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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]

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]

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]

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 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]

Aims: To investigate the glycemic efficacy, effects on cardiovascular risk factors, and safety of exenatide once weekly (QW) in patients with type 2 diabetes over 7 years in the DURATION-1 study.Methods: Patients were initially randomized to exenatide QW 2 mg or exenatide twice daily for 30 weeks, after which they received open-label, open-ended treatment with exenatide QW 2 mg for up to 7 years. Efficacy analyses included changes from baseline in glycated hemoglobin (HbA1C) and cardiovascular risk factors.Results: Of 295 patients in the intention-to-treat population, 122 (41%) completed 7 years of treatment. Patients in the 7-year completer population showed sustained glycemic improvements from baseline (7-year least-squares mean [LSM] change in HbA1C, -1.53%) and significant improvements in several cardiovascular risk factors, including body weight, diastolic blood pressure, total cholesterol, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Seven-year completers who received no additional glucose-lowering therapies (n = 65 [53%]) had similar improvements in HbA1C, and numerically greater reductions in body weight (7-year LSM change, -6.46 kg vs -3.87 kg), compared with the overall cohort. There were no unexpected safety findings.Conclusions: Treatment with exenatide QW for 7 years was associated with sustained improvements in glycemic control and several cardiovascular risk factors. [ABSTRACT FROM AUTHOR]

Background: Reducing glycemic fluctuation is important for optimal diabetes management. This post hoc analysis examined glycemic fluctuations and the proportion of subjects achieving recommended blood glucose targets with the fixed ratio combination of insulin degludec and liraglutide (IDegLira) compared to insulin degludec (IDeg) and liraglutide alone.Methods: We analyzed nine-point self-monitored blood glucose (SMBG) profiles from two randomized trials involving IDegLira in patients with type 2 diabetes (T2D), and continuous glucose monitoring (CGM) data from a subset of patients in one of these trials to assess glycemic fluctuation and day-to-day variability.Results: Compared with IDeg, IDegLira resulted in a greater proportion of subjects with SMBG values within target ranges (3.9-9.0 mmol/L) than IDeg for all pre- and postprandial values, and for the full nine-point profile (P < 0.05 for all). IDegLira also resulted in a greater reduction in the range of SMBG values over 24 h than IDeg (P ≤ 0.0001). CGM data showed that IDegLira provided greater reductions in interstitial glucose (IG) fluctuation (P = 0.0018) and postprandial IG increment (P = 0.0288) compared with IDeg. Compared with liraglutide, IDegLira brought a higher proportion of subjects within SMBG target ranges (all pre- and all postprandial values, and the full nine-point profile, P < 0.01 for all) and resulted in a greater reduction of time outside the IG target range (P = 0.0072). IDegLira also reduced mean IG more than liraglutide (P < 0.0001).Conclusions: Treatment with IDegLira allows more patients with T2D to maintain blood glucose within target ranges throughout the day than either IDeg or liraglutide alone. [ABSTRACT FROM AUTHOR]

The article discusses the innovations in insulin degludec U-100 and U-200 formulations. These include the modification of the insulin structure at the B30 position to allow the conformation of a di-hexamer, the duration of the glucose-lowering effect of the degludec, and the similar pharmacodynamic profiles of both insulin formulations at steady-state.

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]

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 m 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 m San Diego County with HbA1c, >8% were randomly assigned to the Project Dulce peer intervention or continuation of standard diabetes care. The primary outcome of interest was HbA1c. 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 HbA1c levels. Significant time-by-group interaction effects for HbA1c (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 m absolute levels of HbA1c (- 1.7%, P = 0.001) and HDL cholesterol (+1.4 mg/dL, P = 0.0l) and from baseline to month 10 in absolute levels of HbA1c (- 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]

Abstract: Background:: Many patients with poorly controlled type 2 diabetes mellitus (DM) receive, as initial insulin treatment, the addition of a basal formulation to an existing regimen of oral antidiabetic drug (OAD) therapy. Used this way, the insulin analogue detemir has been associated with improved glycemic control of a magnitude similar to neutral protamine Hagedorn (NPH), with lower rates of hypoglycemia and weight gain. Initial studies investigated detemir administered BID, but pharmacologic data suggest that detemir might be effective with QD administration. Objectives:: The aims of this study were to compare the effectiveness and tolerability of detemir versus NPH administered QD together with ?1 OAD in poorly controlled type 2 DM, and to compare different administration times of detemir. Methods:: This 20-week, multicenter, randomized, open-label, 3-arm, parallel-group trial was conducted at 91 centers across Europe and the United States. Men and women were eligible for participation if they were aged ≥18 years, had a body mass index (BMI) ≤40 kg/m2, had a diagnosis of type 2 DM of at least 12 months'' duration, and were insulin naive. Eligible patients also had a glycosylated hemoglobin (HbA1c) concentration value not outside the range of 7.5% to 11.0% following at least 3 months'' treatment with ≥10 AD. Patients were randomly assigned to receive an evening SC injection of detemir, a prebreakfast injection of detemir, or an evening injection of NPH insulin (1:1:1), administered at initial doses of 10 IU (U). Results:: A total of 504 patients were enrolled 5 men, 219 women; mean [SD] age, 59 [11] years; mean [SD] BMI, 30 [5] kg/m2; insulin detemir before breakfast, 168; insulin detemir evening, 170; NPH insulin evening, 166). The intent-to-treat population comprised 498 patients. Morning and evening detemir were associated with reductions in HbA1c similar to those with evening NPH (raw mean decreases, -1.58%, −1.48%, and −1.74%, respectively). Nine-point profile and fasting and predinner plasma glucose data found morning detemir to be associated with a different diurnal glycemic profile compared with the evening regimens. Compared with evening NPH, 24-hour and nocturnal hypoglycemia were reduced by 53% (P = 0.019) and 65% (P = 0.031), respectively, with evening detemir. Incidences of hypoglycemia did not differ significantly between groups that received morning and evening detemir, but nocturnal hypoglycemia was reduced further, by 87%, with morning detemir compared with evening NPH (P < 0.001). Weight gain was 1.2, 0.7, and 1.6 kg with morning detemir, evening detemir, and NPH, respectively (P = 0.005 for evening detemir vs NPH). No between-treatment differences were seen in other tolerability end points. Conclusions:: The results of this study in patients whose type 2 DM was poorly controlled with ≥1 OAD suggest that insulin detemir QD in the morning or evening can be used to improve glycemic control. Compared with NPH, insulin detemir may offer some tolerability advantages in this role. [Copyright &y& Elsevier]

OBJECTIVE — To improve clinical diabetes care, patient knowledge, and treatment satisfaction and to reduce health-adverse culture-based beliefs in underserved and underinsured populations with diabetes. RESEARCH DESIGN AND METHODS — A total of 153 high-risk patients with diabetes recruited from six community clinic sites in San Diego County, California were enrolled in a nurse case management (NCM) and peer education/empowerment group. Baseline and 1-year levels o[ HbA[sub 1c], lipid parameters, systolic and diastolic blood pressure, knowledge of diabetes, culture-based beliefs in ineffective remedies, and treatment satisfaction were prospectively measured. The NCM and peer education/empowerment group was compared with 76 individuals in a matched control group (CG) derived from patients referred but not enrolled in Project Dulce. RESULTS — After 1 year in Project Dulce, the NCM and peer education/empowerment group had significant improvements in HbA[sub 1c] (12.0-8.3%, P < 0.0001), total cholesterol (5.82-4.86 mmol/l, P < 0.0001), LDL cholesterol (.3.39-2.79 mmol/l, P < 0.0001), and diastolic blood pressure (80-76 mmHg, P < 0.009), which were significantly better than in the CG, in which no significant changes were noted. Accepted American Diabetes Association standards of diabetes care, knowledge of diabetes (P = 0.024), treatment satisfaction (P = 0.001), and culture based beliefs (P = 0.001) were also improved. CONCLUSIONS — A novel, culturally appropriate, community-based, nurse case manage merit/peer education diabetes care model leads to significant improvement in clinical diabetes care, self-awareness, and understanding of diabetes in underinsured populations. [ABSTRACT FROM AUTHOR]

Aims: To compare derived time in range (dTIR) with insulin degludec/liraglutide (IDegLira) and insulin glargine 100 units/mL (IGlar U100) in patients with type 2 diabetes (T2D). Methods: Data from DUAL V, a trial of patients with T2D uncontrolled on IGlar U100 randomized to switch to IDegLira or up-titration of IGlar U100 (+metformin; n=557), and DUAL VIII, a durability trial of insulin-naïve patients with T2D randomized to either IDegLira or IGlar U100 (+ oral antidiabetic drugs; n=1012), were evaluated post hoc. Self-monitored blood glucose profiles (weeks 0, 12, and 26 [DUAL V] or weeks 0, 26, and 104 [DUAL VIII]) were used to derive the proportion of available readings within (dTIR: 70-180 mg/dL [3.9-10 mmol/L]), below (dTBR: <70 mg/dL [<3.9 mmol/L]), or above (dTAR: >180 mg/dL [>10 mmol/L]) target range. Results: Estimated treatment differences (IDegLira− IGlar U100) for change from baseline to end of treatment (EOT) in dTIR were significantly greater with IDegLira vs. IGlar U100 (Figure). The proportion of patients achieving ≥70% dTIR at EOT with IDegLira and IGlar U100, respectively, was 62% and 60% in DUAL V, and 50% and 26% in DUAL VIII; the proportion achieving a ≥5% increase in dTIR from baseline to EOT was 63% in both groups in DUAL V, and 44% and 25%, respectively, in DUAL VIII. Conclusion: IDegLira was associated with significantly greater dTIR vs. IGlar U100 in insulin-experienced and insulin-naïve patients with T2D. Disclosure: A. Philis-tsimikas: Advisory Panel; Self; Bayer Inc., Lilly Diabetes, Medtronic, Novo Nordisk, Consultant; Self; Sanofi-Aventis, Employee; Spouse/Partner; Ionis, Other Relationship; Self; Merck & Co., Inc., Research Support; Self; Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk, Sanofi-Aventis. V. R. Aroda: Consultant; Self; Applied Therapeutics, Duke, Novo Nordisk, Pfizer Inc., Sanofi, Employee; Spouse/Partner; Janssen , Merck , Research Support; Self; Applied Therapeutics, Eli Lilly and Company, Fractyl , Medpace, Medpace, Novo Nordisk, Premier , Sanofi, Stock/Shareholder; Spouse/Partner; Janssen, Merck. C. De block: Advisory Panel; Self; A. Menarini Diagnostics, Abbott Diagnostics, AstraZeneca, Boehringer Ingelheim , Eli Lilly and Company, MSD, Novartis AG, Novo Nordisk, Roche Diagnostics, Sanofi, Research Support; Self; AstraZeneca, Novo Nordisk, Speaker's Bureau; Self; A. Menarini Diagnostics, Abbott Diagnostics, Boehringer Ingelheim , Eli Lilly and Company, Novo Nordisk, Sanofi. L. K. Billings: Advisory Panel; Self; Bayer Inc., Lilly Diabetes, Novo Nordisk, Sanofi. E. Hachmann-nielsen: Employee; Self; Novo Nordisk A/S. A. Liebl: Advisory Panel; Self; AstraZeneca, Becton, Dickinson and Company, Boehringer Ingelheim International GmbH, Eli Lilly and Company, MSD, Novo Nordisk, Roche, Speaker's Bureau; Self; AstraZeneca, Bayer, Becton, Dickinson and Company, Boehringer Ingelheim International GmbH, Bristol Myers Squibb , Dexcom, Inc., Eli Lilly and Company, Medtronic, MSD, Novo Nordisk, OmniaMed, Roche, Sanofi. R. Sivarathinasami: Employee; Self; Novo Nordisk Service Centre India Private Ltd. J. M. D'cruz: Employee; Self; NovoNordisk GBS. I. Lingvay: Advisory Panel; Self; Bayer Healthcare Pharmaceuticals Inc., Lilly Diabetes, Consultant; Self; TARGET PharmaSolutions, Other Relationship; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk, Pfizer Inc., Zealand Pharma A/S, Research Support; Self; Mylan N. V., Sanofi. Funding: Novo Nordisk A/S [ABSTRACT FROM AUTHOR]

In the US, nearly 11% of adults were living with diagnosed diabetes in 2017, and significant type 2 diabetes (T2D) disparities are experienced by socioeconomically disadvantaged, racial/ethnic minority populations, including Hispanics. The standard 15-min primary care visit does not allow for the ongoing self-management support that is needed to meet the complex needs of individuals with diabetes. "Team-based" chronic care delivery is an alternative approach that supplements physician care with contact from allied health personnel in the primary care setting (e.g., medical assistants; MAs) who are specially trained to provide ongoing self-management support or "health coaching." While rigorous trials have shown MA health coaching to improve diabetes outcomes, less is known about if and how such a model can be integrated within real world , primary care clinic workflows. Medical Assistant Health Coaching for Type 2 Diabetes in Diverse Primary Care Settings – A Pragmatic, Cluster-Randomized Controlled Trial will address this gap. Specifically, this study compares MA health coaching versus usual care in improving diabetes clinical control among N = 600 at-risk adults with T2D, and is being conducted at four primary care clinics that are part of two health systems that serve large, ethnically/racially, and socioeconomically diverse populations in Southern California. Electronic medical records are used to identify eligible patients at both health systems, and to examine change in clinical control over one year in the overall sample. Changes in behavioral and psychosocial outcomes are being evaluated by telephone assessment in a subset (n = 300) of participants, and rigorous process and cost evaluations will assess potential for sustainability and scalability. [ABSTRACT FROM AUTHOR]

Hispanics have a 66% higher risk of developing type 2 diabetes (T2D), and exhibit worse outcomes than non-Hispanic whites. Many Hispanics lack access to diabetes self-management education and support (DSME/S) due to practical, cultural, and other barriers. Mobile health (mHealth) technology has the potential to circumvent such barriers and expand the reach of DSME/S. A 3-group, randomized controlled trial is currently underway to evaluate the effectiveness of mHealth DSME/S approaches in improving diabetes outcomes among predominantly low income, Hispanic adults with T2D and HbA1c ≥ 8% at a Federally Qualified Health Center in Southern California. Dulce Digital-Me (DD-Me) is an adaptive mHealth intervention that integrates educational text messaging with personalized goal-setting and feedback. Over 6 months, participants receive 2-3 messages/day, and are provided with a glucometer and pillbox that wirelessly transmit real-time data to a cloud. Ecological momentary assessment (EMA) gauges progress in healthful eating, exercise, and emotional well-being. Participants' progress in lifestyle changes, medication adherence, and BG monitoring frequency and control is compared to pre-defined targets. Real-time feedback is delivered via automated, algorithm-driven messaging or by medical assistant Health Coach (n = 104 in each group). The control group (n = 207) receives educational text messages alone. Preliminary analyses (N = 163) showed higher BG monitoring frequency in the DD-Me Health Coach group (M = 7.02 ± 0.45 checks/week) versus the DD-Me algorithm-driven (M = 4.80 ± 0.49) and control groups (M = 5.25 ± 0.65), p <.01. Trends towards better medication adherence in the DD-Me groups (M = 6.78 ± 0.60 pillbox openings/week) relative to control (M = 5.40 ± 0.53) were also observed (p = 0.15). Focus groups revealed high satisfaction with the intervention. DD-Me will provide guidance on how to optimize digital health approaches for at-risk, underserved patients with diabetes. Disclosure: A.L. Fortmann: None. A. Philis-Tsimikas: Advisory Panel; Self; Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. S.R.S. Bagsic: None. D.G. Vital: None. J.A. Jones: None. H. Sandoval: None. K.L. Savin: None. T. Clark: None. K. Luu: None. J.G. Godino: None. L. Gallo: None. Funding: National Institutes of Health (1R01DK112322) [ABSTRACT FROM AUTHOR]

Strong evidence for improving clinical outcomes exists for the Diabetes Prevention Program (DPP) and diabetes self-management education (DSME) yet traditional methods of education and outreach have been minimally effective at engaging high-risk Hispanics. Scripps Whittier Diabetes Institute, San Diego, CA, has delivered culturally appropriate DSME and DPP programs for over 25 years and was seeking an effective method to further engage diverse communities. Facebook is the number one platform for U.S. Hispanics' communication. Nearly half (48%) of U.S. Hispanics' Facebook friends are family members, compared to 36% for the total population. Hispanics are the most mobile and socially active group in the U.S. and converse in the language of their preference. On-line messaging developed in Spanish and English utilized patient stories to increase understanding of diabetes risk and encourage an online risk assessment. The audience included adults ages 40+ in Chula Vista; along the Mexican American border. The campaign landing page included calls to action, helpful information regarding diabetes risk factors and links to inspiring patient stories. Nurturing emails were sent to all leads with lifestyle tips and call to action to register for a diabetes program. Bi-lingual telephone outreach was conducted within one week of the risk assessment completion to make a personal connection and answer questions. In the first 75 days of the campaign, 92 assessments were initiated: 66 completed: 26 abandoned. Of the leads sent: 75% were from the Spanish language campaign; 0.67% click-through-rate from Facebook to the landing page; of the 1800 clicks, 75% came from the Spanish language ads; 60-75% of the clicks are from a female audience for both English and Spanish; and nearly 50/50 split between at risk and not at risk for T2DM.This social media campaign pilot was effective in increasing awareness of diabetes risks, DPP and DSME in Hispanic communities, especially in the Spanish speaking, female population. Disclosure: A. Philis-Tsimikas: Advisory Panel; Self; Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. M. Ruiz: None. A.L. Fortmann: None. E. Aguilar: None. R. Johnson: None. A. Kienast: None. C. Walker: None. Funding: Woltman Family Foundation [ABSTRACT FROM AUTHOR]

Self-adjusting insulin is challenging for people with type 2 diabetes (PWT2D). Mobile health technologies (mHealth) can help PWT2D track blood glucose more easily, but it remains unclear whether an mHealth-enabled digital therapeutic tool can effectively support basal insulin (BI) titration in a large multispecialty health care setting. We randomized 242 PWT2D on BI (baseline HbA1c 7.5% - 12.5%) to use either an app-based self-titration tool [Mobile Insulin Dosing System (MIDS)] or an enhanced paper titration tool based on a stepped algorithm with diabetes educator support (control) for 16 weeks. Cohort characteristics for the intent to treat sample (MIDS n = 117; control n = 120) were: median age 61 years [IQR: 53 - 69], 41.7% female, 75.9% non-Hispanic White, 11.4% new to insulin, median duration of diabetes 11 years [IQR: 7 - 18], and median baseline HbA1c of 8.7% [IQR: 8.0 - 9.6]. Improvements in HbA1c (-1.3% [IQR: -2.2 - -.5] and -1.2% [IQR: -1.9 - -.5]; both Ps <.05) with increased median insulin dose (+8 IU [IQR: 2 - 22] and +10 IU [IQR: 2 - 25.5]; both Ps <.05) and no change in hypoglycemia were observed at 16 weeks in both the MIDS and control groups, respectively. No differences in HbA1c (P =.48) or insulin dose change (P =.34) were observed between the groups. Among SMBG readings recorded during the study, the mean proportion of readings between 70-180 mg/dL (76.8% ± 22.0; 70.0% ± 26.7; p<0.05) and >250 mg/dL (4.9% ± 9.2; 9.2% ± 18.4; p<0.05) both favored the MIDS group. The use of MIDS and the enhanced paper-based tool for BI self-titration both resulted in higher insulin dose and significantly improved glycemic control among PWT2D who were relatively uncontrolled despite most already being treated with insulin. An mHealth-enabled digital therapeutic tool such as MIDS may offer an effective alternative option for PWT2D and their HCPs for titrating BI to non-mHealth approaches; future RCTs will more clearly elucidate the efficacy of MIDS compared to usual care. Disclosure: A. Philis-Tsimikas: Advisory Panel; Self; Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Boehringer Ingelheim Pharmaceuticals, Inc., Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk A/S, Sanofi. A.L. Fortmann: None. A. Bastian: None. A. Kanchi: Employee; Self; Glooko, Inc. Stock/Shareholder; Self; Glooko, Inc. R. Abad: Employee; Self; Glooko, Inc. T. Sheng: Employee; Self; Glooko, Inc. L. Parks: Employee; Self; Glooko, Inc. M. Greenfield: Consultant; Self; Glooko, Inc. M.A. Clements: Consultant; Self; Glooko, Inc. Other Relationship; Self; Glooko, Inc. [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]

BRIGHT demonstrated similar HbA1c reduction and hypoglycemia risk with the second-generation basal insulin analogs insulin glargine 300 U/mL (Gla-300) and insulin degludec 100 U/mL (IDeg) over 24 weeks, and less anytime (24 h) hypoglycemia with Gla-300 during the first 12 weeks, in T2DM. This analysis examined HbA1c change and confirmed (≤70 mg/dL and <54 mg/dL) hypoglycemia by baseline characteristics. BRIGHT was a multicenter, open-label, randomized, active-controlled, parallel-group trial in T2DM. Participants receiving multiple oral agents ± GLP-1 RAs were randomized to Gla-300 (N=466) or IDeg (N=463), titrated to a fasting SMPG of 80-100 mg/dL. Efficacy and safety with Gla-300 vs. IDeg were unaffected by age (≥65 years), gender, BMI category (<30/30-35/≥35 kg/m2) or diabetes duration (≥10 years). However, significant heterogeneity of treatment effect across subgroups (p=0.015) suggested greater HbA1c reduction with Gla-300 than IDeg with impaired renal function (eGFR <60 mL/min/1.73 m2) (Table), with no difference in hypoglycemia incidence or rates. Further analyses revealed lower confirmed (≤70 mg/dL) hypoglycemia rates with Gla-300 vs. IDeg in those with normal renal function, with comparable HbA1c reduction (Table). In conclusion, Gla-300 appears to confer advantages vs. IDeg in those with impaired renal function, warranting further investigation. Disclosure: M. Haluzik: Advisory Panel; Self; AstraZeneca, Medtronic, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Consultant; Self; Johnson & Johnson, Lilly Diabetes. Speaker's Bureau; Self; Novartis AG. A. Philis-Tsimikas: Advisory Panel; Self; AstraZeneca, Lilly Diabetes, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Dexcom, Inc., Glooko, Inc., National Institute of Diabetes and Digestive and Kidney Diseases. Stock/Shareholder; Spouse/Partner; Ionis Pharmaceuticals, Inc., Novo Nordisk Inc. Z. Bosnyak: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi. D. Müller-Wieland: Advisory Panel; Self; Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH. Speaker's Bureau; Self; Amgen Inc., AstraZeneca, Bayer AG, Boehringer Ingelheim Pharmaceuticals, Inc., Merck Sharp & Dohme Corp., Novo Nordisk Inc., Sanofi-Aventis Deutschland GmbH. F. Lauand: Employee; Self; Sanofi. L. Melas-Melt: Consultant; Self; Sanofi. J. Rosenstock: Research Support; Self; AstraZeneca, Bristol-Myers Squibb Company, Genentech, Inc., GlaxoSmithKline plc., Lexicon Pharmaceuticals, Inc., Melior Pharmaceuticals, Inc., Bukwang Pharm. Co., Ltd., Merck & Co., Inc., Oramed Pharmaceuticals, PegBio Co., Ltd., Pfizer Inc. Other Relationship; Self; Boehringer Ingelheim International GmbH, Eli Lilly and Company, Intarcia Therapeutics, Inc., Janssen Pharmaceuticals, Inc., Novo Nordisk Inc., Sanofi. G.B. Bolli: Advisory Panel; Self; Sanofi. Research Support; Self; A. Menarini Diagnostics, Medtronic. Funding: Sanofi (NCT02738151) [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]

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]

Abstract: Primary care practitioners are increasingly responsible for the management of the escalating numbers of patients with type 2 diabetes. The majority of these patients will require insulin replacement therapy as their disease progresses, because glycemic control is often unsustainable using oral antidiabetic drugs. This review explains the practicalities of initiating and optimizing basal insulin in clinical practice, emphasizing the need for regular glycated hemoglobin (A1c) monitoring to allow timely initiation of insulin when the A1c target is not met. The importance of patient education in overcoming barriers to insulin is discussed, as well as the choice of available basal insulins and the necessity to optimize basal insulin dosage by self-titration. The traditional view of insulin therapy as a last resort is challenged with the modern basal insulin analogues (insulin detemir and insulin glargine), which offer simple and effective glycemic control with a reduced risk of hypoglycemia compared with older insulin formulations such as neutral protamine Hagedorn. [Copyright &y& Elsevier]

The article discusses studies which examined the effects of Colesevelam HC1 (COL), a bile acid sequestrant indicated to lower low-density lipoprotein cholesterol, versus placebo (PL) when combined with metformin, sulfonylurea or insulin-based therapy. A pilot study showed that COL improves the lipid profile and glycemic control when added to an established antidiabetic regimen in patients with type 2 diabetes mellitus (T2DM). Also reported is the analysis of glycemic control based on age.

Obese patients with type 2 diabetes mellitus (T2DM) run a higher cardiovascular risk than normal-weight patients. Therefore, potential weight gain is of special concern once insulin therapy is initiated. Many trials suggest that insulin detemir (detemir) is associated with less weight gain than Neutral Protamine Hagedorn (NPH). The latest, a 20-week multinational, open-label, randomized parallel group trial demonstrated less weight gain with detemir than with NPH when administered once daily in the evening. Based on this trial, a comparison of 168 vs. 163 insulin-naive subjects with T2DM ≥ 1 year poorly controlled on l ≥ OAD(s) was made. Subject characteristics were: mean age 58.7 vs. 58.4 yrs, HbA[sub 1c] 8.9 vs. 9.2%, weight 83.5 vs. 85.3 kg and BMI 29.7 vs. 30.4 kg/m² at baseline with detemir and NPH, respectively. Insulin treatment, initiated at l0 units/day as add-on to OADs, was titrated individually based on fasting plasma glucose (PG) with pre-breakfast and pre-dinner PG targets of 6.0 mmol/L. After 20 weeks, glycemic control was similar. HbA[sub 1c] was reduced by 1.6 vs. 1.7% and fasting PG was reduced by 4.1 vs. 3.7 mmol/L with detemir and NPH, respectively and less weight gain was observed with detemir (0.7 vs. 1.6 kg, p=0.005) at equal doses (0.4 units/kg). To explore this difference in weight development even further, weight changes were compared between detemir and NPH by baseline BMI. Using a model of linear regression (lr) with BMI at baseline as a covariate, the overall weight benefit of detemir was confirmed. Furthermore, the model demonstrated less weight gain by increasing baseline BMI with detemir, whereas more weight gain by increasing baseline BMI was demonstrated with NPH, as illustrated in the figure. This difference in weight change by BMI was statistical significant between detemir and NPH (p=0.004). To conclude, once daily determir when added to OADs in T2DM improved glycemic control with less weight gain, particularly in overweight or obese subjects initiating insulin therapy. [ABSTRACT FROM AUTHOR]

Objective: To evaluate safety and effectiveness of MiniMed™ 670G hybrid closed loop in comparison with continuous subcutaneous insulin infusion (CSII) therapy for six months, in persons with type 1 diabetes (T1D).Methods: Adults (aged 18-80 years), adolescents, and children (aged 2-17 years) with T1D who were using CSII therapy were enrolled and randomized (1:1) to six months of HCL intervention (N=151, mean age of 39.9±19.8 years) or CSII control (N=151, 35.7±18.4 years) without continuous glucose monitoring. Primary effectiveness endpoints included change in A1C for Group 1 (baseline A1C >8.0%), from baseline to the end of study, and difference in the end of study percentage of time spent below 70 mg/dL (%TBR<70 mg/dL) for Group 2 (baseline A1C ≤8.0%), to show superiority of HCL intervention versus control. Secondary effectiveness endpoints were change in A1C and %TBR<70 mg/dL for Group 2 and Group 1, respectively, to show non-inferiority of HCL intervention versus control. Primary safety endpoints were rates of severe hypoglycemia and diabetic ketoacidosis (DKA).Results: Change in A1C and difference in %TBR<70 mg/dL for the overall group were significantly improved, in favor of HCL intervention. In addition, a significant mean (95% CI) change in A1C was observed for both Group 1 (-0.8% [-1.1%,-0.4%], p<0.0001) and Group 2 (-0.3% [-0.5%,-0.1%], p<0.0001), in favor of HCL intervention. The same was observed for difference in %TBR<70 mg/dL for Group 1 (-2.2% [-3.6%,-0.9%]) and Group 2 (-4.9% [-6.3%,-3.6%]) (p<0.0001 for both). There was one DKA event during run-in and six severe hypoglycemic events: two during run-in and four during study (HCL: N=0 and CSII: N=4 [6.08 per 100 patient-years]).Conclusions: This RCT demonstrate that the MiniMed 670G system safely and significantly improved A1C and %TBR<70 mg/dL with HCL intervention compared with CSII control in persons with T1D, irrespective of baseline A1C level. [ABSTRACT FROM AUTHOR]

• Clinical data were reported for once-weekly insulin icodec in the ONWARDS trials. • We report patient and physician insights from three of these phase 3a trials. • Patient treatment satisfaction was higher with once-weekly vs. daily basal insulin. • Patients and physicians strongly preferred once-weekly vs. daily basal insulin. • Patients were willing to continue and recommend once-weekly basal insulin therapy. The ONWARDS phase 3a clinical trials evaluated once-weekly insulin icodec (icodec) versus once-daily basal insulin in type 2 diabetes. This analysis investigated the treatment-related experiences of participants from ONWARDS 5 and 2, and physicians from ONWARDS 1. Patient-reported outcomes were only collected during ONWARDS 5 (icodec with a dosing guide app vs. once-daily basal analogues) and 2 (icodec vs. once-daily insulin degludec). ONWARDS 1 (icodec vs. once-daily insulin glargine U100) physicians' treatment preferences and satisfaction were obtained via an online survey. In ONWARDS 5 and 2, there was a statistically significantly greater increase in total treatment satisfaction from baseline to end of treatment for icodec/icodec with app versus once-daily comparators, mostly driven by participants' willingness to continue and recommend treatment. In ONWARDS 2, 93.7 % of icodec users preferred once-weekly over once-daily basal insulin, mainly owing to less frequent injections and ease of use. ONWARDS 1 physicians reported greater satisfaction with once-weekly than with once-daily basal insulin and were more likely to recommend once-weekly injections. These results demonstrate improved treatment satisfaction with, and strong preferences for, once-weekly versus once-daily basal insulin. Treatment convenience and willingness to continue and recommend once-weekly basal insulin treatment were highlighted. Clinical trial registrations : ONWARDS 1: NCT04460885; ONWARDS 2: NCT04770532; ONWARDS 5: NCT04760626 [ABSTRACT FROM AUTHOR]

Diabetes distress (DD) is a prevalent concern among people with type 1 diabetes (T1D) and is linked to poor clinical outcomes. Instead of targeting the elimination of DD, we propose a novel approach that empowers individuals with strategies to manage their diabetes effectively in the context of DD: Acceptance and Commitment Therapy (ACT). The purpose of this in-progress trial is to compare an ACT group intervention (ACT1VATE) with usual care in improving HbA1c, DD, quality of life, and cost-effectiveness in adults with T1D. This is a two-arm, parallel group, randomized controlled superiority trial enrolling N = 250 adults with T1D, elevated HbA1c, and significant DD in a real-world community-based health system. Participants are randomized to receive ACT1VATE (a five-week ACT group telehealth intervention) or diabetes self-management education and support (usual care as the first-line recommended intervention for DD). The trial will examine comparative effectiveness in improving HbA1c, DD, quality of life, and cost-effectiveness over 12 months. We predict that ACT1VATE will be superior given its (1) specific focus on DD, without any expectation that difficult diabetes-related thoughts and emotions must (or can) be completely eliminated; and (2) purposeful linkage of diabetes self-care behaviors to an individual's deeply held values, thus eliciting intrinsic, patient-centric motivation for meaningful and lasting health behavior changes. This trial will provide a valuable test of real-world effectiveness, drive sustainability and scalability, and inform the future of chronic disease care. Trial registration: NCT04933851 (https://clinicaltrials.gov/ct2/show/NCT04933851). Clinical Trial: Clinicaltrials.gov NCT04933851 https://clinicaltrials.gov/study/NCT04933851 [ABSTRACT FROM AUTHOR]

Introduction: This trial assessed safety and effectiveness of an advanced hybrid closed-loop (AHCL) system with automated basal (Auto Basal) and automated bolus correction (Auto Correction) in adolescents and adults with type 1 diabetes (T1D). Materials and Methods: This multicenter single-arm study involved an intent-to-treat population of 157 individuals (39 adolescents aged 14-21 years and 118 adults aged ≥22-75 years) with T1D. Study participants used the MiniMed™ AHCL system during a baseline run-in period in which sensor-augmented pump +/- predictive low glucose management or Auto Basal was enabled for ∼14 days. Thereafter, Auto Basal and Auto Correction were enabled for a study phase (∼90 days), with glucose target set to 100 or 120 mg/dL for ∼45 days, followed by the other target for ∼45 days. Study endpoints included safety events and change in mean A1C, time in range (TIR, 70-180 mg/dL) and time below range (TBR, <70 mg/dL). Run-in and study phase values were compared using Wilcoxon signed-rank test or paired t-test. Results: Overall group time spent in closed loop averaged 94.9% ± 5.4% and involved only 1.2 ± 0.8 exits per week. Compared with run-in, AHCL reduced A1C from 7.5% ± 0.8% to 7.0% ± 0.5% (<0.001, Wilcoxon signed-rank test, n = 155), TIR increased from 68.8% ± 10.5% to 74.5% ± 6.9% (<0.001, Wilcoxon signed-rank test), and TBR reduced from 3.3% ± 2.9% to 2.3% ± 1.7% (<0.001, Wilcoxon signed-rank test). Similar benefits to glycemia were observed for each age group and were more pronounced for the nighttime (12 AM-6 AM). The 100 mg/dL target increased TIR to 75.4% (n = 155), which was further optimized at a lower active insulin time (AIT) setting (i.e., 2 h), without increasing TBR. There were no severe hypoglycemic or diabetic ketoacidosis events during the study phase. Conclusions: These findings show that the MiniMed AHCL system is safe and allows for achievement of recommended glycemic targets in adolescents and adults with T1D. Adjustments in target and AIT settings may further optimize glycemia and improve user experience. Clinical Trial Registration number: NCT03959423. [ABSTRACT FROM AUTHOR]

Background: Diabetes is the sixth leading cause of death and results in significant morbidity. The purpose of this study is to determine what demographic, health status, treatment, access/quality of care, and behavioral factors are associated with poor glycemic control in a Type 2 diabetic, low-income, minority, San Diego population. Methods: Longitudinal observational data was collected on patients with Type 2 diabetes from Project Dulce, a program in San Diego County designed to care for an underserved diabetic population. The study sample included 573 patients with a racial/ethnic mix of 53% Hispanic, 7% black, 18% Asian, 20% white, and 2% other. We utilized mixed effects models to determine the factors associated with poor glycemic control using hemoglobin A1C (A1C) as the outcome of interest. A multi-step model building process was used resulting in a final parsimonious model with main effects and interaction terms. Results: Patients had a mean age of 55 years, 69% were female, the mean duration of diabetes was 7.1 years, 31% were treated with insulin, and 57% were obese. American Diabetes Association (ADA) recommendations for blood pressure and total cholesterol were met by 71% and 68%, respectively. Results of the mixed effects model showed that patients who were uninsured, had diabetes for a longer period of time, used insulin or multiple oral agents, or had high cholesterol had higher A1C values over time indicating poorer glycemic control. The younger subjects also had poorer control. Conclusion: This study provides factors that predict glycemic control in a specific low-income, multiethnic, Type 2 diabetic population. With this information, subgroups with high risk of disease morbidity were identified. Barriers that prevent these patients from meeting their goals must be explored to improve health outcomes. [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]

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]

COVID-19 challenges organizations to modify approaches to optimize diabetes management while reducing Personal Protective Equipment (PPE) use and nurse time, and maintaining patient safety. In April 2020, Scripps Health, a five-hospital health system in southern California created a subcutaneous Diabetes Ketoacidosis (DKA) treatment option for use with adults, admitted with mild to moderate DKA. Primary aims were to achieve DKA resolution and glycemic targets similar to the intravenous (IV) insulin treatment option, and no hypoglycemia <70 mg/dL. The new order set utilized weight-based dosing, with similar orders for labs, electrolyte and IV fluid replacement, and resolution criteria. Differences included automatic insulin dosing and basal/bolus insulin. Key changes were a reduced frequency of point of care testing (POCT) and ≤140 mg/dL hypoglycemia prevention orders. Post-implementation audits between April - July 2020 showed no hypoglycemia and resolution time similar to IV insulin. However, only 6% (N=17) of DKA cases were managed with subcutaneous, as compared to IV insulin. To help understand why there was such a limited uptake, a detailed retrospective chart review was undertaken on a subset of twenty-two DKA cases managed with IV insulin. Findings showed that 17 (77%) had type 2 diabetes, 5 (23%) had type 1 diabetes. 47% of cases had opportunities for subcutaneous management based on DKA classification and no contraindications for subcutaneous therapy. Findings indicate organizations should consider a DKA subcutaneous option. Lack of knowledge of DKA severity may be a factor in low utilization, therefore an EHR DKA Classification tool was implemented to support providers. Research is needed to determine if this increases utilization of the subcutaneous treatment option and what other barriers exist. Disclosure: D. Meehan: None. L. Talavera: None. A. Philis-tsimikas: Advisory Panel; Self; Bayer Inc., Lilly Diabetes, Medtronic, Novo Nordisk, Consultant; Self; Sanofi-Aventis, Employee; Spouse/Partner; Ionis, Other Relationship; Self; Merck & Co., Inc., Research Support; Self; Dexcom, Inc., Lilly Diabetes, Medtronic, Novo Nordisk, Sanofi-Aventis. A. L. Fortmann: None. [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]

Hispanic individuals have higher type 2 diabetes (T2D) prevalence, poorer outcomes, and are disproportionately affected by COVID-19. Culturally-tailored, diabetes educational text messaging has previously improved HbA1c in this population. During the pandemic, hospitalized Hispanic adults with T2D (N = 172) were randomized to receive Dulce Digital-COVID Aware ("DD-CA") texting platform upon discharge plus diabetes transition service (DTS) or DTS alone. DD-CA includes diabetes educational messaging with additional COVID-safe messaging (e.g., promoting masking; social distancing; vaccination). Among adults with poorly-controlled diabetes (Mean HbA1c = 9.6 ± 2.2 %), DD-CA did not reduce 30- or 90-day readmissions compared to standard care (28 % vs 15 %, p =.06; 37 % vs 35 %, p =.9, respectively). However, the improvement in HbA1c was larger among those in the DD-CA compared to DTS at 3 months (n = 56; −2.69 % vs. −1.45 %, p =.0496) with reduced effect at 6 months (n = 64; −2.03 % vs −0.91 %, p =.07). Low follow-up completion rates and the addition of covariates (to control for baseline group differences that existed despite randomization) impacted statistical power. During the pandemic, DD-CA offered an alternative digital approach to diabetes and COVID education and support for a high-risk Hispanic population and achieved trends toward improvement in glycemic control despite relatively low engagement and not reducing hospital readmissions. [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]

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]

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]

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]

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]

The enhanced recovery after surgery (ERAS) protocol is a perioperative care pathway adopted in health systems across the nation as part of quality improvement efforts. A bundle of 20 elements demonstrated improved clinical and financial outcomes. A key element promotes carbohydrate loading a few hours before surgery using beverages such as Boost or ClearFast. There is limited data on pre-DM and DM patients and no clear guidelines on use in these populations. Scripps Health, a large health system in Southern California, adopted the ERAS protocol as a systemwide approach for care improvement in the perioperative process in 2018. Pre-DM and DM patients were represented more commonly in the bariatric surgery group thus providing an opportunity to compare outcomes in these patients receiving a carbohydrate loaded beverage pre and post implementation of the standardized ERAS protocol. We compared N=97 bariatric pre-DM and DM patients who did not receive Clearfast from Jan-Sept 2017 to N=64 bariatric pre-DM and DM patients who received Clearfast from Jan-Sept 2018. See Table 1. Interestingly, in patients with pre-DM and DM, there was a substantial increase in pre-op hyperglycemia but a post-op decrease was noted when a carb-loaded beverage-Clearfast was given to patients prior to bariatric surgery when compared to the previous year when ERAS and carb loading were not part of the perioperative preparation process. Disclosure: K.L. Barthelmess: None. L. Talavera: None. A. Philis-Tsimikas: Advisory Panel; Self; AstraZeneca, Lilly Diabetes, Novo Nordisk A/S, Sanofi. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc. Research Support; Self; Dexcom, Inc., Glooko, Inc., National Institute of Diabetes and Digestive and Kidney Diseases. Stock/Shareholder; Spouse/Partner; Ionis Pharmaceuticals, Inc., Novo Nordisk Inc. [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]