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Background: Anecdotal reports suggest that insulin degludec (IDeg) may offer unique health-related quality of life (HRQoL) benefits. As the nature of these benefits remain unclear, this study utilized qualitative research methods to investigate and elucidate the experience of "feeling better" after initiating IDeg.Methods: Twenty adults with type 2 diabetes (T2D) who reported "feeling better" on IDeg for > 3 months participated in 90-min interviews. One focus group and nine telephone interviews were conducted at two sites in the United States (US) and one focus group was conducted in Switzerland. Patients were ≥ 18 years of age, did not take mealtime insulin, and had switched to IDeg from another basal insulin. Discussions were audio-recorded, transcribed and translated (Swiss German). Utilizing grounded theory, transcripts were analyzed by sorting quotes into concepts using thematic analysis.Results: Participants' mean age was 66 years and the average duration of T2D was 17.6 years. Mean duration of IDeg use was 1.45 years. Four major factors were identified as key contributors to patients' sense of "feeling better": 1) reduced sense of diabetes as burdensome and requiring excessive attention; 2) enhanced feelings of adaptability and freedom; 3) heightened sense of security, especially regarding concerns about hypoglycemia; and 4) greater sense of physical well-being (greater energy/less fatigue). Content saturation was achieved. Generally, patients from the US sites were more focused on medical results than Swiss patients, who were more likely to identify IDeg's effect on overall HRQoL. A limitation of the study was that the population was primarily white, > 60 and otherwise healthy (no comorbid physical or mental condition).Conclusions: A group of patients with T2D, who had switched to IDeg from another basal insulin, reported HRQoL benefits which were attributed to both diabetes-specific improvements (feeling less burdened by day-to-day diabetes demands) and non-specific gains (greater energy). The conclusions may have limited transferability due to the characteristics of the sample population and further research is needed. [ABSTRACT FROM AUTHOR]

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. 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., (© 2024. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

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., (© 2024 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

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., (© 2024 by the American Diabetes Association.)

Background: Derived time in range (dTIR), calculated from self-monitored blood glucose (SMBG-dTIR) profiles, has demonstrated correlation with risk of cardiovascular and microvascular complications. This post hoc analysis of the DUAL V and DUAL VIII trials aimed to compare dTIR with an insulin degludec/liraglutide fixed-ratio combination (IDegLira) versus insulin glargine 100 units/mL (glargine U100) in people with type 2 diabetes (T2D)., Materials and Methods: Nine-point SMBG profiles were taken more than 24 hours at baseline and end of trial (EOT: 26 weeks [DUAL V] and 104 weeks [DUAL VIII]) and used to derive the percentage of readings within target range (70-180 mg/dL). Estimated treatment differences (ETDs, IDegLira-glargine U100) were analyzed using analysis of covariance, with treatment as fixed effects and baseline response as a covariate., Results: ETDs for change from baseline to EOT in dTIR were significantly greater with IDegLira versus glargine U100 in DUAL V (4.18%, P = .027) and DUAL VIII (5.17%, P = .001). The proportions of people achieving ≥70% dTIR at EOT with IDegLira and glargine U100, respectively, were 62% and 60% in DUAL V ( P = .7541), and 50% and 26% in DUAL VIII ( P < .0001). The proportion achieving a ≥5% increase in dTIR from baseline to EOT with IDegLira and glargine U100 was 63% in both groups in DUAL V ( P = .9043), and 44% and 25%, respectively, in DUAL VIII ( P < .0001)., Conclusions: IDegLira was associated with significantly greater increases in dTIR versus basal insulin alone in people with T2D., Trial Id(s): ClinicalTrials.gov, NCT01952145 (DUAL V); ClinicalTrials.gov, NCT02501161 (DUAL VIII)., Competing Interests: Declaration of Conflicting InterestsThe author(s) declared the following potential conflicts of interest with respect to the research, authorship, and/or publication of this article: AP-T provides consulting and research services to Novo Nordisk, Lilly, Bayer, Dexcom, and Medtronic on behalf of her employer but receives no direct or indirect reimbursement for the services. VRA reports consulting fees from Applied Therapeutics, Fractyl, Novo Nordisk, Pfizer, Sanofi, and institutional contracts for research from Applied Therapeutics/Medpace, Eli Lilly, Premier/Fractyl, Novo Nordisk, and Sanofi/Medpace. Her spouse is an employee of Janssen. CDB reports consulting fees and honoraria for speaking for Abbott, AstraZeneca, Boehringer-Ingelheim, Eli Lilly, Insulet, Medtronic, Novo Nordisk, and Roche. LKB reports honoraria for attending advisory boards or consulting services provided to Lilly, Novo Nordisk, Xeris, Bayer, and Sanofi. AL has received research support and honoraria for giving presentations and attending advisory boards: AstraZeneca, Bayer, Becton Dickinson, Boehringer-Ingelheim, Bristol Myers Squibb, Lilly, Medtronic, MSD, Novo Nordisk, Roche, and Sanofi. IL reports receiving advisory board fees and consulting fees from AstraZeneca, consulting fees from Bayer Healthcare Pharmaceuticals, Eli Lilly and Company, Intarcia, Intercept Pharmaceuticals, Janssen Global Services, MannKind Corporation, Target Pharma, Valeritas, and Zealand Pharma; advisory board fees from Boehringer-Ingelheim and Sanofi US Services; grant support, paid to UT Southwestern, from Merck; grant support, paid to her institution, from Mylan Pharmaceuticals and Pfizer; grant support, paid to UT Southwestern; and advisory board fees, consulting fees, and travel support from Novo Nordisk. RS and JMD’C are employees of Novo Nordisk A/S.

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., (© 2024 by the American Diabetes Association.)

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., (© Society of Behavioral Medicine 2023. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.)

Background: A composite metric for the quality of glycemia from continuous glucose monitor (CGM) tracings could be useful for assisting with basic clinical interpretation of CGM data., Methods: We assembled a data set of 14-day CGM tracings from 225 insulin-treated adults with diabetes. Using a balanced incomplete block design, 330 clinicians who were highly experienced with CGM analysis and interpretation ranked the CGM tracings from best to worst quality of glycemia. We used principal component analysis and multiple regressions to develop a model to predict the clinician ranking based on seven standard metrics in an Ambulatory Glucose Profile: very low-glucose and low-glucose hypoglycemia; very high-glucose and high-glucose hyperglycemia; time in range; mean glucose; and coefficient of variation., Results: The analysis showed that clinician rankings depend on two components, one related to hypoglycemia that gives more weight to very low-glucose than to low-glucose and the other related to hyperglycemia that likewise gives greater weight to very high-glucose than to high-glucose. These two components should be calculated and displayed separately, but they can also be combined into a single Glycemia Risk Index (GRI) that corresponds closely to the clinician rankings of the overall quality of glycemia (r = 0.95). The GRI can be displayed graphically on a GRI Grid with the hypoglycemia component on the horizontal axis and the hyperglycemia component on the vertical axis. Diagonal lines divide the graph into five zones (quintiles) corresponding to the best (0th to 20th percentile) to worst (81st to 100th percentile) overall quality of glycemia. The GRI Grid enables users to track sequential changes within an individual over time and compare groups of individuals., Conclusion: The GRI is a single-number summary of the quality of glycemia. Its hypoglycemia and hyperglycemia components provide actionable scores and a graphical display (the GRI Grid) that can be used by clinicians and researchers to determine the glycemic effects of prescribed and investigational treatments.

Background: Insulin icodec (icodec) is a once-weekly basal insulin currently under development. ONWARDS 2 aimed to assess the efficacy and safety of once-weekly icodec versus once-daily insulin degludec (degludec) in basal insulin-treated type 2 diabetes., Methods: This 26-week, randomised, open-label, active-controlled, multicentre, treat-to-target phase 3a trial was conducted in 71 sites in nine countries. Eligible participants with type 2 diabetes inadequately controlled on once-daily or twice-daily basal insulin, with or without non-insulin glucose-lowering agents, were randomly assigned (1:1) to once-weekly icodec or once-daily degludec. The primary outcome was change from baseline to week 26 in HbA 1c ; the margin used to establish non-inferiority of icodec compared with degludec was 0·3 percentage points. Safety outcomes (hypoglycaemic episodes and adverse events) and patient-reported outcomes were also assessed. The primary outcome was evaluated in all randomly assigned participants; safety outcomes were evaluated descriptively based on all randomly assigned participants who received at least one dose of trial product, with statistical analyses based on all randomly assigned participants. This trial is registered with ClinicalTrials.gov, NCT04770532, and is now complete., Findings: Between March 5 and July 19, 2021, 635 participants were screened, of whom 109 were ineligible or withdrew, and 526 were randomly assigned to icodec (n=263) or degludec (n=263). From a mean baseline of 8·17% (icodec; 65·8 mmol/mol) and 8·10% (degludec; 65·0 mmol/mol), HbA 1c was reduced to a greater extent with icodec than degludec (7·20% vs 7·42% [55·2 vs 57·6 mmol/mol], respectively) at week 26. This translates to an estimated treatment difference (ETD) of -0·22 percentage points (95% CI -0·37 to -0·08) or -2·4 mmol/mol (95% CI -4·1 to -0·8), demonstrating non-inferiority (p<0·0001) and superiority (p=0·0028). The estimated mean change from baseline to week 26 in bodyweight was +1·40 kg for icodec and -0·30 kg for degludec (ETD 1·70 [95% CI 0·76 to 2·63]). Overall rates of combined level 2 or level 3 hypoglycaemia were less than one event per patient-year of exposure for both groups (0·73 [icodec] vs 0·27 [degludec]; estimated rate ratio 1·93 [95% CI 0·93 to 4·02]). Overall, 161 (61%) of 262 participants receiving icodec and 134 (51%) of 263 participants receiving degludec experienced an adverse event; 22 (8%) and 16 (6%), respectively, experienced a serious adverse event. One serious adverse event (degludec) was assessed as being possibly related to treatment. No new safety issues were identified in relation to icodec compared with degludec in this trial., Interpretation: Among adults with basal insulin-treated type 2 diabetes, treatment with once-weekly icodec versus once-daily degludec demonstrated non-inferiority and statistical superiority in HbA 1c reduction after 26 weeks, associated with modest weight gain. Overall rates of hypoglycaemia were low, with numerically but not statistically significantly higher event rates of level 2 or level 3 hypoglycaemia with icodec versus degludec., Funding: Novo Nordisk., Competing Interests: Declaration of interests AP-T performs research and serves as an advisor on behalf of their employer for Abbott, Dexcom, Eli Lilly, Medtronic, Novo Nordisk, and Sanofi; there have been no direct or indirect transfer of funds. EF serves as an advisor for Boehringer-Ingelheim, Eli Lilly, and Novo Nordisk, and has received lecture fees from Bayer, Bioton, Boehringer-Ingelheim, Eli Lilly, and Servier. TJ, MA, and KS are employees and shareholders of Novo Nordisk. JR has served on advisory panels for Applied Therapeutics, Boehringer Ingelheim, Eli Lilly, Intarcia, Novo Nordisk, Oramed, Hanmi, Sanofi, and Zealand, and has received research support from Applied Therapeutics, AstraZeneca, Boehringer Ingelheim, Eli Lilly, Genentech, Novartis, Intarcia, Merck, Novo Nordisk, Oramed, Pfizer, and Sanofi. HW acted as an advisory board member for Novo Nordisk, as a speaker for Astellas Pharma, AstraZeneca, Eli Lilly Japan, FUJIFILM Pharma, Kissei Pharmaceutical, Kowa Pharmaceutical, Merck Sharp & Dohme, Mitsubishi Tanabe Pharma, Nippon Boehringer Ingelheim, Novartis, Novo Nordisk, Ono Pharmaceutical, Sanofi, Sanwa Kagaku Kenkyusho, Sumitomo Dainippon Pharma, and Takeda Pharmaceutical, and is receiving grants from Astellas Pharma, AstraZeneca, Daiichi Sankyo, Eli Lilly Japan, Johnson & Johnson, Kowa, Kyowa Hakko Kirin, Merck Sharp & Dohme, Mitsubishi Tanabe Pharma, Mochida Pharmaceutical, Nippon Boehringer Ingelheim, Novartis Pharma, Novo Nordisk Pharma, Ono Pharmaceutical, Pfizer Japan, Sanofi, Sumitomo Dainippon Pharma, Taisho Toyama Pharmaceutical, Takeda Pharmaceutical, and Terumo. MK received honoraria for speaker's bureau or advisory board attendance with Abbott Diabetes Care, AstraZeneca, Bayer AG, Boehinger Ingelheim, Eli Lilly, MSD, Novo Nordisk, and Sanofi, and has also participated in randomised controlled trials funded by AstraZeneca, Eli Lilly, and Novo Nordisk., (Copyright © 2023 Elsevier Ltd. All rights reserved.)

Background: Glycemic control in the hospital setting is imperative for improving outcomes among patients with diabetes. Bedside point-of-care (POC) glucose monitoring has remained the gold standard for decades, while only providing momentary glimpses into a patient's glycemic control. Continuous glucose monitoring (CGM) has been shown to improve glycemic control in the ambulatory setting. However, a paucity of inpatient experience and data remains a barrier to US Food and Drug Administration (FDA) approval and expanded/non-research use in the hospital setting., Method: Amid the COVID-19 pandemic, the FDA exercised its enforcement discretion to not object to the use of CGM systems for the treatment of patients in hospital settings to support COVID-19 health care-related efforts to reduce viral exposure of health care workers. Following this announcement, Scripps Health, a large not-for-profit health care system in San Diego, California, implemented CGM as the new "standard of care" (CGM as SOC) for glucose monitoring and management in the hospital., Results: The present report serves to (1) detail the implementation procedures for employing this new SOC; (2) describe the patients receiving CGM as SOC, their glycemic control, and hospital outcomes; and (3) share lessons learned over two years and nearly 900 hospital encounters involving CGM., Conclusions: Here, we conclude that CGM is feasible in the hospital setting by using a dedicated diabetes care team and the CGM technology with remote monitoring.

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., (© 2022 The Authors. Diabetes, Obesity and Metabolism published by John Wiley & Sons Ltd.)

Objective: To evaluate glycemic outcomes in the Wireless Innovation for Seniors with Diabetes Mellitus (WISDM) randomized clinical trial (RCT) participants during an observational extension phase. Research Design and Methods: WISDM RCT was a 26-week RCT comparing continuous glucose monitoring (CGM) with blood glucose monitoring (BGM) in 203 adults aged ≥60 years with type 1 diabetes. Of the 198 participants who completed the RCT, 100 (98%) CGM group participants continued CGM (CGM-CGM cohort) and 94 (98%) BGM group participants initiated CGM (BGM-CGM cohort) for an additional 26 weeks. Results: CGM was used a median of >90% of the time at 52 weeks in both cohorts. In the CGM-CGM cohort, median time <70 mg/dL decreased from 5.0% at baseline to 2.6% at 26 weeks and remained stable with a median of 2.8% at 52 weeks ( P  < 0.001 baseline to 52 weeks). Participants spent more time in range 70-180 mg/dL (TIR) (mean 56% vs. 64%; P  < 0.001) and had lower hemoglobin A1c (HbA1c) (mean 7.6% [59 mmol/mol] vs. 7.4% [57 mmol/mol]; P  = 0.01) from baseline to 52 weeks. In BGM-CGM, from 26 to 52 weeks median time <70 mg/dL decreased from 3.9% to 1.9% ( P  < 0.001), TIR increased from 56% to 60% ( P  = 0.006) and HbA1c decreased from 7.5% (58 mmol/mol) to 7.3% (57 mmol/mol) ( P  = 0.025). In BGM-CGM, a severe hypoglycemic event was reported for nine participants while using BGM during the RCT and for two participants during the extension phase with CGM ( P  = 0.02). Conclusions: CGM use reduced hypoglycemia without increasing hyperglycemia in older adults with type 1 diabetes. These data provide further evidence for fully integrating CGM into clinical practice. Clinicaltrials.gov (NCT03240432).

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 ., (© 2022. The Author(s).)

Throughout history, up to the early part of the 20th century, diabetes has been a devastating disorder, particularly when diagnosed in childhood when it was usually fatal. Consequently, the successful pancreatic extraction of insulin in 1921 was a miraculous, life-changing advance. In this review, the truly transformative effect that insulin has had on the lives of people with type 1 diabetes and on those with type 2 diabetes who are also dependent on insulin is described, from the time of its first successful use to the present day. We have highlighted in turn how each of the many facets of improvements over the last century, from advancements in the properties of insulin and its formulations to the evolution of different methods of delivery, have led to continued improvement in clinical outcomes, through the use of illustrative stories from history and from our own clinical experiences. This review concludes with a brief look at the current challenges and where the next century of technological innovation in insulin therapy may take us., Competing Interests: Competing interests: JBB’s contracted consulting fees and travel support for contracted activities are paid to the University of North Carolina by Adocia, AstraZeneca, Eli Lilly, Fractyl, Intarcia Therapeutics, Lexicon, MannKind, Metavention, Novo Nordisk, Sanofi, Senseonics, vTv Therapeutics and Zafgen; he reports grant support from AstraZeneca, Eli Lilly, Intarcia Therapeutics, Johnson & Johnson, Lexicon, NovaTarg, Novo Nordisk, Sanofi, Theracos, Tolerion and vTv Therapeutics; he has received fees for consultation from Cirius Therapeutics, Eli Lilly, Fortress Biotech, Moderna, Pendulum Therapeutics and Zealand Pharma; he holds stock/options in Mellitus Health, Pendulum Therapeutics, PhaseBio, Praetego and Stability Health; and he is supported by grants from the National Institutes of Health, Patient Centered Research Institute, Juvenile Diabetes Research Foundation International and the American Diabetes Association. JBB is a member of the editorial board for BMJ Open Diabetes Research & Care. MJD has acted as consultant, advisory board member and speaker for Boehringer Ingelheim, Lilly, Novo Nordisk and Sanofi; an advisory board member and speaker for AstraZeneca; an advisory board member for Gilead Sciences, Janssen, Lexicon and Servier; and as a speaker for Mitsubishi Tanabe Pharma Corporation, Napp Pharmaceuticals and Takeda Pharmaceuticals International. She has received grants in support of investigator and investigator-initiated trials from AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, Novo Nordisk and Sanofi-Aventis. BMF has served on advisory boards for Eli Lilly and Zucara Therapeutics, and has given lectures for Abbott, Eli Lilly, MSD, Novo Nordisk, Roche and Sanofi. AP-T conducts research and serves on advisory boards for Abbott, Dexcom, Eli Lilly, Novo Nordisk and Sanofi. Compensation is provided to her employer Scripps Health, and no direct or indirect funds are transferred to the author., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)

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., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Background: Semaglutide is a once-weekly glucagon-like peptide-1 (GLP-1) analogue for type 2 diabetes. Few clinical trials have reported on the concomitant use of GLP-1 receptor agonists with sodium-glucose cotransporter-2 (SGLT-2) inhibitors. We aimed to investigate the efficacy and safety of semaglutide when added to SGLT-2 inhibitor therapy in patients with inadequately controlled type 2 diabetes., Methods: The SUSTAIN 9 double-blind, parallel-group trial was done at 61 centres in six countries (Austria, Canada, Japan, Norway, Russia, and the USA). Adults with type 2 diabetes and HbA 1c 7·0-10·0% (53-86 mmol/mol), despite at least 90 days of treatment with an SGLT-2 inhibitor, were randomly assigned (1:1) to receive subcutaneous semaglutide 1·0 mg or volume-matched placebo once weekly for 30 weeks, after a dose-escalation schedule of 4 weeks of 0·25 mg semaglutide or placebo and 4 weeks of 0·5 mg semaglutide or placebo. Existing antidiabetic medications, including SGLT-2 inhibitor treatment, were continued for the duration of the trial. Rescue medication, defined as intensification of background antidiabetic treatment or the initiation of new glucose-lowering medications, could be given to patients meeting specific criteria at the discretion of the investigator. The primary outcome was change in HbA 1c from baseline at week 30, assessed in the full analysis set (all patients randomly allocated to treatment) using on-treatment data collected before rescue medication was started. The confirmatory secondary outcome was change in bodyweight from baseline to week 30. Safety was also assessed in the safety analysis set (all patients who received at least one dose of treatment). The trial was registered with ClinicalTrials.gov (NCT03086330)., Findings: Between March 15, and Dec 4, 2017, 302 patients were enrolled and randomly assigned to receive semaglutide 1·0 mg or placebo (full analysis set), of whom 301 received at least one dose of treatment (safety analysis set). One patient was assigned to semaglutide but was not treated (reason unknown). 294 (97·4%) patients completed the trial and 267 (88·4%) completed treatment. Baseline characteristics were generally comparable between groups. In addition to randomised medication and SGLT-2 inhibitor, 216 (71·5%) patients were taking metformin and 39 (12·9%) were taking sulphonylurea. Patients given semaglutide had greater reductions in HbA 1c (estimated treatment difference -1·42% [95% CI -1·61 to -1·24]; -15·55 mmol/mol [-17·54 to -13·56]) and bodyweight (-3·81 kg [-4·70 to -2·93]) versus those randomised to placebo (both p<0·0001). 356 adverse events were reported by 104 (69·3%) patients in the semaglutide group, and 247 adverse events were reported by 91 (60·3%) patients in the placebo group. Gastrointestinal adverse events were most common and were reported in 56 (37·3%) patients in the semaglutide group and 20 (13·2%) in the placebo group. Serious adverse events occurred in seven (4·7%) patients in the semaglutide group and six (4·0%) in the placebo group. Severe or blood glucose-confirmed hypoglycaemic events were reported in four patients on semaglutide (2·7%). 16 patients stopped treatment early because of an adverse event, 13 of whom were in the semaglutide group. There were no deaths during the trial., Interpretation: Adding semaglutide to SGLT-2 inhibitor therapy significantly improves glycaemic control and reduces bodyweight in patients with inadequately controlled type 2 diabetes, and is generally well tolerated., Funding: Novo Nordisk., (Copyright © 2019 Elsevier Ltd. All rights reserved.)

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.

Insulin degludec (IDeg) is a long-acting basal human insulin analog produced using recombinant DNA technology. The insulin structure is modified at the B30 position to allow a di-hexamer conformation in the presence of phenol and zinc.

Hyperglycemia and glucose variability in the hospital environment are associated with higher rates of complications, longer lengths of stay, and mortality. Standardized metrics are needed to assess the efficacy and safety of glucose management interventions. Glucometric data were collected from 2024 inpatients in a San Diego hospital between 2009 and 2011. As a complementary measure of glucose control, individual patient excursion rates were calculated using counts of distinct excursions from normal to critical glucose ranges >180 or <70 mg/dL. Prediction models for excursion rates were devised, based on patient demographic and clinical characteristics. Patients were predominantly male (51.2%), Caucasian (86.0%), and elderly (median age 72 years). Obesity was prevalent: 32% were overweight and 33% were obese. Median length of hospitalization was 5.0 days (range, 0.8-139.4 days). Unadjusted rate of excursions >180 mg/dL was 0.456 per 24 hours. The proportion of zero excursions decreased as severity of illness decreased, but was unrelated to age. Excursion rates were slightly smaller for major and extreme severity of illness compared to mild or moderate illness severity. Excursion rates did not vary in a monotone fashion with age, although the general pattern reflected a reduction in excursion rates from the first age quartile (19 to 59) through the last age quartile (83 to 100). Using the Akaike information criterion, zero-inflated negative binomial models were identified as appropriate for analyzing glucose excursion rates. Systematic approaches to glucose reporting and management in the hospital environment offer "windows of opportunity" to improve diabetes care., (© 2014 Diabetes Technology Society.)

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., (© 2013 American College of Clinical Pharmacy.)

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.

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.

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 (HbA1c) decreased from baseline to week 26 in both groups (-1.09%, IDegSimple; -0.93%, IDegStep-wise). IDegSimple was non-inferior to IDegStep-wise in lowering HbA1c [estimated treatment difference (IDegSimple - IDegStep-wise): -0.16% points (-0.39; 0.07)95% CI]. Fasting plasma glucose was reduced (-3.27 mmol/L, IDegSimple; -2.68 mmol/L, IDegStep-wise) with no significant difference between groups. Rates of confirmed hypoglycemia [1.60, IDegSimple; 1.17, IDegStep-wise events/patient year of exposure (PYE)] and nocturnal confirmed hypoglycemia (0.21, IDegSimple; 0.10, IDegStep-wise events/PYE) were low, with no significant differences between groups. Daily insulin dose after 26 weeks was 0.61 U/kg (IDegSimple) and 0.50 U/kg (IDegStep-wise). No significant difference in weight change was seen between groups by week 26 (+1.6 kg, IDegSimple; +1.1 kg, IDegStep-wise), 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.

Objective: Although active diabetes self-management is required to achieve glycemic control, adherence is poor among ethnic minorities, especially Latinos. Research shows that individuals who report greater social-environmental support resources for disease management manage their diabetes more effectively than those with fewer support resources., Methods: Path analysis was conducted to investigate the value of a multiple-mediator model in explaining how support resources for disease management influence hemoglobin A1c (HbA1c) levels in a sample of 208 Latinos with Type 2 diabetes recruited from low-income serving community clinics in San Diego County. We hypothesized that the relationship between support resources for disease-management and HbA1c would be mediated by diabetes self-management and/or depression., Results: Participants who perceived greater support resources for disease-management reported better diabetes self-management (β = .40, p < .001) and less depression (β = -.19, p < .01). In turn, better diabetes self-management and less depression were associated with tighter glycemic control (HbA1c; β = -.17, p < .05 and β = .15, p < .05, respectively). Once the indirect effects via diabetes self-management (95% CI [-.25; -.03]) and depression (95% CI [-.14; -.01]) were statistically controlled, the direct pathway from support resources to HbA1c was markedly reduced (p = .57)., Conclusions: These findings demonstrate the important connection that support resources for disease management can have with diabetes self-management, emotional well-being, and glycemic control among Latinos. Thus, programs targeting diabetes self-management and glycemic control in this population should consider culturally relevant, multilevel influences on health outcomes., ((c) 2011 APA, all rights reserved.)

Purpose: The purpose of this study was to investigate the opinions of primary care physicians (PCPs) and diabetes specialists on their perceived role in tackling type 2 diabetes (T2D) and the challenges they face, particularly regarding insulin intensification., Methods: Six hundred physicians from Germany, Japan, Spain, Turkey, the United Kingdom, and the United States were recruited to complete an online survey. Screening criteria included T2D patients seen per week (Europe/Japan: all ≥ 2; United States: PCPs ≥ 5; specialists ≥ 10) and years in practice (3-30 years)., Results: Most physicians had seen an increase in TD2 patients in the past 5 years, and almost all agreed that the burden of diabetes is increasing. Notable proportions of PCPs never initiate/modify insulin and never/rarely intensify insulin. Main barriers to insulin intensification cited were lack of experience and lack of time to educate patients. Better collaboration between primary and secondary care was considered one of the most important factors in improving insulin treatment of T2D., Conclusions: PCPs are less involved in the initiation and intensification of insulin than specialists; however, all physicians appreciate the need for increased PCP involvement. A multidisciplinary approach that includes using the skills of diabetes educators will assist physicians in improving management of T2D.

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 > or =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 > or =18 years, had a body mass index (BMI) < or =40 kg/m(2), had a diagnosis of type 2 DM of at least 12 months' duration, and were insulin naive. Eligible patients also had a glycosylated hemoglobin (HbA(1c)) concentration value not outside the range of 7.5% to 11.0% following at least 3 months' treatment with > or =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 HbA(1c) 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 > or =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.

Introduction: The objective of this study was to determine the demographic, treatment, clinical, and behavioral factors associated with dropping out of a nurse-based, low-income, multiethnic San Diego diabetes program., Methods: Data were collected during a 17-month period in 2000 and 2002 on patients with type 2 diabetes from Project Dulce, a disease management program in San Diego County designed to care for an underserved diabetic population. The study sample included 69 cases and 504 controls representing a racial/ethnic mix of 53% Hispanic, 7% black, 16% Asian, 22% white, and 2% other. Logistic regression was used to determine factors associated with patient dropout., Results: Patients who had high initial clinical indicators including blood pressure and hemoglobin A1c and those who smoked currently or smoked in the past were more likely to drop out of the diabetes program., Conclusion: This study provides markers of patient dropout in a low-income, multiethnic, type 2 diabetic population. Reasons for dropout in this program can be investigated to prevent further cohort loss.