Benefits of Electronic Consultations in Improving Diabetes Care Within a Safety-Net Health System.

Quality Improvement Success Stories are published by the American Diabetes Association in collaboration with the American College of Physicians and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of Clinical Diabetes. The following article describes an initiative aimed at improving access to diabetes specialty care for patients within a safety-net health system in Dallas County, TX, through the implementation of electronic consultations.

Strategies for overcoming therapeutic inertia in type 2 diabetes: A systematic review and meta-analysis.

AIMS: To systematically investigate the effect of interventions to overcome therapeutic inertia on glycaemic control in individuals with type 2 diabetes. MATERIALS AND METHODS: We electronically searched for randomized controlled trials or quasi-experimental studies published between January 1, 2004 and December 31, 2019 evaluating the effect of interventions on glycated haemoglobin (HbA1c) control. Characteristics of included studies and HbA1c difference between intervention and control arms (main outcome) were extracted. Interventions were grouped as: care management and patient education; nurse or certified diabetes educator (CDE); pharmacist; or physician-based. RESULTS: Thirty-six studies including 22 243 individuals were combined in nonlinear random-effects meta-regressions; the median (range) duration of intervention was 1 year (0.9 to 36 months). Compared to the control arm, HbA1c reduction ranged from: -17.7 mmol/mol (-1.62%) to -4.4 mmol/mol (-0.40%) for nurse- or CDE-based interventions; -13.1 mmol/mol (-1.20%) to 3.3 mmol/mol (0.30%) for care management and patient education interventions; -9.8 mmol/mol (-0.90%) to -6.6 mmol/mol (-0.60%) for pharmacist-based interventions; and -4.4 mmol/mol (-0.40%) to 2.8 mmol/mol (0.26%) for physician-based interventions. Across the included studies, a reduction in HbA1c was observed only during the first year (6 months: -4.2 mmol/mol, 95% confidence interval [CI] -6.2, -2.2 [-0.38%, 95% CI -0.56, -0.20]; 1 year: -1.6 mmol/mol, 95% CI -3.3, 0.1 [-0.15%, 95% CI -0.30, 0.01]) and in individuals with preintervention HbA1c >75 mmol/mol (9%). CONCLUSIONS: The most effective approaches to mitigating therapeutic inertia and improving HbA1c were those that empower nonphysician providers such as pharmacists, nurses and diabetes educators to initiate and intensify treatment independently, supported by appropriate guidelines.

Decolonizing Care at Diagnosis: Culture, History, and Family at an Urban Inter-tribal Clinic.

The decolonization framework in medical anthropology is slowly reframing tropes of cultural competency toward decolonizing health care. For decolonization of health care to occur, both colonial histories and continuing postcolonial inequities must be recognized from the first diagnostic moment. We report on qualitative research into the role of culture, history, and family experience in person-specific reactions to receipt of a diagnosis. A collaborative approach at an urban inter-tribal clinic was used to interview patients with a recent (within six months) diagnosis of diabetes or related condition. Interviews revealed ways that the Relocation Act eventuated in isolation, poverty, and diabetes among now-urban Native Americans. We discuss how patients may or may not have the ability to (re)connect with their heritage and may simultaneously perceive only recent family contexts as influential in their diabetes. We conclude by acknowledging how postcolonial harms are not captured in diagnoses but should not be left out of diagnostic discussions.

Optimizing Glucose Meter Downloads at Parkland Diabetes Clinic.

Quality Improvement Success Stories are published by the American Diabetes Association in collaboration with the American College of Physicians and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of Clinical Diabetes. The following article describes a project aimed at increasing the number of patients who bring their glucose meters to their appointments for downloading at a diabetes specialty clinic with a diverse patient population in Dallas, TX.

Target attainment in insulin-naive patients at high risk for hypoglycemia: Results from ACHIEVE Control.

AIMS: To better understand outcomes in people with type 2 diabetes at high risk of hypoglycemia, we conducted post hoc analyses in subgroups of participants from the real-world ACHIEVE Control study (NCT02451137) with ≥1 hypoglycemia risk factor. METHODS: Insulin-naive adults with type 2 diabetes and A1c ≥8% were randomized 1:1 to insulin glargine 300 U/mL (Gla-300) or standard-of-care basal insulin (SOC-BI). Participants had documented history of ≥1 risk factors for hypoglycemia: chronic kidney disease, cardiovascular disease, dementia or blindness, age ≥65 years, or history of hypoglycemia. Outcomes included individualized A1c target attainment without documented symptomatic hypoglycemia (blood glucose [BG] ≤3.9 mmol/L or <3.0 mmol/L) or severe hypoglycemia, A1c target attainment, and absence of documented symptomatic or severe hypoglycemia at 6 and 12 months. RESULTS: Within subgroups, odds ratios generally showed trends favoring Gla-300 versus SOC-BI, particularly for hypoglycemia avoidance in participants ≥65 years of age (BG ≤3.9 mmol/L; odds ratio, 1.52; 95% confidence interval, 1.14-2.03) and those with chronic kidney disease (BG ≤3.9 mmol/L; odds ratio, 2.28; 95% confidence interval, 1.26-4.12). Results were consistent with the overall population. CONCLUSIONS: These data suggest potential benefit of Gla-300 versus SOC-BI for avoiding hypoglycemia in participants with ≥1 hypoglycemia risk factor.

Type 2 Diabetes and HbA1c Predict All-Cause Post-Metabolic and Bariatric Surgery Hospital Readmission.

OBJECTIVE: The main goal of this analysis was to determine whether type 2 diabetes and hemoglobin A1c (HbA1c) predict all-cause 30-day hospital readmission after metabolic and bariatric surgery (MBS). It was hypothesized that a diagnosis of type 2 diabetes or high HbA1c values would predict all-cause hospital readmission rates post MBS. METHODS: A retrospective analysis from the 2015-2018 Metabolic and Bariatric Surgery Accreditation and Quality Improvement Program (MBSAQIP) cohort was completed (N = 744,776); 30,972 participants were readmitted during the 30 days post MBS. RESULTS: Mean age of the MBSAQIP sample was 45.1 (11.5) years, and the majority were female (80.7%) and non-Hispanic White (59.4%). The all-cause hospital readmission rate was 4.2% and increased by 10% in those with uncontrolled type 2 diabetes (HbA1c > 7.5% [> 58 mmol/mol]); after adjustment, diabetes was not associated with increased readmission. Uncontrolled type 2 diabetes, type 2 diabetes, and prediabetes resulted in less weight loss 30 days post MBS. CONCLUSIONS: These results based on a national MBS cohort showed that uncontrolled type 2 diabetes is associated with a greater likelihood of all-cause hospital readmission and reduced weight loss 30 days post MBS. Both type 2 diabetes and prediabetes were also associated with decreased weight loss 30 days post MBS. These findings highlight the need to classify and optimize glycemic control prior to MBS.

Design and Implementation of an Electronic Tool to Measure Medication Adherence at the Point of Care.

Quality Improvement Success Stories are published by the American Diabetes Association in collaboration with the American College of Physicians and the National Diabetes Education Program. This series is intended to highlight best practices and strategies from programs and clinics that have successfully improved the quality of care for people with diabetes or related conditions. Each article in the series is reviewed and follows a standard format developed by the editors of Clinical Diabetes. The following article describes a project to build a point-of-care tool for assessing patients' adherence to their prescribed medications.

Addressing Therapeutic Inertia in 2020 and Beyond: A 3-Year Initiative of the American Diabetes Association.

Research has shown that getting to glycemic targets early on leads to better outcomes in people with type 2 diabetes; yet, there has been no improvement in the attainment of A1C targets in the past decade. One reason is therapeutic inertia: the lack of timely adjustment to the treatment regimen when a person's therapeutic targets are not met. This article describes the scope and priorities of the American Diabetes Association's 3-year Overcoming Therapeutic Inertia Initiative. Its planned activities include publishing a systematic review and meta-analysis of approaches to reducing therapeutic inertia, developing a registry of effective strategies, launching clinician awareness and education campaigns, leveraging electronic health record and clinical decision-support tools, influencing payer policies, and potentially executing pragmatic research to test promising interventions.

Impact of Quality Improvement (QI) Program on 5-Year Risk of Diabetes-Related Complications: A Simulation Study.

OBJECTIVE: We successfully implemented the American Diabetes Association's (ADA) Diabetes INSIDE (INspiring System Improvement with Data-Driven Excellence) quality improvement (QI) program at a university hospital and safety-net health system (Tulane and Parkland), focused on system-wide improvement in poorly controlled type 2 diabetes (HbA1c >8.0% [64 mmol/mol]). In this study, we estimated the 5-year risk reduction in complications and mortality associated with the QI program. RESEARCH DESIGN AND METHODS: The QI implementation period was 1 year, followed by the postintervention period of 6 months to evaluate the impact of QI on clinical measures. We measured the differences between the baseline and postintervention clinical outcomes in 2,429 individuals with HbA1c >8% (64 mmol/mol) at baseline and used the Building, Relating, Assessing, and Validating Outcomes (BRAVO) diabetes model to project the 5-year risk reduction of diabetes-related complications under the assumption that intervention benefits persist over time. An alternative assumption that intervention benefits diminish by 30% every year was also tested. RESULTS: The QI program was associated with reductions in HbA1c (-0.84%) and LDL cholesterol (LDL-C) (-5.94 mg/dL) among individuals with HbA1c level >8.0% (64 mmol/mol), with greater reduction in HbA1c (-1.67%) and LDL-C (-6.81 mg/dL) among those with HbA1c level >9.5% at baseline (all P < 0.05). The implementation of the Diabetes INSIDE QI program was associated with 5-year risk reductions in major adverse cardiovascular events (MACE) (relative risk [RR] 0.78 [95% CI 0.75-0.81]) and all-cause mortality (RR 0.83 [95% CI 0.82-0.85]) among individuals with baseline HbA1c level >8.0% (64 mmol/mol), and MACE (RR 0.60 [95% CI 0.56-0.65]) and all-cause mortality (RR 0.61 [95% CI 0.59-0.64]) among individuals with baseline HbA1c level >9.5% (80 mmol/mol). Sensitivity analysis also identified a substantially lower risk of diabetes-related complications and mortality associated with the QI program. CONCLUSIONS: Our modeling results suggest that the ADA's Diabetes INSIDE QI program would benefit the patients and population by substantially reducing the 5-year risk of complications and mortality in individuals with diabetes.

A pragmatic randomized clinical trial of insulin glargine 300 U/mL vs first-generation basal insulin analogues in insulin-naïve adults with type 2 diabetes: 6-month outcomes of the ACHIEVE Control study.

AIMS: To compare the safety and efficacy of insulin glargine 300 U/mL (Gla-300) versus first-generation standard-of-care basal insulin analogues (SOC-BI; insulin glargine 100 U/mL or insulin detemir) at 6 months. METHODS: In the 12-month, open-label, multicentre, randomized, pragmatic ACHIEVE Control trial, insulin-naïve adults with type 2 diabetes (T2D) and glycated haemoglobin (HbA1c) 64 to 97 mmol/mol (8.0%-11.0%) after ≥1 year of treatment with ≥2 diabetes medications were randomized to Gla-300 or SOC-BI. The composite primary endpoint, evaluated at 6 months, was the proportion of participants achieving individualized HbA1c targets per Healthcare Effectiveness Data and Information Set (HEDIS) criteria without documented symptomatic (blood glucose ≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia at any time of the day at 6 months. RESULTS: Of 1651 and 1653 participants randomized to Gla-300 and SOC-BI, respectively, 31.3% and 27.9% achieved the composite primary endpoint at 6 months (odds ratio [OR] 1.19, 95% confidence interval [CI] 1.01-1.39; P = 0.03 for superiority); 78.4% and 75.3% had no documented symptomatic or severe hypoglycaemia (OR 1.19, 95% CI 1.01-1.41). Changes from baseline to month 6 in HbA1c, fasting plasma glucose, weight, and BI analogue dose were similar between groups. CONCLUSIONS: Among insulin-naïve adults with poorly controlled T2D, Gla-300 was associated with a statistically significantly higher proportion of participants achieving individualized HEDIS HbA1c targets without documented symptomatic or severe hypoglycaemia (vs SOC-BI) in a real-life population managed in a usual-care setting. The ACHIEVE Control study results add value to treatment decisions and options for patients, healthcare providers, payers and decision makers.

Insulin glargine 300 U/mL versus first-generation basal insulin analogues in insulin-naïve adults with type 2 diabetes: 12-month outcomes of ACHIEVE Control, a prospective, randomized, pragmatic real-life clinical trial.

AIM: To report the effectiveness and safety of insulin glargine 300 U/mL (Gla-300) versus standard-of-care basal insulin analogues (SOC-BI) at 12 months in the ACHIEVE Control trial, which is a prospective pragmatic randomized real-life study in insulin-naïve adults with type 2 diabetes (T2D). METHODS: A total of 3304 insulin-naïve adults with T2D and glycated haemoglobin (HbA1c) concentration of 64 to 97 mmol/mol (8.0% to 11.0%) after ≥1 year of treatment with two or more antihyperglycaemic agents were randomized to Gla-300 or SOC-BI. Key secondary endpoints included HbA1c target attainment without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia at 12 months. RESULTS: At 12 months, 26.1% (Gla-300) and 23.7% (SOC-BI) of adults achieved HbA1c targets without documented symptomatic (≤3.9 mmol/L [≤70 mg/dL]) or severe hypoglycaemia (odds ratio [OR] 1.14, 95% confidence interval [CI] 0.97-1.35); 33.0% and 29.5%, respectively, achieved HbA1c targets without documented symptomatic (<3.0 mmol/L [<54 mg/dL]) or severe hypoglycaemia (OR 1.19, 95% CI 1.02-1.38). The OR for HbA1c target achievement was 1.15 (95% CI 0.99-1.34), and favoured Gla-300 versus SOC-BI for absence of documented symptomatic or severe hypoglycaemia at 12 months for both ≤3.9 mmol/L (≤70 mg/dL; OR 1.21, 95% CI 1.05-1.40) and < 3.0 mmol/L (<54 mg/dL; OR 1.26, 95% CI 1.07-1.48). CONCLUSION: Gla-300 tended to be associated with lower hypoglycaemia risk than SOC-BI in real-world clinical practice during the 12-month follow-up.

Multilevel Variation in Diabetes Screening Within an Integrated Health System.

OBJECTIVE: Variation in diabetes screening in clinical practice is poorly described. We examined the interplay of patient, provider, and clinic factors explaining variation in diabetes screening within an integrated health care system in the U.S. RESEARCH DESIGN AND METHODS: We conducted a retrospective cohort study of primary care patients aged 18-64 years with two or more outpatient visits between 2010 and 2015 and no diagnosis of diabetes according to electronic health record (EHR) data. Hierarchical three-level models were used to evaluate multilevel variation in screening at the patient, provider, and clinic levels across 12 clinics. Diabetes screening was defined by a resulted gold standard screening test. RESULTS: Of 56,818 patients, 70% completed diabetes screening with a nearly twofold variation across clinics (51-92%; P < 0.001). Of those meeting American Diabetes Association (ADA) (69%) and U.S. Preventive Services Task Force (USPSTF) (36%) screening criteria, three-quarters were screened with a nearly twofold variation across clinics (ADA 53-92%; USPSTF 49-93%). The yield of ADA and USPSTF screening was similar for diabetes (11% vs. 9%) and prediabetes (38% vs. 36%). Nearly 70% of patients not eligible for guideline-based screening were also tested. The USPSTF guideline missed more cases of diabetes (6% vs. 3%) and prediabetes (26% vs. 19%) than the ADA guideline. After adjustment for patient, provider, and clinic factors and accounting for clustering, twofold variation in screening by provider and clinic remained (median odds ratio 1.97; intraclass correlation 0.13). CONCLUSIONS: Screening practices vary widely and are only partially explained by patient, provider, and clinic factors available in the EHR. Clinical decision support and system-level interventions are needed to optimize screening practices.

Making Inroads in Addressing Population Health in Underserved Communities With Type 2 Diabetes.

IN BRIEF Diabetes continues to represent a substantial individual and societal burden for those affected by the disease and its complications in the United States, and especially for racial/ethnic minorities, the socioeconomically disadvantaged, and the underinsured. Although tools and strategies are now available to manage the condition and its associated comorbidities at the patient level, we continue to struggle to gain control of this health burden at the population health level. Most patients are not achieving desired clinical goals and thus continue to be exposed to preventable risks and complications. As the U.S. health system moves toward a more value-based system of reimbursement, there are opportunities to rethink our approaches to patient and population health management and to harness the available tools and technologies to better understand the disease burden, stratify our patient populations by risk, redirect finite resources to high-impact initiatives, and facilitate better diabetes care management for patients and providers alike.

Diabetic Skin Changes Can Benefit from Moisturizer and Cleanser Use: A Review

INTRODUCTION: Diabetes mellitus (DM) associated skin changes, which may be the first sign of DM in undiagnosed patients. Frequently these patients present with dry skin, which may benefit from the use of gentle cleansers and moisturizers. A review paper was developed to explore DM-associated skin changes and possible benefits of cleanser and moisturizer use. METHODS: For this purpose, an expert panel of physicians involved in the care of patients with DM selected information from literature searches coupled with expert opinions and experience of the panel. RESULTS: A defective skin barrier predisposes the skin to water loss leading to dryness, hyperkeratosis and inflammation. Skin changes that may benefit from the use of gentle cleansers and moisturizers are, amongst others, diabetic foot syndrome, ichthyosiform skin changes, xerosis, and keratosis pilaris. Adherence to treatment is a considerable challenge making education essential, especially about the need to keep skin clean and what skin care to use. Specifically designed diabetic skin care that contains anti-aging ingredients, urea, and essential ceramides, has demonstrated benefits for dry/itchy skin. CONCLUSIONS: Skin disorders are common complications among either diabetic patients with patients with DM and may lead to serious adverse events. Evidence suggests that daily application of optimal skin care using gentle cleansers and moisturizers is one of the measures that may help improve skin barrier dysfunction, preventing complications by providing early-stage treatment of patients with diabetes. J Drugs Dermatol. 2019;18(12):1211-1217.

Hypoglycaemia and treatment patterns among insulin-treated patients with type 2 diabetes who switched to insulin glargine 300 units/mL versus other basal insulin in a real-world setting.

INTRODUCTION: Type 2 diabetes (T2D) is characterized by worsening pancreatic ß-cell function often requiring treatment escalation with oral antidiabetic drugs (OADs), glucagon-like peptide-1 and eventually insulin. Although there is much evidence available on the initiation of basal insulins, fewer studies have investigated the effects of switching from one basal insulin to another. This study aims to evaluate treatment persistence and hypoglycaemia in adult patients with T2D on prior basal insulin who were switched to insulin glargine 300 units/mL (Gla-300) or other basal insulins in a real-world setting. MATERIALS AND METHODS: This study is a retrospective cohort analysis of patient-level data extracted from the Optum® Clinformatics™ database between 1 October 2014 and 30 June 2016. Adult patients (≥18 years) with T2D who were being treated with basal insulin during the 6-month baseline period, who switched to either Gla-300 or other basal insulins, were followed up for ≥3 months after switching. Outcomes included treatment persistence, and incidence and number of hypoglycaemic events. RESULTS: Of the included patients, 1204 switched to Gla-300 and 616 switched to other basal insulins. Adjusting for baseline confounders, patients who switched to Gla-300 were 34% less likely to discontinue their basal insulin than patients who switched to other basal insulins (hazard ratio [HR] 0.66; 95% confidence interval [CI] 0.54-0.81; P < 0.001). Patients who switched to Gla-300 were less likely to experience hypoglycaemia at 3-month follow-up (odds ratio [OR] 0.56, 95% CI 0.32-0.97; P = 0.039) and at 6-month follow-up (OR 0.58, 95% CI 0.38-0.87; P = 0.009) compared with patients who switched to other basal insulins. CONCLUSIONS: Patients with T2D on prior basal insulin in a real-world setting who switched to Gla-300 were more persistent with their basal insulin and experienced less hypoglycaemia than patients who switched to other basal insulins.

Clinical Characteristics and Glycemic Outcomes of Patients with Type 2 Diabetes Requiring Maximum Dose Insulin Glargine/Lixisenatide Fixed-Ratio Combination or Insulin Glargine in the LixiLan-L Trial.

INTRODUCTION: iGlarLixi is a titratable, fixed-ratio combination of insulin glargine (iGlar, 100 units/ml) and the glucagon-like peptide-1 receptor agonist lixisenatide for the treatment of patients with type 2 diabetes. This post hoc analysis of the phase 3 LixiLan-L trial (NCT02058160) investigated baseline characteristics, glycemic control, and safety outcomes in participants who received the study-specified maximum dose (60 units/day) of iGlarLixi or iGlar vs. those who received < 60 units/day. METHODS: Outcomes were compared for participants receiving 60 or < 60 units/day at week 30. Endpoints analyzed included change in A1C, fasting plasma glucose (FPG), 2-h postprandial glucose (2-h PPG), body weight, proportion of participants achieving A1C < 7.0%, proportion of participants receiving rescue therapy, documented symptomatic hypoglycemia, and gastrointestinal adverse event (GI AE) incidence. RESULTS: By week 30, 27% (iGlarLixi) and 31% (iGlar) of participants received the maximum dose. Participants on 60 vs. < 60 units/day were younger and had higher body weight, body mass index (BMI), FPG, and baseline insulin dose. In both dose groups, A1C change from baseline was significantly greater with iGlarLixi vs. iGlar, and more participants treated with iGlarLixi vs. iGlar achieved A1C < 7.0%. No significant differences were observed in change from baseline for A1C, FPG, 2-h PPG, or GI AE incidence between insulin dose groups, regardless of treatment. In both treatment arms, incidence of symptomatic hypoglycemia was lower in participants receiving 60 units/day vs. those receiving < 60 units/day. Participants treated with iGlarLixi (< 60 or 60 units/day) had modest weight loss over 30 weeks vs. an increase in weight compared with iGlar. CONCLUSIONS: Maximum doses of iGlarLixi were required in participants with a more insulin-resistant clinical phenotype (younger, higher BMI, FPG, and insulin doses). Benefits were observed with iGlarLixi vs. iGlar, even at 60 units/day, with more participants achieving glycemic goals, no increase in symptomatic hypoglycemia, and a modest reduction in body weight. FUNDING: Sanofi US, Inc.

A randomized trial comparing the efficacy and safety of treating patients with type 2 diabetes and highly elevated HbA1c levels with basal-bolus insulin or a glucagon-like peptide-1 receptor agonist plus basal insulin: The SIMPLE study.

AIM: To compare the efficacy and safety of a glucagon-like peptide-1 receptor agonist (GLP1RA) plus basal insulin versus basal-bolus insulin treatment in patients with very uncontrolled type 2 diabetes. MATERIALS AND METHODS: The SIMPLE study was a 6-month pragmatic, randomized, open-label trial testing the effectiveness of two approaches to treat patients with type 2 diabetes and HbA1c ≥10%. We randomized patients to detemir plus liraglutide or detemir plus aspart (before each meal). The primary endpoint was change in HbA1c; changes in body weight, insulin dose, hypoglycaemia and diabetes-related quality-of-life were secondary outcomes. RESULTS: We randomized 120 participants aged 47.4 ± 9.5 years, Hispanic 40%, African American 42%, diabetes duration 10 [25th-75th percentile (6 to 15)] years, body mass index 37.2 ± 10.3 kg/m2 . HbA1c decreased more with GLP1RA plus basal insulin [12.2% (95% CI 11.8% to 12.6%) to 8.1% (95% CI 7.4% to 8.7%)] compared with basal-bolus insulin [11.8% (95% CI 11.5% to 12.2%) to 8.8% (95% CI 88.1% to 9.55%)]; estimated treatment difference (ETD) of -1.1% (95% CI -2.0% to -0.1%) (non-inferiority margin 0.4% and P = .0001, superiority P = .026). Compared with basal-bolus insulin, treatment with GLP1RA plus basal insulin led to a body weight ETD of -3.7 kg (95% CI -5.8 to -1.5; P = .001), fewer patients experiencing hypoglycaemia [66.1% vs 35.2% (P = .002)], and greater improvements in general/current health perception, treatment satisfaction, and fear of hypoglycaemia, while taking a lower total daily dose of insulin [estimated treatment ratio 0.68 (95% CI 0.55 to 0.84)]. CONCLUSIONS: In patients with HbA1c ≥10% treatment with GLP1RA plus basal insulin, compared with basal-bolus insulin, resulted in better glycaemic control and body weight, lower insulin dosage and hypoglycaemia, and improved quality of life. This treatment strategy is an effective and safe alternative to a basal-bolus insulin regimen.

Rates of Hypoglycemia Predicted in Patients with Type 2 Diabetes on Insulin Glargine 300 U/ml Versus First- and Second-Generation Basal Insulin Analogs: The Real-World LIGHTNING Study.

INTRODUCTION: The LIGHTNING study applied conventional and advanced analytic approaches to model, predict, and compare hypoglycemia rates of people with type 2 diabetes (T2DM) on insulin glargine 300 U/ml (Gla-300) with those on first-generation (insulin glargine 100 U/ml [Gla-100]; insulin detemir [IDet]) or second-generation (insulin degludec [IDeg]) basal-insulin (BI) analogs, utilizing a large real-world database. METHODS: Data were collected between 1 January 2007 and 31 March 2017 from the Optum Humedica US electronic health records [EHR] database. Patient-treatments, the period during which a patient used a specific BI, were analyzed for patients who switched from a prior BI or those who newly initiated BI therapy. Data were analyzed using two approaches: propensity score matching (PSM) and a predictive modeling approach using machine learning. RESULTS: A total of 831,456 patients with T2DM receiving BI were included from the EHR data set. Following selection, 198,198 patient-treatments were available for predictive modeling. The analysis showed that rates of severe hypoglycemia (using a modified definition) were approximately 50% lower with Gla-300 than with Gla-100 or IDet in insulin-naïve individuals, and 30% lower versus IDet in BI switchers (all p < 0.05). Similar rates of severe hypoglycemia were predicted for Gla-300 and IDeg, regardless of prior insulin experience. Similar results to those observed in the overall cohorts were seen in analyses across subgroups at a particularly high risk of hypoglycemia. PSM (performed on 157,573 patient-treatments) revealed comparable reductions in HbA1c with Gla-300 versus first- and second-generation BI analogs, alongside lower rates of severe hypoglycemia with Gla-300 versus first-generation BI analogs (p < 0.05) and similar rates versus IDeg in insulin-naïve and BI-switcher cohorts. CONCLUSIONS: Based on real-world data, predicted rates of severe hypoglycemia with Gla-300 tended to be lower versus first-generation BI analogs and similar versus IDeg in a wide spectrum of patients with T2DM. FUNDING: Sanofi, Paris, France.