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.

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.

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.

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.

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.

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.

Commencing insulin glargine 100 U/mL therapy in individuals with type 2 diabetes: Determinants of achievement of HbA1c goal less than 7.0.

AIMS: To identify factors associated with achievement of glycated haemoglobin A1c (HbA1c) target at 24 weeks after commencing basal insulin therapy in individuals with type 2 diabetes mellitus (T2DM). MATERIALS AND METHODS: Post-hoc pooled analysis of 16 randomized, treat-to-target trials involving individuals with T2DM inadequately controlled with oral anti-hyperglycaemic drugs (n = 3415) initiated on once-daily insulin glargine 100 U/mL (Gla-100). Clinical outcomes were assessed by HbA1c response at 24 weeks and individuals were classified as "good responders" with HbA1c <7.0% (<53 mmol/mol) or as "poor responders" with HbA1c ≥7.0% (≥53 mmol/mol). Univariable and multivariable stepwise logistic regression analyses were performed to identify predictive factors for attaining HbA1c <7.0%. RESULTS: Lower levels of baseline HbA1c, fasting plasma glucose (FPG) and post-prandial plasma glucose (PPG), higher body mass index (BMI), shorter diabetes duration and male sex were associated with a good glycaemic response, but not age or baseline C-peptide levels. Gla-100 dose (U/kg) was highest in the poor-responder group, which had the fewest hypoglycaemia episodes. Univariable analysis for achievement of HbA1c <7.0% confirmed these observations. Multivariable analysis retained baseline HbA1c, body weight, BMI, sex, 2-hours PPG and diabetes duration as predictors of a good response. Continued use of sulfonylureas, hypoglycaemia and change in body weight were indicative of poor response. CONCLUSIONS: Baseline HbA1c was the strongest determinant for achieving target HbA1c <7.0% by supplementary Gla-100 therapy, while sex and BMI were also useful indicators. However, age and C-peptide levels at baseline did not predict glycaemic response to the introduction of basal insulin.

The Diabetes Unmet Need with Basal Insulin Evaluation (DUNE) study in type 2 diabetes: Achieving HbA1c targets with basal insulin in a real-world setting.

AIMS: To describe in a real-world setting the achievement of physician-selected individualized HbA1c targets in individuals with type 2 diabetes, newly or recently initiated with basal insulin, and the association of hypoglycaemia with target achievement. MATERIALS AND METHODS: A 12-week, prospective, single-arm, observational study of adults with type 2 diabetes, either newly initiated with any basal insulin or start on basal insulin within the preceding 12 months. At enrollment, eligible participants from 28 countries were treated with or without oral antihyperglycaemic drugs and/or GLP-1 receptor agonists. RESULTS: Individualized targets for almost all of the 3139 evaluable participants (99.7%) had been set by their physicians, with 57% of participants having HbA1c targets between 7.0% and <7.5% (53 and <58 mmol/mol). By week 12, 28% and 27% of newly and previously initiated participants, respectively, achieved individualized HbA1c targets with modest average increases in daily insulin dose of 9 and 5 U (0.10 and 0.06 U/kg), respectively, from baseline (14 and 23 U [0.17 and 0.29 U/kg], respectively). Overall, 16% of participants experienced at least one episode of hypoglycaemia. Both the incidence and frequency of hypoglycaemia, but not the severity, were positively associated with a higher likelihood of achieving individualized HbA1c targets (P < 0.05). CONCLUSIONS: In this prospective real-world study, most participants using basal insulin did not achieve the individualized HbA1c targets set by their physicians. Participants who experienced symptomatic hypoglycaemia were more likely to achieve HbA1c targets than those who did not.

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.

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.

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.

Association of hypoglycaemia severity with clinical, patient-reported and economic outcomes in US patients with type 2 diabetes using basal insulin.

AIMS: To evaluate the clinical and patient-reported outcomes and healthcare utilization and costs associated with patient-reported hypoglycaemia in US adults with type 2 diabetes (T2D) treated with basal insulin. MATERIALS AND METHODS: This was an observational, cross-sectional, survey-based study of adults with T2D on basal insulin ± oral antidiabetes drugs (OADs) or rapid-acting/premixed insulin, who had in the past ever experienced hypoglycaemia, using US data from the National Health and Wellness Survey. Eligible patients were categorized as having no hypoglycaemia (38.7%), non-severe hypoglycaemia (55.1%), or severe hypoglycaemia (6.2%) in the preceding 3 months. Outcomes included health-related quality of life (HRQoL), work productivity and activity impairment, healthcare resource utilization, and estimated direct and indirect costs. Multivariable regression models were performed to control for patient characteristics. RESULTS: Patients who experienced severe hypoglycaemia had significantly (P < .05) lower HRQoL scores, greater overall impairment of work productivity and activity, greater healthcare resource utilization, and higher costs compared with those who experienced non-severe or no hypoglycaemia. Patients with non-severe hypoglycaemia also reported an impact on the number of provider visits, indirect costs, and HRQoL. CONCLUSIONS: Patients with T2D using basal insulin ± OADs or rapid-acting/premixed insulin in the United States who experienced severe hypoglycaemia had greater impairment of activity and work productivity, utilized more healthcare resources, and incurred higher associated costs than those with non-severe or no hypoglycaemia. The study also demonstrated the impact that non-severe hypoglycaemic events have on economic and HRQoL outcomes. Reducing the incidence and severity of hypoglycaemia could lead to clinically meaningful improvements in HRQoL and may result in lower healthcare utilization and associated costs.

Impact of delaying treatment intensification with a glucagon-like peptide-1 receptor agonist in patients with type 2 diabetes uncontrolled on basal insulin: A longitudinal study of a US administrative claims database.

AIM: To evaluate the effect of delaying treatment intensification with a glucagon-like peptide-1 receptor agonist (GLP-1 RA) on clinical and economic outcomes in patients with type 2 diabetes (T2D). METHODS: We conducted a retrospective observational claims study using IMPACT (Impact National Managed Care Benchmark Database) in adult patients with T2D who initiated basal insulin between January 1, 2005 and December 31, 2012, with or without OADs, who remained uncontrolled (glycated haemoglobin [HbA1c] ≥7.0%). Patients were categorized into 3 groups: early, delayed, and no intensification with a GLP-1 RA. We evaluated changes from baseline to follow-up at 12 months for HbA1c level, rate of hypoglycaemic events, and healthcare costs, and we assessed the association between baseline patient characteristics and subsequent treatment intensification. RESULTS: A total of 139 patients (9.0% of 1552 eligible patients) met criteria for inclusion in the early intensification group, 588 patients (37.9%) met criteria for inclusion in the delayed intensification group, and 825 patients (53.2%) met criteria for inclusion in the no intensification group. Mean baseline HbA1c values were 9.16%, 9.07%, and 9.34%, respectively. At follow-up, delayed intensification was associated with significantly smaller decreases in HbA1c from baseline (-0.68%) compared with early intensification (-1.01%). Rates of overall hypoglycaemia were numerically greater in the delayed intensification group than in the early intensification group (0.26 vs 0.06 events/patient-years of exposure, respectively). Change in semi-annual total healthcare costs was greater in the no intensification group (+5266 USD) compared with the early intensification group (-560 USD) and the delayed intensification group (+1943 USD). CONCLUSIONS: Timely addition of a GLP-1 RA to therapy for patients with T2D who were not adequately controlled with basal insulin is associated with better clinical and economic outcomes.

Relationship between treatment persistence and A1C trends among patients with type 2 diabetes newly initiating basal insulin.

This study examines the relationship between glycated haemoglobin (A1C) levels and treatment persistence with, or time to discontinuation of, basal insulin in patients with type 2 diabetes (T2D) newly initiating insulin. Claims data were extracted from the Optum Clinformatics database from January 2010 to June 2015. Adult patients with T2D initiating insulin glargine 100 U/mL (Gla-100) or insulin detemir (DET) with ≥1 A1C measurement during 12-month baseline and 18-month follow-up periods were included. Patients with a refill gap of >90 days were considered non-persistent; otherwise, patients were considered persistent with insulin. The main outcome was A1C, measured closest to the end of each quarter during the follow-up period. A total of 3993 of 109 934 patients met the inclusion criteria (43.0% persistent; 57.0% non-persistent). Persistent patients were older (54.7 vs 52.7 years; P < .001), were more likely to be male (59.4% vs 54.4%; P = .002), and had significantly lower mean unadjusted A1C values at 18 months (8.26% vs 8.60%; P < .001) and quarterly. Only 43.0% of adults initiating basal insulin persisted with treatment for 18 months, with earlier discontinuation associated with higher A1C.

More patients reach glycaemic control with a fixed-ratio combination of insulin glargine and lixisenatide (iGlarLixi) than with basal insulin at 12 weeks of treatment: A post hoc time-to-control analysis of LixiLan-O and LixiLan-L.

The present post hoc analysis of two 30-week clinical trials compared efficacy and hypoglycaemia outcomes at early study visits with iGlarLixi (insulin glargine U100 [iGlar] and lixisenatide) vs iGlar alone in patients with type 2 diabetes (T2D) uncontrolled on oral antidiabetic drugs (OADs; LixiLan-O trial) or basal insulin (LixiLan-L trial). Time to control, defined as days to achieve glycated haemoglobin (HbA1c) <53 mmol/mol (<7%) or fasting plasma glucose (FPG) ≤7.2 mmol/L, was estimated using the Kaplan-Meier method. In the LixiLan-O and LixiLan-L trials, 60% and 46% of patients, respectively, reached HbA1c <53 mmol/mol (<7%) with iGlarLixi at 12 weeks, vs 45% and 24%, respectively, with iGlar. In the LixiLan-O trial, the median time to target HbA1c was approximately half with iGlarLixi vs iGlar (85.0 vs 166.0 days; P < .0001). In the LixiLan-L trial, the median time to target HbA1c was 153.0 days with iGlarLixi, while target HbA1c was never reached by 50% of patients with iGlar (P < .0001). Time-to-target FPG and hypoglycaemia outcomes were similar between treatments. In T2D uncontrolled on OADs or basal insulin, iGlarLixi resulted in glycaemic control in more patients than did iGlar at early treatment time points.

Glycaemic control and hypoglycaemia burden in patients with type 2 diabetes initiating basal insulin in Europe and the USA.

AIMS: To evaluate short- and long-term glycaemic control and hypoglycaemia incidence in insulin-naïve patients ≥30 years of age with type 2 diabetes (T2DM) initiating basal insulin (BI) with or without oral anti-hyperglycaemic drugs (OADs). METHODS: This was an observational, retrospective longitudinal analysis of electronic medical records from 5 European countries and the USA. A multivariable logistic regression model assessed baseline and short-term (0-3 months post BI initiation) factors associated with long-term (3-24 months) glycaemic control and hypoglycaemia. RESULTS: Overall, 40 627 patients were included; 20.9% and 27.8% achieved the general HbA1c target of ≤7% at 3 and 24 months post BI initiation, respectively. Failure to achieve HbA1c ≤7% at 3 months was associated with increased risk of failing to achieve target at 24 months (odds ratio [OR], 3.70 [95% CI, 3.41-4.00]). Over 24 months, 8.9% of patients experienced a recorded hypoglycaemic event. Hypoglycaemia during the initial 3-month period was associated with longer-term risk of these events over the ensuing 3 to 24 months (OR, 5.71 [95% CI, 4.67-6.99]). CONCLUSIONS: Initiating BI with or without OADs is associated with short- and long-term suboptimal glycaemic control; the majority of patients fail to achieve HbA1c target ≤7% in the first 3 months, or after 2 years of BI treatment. Treatment response and hypoglycaemia incidence by 3 months post BI initiation are associated with longer-term glycaemic control and hypoglycaemic risk, respectively. These results support the need for early anti-hyperglycaemic interventions that more effectively control blood glucose levels without increasing the risk of hypoglycaemia.

Short-term intensive insulin therapy at diagnosis in type 2 diabetes: plan for filling the gaps.

Short-term intensive insulin therapy is unique amongst therapies for type 2 diabetes because it offers the potential to preserve and improve beta-cell function without additional pharmacological treatment. On the basis of clinical experience and the promising results of a series of studies in newly diagnosed patients, mostly in Asian populations, an expert workshop was convened to assess the available evidence and the potential application of short-term intensive insulin therapy should it be advocated for inclusion in clinical practice. Participants included primary care physicians and endocrinologists. We endorse the concept of short-term intensive insulin therapy as an option for some patients with type 2 diabetes at the time of diagnosis and have identified the following six areas where additional knowledge could help clarify optimal use in clinical practice: (1) generalizability to primary care, (2) target population and biomarkers, (3) follow-up treatment, (4) education of patients and providers, (5) relevance of ethnicity, and (6) health economics.

Insulin stacking versus therapeutic accumulation: understanding the differences.

OBJECTIVE: The build-up in insulin levels following repeated injection of prandial insulin at close intervals--referred to as insulin stacking--can increase the risk of hypoglycemia. With the development of basal insulins with a half-life > 24 hours and a duration of action > 40 hours, clinicians may be concerned about stacking when these long-acting formulations are administered once daily. The objective of this review is to clarify the difference between inappropriate insulin stacking when shorter-acting insulin formulations are repeatedly used to correct hyperglycemia and the appropriate accumulation of long-acting insulin formulations dosed to steady-state pharmacokinetic (PK) profiles. METHODS: Relevant literature on insulin stacking, glucose-clamp studies, and clinical studies of insulin, in conjunction with the clinical experience of the authors, were used to present an overview of insulin PK properties and the effects of appropriate and inappropriate dosing intervals on steady-state conditions and likely clinical outcomes. RESULTS: Clinical studies confirm theoretical PK principles showing that unwanted insulin stacking (excessive concentrations) for basal insulin can be avoided by following recommended dosing and titration algorithms. Long-acting basal insulins need more time to reach steady state than shorter-acting basal insulins but then show reduced peak-trough fluctuations, translating into more consistent biologic action over a 24-hour period. CONCLUSION: The unwanted stacking and consequent hypoglycemia that can occur when correctional doses of rapid-acting insulin are administered at close intervals does not occur when long-acting basal insulins are dosed in appropriate amounts and adjusted at appropriate time intervals (e.g., insulin stacking, insulin administration, diabetes, ultralong duration of action, hypoglycemia every three or more days), allowing for pharmacologic steady-state accumulation.