: To determine whether CGM is effective in reducing hypoglycemia compared with standard blood glucose monitoring (BGM) in older adults with type 1 diabetes.Design, Setting, and Participants: Randomized clinical trial conducted at 22 endocrinology practices in the United States among 203 adults at least 60 years of age with type 1 diabetes.Interventions: Participants were randomly assigned in a 1:1 ratio to use CGM (n = 103) or standard BGM (n = 100).Main Outcomes and Measures: The primary outcome was CGM-measured percentage of time that sensor glucose values were less than 70 mg/dL during 6 months of follow-up. There were 31 prespecified secondary outcomes, including additional CGM metrics for hypoglycemia, hyperglycemia, and glucose control; hemoglobin A1c (HbA1c); and cognition and patient-reported outcomes, with adjustment for multiple comparisons to control for false-discovery rate.Results: Of the 203 participants (median age, 68 [interquartile range {IQR}, 65-71] years; median type 1 diabetes duration, 36 [IQR, 25-48] years; 52% female; 53% insulin pump use; mean HbA1c, 7.5% [SD, 0.9%]), 83% used CGM at least 6 days per week during month 6. Median time with glucose levels less than 70 mg/dL was 5.1% (73 minutes per day) at baseline and 2.7% (39 minutes per day) during follow-up in the CGM group vs 4.7% (68 minutes per day) and 4.9% (70 minutes per day), respectively, in the standard BGM group (adjusted treatment difference, -1.9% (-27 minutes per day); 95% CI, -2.8% to -1.1% [-40 to -16 minutes per day]; P <.001). Of the 31 prespecified secondary end points, there were statistically significant differences for all 9 CGM metrics, 6 of 7 HbA1c outcomes, and none of the 15 cognitive and patient-reported outcomes. Mean HbA1c decreased in the CGM group compared with the standard BGM group (adjusted group difference, -0.3%; 95% CI, -0.4% to -0.1%; P <.001). The most commonly reported adverse events using CGM and standard BGM, respectively, were severe hypoglycemia (1 and 10), fractures (5 and 1), falls (4 and 3), and emergency department visits (6 and 8).Conclusions and Relevance: Among adults aged 60 years or older with type 1 diabetes, continuous glucose monitoring compared with standard blood glucose monitoring resulted in a small but statistically significant improvement in hypoglycemia over 6 months. Further research is needed to understand the long-term clinical benefit.Trial Registration: ClinicalTrials.gov Identifier: NCT03240432. [ABSTRACT FROM AUTHOR]

Purpose: The purpose of this study was to examine whether baseline levels of diabetes distress (DD) impacted clinical benefit from a mobile health (mHealth) diabetes self-management education and support (DSME/S) intervention ("Dulce Digital"). Methods: This secondary analysis included the full sample of 126 Hispanic adults (mean age = 48.43 years, SD = 9.80) with type 2 diabetes and glycosylated hemoglobin A1C >7.5% enrolled from a Federally Qualified Health Center in a randomized, nonblinded clinical trial that compared Dulce Digital to usual care. Dulce Digital participants received educational/motivational, medication reminders, and blood glucose monitoring prompt text messages over 6 months. Results: Baseline levels of DD prospectively moderated the effect of Dulce Digital (vs usual care) on glycemic control over 6 months, such that Dulce Digital participants with higher DD experienced relatively greater benefit from the intervention. The effect of the intervention on A1C change was 178% larger among individuals experiencing moderate/high versus no/low DD. Conclusions: Although research has found DD to be associated with poorer self-management and clinical outcomes, individuals already distressed about their diabetes may benefit from a lower-burden mHealth DSME/S approach. [ABSTRACT FROM AUTHOR]

Aim: Treat‐to‐target, randomized controlled trials have confirmed lower rates of hypoglycaemia at equivalent glycaemic control with insulin degludec (degludec) versus insulin glargine 100 units/mL (glargine U100) in patients with type 1 (T1D) or type 2 diabetes (T2D). Treat‐to‐target trials are designed to enable comparisons of safety and tolerability at a similar HbA1c level. In this post hoc analysis of the SWITCH 1 and 2 trials, we utilised a patient‐level modelling approach to compare how glycaemic control might differ between basal insulins at a similar rate of hypoglycaemia. Materials and Methods: Data for HbA1c and symptomatic hypoglycaemia from the SWITCH 1 and SWITCH 2 trials were analyzed separately for patients with type 1 diabetes and type 2 diabetes, respectively. The association between the individual patient‐level risk of hypoglycaemia and HbA1c was investigated using a Poisson regression model and used to estimate potential differences in glycaemic control with degludec versus glargine U100, at the same rate of hypoglycaemia. Results: Improvements in glycaemic control increased the incidence of hypoglycaemia with both basal insulins across diabetes types. Our analysis suggests that patients could achieve a mean HbA1c reduction of 0.70 [0.05; 2.20]95% CI (for type 1 diabetes) or 0.96 [0.39; 1.99]95% CI (for type 2 diabetes) percentage points (8 [1; 24]95% CI or 10 [4; 22]95% CI mmol/mol, respectively) further with degludec than with glargine U100 before incurring an equivalent risk of hypoglycaemia. Conclusion: Our findings suggest that patients in clinical practice may be able to achieve lower glycaemia targets with degludec versus glargine U100, before incurring an equivalent risk of hypoglycaemia. [ABSTRACT FROM AUTHOR]

Aim: To investigate the efficacy and safety of initiating insulin degludec/liraglutide (IDegLira) in patients with type 2 diabetes (T2D) who had discontinued pretrial sulphonylureas (SUs) or dipeptidyl peptidase‐4 inhibitors (DPP4is) versus patients not previously treated with these regimens. Materials and Methods: In DUAL II, patients with T2D uncontrolled on basal insulin and metformin ± SU/glinides were randomized to insulin degludec or IDegLira (both capped at 50 U). In DUAL IX, patients were randomized to insulin glargine U100 (no maximum dose) or IDegLira, as add‐on to sodium‐glucose co‐transporter‐2 inhibitors ± oral antidiabetic drugs. In this post hoc analysis, patients were grouped according to pretrial use of SU (DUAL II) or DPP4i (DUAL IX). Results: Regardless of pretrial SU/DPP4i use, IDegLira was favourable versus insulin comparators with respect to change in HbA1c and body weight. Lower hypoglycaemia rates and comparable end‐of‐trial daily insulin dose were achieved with IDegLira, regardless of pretrial regimen. There was no clinically relevant increase in mean self‐measured blood glucose in the early weeks after IDegLira initiation. There was no statistically significant interaction between the randomized treatments and previous SU/DPP4i use. Conclusions: IDegLira was more favourable compared with degludec or glargine U100 in terms of change in HbA1c and body weight, regardless of antecedent treatment. Clinicians should be aware of a potential transient rise in self‐measured blood glucose when transitioning therapy in patients. This shows that SUs/DPP4is can be safely discontinued, without deterioration in glycaemic control when initiating IDegLira, allowing a simplified treatment regimen. [ABSTRACT FROM AUTHOR]

Aims/hypothesis: A head-to-head randomised trial was conducted to evaluate hypoglycaemia safety with insulin degludec 200 U/ml (degludec U200) and insulin glargine 300 U/ml (glargine U300) in individuals with type 2 diabetes treated with basal insulin. Methods: This randomised (1:1), open-label, treat-to-target, multinational trial included individuals with type 2 diabetes, aged ≥18 years with HbA1c ≤80 mmol/mol (9.5%) and BMI ≤45 kg/m2. Participants were previously treated with basal insulin with or without oral glucose-lowering drugs (excluding insulin secretagogues) and had to fulfil at least one predefined criterion for hypoglycaemia risk. Both degludec U200 and glargine U300 were similarly titrated to a fasting blood glucose target of 4.0–5.0 mmol/l. Endpoints were assessed during a 36 week maintenance period and a total treatment period up to 88 weeks. There were three hypoglycaemia endpoints: (1) overall symptomatic hypoglycaemia (either severe, an event requiring third-party assistance, or confirmed by blood glucose [<3.1 mmol/l] with symptoms); (2) nocturnal symptomatic hypoglycaemia (severe or confirmed by blood glucose with symptoms, between 00:01 and 05:59 h); and (3) severe hypoglycaemia. The primary endpoint was the number of overall symptomatic hypoglycaemic events in the maintenance period. Secondary hypoglycaemia endpoints included the number of nocturnal symptomatic events and number of severe hypoglycaemic events during the maintenance period. Results: Of the 1609 randomised participants, 733 of 805 (91.1%) in the degludec U200 arm and 734 of 804 (91.3%) in the glargine U300 arm completed the trial (87.3% and 87.8% completed on treatment, respectively). Baseline characteristics were comparable between the two treatment arms. For the primary endpoint, the rate of overall symptomatic hypoglycaemia was not significantly lower with degludec U200 vs glargine U300 (rate ratio [RR] 0.88 [95% CI 0.73, 1.06]). As there was no significant difference between treatments for the primary endpoint, the confirmatory testing procedure for superiority was stopped. The pre-specified confirmatory secondary hypoglycaemia endpoints were analysed using pre-specified statistical models but were now considered exploratory. These endpoints showed a lower rate of nocturnal symptomatic hypoglycaemia (RR 0.63 [95% CI 0.48, 0.84]) and severe hypoglycaemia (RR 0.20 [95% CI 0.07, 0.57]) with degludec U200 vs glargine U300. Conclusions/interpretation: There was no significant difference in the rate of overall symptomatic hypoglycaemia with degludec U200 vs glargine U300 in the maintenance period. The rates of nocturnal symptomatic and severe hypoglycaemia were nominally significantly lower with degludec U200 during the maintenance period compared with glargine U300. Trial registration: ClinicalTrials.gov NCT03078478 Funding: This trial was funded by Novo Nordisk (Bagsvaerd, Denmark) [ABSTRACT FROM AUTHOR]

Background: Multimorbidity affects four of ten US adults and eight of ten adults ages 65 years and older, and frequently includes both cardiometabolic conditions and behavioral health concerns. Hispanics/Latinos (hereafter, Latinos) and other ethnic minorities are more vulnerable to these conditions, and face structural, social, and cultural barriers to obtaining quality physical and behavioral healthcare. We report the protocol for a randomized controlled trial that will compare Mi Puente (My Bridge), a cost-efficient care transitions intervention conducted by a specially trained Behavioral Health Nurse and Volunteer Community Mentor team, to usual care or best-practice discharge approaches, in reducing hospital utilization and improving patient reported outcomes in Latino adults with multiple cardiometabolic conditions and behavioral health concerns. The study will examine the degree to which Mi Puente produces superior reductions in hospital utilization at 30 and 180 days (primary aim) and better patient-reported outcomes (quality of life/physical health; barriers to healthcare; engagement with outpatient care; patient activation; resources for chronic disease management), and will examine the cost effectiveness of the Mi Puente intervention relative to usual care.Methods: Participants are enrolled as inpatients at a South San Diego safety net hospital, using information from electronic medical records and in-person screenings. After providing written informed consent and completing self-report assessments, participants randomized to usual care receive best-practice discharge processes, which include educational materials, assistance with outpatient appointments, referrals to community-based providers, and other assistance (e.g., with billing, insurance) as required. Those randomized to Mi Puente receive usual-care materials and processes, along with inpatient visits and up to 4 weeks of follow-up phone calls from the intervention team to address their integrated physical-behavioral health needs and support the transition to outpatient care.Discussion: The Mi Puente Behavioral Health Nurse and Volunteer Community Mentor team intervention is proposed as a cost-effective and culturally appropriate care transitions intervention for Latinos with multimorbidity and behavioral health concerns. If shown to be effective, close linkages with outpatient healthcare and community organizations will help maximize uptake, dissemination, and scaling of the Mi Puente intervention.Trial Registration: ClinicalTrials.gov: NCT02723019. Registered on 30 March 2016. [ABSTRACT FROM AUTHOR]

In the United States, Hispanics have a 66% greater risk of developing type 2 diabetes and, once diagnosed, exhibit worse outcomes than non-Hispanic whites. It is therefore imperative to ensure that interventions meet the specific needs of this at-risk group. This article provides a selective review of the evidence on innovative, real-world approaches (both live and technology-based) to improving behavioral, psychosocial, and clinical outcomes in underserved Hispanics with type 2 diabetes. Key aspects of successful live interventions have included multimodal delivery, greater dosage/attendance, and at least some in-person delivery; effective technology-based approaches involved frequent but intermittent communication, bi-directional messaging, tailored feedback, multimodal delivery, and some human interaction. Across modalities, cultural tailoring also improved outcomes. Additional research is needed to address methodological limitations of studies to date and pinpoint the most efficacious components and optimal duration of interventions. Future efforts should also attend to variability within the U.S. Hispanic populatio [ABSTRACT FROM AUTHOR]

Aim: To investigate the efficacy and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine 100 units/mL (IGlar U100) as add‐on to sodium‐glucose co‐transporter‐2 (SGLT2) inhibitor therapy. Materials and methods: In this 26‐week, phase IIIb, open‐label, parallel‐group, treat‐to‐target trial, conducted at 74 sites in 11 countries, insulin‐naïve people aged ≥18 years with glycated haemoglobin (HbA1c) 53–97 mmol/mol (7.0–11.0%), body mass index 20–40 kg/m2 and inadequately controlled type 2 diabetes (T2D) on SGLT2 inhibitor ± oral antidiabetic drugs were randomized 1:1 to once‐daily IDegLira or IGlar U100, both as add‐on to existing therapy. The primary endpoint was change in HbA1c from baseline to week 26. Results: A total of 210 participants were randomized to each treatment arm. Mean HbA1c reductions were 21 mmol/mol (1.9%‐points) with IDegLira and 18 mmol/mol (1.7%‐points) with IGlar U100; confirming non‐inferiority (P < 0.0001) and superiority of IDegLira (difference in HbA1c change –3.90 mmol/mol; 95% confidence interval [CI] –5.45; –2.35 (−0.36%‐points; 95% CI –0.50, –0.21)). Superiority for IDegLira over IGlar U100 was also confirmed for: body weight (difference −1.92 kg; 95% CI –2.64, –1.19); severe or blood‐glucose‐confirmed symptomatic hypoglycaemia (rate ratio 0.42; 95% CI 0.23, 0.75); total daily insulin dose (difference −15.37 U; 95% CI –19.60, −11.13). The overall treatment‐emergent adverse event rate was higher with IDegLira as a result of higher increased lipase and nausea rates. Conclusions: The favourable safety and efficacy profile of IDegLira in people with uncontrolled T2D on SGLT2 inhibitors, and lower weight gain and hypoglycaemia risk versus IGlar U100, suggest that clinicians should consider IDegLira initiation in this population. [ABSTRACT FROM AUTHOR]

Introduction: Insulin dosing based on carbohydrate counting is the gold standard for improving glycaemic control in type 1 diabetes (T1D). This post hoc analysis aimed to explore the efficacy and safety of fast-acting insulin aspart (faster aspart) according to bolus dose adjustment method in people with T1D. Methods: Post hoc analysis of two 26-week, treat-to-target, randomised trials investigating treatment with double-blind mealtime faster aspart, insulin aspart (IAsp), or open-label post-meal faster aspart (onset 1, n = 1143; onset 8, n = 1025). Participants with previous experience continued carbohydrate counting (onset 1, n = 669 [58.5%]; onset 8, n = 428 [41.8%]), while remaining participants used a bolus algorithm. Results: In onset 1, HbA1c reduction was statistically significantly in favour of mealtime faster aspart versus IAsp with carbohydrate counting (estimated treatment difference [ETD 95% CI] − 0.19% [− 0.30; − 0.09]; − 2.08 mmol/mol [− 3.23; − 0.93]). In onset 8, there was no statistically significant difference in HbA1c reduction with either dose adjustment method, although a trend towards improved HbA1c was observed for mealtime faster aspart with carbohydrate counting (ETD − 0.14% [− 0.28; 0.003]; − 1.53 mmol/mol [− 3.10; 0.04]). In both trials, bolus insulin doses and overall rates of severe or blood glucose-confirmed hypoglycaemia were similar between treatments across dose adjustment methods. Conclusion: For people with T1D using carbohydrate counting, mealtime faster aspart may offer improved glycaemic control versus IAsp, with similar insulin dose and weight gain and no increased risk of hypoglycaemia. Trial Registration: ClinicalTrials.gov: NCT01831765 (onset 1) and NCT02500706 (onset 8). Funding: Novo Nordisk. [ABSTRACT FROM AUTHOR]

Aims: To investigate the association between day‐to‐day fasting self‐monitored blood glucose (SMBG) variability and risk of hypoglycaemia in type 1 (T1D) and type 2 diabetes (T2D), and to compare day‐to‐day fasting SMBG variability between treatments with insulin degludec (degludec) and insulin glargine 100 units/mL (glargine U100). Materials and Methods: Data were retrieved from two double‐blind, randomized, treat‐to‐target, two‐period (32 weeks each) crossover trials of degludec vs glargine U100 in T1D (SWITCH 1, n = 501) and T2D (SWITCH 2, n = 720). Available fasting SMBGs were used to determine the standard deviation (SD) of day‐to‐day fasting SMBG variability for each patient and the treatment combination. The association between day‐to‐day fasting SMBG variability and overall symptomatic, nocturnal symptomatic and severe hypoglycaemia was analysed for the pooled population using linear regression, with fasting SMBG variability included as a three‐level factor defined by population tertiles. Finally, day‐to‐day fasting SMBG variability was compared between treatments. Results: Linear regression showed that day‐to‐day fasting SMBG variability was significantly associated with overall symptomatic, nocturnal symptomatic and severe hypoglycaemia risk in T1D and T2D (P < 0.05). Day‐to‐day fasting SMBG variability was significantly associated (P < 0.01) with all categories of hypoglycaemia risk, with the exception of severe hypoglycaemia in T2D when analysed within tertiles. Degludec was associated with 4% lower day‐to‐day fasting SMBG variability than glargine U100 in T1D (P = 0.0082) and with 10% lower day‐to‐day fasting SMBG variability in T2D (P < 0.0001). Conclusions: Higher day‐to‐day fasting SMBG variability is associated with an increased risk of overall symptomatic, nocturnal symptomatic and severe hypoglycaemia. Degludec has significantly lower day‐to‐day fasting SMBG variability vs glargine U100. [ABSTRACT FROM AUTHOR]

Hispanic patients with type 2 diabetes have poorer glycemic control and are at higher risk of severe diabetes complications and mortality than non-Hispanic white patients. This post hoc analysis investigated the safety and efficacy of insulin degludec versus insulin glargine 100 units/mL (glargine U100) in the Hispanic patient subpopulation from the SWITCH 2 trial. In Hispanic patients, hypoglycemia was consistently lower and nocturnal hypoglycemia was significantly lower with degludec versus glargine U100 at similar levels of glycemic control. Overall, results in Hispanic patients in SWITCH 2 were consistent with those in non-Hispanic patients. [ABSTRACT FROM AUTHOR]

Aims: To compare the safety and efficacy of fast‐acting insulin aspart (faster aspart) with conventional insulin aspart (IAsp) in adults with type 1 diabetes (T1D). Materials and methods: onset 1 was a randomized, multicentre, treat‐to‐target, phase III, 52‐week (initial 26 weeks + additional 26 weeks) trial conducted at 165 sites across 9 countries. Adults with T1D were randomly allocated to double‐blind mealtime faster aspart or IAsp, each with once‐ or twice‐daily insulin detemir. The primary endpoint, change in glycated haemoglobin (HbA1c) from baseline after the initial 26 weeks, has been reported previously. In the present paper, we report data from the full 52‐week study period. Results: Between August 2013 and June 2015, 381 participants were assigned to double‐blind faster aspart and 380 participants to IAsp. After 52 weeks, estimated mean changes from baseline in HbA1c levels were −0.08% (faster aspart) and +0.01% (IAsp); estimated treatment difference significantly favoured faster aspart (−0.10% [95% confidence interval {CI} −0.19;−0.00]; P = .0424). Changes from baseline in 1‐hour postprandial plasma glucose (PPG) increment (meal test; faster aspart −1.05 mmol/L; IAsp −0.14 mmol/L) also significantly favoured faster aspart (estimated treatment difference −0.91 mmol/L [95% CI −1.40;−0.43]; −16.48 mg/dL [95% CI −25.17;−7.80]; P = .0002). There was no difference in overall severe or blood glucose‐confirmed hypoglycaemic episodes or treatment‐emergent adverse events between treatments. Conclusions: At 52 weeks, overall glycaemic control had significantly improved with faster aspart vs IAsp, consistent with the 26‐week study findings. Achieving an insulin profile closer to physiological insulin secretion with faster aspart translates into lower PPG and HbA1c levels compared with those achieved with IAsp in people with T1D. [ABSTRACT FROM AUTHOR]

Purpose The purpose of the study was to test the preliminary effectiveness, feasibility, and acceptability of a peer-led, culturally appropriate, Diabetes Prevention Program (DPP)–based lifestyle intervention for Latina women at high-risk for type 2 diabetes (T2DM). Methods Participants (N = 61) were overweight/obese (body mass index [BMI] ≥25) Latina women with no diabetes, at elevated risk either due to midlife age (45-65 years; n = 37) or history of gestational diabetes mellitus (n = 24). The study used a 1-group pretest-posttest design and offered 12 weeks of peer-led education sessions in a community setting. The intervention targeted physical activity and dietary behaviors to facilitate weight reduction and included culturally appropriate content, age-specific health information, and stress/emotion management strategies. Clinical and self-report assessments were conducted at baseline, month 3, and month 6. Results Mean participant age was 47.8 years (SD = 10.8). Most (91.2%) were born in Mexico, and 43.3% had a ninth-grade education or less. At month 6, participants achieved a mean reduction of 4.1% body weight (7 lb [3.2 kg]). Statistically significant improvements were observed for dietary behaviors, stress, and depression symptoms. Attrition was low, 5% (3 women). Focus groups indicated that intervention content increased knowledge, was applicable, highly valued, culturally relevant, and would be recommended to others. Conclusions This culturally tailored DPP adaptation was feasible and acceptable for 2 groups of Latina women at high-risk for T2DM and showed preliminary effectiveness in reducing weight and modifying self-reported dietary behaviors, stress, and depression symptoms. Further research is needed to identify ways to enhance weight loss and diabetes prevention in this at-risk, underserved population. [ABSTRACT FROM AUTHOR]

Objective: Type 2 diabetes is growing in epidemic proportions and disproportionately affects lower-income, diverse communities. Text messaging may provide one of the most rapid methods to overcome the "digital divide" to improve care.Research Design and Methods: A randomized, nonblinded, parallel-groups clinical trial design allocated N = 126 low-income, Hispanic participants with poorly controlled type 2 diabetes to receive the Dulce Digital intervention or usual care (UC). Dulce Digital participants received up to three motivational, educational, and/or call-to-action text messages per day over 6 months. The primary outcome was HbA1c; lipids, blood pressure, and BMI were secondary outcomes. Satisfaction and acceptability were evaluated via focus groups and self-report survey items.Results: The majority of patients were middle-aged (mean age 48.43 years, SD 9.80), female (75%), born in Mexico (91%), and uninsured (75%) and reported less than a ninth-grade education level (73%) and mean baseline HbA1c 9.5% (80 mmol/mol), SD 1.3, and fasting plasma glucose 187.17 mg/dL, SD 64.75. A statistically significant time-by-group interaction effect indicated that the Dulce Digital group achieved a significantly greater reduction in HbA1c over time compared with UC (P = 0.03). No statistically significant effects were observed for secondary clinical indicators. The number of blood glucose values texted in by participants was a statistically significant predictor of month 6 HbA1c (P < 0.05). Satisfaction and acceptability ratings for the Dulce Digital intervention were high.Conclusions: Use of a simple, low-cost text messaging program was found to be highly acceptable in this sample of high-risk, Hispanic individuals with type 2 diabetes and resulted in greater improvement in glycemic control compared with UC. [ABSTRACT FROM AUTHOR]

Importance: Hypoglycemia, common in patients with type 1 diabetes, is a major barrier to achieving good glycemic control. Severe hypoglycemia can lead to coma or death.Objective: To determine whether insulin degludec is noninferior or superior to insulin glargine U100 in reducing the rate of symptomatic hypoglycemic episodes.Design, Setting, and Participants: Double-blind, randomized, crossover noninferiority trial involving 501 adults with at least 1 hypoglycemia risk factor treated at 84 US and 6 Polish centers (January 2014-January 12, 2016) for two 32-week treatment periods, each with a 16-week titration and a 16-week maintenance period.Interventions: Patients were randomized 1:1 to receive once-daily insulin degludec followed by insulin glargine U100 (n = 249) or to receive insulin glargine U100 followed by insulin degludec (n = 252) and randomized 1:1 to morning or evening dosing within each treatment sequence.Main Outcomes and Measures: The primary end point was the rate of overall severe or blood glucose-confirmed (<56 mg/dL) symptomatic hypoglycemic episodes during the maintenance period. Secondary end points included the rate of nocturnal symptomatic hypoglycemic episodes and proportion of patients with severe hypoglycemia during the maintenance period. The noninferiority criterion for the primary end point and for the secondary end point of nocturnal hypoglycemia was defined as an upper limit of the 2-sided 95% CI for a rate ratio of 1.10 or lower; if noninferiority was established, 2-sided statistical testing for superiority was conducted.Results: Of the 501 patients randomized (mean age, 45.9 years; 53.7% men), 395 (78.8%) completed the trial. During the maintenance period, the rates of overall symptomatic hypoglycemia were 2200.9 episodes per 100 person-years' exposure (PYE) in the insulin degludec group vs 2462.7 episodes per 100 PYE in the insulin glargine U100 group for a rate ratio (RR) of 0.89 (95% CI, 0.85-0.94; P < .001 for noninferiority; P < .001 for superiority; rate difference, -130.31 episodes per 100 PYE; 95% CI, -193.5 to -67.16). The rates of nocturnal symptomatic hypoglycemia were 277.1 per 100 PYE in the insulin degludec group vs 428.6 episodes per 100 PYE in the insulin glargine U100 group, for an RR of 0.64 (95% CI, 0.56-0.73; P < .001 for noninferiority; P < .001 for superiority; rate difference, -61.94 episodes per 100 PYE; 95% CI, -83.85 to -40.03). A lower proportion of patients in the insulin degludec than in the insulin glargine U100 group experienced severe hypoglycemia during the maintenance period (10.3%, 95% CI, 7.3%-13.3% vs 17.1%, 95% CI, 13.4%-20.8%, respectively; McNemar P = .002; risk difference, -6.8%; 95% CI, -10.8% to -2.7%).Conclusions and Relevance: Among patients with type 1 diabetes and at least 1 risk factor for hypoglycemia, 32 weeks' treatment with insulin degludec vs insulin glargine U100 resulted in a reduced rate of overall symptomatic hypoglycemic episodes.Trial Registration: clinicaltrials.gov Identifier: NCT02034513. [ABSTRACT FROM AUTHOR]

Objective: This multicenter, treat-to-target, phase 3 trial evaluated the efficacy and safety of fast-acting insulin aspart (faster aspart) versus conventional insulin aspart (IAsp) in adults with type 1 diabetes.Research Design and Methods: The primary end point was change from baseline in HbA1c after 26 weeks. After an 8-week run-in, subjects were randomized (1:1:1) to double-blind mealtime faster aspart (n = 381), IAsp (n = 380), or open-label postmeal faster aspart (n = 382)-each with insulin detemir.Results: HbA1c was reduced in both treatment groups, and noninferiority to IAsp was confirmed for both mealtime and postmeal faster aspart (estimated treatment difference [ETD] faster aspart-IAsp, mealtime, -0.15% [95% CI -0.23; -0.07], and postmeal, 0.04% [-0.04; 0.12]); mealtime faster aspart statistically significantly reduced HbA1c versus IAsp (P = 0.0003). Postprandial plasma glucose (PPG) increments were statistically significantly lower with mealtime faster aspart at 1 h (ETD -1.18 mmol/L [95% CI -1.65; -0.71], -21.21 mg/dL [-29.65; -12.77]; P < 0.0001) and 2 h (-0.67 mmol/L [-1.29; -0.04], -12.01 mg/dL [-23.33; -0.70]; P = 0.0375) after the meal test; superiority to IAsp for the 2-h PPG increment was confirmed. The overall rate of severe or blood glucose-confirmed (plasma glucose <3.1 mmol/L [56 mg/dL]) hypoglycemic episodes and safety profiles were similar between treatments.Conclusions: Faster aspart effectively improved HbA1c, and noninferiority to IAsp was confirmed, with superior PPG control for mealtime faster aspart versus IAsp. Subjects randomized to postmeal faster aspart for all meals maintained HbA1c noninferior to that obtained with mealtime IAsp. [ABSTRACT FROM AUTHOR]

Objective: To determine whether the use of continuous glucose monitoring (CGM) without confirmatory blood glucose monitoring (BGM) measurements is as safe and effective as using CGM adjunctive to BGM in adults with well-controlled type 1 diabetes (T1D).Research Design and Methods: A randomized noninferiority clinical trial was conducted at 14 sites in the T1D Exchange Clinic Network. Participants were ≥18 years of age (mean 44 ± 14 years), had T1D for ≥1 year (mean duration 24 ± 12 years), used an insulin pump, and had an HbA1c ≤9.0% (≤75 mmol/mL) (mean 7.0 ± 0.7% [53 ± 7.7 mmol/mol]); prestudy, 47% were CGM users. Participants were randomly assigned 2:1 to the CGM-only (n = 149) or CGM+BGM (n = 77) group. The primary outcome was time in range (70-180 mg/dL) over the 26-week trial, with a prespecified noninferiority limit of 7.5%.Results: CGM use averaged 6.7 ± 0.5 and 6.8 ± 0.4 days/week in the CGM-only and CGM+BGM groups, respectively, over the 26-week trial. BGM tests per day (including the two required daily for CGM calibration) averaged 2.8 ± 0.9 and 5.4 ± 1.4 in the two groups, respectively (P < 0.001). Mean time in 70-180 mg/dL was 63 ± 13% at both baseline and 26 weeks in the CGM-only group and 65 ± 13% and 65 ± 11% in the CGM+BGM group (adjusted difference 0%; one-sided 95% CI -2%). No severe hypoglycemic events occurred in the CGM-only group, and one occurred in the CGM+BGM group.Conclusions: Use of CGM without regular use of confirmatory BGM is as safe and effective as using CGM with BGM in adults with well-controlled T1D at low risk for severe hypoglycemia. [ABSTRACT FROM AUTHOR]

This study assessed perspectives on whole-genome sequencing (WGS) for rare disease diagnosis and the process of receiving genetic results. Semistructured interviews were conducted with adult patients and parents of minor patients affected by idiopathic diseases (n = 10 cases). Three main themes were identified through qualitative data analysis and interpretation: perceived benefits of WGS; perceived drawbacks of WGS; and perceptions of the return of results from WGS. Findings suggest that patients and their families have important perspectives on the use of WGS in diagnostic odyssey cases. These perspectives could inform clinical sequencing research study designs as well as the appropriate deployment of patient and family support services in the context of clinical genome sequencing. [ABSTRACT FROM AUTHOR]

An introduction to articles in the issue is presented on topics including the successful use of digital interventions across broad communities, population health management models that were implemented to drive system processes for improvement, and programs and recommendations to intervene and control blood glucose to offer safe deliveries for mothers and infants.

Latina women with prior gestational diabetes mellitus (GDM) are at elevated risk for type 2 diabetes mellitus and cardiovascular disease. Few primary prevention programs are designed for low socioeconomic status, Spanish-speaking populations. We examined the effectiveness of a Diabetes Prevention Program (DPP) translation in low-income Latinas with a history of GDM. Eighty-four Latinas, 18-45 years old with GDM in the past 3 years, underwent an 8-week peer-educator-led group intervention, with tailoring for Latino culture and recent motherhood. Lifestyle changes and diabetes and cardiovascular risk factors were assessed at study baseline, month 3 and month 6. Participants showed significant improvements in lipids, blood pressure, physical activity, dietary fat intake, and fatalistic and cultural diabetes beliefs ( p < 0.05). Formative evaluation provides preliminary evidence of program acceptability. A peer-led, culturally appropriate DPP translation was effective in improving lifestyle changes and some indicators of cardiovascular and diabetes risk in Latinas with GDM. [ABSTRACT FROM AUTHOR]

Basal insulin represents an essential tool in the treatment of diabetes mellitus; it can be prescribed with oral antidiabetic agents for the management of type 2 diabetes (T2D) or used as part of a basal-bolus regimen in type 1 diabetes (T1D) and more advanced T2D. The basal insulin products currently on the market, although improved, do not optimally mimic endogenous insulin secretion. It is therefore important to investigate how the action of a basal insulin can be improved to match the physiologic profile more precisely and consequently to examine the desired properties of an ideal new-generation basal insulin. Some of these characteristics would include stable pharmacokinetic (PK) and pharmacodynamic (PD) profiles, true 24-hour duration of action in all patients, low within-person variability in absorption and glucose-lowering action, more flexible dose timing, and low occurrence of hypoglycemia. A new-generation basal insulin, insulin degludec, currently approved in Japan, Mexico, and Europe, was designed to provide a more stable pharmacotherapeutic option with a lower risk of hypoglycemia than the currently available basal insulins while retaining an efficacious profile. The characteristics of an ideal basal insulin are reviewed, and the pharmacology and clinical attributes of insulin degludec are discussed. [ABSTRACT FROM AUTHOR]

Diabetes affects a large and growing segment of the US population. Ethnic and racial minorities are at disproportionate risk for diabetes, with Hispanics and non-Hispanic Blacks showing a near doubling of risk relative to non-Hispanic Whites. There is an urgent need to identify low cost, effective, and easily implementable primary and secondary prevention approaches, as well as tertiary strategies that delay disease progression, complications, and associated deterioration in function in patients with diabetes. The Chronic Care Model provides a well-accepted framework for improving diabetes and chronic disease care in the community and primary care medical home. A number of community-based diabetes programs have incorporated this model into their infrastructure. Diabetes programs must offer accessible information and support throughout the community and must be delivered in a format that is understood, regardless of literacy and socioeconomic status. This article will discuss several successful, culturally competent community-based programs and the key elements needed to implement the programs at a community or health system level. Health systems together with local communities can integrate the elements of community-based programs that are effective across the continuum of the care to enhance patient-centered outcomes, enable patient acceptability and ultimately lead to improved patient engagement and satisfaction. [ABSTRACT FROM AUTHOR]

Introduction: Insulin degludec (IDeg) is a new basal insulin in development with a flat, ultra-long action profile that may permit dosing using a simplified titration algorithm with less frequent self-measured blood glucose (SMBG) measurements and more simplified titration steps than currently available basal insulins. Methods: This 26-week, multi-center, open-label, randomized, treat-to-target study compared the efficacy and safety of IDeg administered once-daily in combination with metformin in insulin-naïve subjects with type 2 diabetes using two different patient-driven titration algorithms: a 'Simple' algorithm, with dose adjustments based on one pre-breakfast SMBG measurement ( n = 111) versus a 'Step-wise' algorithm, with adjustments based on three consecutive pre-breakfast SMBG values ( n = 111). IDeg was administered using the FlexTouch insulin pen (Novo Nordisk A/S, Bagsværd, Denmark), with once-weekly dose titration in both groups. Results: Glycosylated hemoglobin (HbA) decreased from baseline to week 26 in both groups (−1.09%, IDeg; −0.93%, IDeg). IDeg was non-inferior to IDeg in lowering HbA [estimated treatment difference (IDeg − IDeg): −0.16% points (−0.39; 0.07)]. Fasting plasma glucose was reduced (−3.27 mmol/L, IDeg; −2.68 mmol/L, IDeg) with no significant difference between groups. Rates of confirmed hypoglycemia [1.60, IDeg; 1.17, IDeg events/patient year of exposure (PYE)] and nocturnal confirmed hypoglycemia (0.21, IDeg; 0.10, IDeg events/PYE) were low, with no significant differences between groups. Daily insulin dose after 26 weeks was 0.61 U/kg (IDeg) and 0.50 U/kg (IDeg). No significant difference in weight change was seen between groups by week 26 (+1.6 kg, IDeg; +1.1 kg, IDeg), and there were no clinically relevant differences in adverse event profiles. Conclusion: IDeg was effective and well tolerated using either the Simple or Step-wise titration algorithm. While selection of an algorithm must be based on individual patient characteristics and goals, the ability to attain good glycemic control using a simplified titration algorithm may enable patient empowerment through self-titration, improved convenience, and reduced costs. [ABSTRACT FROM AUTHOR]

Objective: To compare ultra-long-acting insulin degludec with glargine for efficacy and safety in insulin-naive patients with type 2 diabetes inadequately controlled with oral antidiabetic drugs (OADs).Research Design and Methods: In this 1-year, parallel-group, randomized, open-label, treat-to-target trial, adults with type 2 diabetes with A1C of 7-10% taking OADs were randomized 3:1 to receive once daily degludec or glargine, both with metformin. Insulin was titrated to achieve prebreakfast plasma glucose (PG) of 3.9-4.9 mmol/L. The primary end point was confirmation of noninferiority of degludec to glargine in A1C reduction after 52 weeks in an intent-to-treat analysis.Results: In all, 1,030 participants (mean age 59 years; baseline A1C 8.2%) were randomized (degludec 773, glargine 257). Reduction in A1C with degludec was similar (noninferior) to that with glargine (1.06 vs. 1.19%), with an estimated treatment difference of degludec to glargine of 0.09% (95% CI -0.04 to 0.22). Overall rates of confirmed hypoglycemia (PG <3.1 mmol/L or severe episodes requiring assistance) were similar, with degludec and glargine at 1.52 versus 1.85 episodes/patient-year of exposure (PYE). There were few episodes of nocturnal confirmed hypoglycemia in the overall population, and these occurred at a lower rate with degludec versus glargine (0.25 vs. 0.39 episodes/PYE; P = 0.038). Similar percentages of patients in both groups achieved A1C levels <7% without hypoglycemia. End-of-trial mean daily insulin doses were 0.59 and 0.60 units/kg for degludec and glargine, respectively. Adverse event rates were similar.Conclusions: Insulins degludec and glargine administered once daily in combination with OADs provided similar long-term glycemic control in insulin-naive patients with type 2 diabetes, with lower rates of nocturnal hypoglycemia with degludec. [ABSTRACT FROM AUTHOR]

OBJECTIVE-To compare ultra-long-acting insulin degludec with glargine for efficacy and safety in insulin-naive patientswith type 2 diabetes inadequately controlled with oral antidiabetic drugs (OADs). RESEARCH DESIGN AND METHODS-In this 1-year, parallel-group, randomized, open-label, treat-to-target trial, adults with type 2 diabetes with A1C of 7-10% taking OADs were randomized 3:1 to receive once daily degludec or glargine, both with metformin. Insulin was titrated to achieve prebreakfast plasma glucose (PG) of 3.9-4.9 mmol/L. The primary end point was confirmation of noninferiority of degludec to glargine in A1C reduction after 52 weeks in an intent-to-treat analysis. RESULTS-In all, 1,030 participants (mean age 59 years; baseline A1C 8.2%) were randomized (degludec 773, glargine 257). Reduction in A1C with degludec was similar (noninferior) to that with glargine (1.06 vs. 1.19%), with an estimated treatment difference of degludec to glargine of 0.09% (95% CI -0.04 to 0.22). Overall rates of confirmed hypoglycemia (PG <3.1 mmol/L or severe episodes requiring assistance) were similar, with degludec and glargine at 1.52 versus 1.85 episodes/patient-year of exposure (PYE). There were few episodes of nocturnal confirmed hypoglycemia in the overall population, and these occurred at a lower rate with degludec versus glargine (0.25 vs. 0.39 episodes/PYE; P = 0.038). Similar percentages of patients in both groups achieved A1C levels <7% without hypoglycemia. End-of-trial mean daily insulin doses were 0.59 and 0.60 units/kg for degludec and glargine, respectively. Adverse event rates were similar. CONCLUSIONS-Insulins degludec and glargine administered once daily in combination with OADs provided similar long-term glycemic control in insulin-naive patients with type 2 diabetes, with lower rates of nocturnal hypoglycemia with degludec. [ABSTRACT FROM AUTHOR]

The article discusses the benefits of community-created programs such as the Chronic Care Model (CCM) developed by Ed Wagner and colleagues, which recognizes that a major portion of chronic care management takes place outside of formal health delivery settings. Project Dulce was developed in San Diego, California to meet the American Diabetes Association (ADA) Standards of Medical Care and achieve improvements in A1C, blood pressure, and lipid parameters, and has been quite successful.

Objective: To evaluate the effect of a culturally sensitive diabetes self-management education program that uses a low-cost, peer-educator format (Project Dulce) on glucose control and metabolic parameters in low-income Mexican Americans with type 2 diabetes.Research Design and Methods: A total of 207 Mexican-American patients recruited from federally funded community health centers in San Diego County with HbA(1c) >8% were randomly assigned to the Project Dulce peer intervention or continuation of standard diabetes care. The primary outcome of interest was HbA(1c).Results: The majority of subjects were born in Mexico, were female, were middle-aged, had less than an eighth-grade education, and had high baseline HbA(1c) levels. Significant time-by-group interaction effects for HbA(1c) (P = 0.02) and diastolic blood pressure (P = 0.04) indicated that the Project Dulce group exhibited greater improvement (i.e., decreases) across time. Within-group analyses showed that the intervention group exhibited significant improvements from baseline to month 4 in absolute levels of HbA(1c) (-1.7%, P = 0.001) and HDL cholesterol (+1.4 mg/dL, P = 0.01) and from baseline to month 10 in absolute levels of HbA(1c) (-1.5%, P = 0.01), total cholesterol (-7.2 mg/dL, P = 0.04), HDL cholesterol (+1.6 mg/dL, P = 0.01), and LDL cholesterol (-8.1 mg/dL, P = 0.02). No significant changes were noted in the control group.Conclusions: This randomized trial, using the Project Dulce model of culturally sensitive, peer-led education, demonstrates improvement in glucose and metabolic control and suggests that this low-cost approach to self-management education for high-risk diabetic populations is effective. [ABSTRACT FROM AUTHOR]