A rapid point-of-care ultrasound marker for muscle mass and muscle strength in older adults.

BACKGROUND/OBJECTIVES: Sarcopenia is defined as the gradual age-associated loss of both muscle quantity and strength in older adults, and is associated with increased mortality, falls, fractures and hospitalisations. Current sarcopenia criteria use dual-energy X-ray absorptiometry (DXA) measures of muscle mass, a test that cannot be performed at the bedside, unlike point-of-care ultrasound (PoCUS). We examined the association between ultrasonic measures of muscle thickness (MT, vastus medialis muscle thickness) and measures of muscle quantity and strength in older adults. METHODS: A total of 150 older adults (age ≥ 65; mean age 80.0 ± 0.5 years, 66 women, 84 men) were recruited sequentially from geriatric medicine clinics. Each subject had lean body mass (LBM, by bioimpedance assay), grip strength, mid-arm biceps circumference (MABC), gait speed and MT measured. All initial models were adjusted for biological sex. RESULTS: In our final parsimonious models, MT showed a strong significant correlation with all measures of muscle mass, including LBM (Standardised ß = 0.204 ± 0.058, R2 = 0.577, P < 0.001) and MABC (Standardised ß = 0.141 ± 0.067, R2 = 0.417, P = 0.038). With respect to measures of muscle quality, there was a strong significant correlation with grip strength (Standardised ß = 0.118 ± 0.115, R2 = 0.511, P < 0.001) but not with subject performance (gait speed). CONCLUSIONS: MT showed strong correlations with both measures of muscle mass (LBM and MABC) and with muscle strength (grip strength). Although more work needs to be done, PoCUS shows potential as a screening tool for sarcopenia in older adults.

Baroreflex function and postprandial hypotension in older adults.

PURPOSE: Postprandial hypotension (PPH) is a common but poorly understood etiology for fainting in older adults. One potential mechanism is age-related baroreflex dysfunction. We examined baroreflex function in older adults with PPH and without PPH (noPPH) during a standardized meal test. METHODS: 57 adults (age ≥ 65; 24 PPH, 33 noPPH, mean age 77.9 ± 0.9 years, 54% female) were recruited and had meal tests performed. The baroreflex effectiveness index (BEI, %) and baroreflex sensitivity (BRS, ms/mm Hg) were calculated using the sequence method. RESULTS: Baseline BEI (22 ± 2 versus 23 ± 2 percent, t = - 0.411, p = 0.682) and BRS (14.1 ± 2.4 versus 13.8 ± 2.5 ms/mm of Hg, t = - 0.084, p = 0.933) were similar in PPH and noPPH subjects. During the meal test PPH subjects showed significantly lower BEI as compared to noPPH subjects (time × PPH, F = 2.791, p = 0.042), while there was no difference in the postprandial change in BRS (time, F = 0.618, p = 0.605). CONCLUSION: Patients with PPH demonstrated an acute postprandial decrease in baroreflex effectiveness during meal testing as compared with normal subjects, suggesting a potential contributing mechanism for this condition.

Blood pressure measurement and the prevalence of postprandial hypotension.

BACKGROUND: Postprandial hypotension (PPH) is a serious condition that has been shown to be an independent risk factor for falls, fractures and death. PURPOSE: The prevalence of this problem in older adults with a past history of falls has shown a wide variability in the literature; the present study seeks to examine how the frequency with which blood pressure is measured impacts the prevalence and severity of PPH. METHODS: Older adults were recruited sequentially from a geriatric medicine falls clinic for meal testing (n=95). All subjects (mean age 77.5±0.7 years, 61±5% female) were fasting prior to each 90 min standardized meal test. A Finometer (Finapres Medical Systems BV) was used to monitor blood pressure. Beat-by-beat systolic (SBP) measures were averaged for 0.5, 1, 2, 3, 5, 6, 9, 10, 15, 18, 30, 45 and 90 min respectively during the meal test. RESULTS: Using the original diagnostic method of checking mean blood pressure every 10 min resulted in a PPH prevalence of 42.1±5.1% in our population, with an overall range from 81.1±4.0% to 11.6±3.3% depending on the frequency of calculating SBP. The maximal observed postprandial decrease in SBP also showed a significant difference with blood pressure measurement frequency (p.

Remote assessment via video evaluation (RAVVE): a pilot study to trial video-enabled peer feedback on clinical performance.

BACKGROUND: Video review processes for evaluation and coaching are often incorporated into medical education as a means to accurately capture physician-patient interactions. Compared to direct observation they offer the advantage of overcoming many logistical challenges. However, the suitability and viability of using video-based peer consultations for professional development requires further investigation. This study aims to explore the acceptability and feasibility of video-based peer feedback to support professional development and quality improvement in patient care. METHODS: Five rheumatologists each provided four videos of patient consultations. Peers evaluated the videos using five-point scales, providing annotations in the video recordings, and offering recommendations. The rheumatologists reviewed the videos of their own four patient interactions along with the feedback. They were asked to document if they would make practice changes based on the feedback. Focus groups were conducted and analysed to explore the effectiveness of video-based peer feedback in assisting physicians to improve clinical practice. RESULTS: Participants felt the video-based feedback provided accurate and detailed information in a more convenient, less intrusive manner than direct observation. Observations made through video review enabled participants to evaluate more detailed information than a chart review alone. Participants believed that reviewing recorded consultations allowed them to reflect on their practice and gain insight into alternative communication methods. CONCLUSIONS: Video-based peer feedback and self-review of clinical performance is an acceptable and pragmatic approach to support professional development and improve clinical care among peer clinicians. Further investigation into the effectiveness of this approach is needed.

Comparing Physical Examination With Sonographic Versions of the Same Examination Techniques for Splenomegaly.

OBJECTIVES: To determine whether sonographic versions of physical examination techniques can accurately identify splenomegaly, Castell's method (Ann Intern Med 1967; 67:1265-1267), the sonographic Castell's method, spleen tip palpation, and the sonographic spleen tip technique were compared with reference measurements. METHODS: Two clinicians trained in bedside sonography patients recruited from an urban hematology clinic. Each patient was examined for splenomegaly using conventional percussion and palpation techniques (Castell's method and spleen tip palpation, respectively), as well as the sonographic versions of these maneuvers (sonographic Castell's method and sonographic spleen tip technique). Results were compared with a reference standard based on professional sonographer measurements. RESULTS: The sonographic Castell's method had greater sensitivity (91.7% [95% confidence interval, 61.5% to 99.8%]) than the traditional Castell's method (83.3% [95% confidence interval, 51.6% to 97.9%]) but took longer to perform [mean ± SD, 28.8 ± 18.6 versus 18.8 ± 8.1 seconds; P = .01). Palpable and positive sonographic spleen tip results were both 100% specific, but the sonographic spleen tip method was more sensitive (58.3% [95% confidence interval, 27.7% to 84.8%] versus 33.3% [95% confidence interval, 9.9% to 65.1%]). CONCLUSIONS: Sonographic versions of traditional physical examination maneuvers have greater diagnostic accuracy than the physical examination maneuvers from which they are derived but may take longer to perform. We recommend a combination of traditional physical examination and sonographic techniques when evaluating for splenomegaly at the bedside.

Does GLP-1 suppress its own basal secretion?

PURPOSE/AIM: Negative feedback controls in endocrine regulatory systems are well recognized. The incretins and their role in glucose regulation have been of major interest recently. Whether the same negative control system applies to the regulation of incretin secretion is not clear. We sought to examine the hypothesis that exogenous administration of glucagon like peptide-1, GLP-1(7-36) amide or its metabolite GLP-1(9-36) amide, reduces the endogenous basal release of this incretin. MATERIALS AND METHODS: We evaluated the endogenous basal release of GLP-1 using two separate study designs. In protocol A we examined the GLP-1(7-36) amide levels during the infusion of GLP-1(9-36) amide. In protocol B, we used PYY and GLP-2 as biomarkers for the endogenous basal release of GLP-1(7-36) amide and assessed the endogenous basal release of these two hormones during the GLP-1(7-36) infusion. Twelve lean and 12 obese subjects were enrolled in protocol A and 10 obese volunteers in protocol B. RESULTS: The plasma levels of GLP-1(7-36) amide in protocol A and PYY and GLP-2 in protocol B remained unchanged during the exogenous infusion of GLP-1(9-36) and GLP-1(7-36) amide, respectively. CONCLUSIONS: The negative feedback control system as described by inhibition of the release of endogenous hormone while infusing it exogenously was not observed for the basal secretion of GLP-1(7-36) amide.

Accuracy of Spleen Measurement by Medical Residents Using Hand-Carried Ultrasound.

OBJECTIVES: Easily palpable splenomegaly can be identified on physical examination, but it is difficult to detect lesser degrees of splenomegaly. Rapid bedside assessment can be conducted with hand-carried ultrasound. We performed this study to determine whether medical residents could reliably assess spleen size using hand-carried ultrasound after a brief educational intervention. METHODS: Postgraduate year 1 internal medicine residents were shown a brief (45-minute) presentation on ultrasound basics, the use of hand-carried ultrasound, and principles of splenic ultrasound imaging. They practiced on each other, using hand-carried ultrasound to assess spleen size, for 1 hour in the presence of an instructor. Patients with varying degrees of splenomegaly and hospital staff were recruited at Vancouver General Hospital. A sonographer measured spleen size in each participant using conventional ultrasound. Subsequently, the trained residents scanned the participants using hand-carried ultrasound, blinded to the sonographer's measurements and the participants' diagnoses. The instructor was not present during scanning. RESULTS: Twelve first-year residents (8 male and 4 female; mean age ± SEM, 28 ± 1 years; all with limited prior ultrasound training) and 19 patients and staff members (10 male and 9 female; mean age, 60 ± 4 years; body mass index, 24 ± 2 kg/m(2)) were recruited. The greatest longitudinal measurements were 14.0 ± 0.7 cm with conventional ultrasound administered by the sonographer and 13.2 ± 0.9 cm with hand-carried ultrasound administered by the residents (P > .05, not significant). The correlation between conventional and hand-carried ultrasound was r = 0.81 (P < .001). CONCLUSIONS: Internal medicine residents can reliably assess spleen size at the point of care using hand-carried ultrasound with minimal training. Our findings, if replicated in other centers and in different clinical scenarios, may change the way that clinicians examine the spleen.

Estimation of spleen size with hand-carried ultrasound.

OBJECTIVES: Physical examination can identify palpable splenomegaly easily, but evaluating lesser degrees of splenomegaly is problematic. Hand-carried ultrasound allows rapid bedside assessment of patients. We conducted this study to determine whether hand-carried ultrasound can reliably assess spleen size. METHODS: Patients with varying degrees of splenomegaly were studied. Two sonographers blindly measured spleen size in each patient using either a hand-carried or conventional ultrasound device in random order. Sonographers completed a data sheet indicating the adequacy of the image, clinical measurements of enlargement, and confidence in their observations. RESULTS: Sixteen patients (10 male and 6 female; mean age ± SEM, 60 ± 4 years) were recruited. Image quality was adequate or better in all scans with conventional ultrasound and in 15 of 16 scans with hand-carried ultrasound. The greatest longitudinal measurement recorded was statistically equivalent across ultrasound techniques, with mean values of 16.4 cm (95% confidence interval, 14.8-18.0 cm) for conventional ultrasound and 15.8 cm (95% confidence interval, 14.1-17.4 cm) for hand-carried ultrasound. The correlation between measurement techniques was r = 0.89 (P < .0001). Sonographers were somewhat or very confident in the outcomes of all scans with conventional ultrasound and in 15 of 16 cases with hand-carried ultrasound. In general, it took longer for sonographers to obtain images with hand-carried ultrasound. CONCLUSIONS: We have shown that hand-carried ultrasound can be used at the point of care by trained individuals to diagnose splenomegaly. However, hand-carried ultrasound images were less likely to be judged excellent, were accompanied by less diagnostic certainty, and took longer to obtain.

Aerobic training in older adults with type 2 diabetes and vasodepressive carotid sinus hypersensitivity.

BACKGROUND AND AIMS: Vasodepressive carotid sinus hypersensitivity (V-CSH) is a common but incurable etiology for fainting in older adults with diabetes (OADM), and is diagnosed by carotid sinus massage (CSM). Aerobic exercise has been shown to be an effective therapy for other neuroautonomic etiologies of syncope (such as orthostatic hypotension), but the effectiveness of aerobic training in V-CSH remains unknown. We examined whether aerobic training could attenuate the vasodepressive response to CSM in OADM (older adults with type 2 diabetes) subjects complicated by V-CSH. METHODS: Forty OADM subjects (mean age 72.2 ± 0.7) complicated by V-CSH were recruited. Subjects were randomized to each of two groups: an aerobic group (AT, n = 20, 3 months vigorous aerobic exercise), and a nonaerobic (NA, n = 20, no aerobic exercise) group. Exercise sessions were supervised by a certified exercise trainer three times per week. The vasodepressive response [defined as the decrease in systolic blood pressure (SBP) during CSM] was measured before and after the training intervention using a Finometer. RESULTS: The intervention had no impact on the number of subjects that met the criteria for V-CSM in either the AT or NA groups, regardless of the criteria used (-10, -20, -30, -40 and -50 mmHg). There was no training effect on the vasodepressive response in either the AT or NA group (P = 0.214, 2-way analysis of variance, -30 mmHg definition for V-CSH). CONCLUSIONS: Aerobic training has no effect on the SBP response to CSM in OADM subjects with V-CSH. Unlike in other neuroautonomic etiologies for fainting, aerobic exercise is not effective as a treatment for V-CSH, at least in the OADM population.

The Growing Role of Technology in the Care of Older Adults With Diabetes.

The integration of technologies such as continuous glucose monitors, insulin pumps, and smart pens into diabetes management has the potential to support the transformation of health care services that provide a higher quality of diabetes care, lower costs and administrative burdens, and greater empowerment for people with diabetes and their caregivers. Among people with diabetes, older adults are a distinct subpopulation in terms of their clinical heterogeneity, care priorities, and technology integration. The scientific evidence and clinical experience with these technologies among older adults are growing but are still modest. In this review, we describe the current knowledge regarding the impact of technology in older adults with diabetes, identify major barriers to the use of existing and emerging technologies, describe areas of care that could be optimized by technology, and identify areas for future research to fulfill the potential promise of evidence-based technology integrated into care for this important population.

Machine Learning Decision Support for Detecting Lipohypertrophy With Bedside Ultrasound: Proof-of-Concept Study.

BACKGROUND: The most common dermatological complication of insulin therapy is lipohypertrophy. OBJECTIVE: As a proof of concept, we built and tested an automated model using a convolutional neural network (CNN) to detect the presence of lipohypertrophy in ultrasound images. METHODS: Ultrasound images were obtained in a blinded fashion using a portable GE LOGIQ e machine with an L8-18I-D probe (5-18 MHz; GE Healthcare). The data were split into train, validation, and test splits of 70%, 15%, and 15%, respectively. Given the small size of the data set, image augmentation techniques were used to expand the size of the training set and improve the model's generalizability. To compare the performance of the different architectures, the team considered the accuracy and recall of the models when tested on our test set. RESULTS: The DenseNet CNN architecture was found to have the highest accuracy (76%) and recall (76%) in detecting lipohypertrophy in ultrasound images compared to other CNN architectures. Additional work showed that the YOLOv5m object detection model could be used to help detect the approximate location of lipohypertrophy in ultrasound images identified as containing lipohypertrophy by the DenseNet CNN. CONCLUSIONS: We were able to demonstrate the ability of machine learning approaches to automate the process of detecting and locating lipohypertrophy.

Short-term aerobic exercise reduces nitroglycerin-induced orthostatic intolerance in older adults with type 2 diabetes.

AIMS/HYPOTHESIS: Older adults are at a high risk for syncope due to orthostatic intolerance (OI), and this risk increases with comorbid type 2 diabetes and vasoactive medications. Despite many benefits, previous investigations have shown worsening OI with aerobic training. We examined whether aerobic exercise reduced OI in older adults with type 2 diabetes who were given a short-acting vasoactive agent (nitroglycerin). METHODS: Forty older adults (25 males and 15 females, mean age 71.4 ± 0.7 years, ranging in age from 65 to 83 years) with type 2 diabetes were recruited. Subjects were randomized to each of 2 groups: an aerobic group (3 months of vigorous aerobic exercise) and a nonaerobic (no aerobic exercise) group. Exercise sessions were supervised by a certified exercise trainer 3 times per week. After being given 400 µg of sublingual nitroglycerin, each subject was placed in a 70° head-up tilt for 30 minutes. RESULTS: When the 2 groups were compared using a Cox proportional hazards model, tilt table tolerance was significantly better in the aerobic group as compared to in the nonaerobic group (χ(2)(MC) = 7.271, P = 0.007). CONCLUSIONS: Our findings indicate that a relatively short aerobic exercise intervention can improve postnitroglycerin orthostatic tolerance in older adults with type 2 diabetes.

Point-of-care ultrasound measures of muscle and frailty measures.

PURPOSE: Frailty is defined as a syndrome of increased vulnerability due to both age and disease that leads to an inability to cope with acute stressors. There has been growing interest in the surgical and emergency medicine literature in the potential use of Point-of-Care ultrasonic (PoCUS) measures of muscle mass to assess frailty in older adults. Our study examined the association between a simple ultrasonic measure of muscle thickness (MT, vastus medialis muscle thickness) and commonly used frailty measures (Cardiovascular Health Study, CHS; Rockwood Clinical Frailty Scale, RCFS) in older adults. METHODS: Participants were recruited sequentially from ambulatory geriatric medicine clinics in an academic medical centre (Vancouver General Hospital, Vancouver, Canada). Each subject had MT measured by PoCUS, as well as the CHS index and Rockwood Clinical Frailty Scale. RESULTS: 150 older adults (age ≥ 65; mean age 80.0 ± 0.5 years, 66 women, 84 men) were recruited. In our final parsimonious models, MT showed a weak inverse association with the CHS index (Standardized ß = - 0.180 ± 0.080, R2 = 0.06, p = 0.027) and no association with the RCFS (p = 0.776). Within the CHS index, most of the association was due to grip strength in men (Standardized ß = - 0.326 ± 0.099, R2 = 0.26, p = 0.001). CONCLUSION: Frailty is a multifactorial syndrome, and caution must be used in trying to screen for this condition with a single ultrasonic measure. Further work might indicate associations with a more restricted syndrome, such as sarcopenia.

Correction to: Combining GLP-1 Receptor Agonists and Basal Insulin in Older Adults with Type 2 Diabetes: Focus on Lixisenatide and Insulin Glargine.

There are some corrections in the original article, Page 11, "/LYXUMIA" word has to be removed from the section RATIONALE FOR COMBINATION THERAPY COMPRISING GLP-1 RAs AND BASAL INSULIN.

Diabetes in ageing: pathways for developing the evidence base for clinical guidance.

Older adults with diabetes are heterogeneous in their medical, functional, and cognitive status, and require careful individualisation of their treatment regimens. However, in the absence of detailed information from clinical trials involving older people with varying characteristics, there is little evidence-based guidance, which is a notable limitation of current approaches to care. It is important to recognise that older people with diabetes might vary in their profiles according to age category, functional health, presence of frailty, and comorbidity profiles. In addition, all older adults with diabetes require an individualised approach to care, ranging from robust individuals to those residing in care homes with a short life expectancy, those requiring palliative care, or those requiring end-of-life management. In this Review, our multidisciplinary team of experts describes the current evidence in several important areas in geriatric diabetes, and outlines key research gaps and research questions in each of these areas with the aim to develop evidence-based recommendations to improve the outcomes of interest in older adults.

A valuation of patients' willingness-to-pay for insulin delivery in diabetes.

OBJECTIVES: The aim of this study was to determine the insulin-delivery system and the attributes of insulin therapy that best meet patients' preferences, and to estimate patients' willingness-to-pay (WTP) for them. METHODS: This was a cross-sectional discrete choice experiment (DCE) study involving 378 Canadian patients with type 1 or type 2 diabetes. Patients were asked to choose between two hypothetical insulin treatment options made up of different combinations of the attribute levels. Regression coefficients derived using conditional logit models were used to calculate patients' WTP. Stratification of the sample was performed to evaluate WTP by predefined subgroups. RESULTS: A total of 274 patients successfully completed the survey. Overall, patients were willing to pay the most for better blood glucose control followed by weight gain. Surprisingly, route of insulin administration was the least important attribute overall. Segmented models indicated that insulin naïve diabetics were willing to pay significantly more for both oral and inhaled short-acting insulin compared with insulin users. Surprisingly, type 1 diabetics were willing to pay $C11.53 for subcutaneous short-acting insulin, while type 2 diabetics were willing to pay $C47.23 to avoid subcutaneous short-acting insulin (p < .05). These findings support the hypothesis of a psychological barrier to initiating insulin therapy, but once that this barrier has been overcome, they accommodate and accept injectable therapy as a treatment option. CONCLUSIONS: By understanding and addressing patients' preferences for insulin therapy, diabetes educators can use this information to find an optimal treatment approach for each individual patient, which may ultimately lead to improved control, through improved compliance, and better diabetes outcomes.

Combining GLP-1 Receptor Agonists and Basal Insulin in Older Adults with Type 2 Diabetes: Focus on Lixisenatide and Insulin Glargine.

Estimates suggest that there are currently 122.8 million adults 65-99 years of age living with diabetes, of whom 90-95% are diagnosed with type 2 diabetes (T2D). Over the past two decades, a greater understanding of the complex and multifactorial pathogenesis of T2D has resulted in the development and introduction of new-generation classes of glucose-lowering therapies, which are now extensively endorsed by prevailing guidelines and are increasingly being used worldwide. These newer agents may further assist in the effective pharmacological management of T2D through the provision of patient-centered care that acknowledges multimorbidity and is respectful of and responsive to individual patient preferences and barriers. Given these considerations, the therapeutic approach in older patients with T2D is complex, particularly in those who have functional dependence, frailty, dementia, or who are at end-of-life. It is currently too early to draw conclusions on the long-term use of newer glucose-lowering agents in this population, as their efficacy and safety in older adults remains largely unknown. In this review, we will discuss considerations for the use of glucose-lowering treatments in older adults, with particular focus on the use of basal insulin and glucagon-like peptide-1 receptor agonists, and the rationale for the use of combination therapy comprising these agents. Finally, we will review clinical data from studies of the fixed-ratio combination of insulin glargine and lixisenatide in older patients with T2D. FUNDING: Sanofi US, Inc.

Characteristics Associated with the Postprandial Hypotensive Response in Falling Older Adults.

Il a été démontré que l'intensité de la réponse hypotensive postprandiale (RHP) peut constituer un facteur de risque pour les chutes, les fractures et le décès. Bien que ce risque ait été bien établi, les cliniques de chutes font rarement des analyses liées aux repas, en raison de contraintes logistiques. Afin de mieux cibler les patients à risque de RHP parmi les personnes âgées affectées par des chutes, cette étude a examiné les caractéristiques individuelles associées à des RHP plus intenses. Cinquante-deux patients (âge moyen : 77,8 ± 0,9 ans, 29 femmes, 23 hommes) référés par des cliniques de prévention des chutes ont été recrutés pour un repas-test de 90 minutes. Les variables significatives ont ensuite été insérées dans un modèle linéaire multivarié incluant l'âge, le sexe, la présence de diabète, la présence d'hypertension, la pression systolique de base (PSB) et la chute de la PSB orthostatique. Bien que de plus amples recherches soient nécessaires, notre étude suggère que les hommes, les patients présentant une tension artérielle élevée et ceux avec une chute orthostatique pourraient être plus à risque de réponses hémodynamiques postprandiales plus intenses.The magnitude of the postprandial hypotensive (PPH) response has been shown to be an independent risk factor for falls, fractures, and death. Despite this well-established risk, meal tests are rarely done in the falls clinic setting because of logistical issues. In order to better target potential PPH patients among older falling adults, this study examines which subject characteristics are associated with larger PPH responses. A total of 52 falls clinic patients (mean age 77.8 ± 0.9 years, 29 women, 23 men) were recruited for a 90 minute meal test. Significant variables were then entered into a stepwise multivariate linear model containing age, sex, presence of diabetes, presence of hypertension, baseline systolic blood pressure (SBP), and the orthostatic drop in SBP. Although further work is required, our study suggests that men, patients with higher blood pressure, and patients with an orthostatic drop might be more likely to have higher postprandial hemodynamic responses.

Efficacy and safety of lixisenatide as add-on therapy to basal insulin in older adults with type 2 diabetes in the GetGoal-O Study.

BACKGROUND: This study compared the efficacy and safety of lixisenatide with placebo as add-on therapy to basal insulin (BI) in adults aged ≥70 years with type 2 diabetes (T2D), with or without moderate renal insufficiency. METHODS: This post hoc analysis evaluated data from non-frail patients with T2D inadequately controlled on BI with or without oral antidiabetic drugs (n = 108), randomized to once-daily lixisenatide 20 µg or placebo for 24 weeks (GetGoal-O Study). The primary endpoint was the change in HbA1c from baseline to Week 24. Secondary endpoints included changes from baseline in fasting plasma glucose, 2-hour postprandial plasma glucose (PPG), average seven-point self-monitored plasma glucose (SMPG), area under the curve for SMPG, daily BI dose, body weight, proportion of patients achieving HbA1c > 0.5%, and composite endpoints. Safety outcomes included the incidence of documented symptomatic hypoglycemia (plasma glucose <60 mg/dL) and gastrointestinal treatment-emergent adverse events (TEAEs). Outcomes were also analyzed by the occurrence of moderate renal insufficiency. RESULTS: Compared with placebo, lixisenatide-treated patients had significantly greater reductions in HbA1c, 2-hour PPG, average seven-point SMPG, and body weight. Documented symptomatic hypoglycemia was approximately two-fold higher in patients treated with placebo than lixisenatide (12.7% vs 5.7%). GI TEAEs occurred more frequently in the lixisenatide- than placebo-treated group (34% vs 9.1%). Moderate renal insufficiency (estimated glomerular filtration rate between ≥30 and <60 mL/min/1.73 m2 ) did not negatively affect lixisenatide efficacy or safety. A greater proportion of patients treated with lixisenatide than placebo achieved composite endpoints. CONCLUSIONS: Add-on therapy with lixisenatide in non-frail patients aged ≥70 years with T2D uncontrolled with BI is effective, safe, and well tolerated and should be considered in this population.