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

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.

OBJECTIVEThe 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 METHODSA 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.RESULTSThe 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 CONCLUSIONSRT-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.

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.

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

Aim\ud \ud 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.\ud \ud \ud \ud Materials and Methods\ud \ud 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.\ud \ud \ud \ud Results\ud \ud 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.\ud \ud \ud \ud Conclusion\ud \ud 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.

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.

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 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.

Background: A head-to-head trial (NCT03078478) between insulin degludec and insulin glargine U300 with the primary objective of comparing the risk of hypoglycemia is being conducted. During trial conduct, safety concerns related to the glycemic data collection system led to a postinitiation protocol amendment, described here. Methods: This randomized (1:1), open-label, treat-to-target, multinational trial was initiated in March 2017 with a planned treatment period of 52 weeks (16 weeks titration + 36 weeks maintenance). Overall, ~1600 insulin-experienced patients at risk of developing hypoglycemia based on predefined risk factors were included. The protocol amendment implemented in February 2018 resulted in assuring patient safety and an extension of the total treatment period up to 88 weeks (16 weeks titration + variable maintenance 1 + 36 weeks maintenance 2). The original glycemic data collection system (MyGlucoHealth blood glucose meter + electronic diary) was discontinued because of safety concerns and replaced with an Abbott blood glucose meter and paper diary to collect self-measured blood glucose and hypoglycemic episodes. The primary endpoint of number of severe or blood-glucose confirmed symptomatic hypoglycemic episodes will be evaluated with the same analysis duration and statistical methods as the original protocol. Only relevant changes were implemented to maintain patient safety while permitting evaluation of the scientific objectives of the trial. Conclusions: These observations highlight the importance of safety surveillance during trial conduct despite the use of currently marketed glucose monitoring devices. The prompt protocol amendment and ensuing actions ensured that the scientific integrity of the trial was not compromised.

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.

IN BRIEF 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.

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.

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; p250 mg/dL (4.9% ± 9.2; 9.2% ± 18.4; p 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.

Continuous glucose monitors (CGM) are an integral aspect in the glucose management of many individuals with type 1 diabetes, and a growing number of people with insulin-requiring type 2 diabetes (T2D). A 2019 meta-analysis of 7 randomized controlled trials that investigated CGMs for T2D reported that CGM users had significantly lower HbA1c and shorter time spent with hypoglycemia compared with self-monitoring blood glucose comparison groups. However, little is known about optimal, real world approaches for integrating CGM in the routine management of patients with T2D. A pragmatic, feasibility pilot (n=6) was conducted to document the preliminary effectiveness and acceptability of introducing CGM in the context of a 5-class diabetes self-management education (DSME) series at Scripps Health, a large, non-profit, private insurance-based health system in San Diego, CA. Prior to class 2, English- (n = 3) and Spanish-speaking (n = 3) adults with T2D self-inserted the CGM and received enough sensors to wear the CGM until 6 weeks post-DSME (10 weeks total). During classes 3-5, time was devoted to reviewing the past week’s CGM data report and participants were encouraged to make associations between glucose trends and eating and exercise patterns. CGM wear ranged from 5 to 10 weeks (M =7.8 ± 1.7 weeks). Time-in-range (70-180 mg/dL) and mean average glucose improved from 54% and 185.1 ± 67.9 mg/dL at baseline to 74% and 159.1 ± 50.5 mg/dL by the end of DSME, and to 84% and 142.7 ± 30.6 mg/dL at 4-weeks post-DSME. Self-report surveys indicated improvements in healthful eating and physical activity over this time, and participants reported very high satisfaction with the CGM; the majority expressed a desire to continue CGM use post-study. Findings highlight DSME as a promising environment for effectively integrating CGM in the management of T2D. Future research should pinpoint the duration and frequency of CGM use for optimal clinical benefit in the general T2D population. Disclosure A.L. Fortmann: None. A. Bastian: None. C.J. Lensing: Employee; Self; UnitedHealth Group. Employee; Spouse/Partner; UnitedHealth Group. S. Hoversten: Employee; Self; UnitedHealth Group. K. Luu: None. K. Barger: None. L. Talavera: 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. Funding UnitedHealth Group; Dexcom, Inc.

Continuous Glucose Monitors (CGM) automatically capture interstitial glucose levels every 5 minutes, 24 hours/day, allowing users to view their glucose levels in real-time and make informed decisions about how to manage diet, exercise, and medications. While CGMs are a central component in the glucose management of type 1 diabetes and insulin-dependent type 2 diabetes, less is known about the potential value of CGMs for diabetes prevention. The original Diabetes Prevention Program (DPP) demonstrated that 5-7% weight loss - an outcome reliant upon healthful eating and exercise - was more effective than medication in preventing or delaying the onset of T2D; however, subsequent DPP translations have not consistently achieved the same weight loss outcomes. CGM may represent a way to reinforce and incentivize hard-to-make health behavior changes in real-time that are crucial to the more distal (and often elusive) weight loss outcome. This small (n=7) feasibility pilot examined the preliminary effectiveness and acceptability of integrating CGM in a DPP at Scripps Health, a large, non-profit, private insurance-based health system in San Diego, CA. Following a brief introduction to the CGM and target glucose ranges, DPP participants self-inserted and wore the CGM for 2 weeks. Mean time-in-range (70-140 mg/dL) improved from 70.4% to 76.4%, and time > 140 mg/dL decreased from 29.4% to 23.1% during this period. Individual change in time-in-range ranged from -9.7% to + 38.8% (M ∆ = +6.0%). Participants reported high satisfaction with the CGM, but expressed a desire for more education on blood glucose management. Given these findings, a longer-term, randomized controlled trial is planned to investigate whether a CGM-enhanced DPP leads to greater weight loss than DPP alone. This research will also further our understanding of the potential benefit of improved glycemic control for diabetes prevention even among the subset of cases who do not ultimately achieve the targeted weight loss goal. Disclosure A.L. Fortmann: None. A. Bastian: None. S.R.S. Bagsic: None. I. Loupasi: None. K. Luu: None. A.R. Hottinger: None. K.A. Barry: None. M. Ruiz: None. C. Walker: 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. Funding Confidence Foundation; Dexcom, Inc.

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 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)

Randomized controlled trials (RCTs) support use of a glucagon-like peptide-1 receptor agonist (GLP-1RA) combined with a sodium-glucose cotransporter-2 inhibitor (SGLT2i) in people with type 2 diabetes (T2D). As RCTs do not fully reflect the real world, there is a need to explore the real-world population on this combination and determine outcomes with this approach. As a first step, in this large-scale cross-sectional study, we identified adults with T2D, ≥2 prescriptions for GLP-1RA and/or SGLT2i and available data from electronic medical records in the U.S. IBM Explorys database. The first prescription of GLP-1RA and/or SGLT2i in 2018 set the index date, irrespective of prior prescriptions. Data 6 months pre-index were used for patient characteristics and up to 5 years pre-index for medical history. Of 41,421 patients, 12.8% had GLP-1RA+SGLT2i prescribed together, 46.0% GLP-1RA and 41.2% SGLT2i. Of those prescribed both drugs, female: 48.0%; BMI ≥35 kg/m2: 50.2%; mean age: 56.2 years; mean HbA1c 8.3%. In multinomial regression, there was little difference between those prescribed GLP-1RA+SGLT2i vs. either drug alone in terms of HbA1c or presence of comorbidities (data not shown). However, those prescribed both drugs vs. GLP-1RA alone were less likely to be ≥65 years (odds ratio 0.57 [95% CI 0.51;0.63]), have a history of chronic kidney disease (CKD; 0.56 [0.49;0.66]) and more likely to have prior prescription of metformin (1.56 [1.46;1.68]). Those prescribed both drugs vs. SGLT2i alone were less likely to be ≥65 years (0.60 [0.54;0.67]) and have prior prescription of dipeptidyl peptidase-4 inhibitor (0.57 [0.52;0.61]), but more likely to have BMI ≥35 kg/m2 (2.11 [1.75;2.54]) and prior prescription of insulin (1.97 [1.84;2.11]). Those prescribed GLP-1RA+SGLT2i vs. either drug in 2018 had many common characteristics. However, key differentiators (age, obesity, CKD history and prior glucose-lowering drugs) reflected considerations for each therapy based on data available then. Disclosure R.J. McCrimmon: Advisory Panel; Self; Novo Nordisk A/S, Sanofi-Aventis. H.N. Christensen: Employee; Self; AstraZeneca, Novo Nordisk A/S. I. Holst: Employee; Self; Novo Nordisk A/S. A. Lenart: Employee; Self; Novo Nordisk A/S. B. Ludvik: Advisory Panel; Self; AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Bayer Healthcare Pharmaceuticals Inc., Eli Lilly and Company, Merck & Co., Inc., Novartis Pharmaceuticals Corporation. Speaker’s Bureau; Self; Amgen. R.S. Brandt: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. J.S. Piltoft: Employee; Self; Novo Nordisk A/S. Stock/Shareholder; Self; Novo Nordisk A/S. 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. Funding Novo Nordisk A/S

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-minute 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. ClinicalTrials.gov: NCT02643797 (registered November 30, 2015: https://clinicaltrials.gov/ct2/show/NCT02643797?term=philis-tsimikas&rank=10) Trial registration: NCT02643797

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.

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

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 A(1c) (HbA(1c)) 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 HbA(1c) level, 9.1% [0.9%]), 165 (94%) completed the trial. Mean HbA(1c) 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

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

Background: Lorcaserin is a serotonin 2C receptor agonist approved in the U.S. as adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in patients with a BMI ≥ 30 or ≥ 27 with at least one weight-related comorbidity. To date, there is limited data on the real-world use of lorcaserin for weight management, including in patients diagnosed with T2DM, prediabetes, and metabolic syndrome. Methods: A retrospective chart review was performed at the Scripps Clinic Weight Management Center. Patients were identified if they had at least one prescription for lorcaserin and were ≥ 18 years old. Weight change at 90 days and reason for discontinuation were assessed for patients with at least one day on pharmacotherapy. Patients with weight loss of ≥ 5% at 90 days were defined as medication “responders.” Results: A total of 118 overweight and obese patients filled a prescription for lorcaserin. Of these, 69 (58%) remained on lorcaserin ≥ 90 days (median follow-up was 306 days). Mean age was 53 years old, 73% were female, and mean baseline weight was 102 kg (BMI= 36). For patients who had follow-up weight information available (N=65), overall mean weight loss at 90 days was -3.5 kg (-4%) from baseline, responders had a decrease -7 kg (-7%, n=24) versus -1 kg (-2%) for non-responders (n=41). For patients diagnosed with metabolic syndrome (n=25), mean weight loss for responders (n=10, 40%) was -6.7 kg (-7%) versus -2.1 kg (-2%) for non-responders (n=15). Similar weight loss was observed in patients with T2DM and prediabetes. Conclusion: These "real world" results represent a group of commercially insured overweight and obese patients and demonstrate that weight loss programs can use lorcaserin and expect to get significant weight loss when used according to the label. Disclosure S.R. Harris: Consultant; Self; Sanofi. Research Support; Self; Eisai Inc. R.L. Knoth: Employee; Self; Eisai Inc. X. Li: Employee; Self; Eisai Inc. I. Khilfeh: Employee; Self; Eisai Inc. J. Choi: Employee; Self; Eisai Inc. Stock/Shareholder; Self; Johnson & Johnson. 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. K. Fujioka: Consultant; Self; Eisai Inc. Funding Eisai Inc.

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

Summary 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 HbA1c 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 HbA1c 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 HbA1c (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 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.

Aim To evaluate the efficacy and safety of adding insulin degludec (IDeg) to treatment in patients with type 2 diabetes receiving liraglutide and metformin and qualifying for treatment intensification because of inadequate glycaemic control. Methods In this 26-week, double-blind trial, patients who still had inadequate glycaemic control after a 15-week run-in period with initiation and dose escalation of liraglutide to 1.8 mg in combination with metformin (≥1500 mg) were randomized to addition of once-daily IDeg (‘IDeg add-on to liraglutide’ arm; n = 174) or placebo (‘placebo add-on to liraglutide’ arm; n = 172), with dosing of both IDeg and placebo based on titration guidelines. Results At 26 weeks, the mean change in glycated haemoglobin level was greater in the IDeg add-on to liraglutide arm (−1.04%) than in the placebo add-on to liraglutide arm (−0.16%; p

Background: The global epidemic of diabetes calls for innovative interventions. This study evaluated the effectiveness of the Project Dulce model, with and without wireless technology, on glycemic control and other clinical and self-reported outcomes in patients with poorly controlled type 2 diabetes in Mexico. Subjects and Methods: Adults with type 2 diabetes and a glycated hemoglobin A1c (HbA1c) level of ≥8% were recruited from Family Medical Unit #27 of the Instituto Mexicano del Seguro Social (IMSS) in Tijuana, México, and randomly assigned to one of three groups: Project Dulce–only (PD); Project Dulce technology-enhanced with mobile tools (PD-TE); or IMSS standard of care/control group (CG). Clinical and self-reported outcomes were assessed at baseline, Month 4, and Month 10. Time-by-group interactions and within-group changes were analyzed. Results: HbA1c reductions from baseline to Month 10 were significantly greater in PD-TE (−3.0% [−33 mmol/mol]) and PD (−2.6% [−28.7 mmol/mol]) compared with CG (−1.3% [−14.2 mmol/mol]) (P = 0.009 and 0.001, respectively). PD-TE and PD also exhibited significant improvement in diabetes knowledge when compared with CG (P

Adherence to recommended self-management behaviors is particularly poor among Hispanics with type 2 diabetes (T2D), which increases risk for developing serious complications. In addition to minority status, research has also shown diabetes distress to predict poorer diabetes self-management. In contrast, social-environmental support for disease management has emerged as a potential protective factor, given associations of greater support with better diabetes self-care. This study aimed to compare the relative associations of support [Chronic Illness Resource Survey] and diabetes distress [Diabetes Distress Scale] with diabetes self-management [Summary of Diabetes Self-Care Activities]. A cross-sectional baseline analysis of N=126 Hispanic adults with poorly controlled T2D (HbA1c ≥ 7.5%) at federally-qualified health centers in Southern California was performed. When examined separately, lower diabetes distress (rs = -.26 and -.18) and higher support (rs = .49 and .22) were both significantly associated with better diet and exercise, respectively (ps < .05). However, when entered in joint linear regression models, only support remained a statistically significant predictor of diet (β = 0.46) and exercise (β = 0.18), ps < .05. The associations of diabetes distress with self-management behaviors decreased in magnitude by 30-58% after control for support, and were no longer statistically significant. While diabetes distress certainly impacts self-management behaviors, these findings indicate that support may be a relatively stronger correlate in this population - perhaps due to the emphasis the Hispanic culture places on interpersonal relationships. Findings point to social-environmental support for disease management (not just distress) as an important target for diabetes self-management interventions. However, further longitudinal research is needed to fully disentangle the associations among distress, support, and self-management behaviors. Disclosure T. Clark: None. J.A. Euyoque: None. A. Philis-Tsimikas: Research Support; Self; Dexcom, Inc.. Advisory Panel; Self; Dexcom, Inc., Eli Lilly and Company, Merck & Co., Inc., Novo Nordisk A/S, Sanofi. Research Support; Self; Novo Nordisk A/S, Sanofi, Mylan. Stock/Shareholder; Spouse/Partner; Novo Nordisk A/S. Employee; Spouse/Partner; Ionis Pharmaceuticals, Inc.. Stock/Shareholder; Spouse/Partner; Esperion Therapeutics, Ionis Pharmaceuticals, Inc.. Advisory Panel; Self; AstraZeneca. L. Gallo: None. A.L. Fortmann: None.

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.

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.

BACKGROUND Degludec is an ultralong-Acting, once-daily basal insulin that is approved for use in adults, adolescents, and children with diabetes. Previous open-label studies have shown lower day-To-day variability in the glucose-lowering effect and lower rates of hypoglycemia among patients who received degludec than among those who received basal insulin glargine. However, data are lacking on the cardiovascular safety of degludec. METHODS We randomly assigned 7637 patients with type 2 diabetes to receive either insulin degludec (3818 patients) or insulin glargine U100 (3819 patients) once daily between dinner and bedtime in a double-blind, treat-To-Target, event-driven cardiovascular outcomes trial. The primary composite outcome in the time-To-event analysis was the first occurrence of an adjudicated major cardiovascular event (death from cardiovascular causes, nonfatal myocardial infarction, or nonfatal stroke) with a prespecified noninferiority margin of 1.3. Adjudicated severe hypoglycemia, as defined by the American Diabetes Association, was the prespecified, multiplicity-Adjusted secondary outcome. RESULTS Of the patients who underwent randomization, 6509 (85.2%) had established cardiovascular disease, chronic kidney disease, or both. At baseline, the mean age was 65.0 years, the mean duration of diabetes was 16.4 years, and the mean (±SD) glycated hemoglobin level was 8.4±1.7%; 83.9% of the patients were receiving insulin. The primary outcome occurred in 325 patients (8.5%) in the degludec group and in 356 (9.3%) in the glargine group (hazard ratio, 0.91; 95% confidence interval, 0.78 to 1.06; P

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 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.