Individualized HbA1c Targets Research Articles

Training Nursing Staff to Improve Diabetes Care for Long-Term Care Facility (LTCF) Residents

One out of four people age 65 and older residing in a long term care facility (LTCF) has type 2 diabetes (T2DM). Care and management of this population is a challenge for nurses and other providers. American Diabetes Association Guidelines (2017) recommend application of individualized HbA1c targets for LTCF residents, especially for those with compromises in clinical and functional status. A needs assessment in a local LTCF identified deficiencies in the provision of evidence-based T2DM care for this LTCF population. This quality improvement (QI) project strove to 1) educate nurses about these residents’ needs and 2) incorporate the use of best practice diabetes standards in the nurse practitioner’s practice by providing in-service education. Specifically, emphasis was placed on HbA1c and finger stick monitoring, eye exams, and foot care. Results indicated that educational in-services were an effective approach to improving knowledge concerning care of complex TD2M patients. The Advanced Practice Registered Nurse (APRN) (60% to 100%), the 3 registered nurses (63% to 87%) and 9 licensed vocational nurses (63% to 71%) increased in knowledge from baseline to the final 10 question post-test. However, ophthalmology and podiatry referrals were not ordered routinely because of APRN, staff, and organizational resistance. Per an audit of 22 patient charts, utilization of standardized orders improved routine T2DM care. There were 13 HbA1c due and 12 were ordered (92%); the one renal panel that was due was ordered, and all 5 urine to albumin creatinine ratio were ordered. In addition, the APRN has awareness to evaluate discrepancies between HbA1c results and finger stick values. QI projects in LTCFs may be difficult to implement and sustain related to staff turnover, understaffing, high patient acuity, and organizational and provider opposition. APRNs must advocate for continual utilization of evidence-based practice guidelines for all LTCF residents. Disclosure A.L. Hubberd: None. C.M. Hernandez: None.

Calculating individualized glycaemic targets using an algorithm based on expert worldwide diabetologists: Implications in real-life clinical practice.

The aim of this study was to assess the clinical implications of calculating an individualized HbA1c target using a recently published algorithm in a real-life clinical setting. General practitioners (GPs) from the Spanish Society of Family Medicine Diabetes Expert Group were invited to participate in the study. Each GP selected a random sample of patients with diabetes from his or her practice and submitted their demographic and clinical data for analysis. Individualized glycaemic targets were calculated according to the algorithm. Predictors of good glycaemic control were studied. The rate of patients attaining their individualized glycaemic target or the uniform target of HbA1c <7.0% was calculated. Forty GPs included 408 patients in the study. Of the 8 parameters included in the algorithm, "comorbidities," "risk of hypoglycaemia from treatment," and "diabetes duration" had the greatest impact on determining the individualized glycaemic target. Number of glucose-lowering agents and adherence were independently associated with glycaemic control. Overall, 60.5% of patients had good glycaemic control per individualized target, and 56.1% were well controlled per the uniform target of HbA1c <7.0% (P=.20). However, 12.8% (23 of 246) of the patients with HbA1c ≥7.0% were adequately controlled per individualized target, and 2.6% (6 of 162) of the patients with HbA1c <7.0% were uncontrolled since their individualized target was lower. In a real-life clinical setting, applying individualized targets did not change the overall rate of patients with good glycaemic control yet led to reclassification of 7.1% (29 of 408) of the patients. More studies are needed to validate these results in different populations.

Control of cardiovascular risk factors in type 2 diabetes in a specialized diabetic clinic

Achieving an adequate control of glycaemic and cardiovascular risk factors (CVRFs) is essential in patients with type 2 diabetes mellitus (T2DM). However, several studies have shown that the percentage of patients achieving these goals is scarce. We evaluated the degree of control of CVRFs target goals in T2DM patients who regularly attend a specialized diabetic clinic. We studied T2DM patients who attended the specialized Diabetic Unit at the Department of Endocrinology of Clínica Universitaria de Navarra with a minimum follow-up of one year. Clinical characteristics, chronic complications and treatments were collected and patients were classified into groups according to the fulfilment of target glycated haemoglobin (HbA1c), LDL cholesterol and blood pressure (BP) levels, predefined according to the presence of different comorbidities and the duration of T2DM. We analysed 137 patients (75% men) with T2DM, with an average age of 67 years and a 12.7 year duration of diabetes. During follow-up, 83.9% of the patients were within the individualized HbA1c target, 76.6% considering BP and 67.2% in terms of LDL-cholesterol. In addition, 68% had concomitantly the three main variables within the target. In our population of T2DM, HbA1c, LDL cholesterol and BP targets were achieved in a substantial proportion of patients (67-91%). Perhaps the intense and individualized care offered through a specialized diabetes unit may explain these results.

Glycaemic outcomes of an Individualized treatMent aPproach for oldER vulnerable patIents: A randomized, controlled stUdy in type 2 diabetes Mellitus (IMPERIUM)

AimsTo compare the glycaemic outcomes of 2 glucose‐lowering treatment strategies in vulnerable (moderately ill and/or frail) patients aged ≥65 years with type 2 diabetes whose individual HbA1c targets were not met with diet/exercise and/or oral anti‐hyperglycaemic medications (OAMs).MethodsThe primary endpoint of this study was a composite of achieving/maintaining individualized HbA1c targets without “clinically significant” hypoglycaemia (severe hypoglycaemia or repeated hypoglycaemia causing interruption of patients’ activities or blood glucose <54 mg/dL). Strategy‐A comprised glucose‐dependent therapies (n = 99) with a non‐sulphonylurea OAM and a glucagon‐like peptide‐1 receptor agonist as the first injectable. Strategy‐B comprised non‐glucose‐dependent therapies (n = 93) with sulphonylurea as the preferred OAM and insulin glargine as the first injectable.ResultsThere was no significant difference between Strategy‐A and Strategy‐B in percentages of patients achieving the primary endpoint (64.5% vs 54.9%; P = .190). Mean incidences (A vs B) of total (10.2% vs 53.8%), documented symptomatic (5.1% vs 36.6%), and asymptomatic (8.2% vs 32.3%) hypoglycaemia were lower for Strategy‐A (P < .001 each). Proportions of patients achieving/maintaining HbA1c target (A, 63.3% vs B, 55.9%) were similar.ConclusionSimilar proportions of older, vulnerable aged ≥65 years patients with type 2 diabetes achieved/maintained glycaemic treatment goals without clinically significant hypoglycaemia with Strategies A or B. However, Strategy‐A resulted in lower risk of total, documented symptomatic, and asymptomatic hypoglycaemia. These results identify an approach of potential clinical benefit in this age group and will inform future clinical research in older patients with type 2 diabetes.

Individualizing treatment targets for elderly patients with type 2 diabetes: factors influencing clinical decision making in the 24-week, randomized INTERVAL study

We tested the feasibility of setting individualized glycemic goals and factors influencing targets set in a clinical trial in elderly patients with type 2 diabetes.A 24-week, randomized, double-blind, placebo-controlled study was conducted in 45 outpatient centers in seven European countries. 278 drug-naïve or inadequately controlled (mean HbA1c 7.9%) patients with type 2 diabetes aged ≥70 years with HbA1c levels ≥7.0% and ≤10.0% were enrolled. Investigator-defined individualized HbA1c targets and the impact of baseline characteristics on individualized treatment targets was evaluated.The average individualized HbA1c target was set at 7.0%. HbA1c at baseline predicted a target setting such that higher the HbA1c, more aggressive was the target (P<0.001). Men were more likely to be set aggressive targets than women (P=0.026). Frailty status of patients showed a trend towards significance (P=0.068), whereas diabetes duration, age, or polypharmacy did not. There was heterogeneity between countries regarding how baseline factors were viewed.Despite training and guidance to individualize HbA1c goals, targets were still set in line with conventional values. A strong influence of country-specific guidelines on target setting was observed; confirming the importance of further education to implement new international guidelines in older adults.

The Clinical use of glimepiride in patients with type 2 diabetes mellitus, uncontrolled on combination of DPP4-inhibitors and metformin: results of ESCALATION observational study

Background. Russian guidelines for T2DM management 2015 recommend intensification to triple combination therapy in patients not reaching glycaemia treatment targets on dual oral antidiabetic therapy for 6 months. Despite this, clinical experience shows that physicians may also switch one component of the dual therapy, or add the third component of the therapy. This study sought to assess the effect of physician-led prescription of glimepiride (GLIM) to individuals with T2DM uncontrolled by metformin (MET) and DPP-inhibitor.&#x0D; Material and methods. This observational study was carried out in real clinical practice in 142 Russian clinical centers, among 1447 T2DM patients, which consume glimepiride according to medical disposal. Entry criteria included 18—80 years male and female with HbA1c≥ 7,6% и ≤10 (during 2 month) and uncontrolled carbohydrate metabolism by individualized HbA1c target level by MET(in a dose ≥1500 mg/per day) and DPP-4i for ≥3 months, which doctor prescribed glimepiride in mono- or combination therapy. Duration of observation after inclusion into research was 24 weeks.&#x0D; Results. Patients were prescribed glimepiride as part of three-component therapy — GLIM+MET+DPP-4i (54.5%), two-component — GLIM+MET (34.4%), in other combinations — GLIM+other (11.1%). Mean HbA1c reduction at 24 weeks was 1.49±0.71%, and fasting blood glucose (FBG) reduction — 2.18±1.38 mmol/l. Significant changes in glycemic control in different groups of patients were not committed. Postprandial blood glucose (PPG, mmol/l) on an average decreased — 3.00±1.71, in groups GLIM+MET+DPP-4i, GLIM+MET and GLIM+other 2.98±1.63; 3.07±1.81 и 2.95±1.84. At week 24, body mass index (BMI, kg/m2 )was overall decrease by 0.36±1.99 and not significantly reduced in the GLIM+MET+DPP-4i, GLIM+MET and GLIM+other groups. Adverse events (AEs), inclusive of symptomatic hypoglycaemia, were reported in 370 patients (25.8% of all participants). In GLIM+MET+DPP-4i, GLIM+MET and GLIM+other groups frequency of symptomatic hypoglycaemia composed 13.2, 8.5 и 14.5%. Incidence of asymptomatic hypoglycaemia was reported at 8.4% of patient. In GLIM+MET+DPP-4i, GLIM+MET and GLIM+other groups it were 8.4, 7.3 и 11.9% , with maximum in GLIM+other group. There were no significant differences in the proportions of patients with hypoglycaemic episodes between other study groups. No episodes of severe hypoglycaemia or serious AEs were reported.&#x0D; Conclusion. More than a half of incidences of uncontrolled T2DM by metformin and DPP-4 inhibitor combination treatment in real-life clinical practice is intensify by prescribing three-component treatment setting. Approximately, in third cases the choice of the therapeutic approach depend on switch of iDPP-IV for the GLIM. Further 11.1% composed combinations glimepiride+ iDPP-IV (DRC). Various combinations of GLI with MET and/or iDPP4 provided improvement of glycemic control, affecting of HbA1c, FPG and PPG. During the study, there was no significant difference in glycemic control between different types of the therapy. Episodes of symptomatic hypoglycemia were more frequent in the DRC group compared with the group GLY+MET. No severe hypoglycemic events and no influence for body weight were reported in research indicating the safety of GLIM at T2DM patients uncontrolled by metformin and DPP-4 inhibitor combination therapy.

Individualized HbA1c Targets and the Factors Concerning Glycemic Goal Achievement in Type 2 Diabetes Patients

Individualized HbA1c Targets and the Factors Concerning Glycemic Goal Achievement in Type 2 Diabetes Patients

Effective Utilization of Oral Hypoglycemic Agents to Achieve Individualized HbA1c Targets in Patients with Type 2 Diabetes Mellitus.

Type 2 diabetes is a progressive condition that may require the combination of three oral treatments to achieve optimal glycemic management to prevent microvascular and macrovascular complications whilst minimizing the risk of acute complications and side effects or adverse reactions to treatments. With the widening availability of treatment options and increasing importance of individualized treatment pathways, including personalized HbA1c targets, this article will explore the mode of action of currently available oral treatments, factors to consider when individualizing HbA1c targets, the relevance of estimated glomerular filtration rate assessment, and the importance of reviewing the clinical impact of all treatment decisions.

Personalized Therapy by Phenotype and Genotype

Upon the publication of the results of the 20-year-long UK Prospective Diabetes Study (UKPDS) (1), the general recommendation was to achieve, in as many as possible of individuals with type 2 diabetes (T2DM), a target HbA1c value ≤7%, i.e., the average value associated with significant reduction in the risk of micro- and macrovascular complications. This “universal” glycemic target, however, has been challenged by the results of subsequent intervention trials (2–4). Given the critical analysis of the results of these trials, the American Diabetes Association (ADA) and the American Heart Association suggested that an individualized HbA1c target should be identified based on the duration of diabetes, life expectancy, presence and severity of diabetes complications, and propensity for hypoglycemia (5). This suggestion has been endorsed by several international guidelines. They also suggest a selection of glucose-lowering strategies to be individualized in order to ensure the most appropriate risk-to-benefit ratio for all patients. According to the ADA/European Association for the Study of Diabetes position statement for T2DM management (6), this can be achieved through balanced assessment of efficacy, risk of hypoglycemia, effect on body weight, and costs of available glucose-lowering agents and their combination. Although the concept of treatment individualization is appealing, how to pursue it in the clinical setting remains highly debated. To this purpose, careful phenotypic description of the person with T2DM may be appropriate. A few years ago, the ABCD approach was proposed to help physicians in individualizing glycemic target and treatment selection (7). “ABCD” stands for four phenotypic traits that are easy to collect and to factor in: age, body weight, complications and comorbidities, and duration of diabetes. ### Age Age is the strongest risk factor for life expectancy and mortality. The number of elderly people with diabetes is growing, and >70% of the elderly with T2DM …

Type 2 diabetes--criteria for the selection of the antidiabetic drug

Modern treatment of type 2 diabetes follows a patient-centered approach. Blood glucose targets depend on patients' individual situation e. g. age, disease duration and comorbidities. Today physicians can choose from several antidiabetics with different modes of action. Based on national guidelines on the step-wise treatment of type 2 diabetes these substances come into consideration after lifestyle intervention and initial pharmacotherapy with metformin proved to be insufficient. Results from clinical trials have in part shown significant differences between distinct drug classes regarding efficacy, risk of hypoglycemia and effect on body weight. Cardiovascular safety is another important aspect to consider. This balance between efficacy and safety is reflected more and more by analyzing a combined endpoint "reaching individual HbA1c-target without hypoglycemia and weight gain". A guideline- and evidence-based classification of present therapeutic options aims to support orientation in diabetes practice.

NICE: type 2 diabetes in adults, 2015

NICE: type 2 diabetes in adults, 2015

Setting the hemoglobin A1c target in type 2 diabetes: a priori, a posteriori, or neither?

Current guidelines specify hemoglobin A1c (HbA1c) targets around or less than 7.0 %, with more (<6.5 %) or less (<8 %) stringent goals being appropriate for selected patients. The difficulty in setting a precise HbA1c target depends, at least in part, on the physician perception of the relative importance of the parameters to be considered when determining the target. Using the "a priori" approach, physicians set the HbA1c target first, then prescribe the appropriate antidiabetic drug in order to cover the distance from the target, i.e., the difference between the current HbA1c value of the patient and the individualized HbA1c target: calculating the distance from the target may also be useful as a predictor of therapeutic success. In the "a posteriori" approach, physicians first prescribe, then decide if the achieved HbA1c is an appropriate level for that patient. Attainment of the HbA1c target ultimately depends on which target the physician set: both approaches ("a priori" and "a posteriori") may be useful for both physicians to make appropriate therapeutic decisions and patients to adhere to the best possible treatment. All this presumably will avoid unnecessary therapeutic inertia.

Individualized HbA1c targets in elderly patients with T2DM

Individualized HbA1c targets in elderly patients with T2DM

Current level of glycaemic control and its associated factors in patients with type 2 diabetes across Europe: data from the PANORAMA study

To provide an update on glycaemic control in European patients with type 2 diabetes based on data from the nine-country, cross-sectional PANORAMA study (NCT00916513). Post-hoc analysis to report the number of patients achieving/not achieving glycaemic goal (HbA(1c) <7%). Patients were randomly or consecutively selected from physician practices in nine countries. Eligible patients were aged ≥40 years, diagnosed with type 2 diabetes >1 year prior to study entry, and had an available medical record of >1 year. All data were collected at a single visit, including HbA1c measurement using a common device (A1CNow). Bivariate and multivariate analyses were used to investigate factors associated with not reaching glycaemic goal. Of 5817 patients enrolled (aged 65·9 ± 10·4 years, 53·7% male), 37·4% had an HbA(1c) ≥7%; (range 25·9% in The Netherlands to 52·0% in Turkey). In adjusted multivariate analyses, higher individual glycaemic target, younger age, poor physician-reported patient adherence to lifestyle/medication, longer diabetes duration, increasing treatment regimen complexity and physician-reported patient's unwillingness to intensify treatment were associated with not achieving goal. However, bivariate analyses also found gender, socioeconomic factors, body mass index, rate of complications and hypoglycaemia to be associated with not achieving goal. In PANORAMA, 37·4% of patients enrolled were not at glycaemic goal. Factors relating to patient characteristics, physician selection of individualized HbA1c target and diabetes itself (longer duration, more complex treatment) were strongly associated with not achieving goal. Further studies are warranted to explore these associations and evaluate strategies for improving glycaemic control.

Optimal management of type 2 diabetes: the evidence

This paper reviews the evidence in relation to the optimal target for HbA1c and outlines a global treatment algorithm for people with type 2 diabetes. While most guidelines recommend a general HbA1c target of 7%, recent large scale intervention studies have examined the potential benefits of lower targets. These studies have generally shown that lower HbA1c targets provide no macrovascular benefits and limited effects on microvascular complications while increasing rates of hypoglycaemia. Overall these studies do not support a general HbA1c target lower than 7.0%. However an individual's HbA1c target should be set and reviewed taking into account treatment benefits, safety, and tolerability. This may mean that an HbA1c target lower than 7% is appropriate for some when it can be easily and safely achieved but equally a higher HbA1c target may be appropriate in others. Clinicians and consumers are fortunate in having a wide range of pharmacological agents available to treat hyperglycaemia, however access to many of these options is limited in many middle and low income countries. Developing treatment algorithms is complex for several reasons. The major limitation is the limited evidence base for choosing particular treatment options or combinations of medications. However it is possible to derive a generic evidence-informed consensus algorithm which considers availability, access and cost of medications which can be adapted for local country use.

Using insulin in people with type 2 diabetes

As the duration of type 2 diabetes increases, beta-cell function deteriorates, resulting in a fall in endogenous insulin and worsening of glycaemic control. Ultimately, this leads to a need for exogenous insulin. In practice, the decision to start insulin depends on a variety of factors, both medical and social, including an individualized HbA1c target, and is arrived at after a full discussion with the patient, taking account of their personal circumstances. Insulin can be safely and conveniently initiated in primary care, but requires a holistic educational package, usually provided by the diabetes nurse specialist. A basal insulin is a common starting point in type 2 diabetes, although intensification of treatment may subsequently be necessary. Oral therapies, notably metformin, can, in the absence of contraindications or intolerances, be continued alongside insulin therapy.