Delays In Treatment Intensification Research Articles

Knowledge and Attitude Towards Insulin Therapy in Type 2 Diabetes Mellitus Patients and Associated Factors at an Adult Endocrine Clinic of SPHMMC Addis Ababa Ethiopia

<i>Background:</i> Diabetes Mellitus (DM), a chronic disease characterized by elevated blood glucose levels, is associated with severe complications. Type 2 DM (T2DM), the most prevalent form of DM in adults, is characterized by varying degrees of insulin deficiency or resistance. The prevention or delay of macrovascular and microvascular problems associated with DM depends on achieving appropriate glycemic control. The percentage of T2DM patients failing to reach glycemic targets keeps rising even with the expanded availability of numerous anti-hyperglycemic drugs and evidence-based treatment guidelines. The delay in treatment intensification despite inadequate glucose control—often referred to as clinical or therapeutic inertia-contributes significantly to this trend.<i> Objective:</i> This study aims to evaluate the understanding and perceptions of insulin therapy among patients with T2DM. The study focuses on patients under follow-up care at the Adult Endocrine Clinic of St. Paul Hospital Millennium Medical College.<i> Method and Material:</i> An institutional-based, cross-sectional study was carried out from January to March 2021 to evaluate knowledge and attitudes regarding insulin therapy and related factors. A structured questionnaire was used for interviews with a representative sample of 271 T2DM patients who are receiving follow-up care at the endocrine clinic at SPHMMC. The SPSS, version 25, was the software utilized. The statistical significance of the relationship between the dependent and independent variables was assessed using a 95% confidence interval and a p-value less than 0.05.<i> Results:</i> The majority of the respondents were between the ages of 56 and 65, with a mean age of 57.35 years. More than half of the participants, accounting for 231 (85.2%) of the total, were from urban areas. Out of the 271 respondents, approximately 85.6% demonstrated poor knowledge of insulin therapy, and around 37.6% exhibited negative attitudes towards it. Factors such as age, occupation, and a history of long-term Oral Antidiabetic Drug use were found to be associated with the level of knowledge about insulin. In addition to these factors, marital status and a family history of insulin use were found to be associated with patients’ attitudes towards insulin. <i>Conclusions:</i> Our study identified a significant knowledge gap about insulin usage among T2DM patients in the designated study area. We recommend the implementation of regular, structured health education programs, delivered by trained health professionals. This approach is expected to enhance both the knowledge and attitudes toward insulin usage among patients attending follow-up sessions at the SPHMMC diabetic clinic.

Time to Treatment Intensification in Patients Receiving DPP4 Inhibitors Versus Sulfonylureas as the First Add-On to Metformin Monotherapy: A Retrospective Cohort Study.

Background: To verify whether, in patients on metformin (MET) monotherapy for type 2 diabetes (T2D), the add-on of a dipeptidyl peptidase inhibitor (DPP4i) compared to a sulfonylurea (SU) can delay the time to the subsequent treatment intensification (TI). Methods: Population-based administrative data banks from four Italian geographic areas were used. Patients aged ≥18 years on MET monotherapy receiving first DPP4i or SU dispensing between 2008 and 2015 (cohort entry) were followed up to the occurrence of TI (insulin dispensing or add-on of a third non-insulin hypoglicemic >180 days after cohort entry), treatment discontinuation, switch, cancer, death, TI occurrence within, end of data availability, end of study period (31 December 2016), whichever came first. Patients on MET + DPP4i were matched 1:1 with those on MET + SU by sex, age, year of cohort entry, and data bank. Hazard Ratio (HR) and 95% confidence intervals (95%CI) were estimated using multivariable Cox regression model including matching variables and potential confounders measured at baseline. Different sensitivity analyses were performed: i) matching at 180 days after cohort entry, ii) intent to treat (ITT) analysis, iii) matching by duration of MET monotherapy, iv) matching by propensity score. Results: The matched study cohort included 10,600 patients. Overall, 763 TI were observed (4.5/100 person-years; mean follow-up = 1.6 years). The primary analysis showed no difference in time to TI between the two groups (HR = 1.02; 95% CI = 0.88–1.19). Sensitivity analyses confirmed this result, except from the ITT analysis (HR = 1.27; 1.13–1.43). Conclusion: The use of a DPP4i rather than a SU as add-on to MET monotherapy was not associated with a delay in treatment intensification.

Assessment of clinical inertia in people with diabetes within primary care.

Clinical inertia, defined as a delay in treatment intensification, is prevalent in people with diabetes. Treatment intensification rates are as low as 37.1% in people with haemoglobin A1c (HbA1c) values >7%. Intensification by addition of medication therapy may take 1.6 to more than 7 years. Clinical inertia increases the risk of cardiovascular events. The primary objective was to evaluate rates of clinical inertia in people whose diabetes is managed by both pharmacists and primary care providers (PCPs). Secondary objectives included characterizing types of treatment intensification, HbA1c reduction, and time between treatment intensifications. Retrospective chart review of persons with diabetes managed by pharmacists at an academic, safety-net institution. Eligible subjects were referred to a pharmacist-managed cardiovascular risk reduction clinic while continuing to see their PCP between October 1, 2016 and June 30, 2018. All progress notes were evaluated for treatment intensification, HbA1c value, and type of medication intensification. Three hundred sixty-three eligible patients were identified; baseline HbA1c 9.6% (7.9, 11.6) (median interquartile range [IQR]). One thousand one hundred ninety-two pharmacist and 1739 PCP visits were included in data analysis. Therapy was intensified at 60.5% (n = 721) pharmacist visits and 39.3% (n = 684) PCP visits (P < .001). The median (IQR) time between interventions was 49 (28, 92) days for pharmacists and 105 (38, 182) days for PCPs (P < .001). Pharmacists more frequently intensified treatment with glucagon-like peptide-1 agonists and sodium glucose cotransporter-2 inhibitors. Pharmacist involvement in diabetes management may reduce the clinical inertia patients may otherwise experience in the primary care setting.

1496-P: Clinical Inertia in Relation to Sociodemographic Factors among Patients with Type 2 Diabetes (T2D) in the United States

Several studies focused on clinical inertia in the U.S. T2D population have demonstrated a significant delay in treatment intensification in real-world clinical practice. The objective of this study was to evaluate if there is a disparity in clinical inertia based on sociodemographic factors. The GE Centricity Electronic Medical Record database (2015 data) was used to identify T2D patients on dual therapy with metformin and another oral antihyperglycemic agent (OAHA). Included patients had ≥12 months of continuous enrollment prior to index date (initiation of dual therapy), further intensified therapy within 2 years following the index date and had an HbA1c measure available within 6 months prior to intensification. Treatment intensification was defined as addition of another OAHA or initiation of insulin/GLP-1RA. 991 patients met the inclusion criteria; mean age of 57.9 years and 47.4% were female. Table lists the distribution of sociodemographic factors by HbA1c categories. Results suggest that older patients were less likely to be intensified at higher HbA1c compared to younger patients. Furthermore, compared to whites, black patients were more likely to be intensified at higher HbA1c levels with no apparent pattern of intensification by region. In conclusion, decision to intensify in clinical practice may be associated with sociodemographic factors such as age and race. Disclosure G. Fernandes: None. B. Sawhney: Consultant; Self; Merck &amp; Co., Inc. H. Hannachi: Employee; Self; Merck &amp; Co., Inc. T. Wang: Employee; Spouse/Partner; Johnson &amp; Johnson. Employee; Self; Merck &amp; Co., Inc. A. McNeill: Employee; Self; Merck &amp; Co., Inc. K. Iglay: Employee; Self; Merck &amp; Co., Inc. Stock/Shareholder; Self; Merck &amp; Co., Inc. S. Rajpathak: None.

Delays in anti-hyperglycaemic therapy initiation and intensification are associated with cardiovascular events, hospitalizations for heart failure and all-cause mortality.

The aims of this study were to assess the impact of delays in treatment intensification (TI) on cardiovascular events, heart failure, and all-cause mortality at typical stages of anti-hyperglycaemic therapy. Using electronic health record data, we created three TI cohorts of diabetes patients who: 1) initiated metformin (MET) as their first anti-hyperglycaemic therapy; 2) added a sulfonylurea (SU) to MET; and 3) initiated insulin (INS) while using MET or SU, alone or in combination. Primary exposure variables were haemoglobin A1C value preceding cohort therapy (pre-TI A1C) and time to intensification, that is, the time between pre-TI A1C >7% and cohort index date. Cox regression models were used to analyse the associated risk of cardiovascular events, hospitalizations for heart failure and all-cause mortality. In the MET cohort, each additional percentage point of pre-TI A1C was associated with a 10% increased risk of a CV event (HR, 1.10; 95% CI, 1.03-1.07; P = 0.004), a 7% increased risk of HF hospitalization (HR, 1.07; 95% CI, 1.01-1.14; P = 0.034) and a 7% increased risk of all-cause mortality (HR, 1.07; 95% CI, 1.01-1.14; P = 0.032). Pre-TI A1C was associated with a 9% increased risk of a CV event in the INS cohort (HR,1.09; 95% CI, 1.04-1.13; P < 0.001). Each month of delay in TI was significantly associated with a 6% increased risk of hospitalization for HF (HR, 1.06; 95% CI, 1.00-1.13; P = 0.040) and all-cause mortality (HR, 1.06; 95% CI, 1.00-1.13; P = 0.050) in the MET cohort. Delays in TI were associated with poor outcomes over a mean follow-up period of nearly five years. Earlier initiation and more rapid intensification of pharmacotherapy could reduce the risk of poor outcomes.

Appropriate Titration of Basal Insulin in Type 2 Diabetes and the Potential Role of the Pharmacist.

A substantial proportion of patients with suboptimal control of their type 2 diabetes experience delays in treatment intensification. Additionally, patients often experience overuse of basal insulin, commonly referred to as “over-basalization,” whereby basal insulin continues to be uptitrated in order to meet targets, when addition of a mealtime bolus insulin dose may be a more appropriate option. In order to overcome these challenges, there is a need to develop the capacity of allied healthcare professionals to provide appropriate support to these patients, such as during initiation or titration of basal insulin. Pharmacists play an integral role in healthcare delivery, with patients seeing their pharmacist, on average, seven times more often than their primary care physician. This places pharmacists in a unique position to provide diabetes education and care, which may help patients avoid clinical inertia. Nevertheless, the management of the disease with basal insulin is becoming increasingly complex, with growing numbers of treatment options (such as recent second-generation longer-acting basal insulin formulations) and frequently updated titration algorithms. The two most common titration schedules specify either increasing doses by a set amount every 2–3 days or a treat-to-target strategy. Neither schedule has been shown to be superior, and the decision to use one or the other should be based on a discussion between the clinician and patient after assessment of mental and physical acumen, comfort of both parties, and follow-up plans. This review article discusses basal insulin therapy options and titration algorithms from the unique perspective of the pharmacist in order to help ensure that optimal antidiabetes therapy is initiated, appropriately titrated, and maintained.Funding: Sanofi US, Inc.

Inercia clínica en el tratamiento con insulina en el primer nivel de atención.

Refusal of physicians to prescribe insulin to their patients has been scarcely evaluated; the delay in treatment intensification hinders adequate and quality care. To identify the perception of primary care physicians about barriers to initiate insulin treatment in patients with diabetes. Using the Smith Index and multivariate analysis, the relevance and grouping of concepts related to barriers to insulin prescription were assessed in 81 family doctors. Only 35.8% of physicians showed confidence for prescribing insulin; almost half of them rated treatment intensification between moderately and little important (39.5% and 6.2%). Barriers were related to the physician (39.5%), the patient (37%), insulin treatment (11.1%) and the institution (6.2%); 6.2 % of physicians did not perceive any barrier. The barriers were grouped in 5 factors that explained 62.48% of the variance: patient cultural level, lack of medical skills, fear of adverse events, insecurity and lack of training. Clinical inertia was not the result of a complex medical condition or patient comorbidities, but of doctor's perception and confidence in his/her clinical and communication skills.

Addressing Clinical Inertia in Type 2 Diabetes Mellitus: A Review.

The current epidemic of type 2 diabetes (T2D) represents a significant global and national health concern. Globally, the prevalence of diabetes has doubled between 1980 and 2014. In 2014 the World Health Organization estimated that there were 422 million adults living with diabetes worldwide. In the USA, the number of people diagnosed with T2D is estimated to increase to over 70 million by 2050, putting an immense strain on the US healthcare system. Achieving glycemic control is widely acknowledged as the key goal of treatment in T2D and is critical for reducing the onset and progression of diabetes-related complications such as cardiovascular diseases, neuropathies, retinopathies, and nephropathies. Despite the increase in the availability of antihyperglycemic medications and evidence-based treatment guidelines, the proportion of people with T2D who fail to achieve glycemic goals continues to rise. One major contributor is a delay in treatment intensification despite suboptimal glycemic control, referred to as clinical or therapeutic inertia. Clinical inertia prolongs the duration of patients’ hyperglycemia which subsequently puts them at increased risk of diabetes-associated complications and reduced life expectancy. Clinical inertia results from a complex interaction between patient, healthcare providers, and healthcare system barriers that need to be addressed together, rather than as separate entities. In this article we provide an overview of clinical inertia in the clinical management of T2D and provide suggestions for overcoming aspects that may have a negative impact on patient care.Funding: Sanofi US, Inc.

Delays in Antihyperglycemic Treatment Intensification and Risk of Diabetes Complications

Longer delays in anti-hyperglycemic treatment intensification (TI) are associated with poorer glycemic control, but whether these delays increase the risk of poor outcomes is unclear. We combined 2005-2016 data from the Northwest and Mid-Atlantic regions of Kaiser Permanente to identify 3 cohorts of patients who intensified therapy by: 1) initiating metformin (MET) as their 1st diabetes drug (n=18,762); 2) adding a sulfonylurea (SU) to existing MET (n=10,076); 3) initiating insulin after MET and/or SU therapy (n=9,778). We used the TI date to calculate time between A1C ≥7% and TI, pre-TI A1C, and achievement of A1C &amp;gt;7% within 1 year. From the ∼1-year post-TI A1C, we followed patients through December 2016 until they experienced an MI, stroke, or other cardiovascular (CV) event, a heart failure (HF) hospitalization or all-cause mortality, censoring follow-up when the cohort therapy changed. Multivariable cox regression controlled for CV risk factors including age, sex, race/ethnicity, smoking, blood pressure, statin and ACE/ARB use, and prior history of CV or HF. After adjustment for CV risk factors, Pre-TI A1C and time from A1C ≥7% to TI date was significantly associated with the outcomes (Table). Delays in treatment intensification increase CV, HF and mortality risk at all stages of diabetes therapy; intensifying therapy at the first sign of deteriorating glycemic control may be critically important. Disclosure G. Nichols: Research Support; Self; Boehringer Ingelheim GmbH, Amarin Corporation, Janssen Pharmaceuticals, Inc., Sanofi. V.J. Romo-LeTourneau: Employee; Self; Sanofi. S. Vupputuri: Research Support; Self; Sanofi US. S. Thomas: Employee; Self; Sanofi. Stock/Shareholder; Self; Sanofi.

Cumulative Delays in Treatment Intensification over Three Typical Stages of Antihyperglycemic Treatment

Although delays in treatment intensification (TI) have been documented for anti-hyperglycemic medications, cumulative delays over the life course of diabetes treatment have not been reported. We combined 2005-2016 data from the Northwest and Mid-Atlantic regions of Kaiser Permanente to identify 248 patients who: (1) initiated metformin (MET); (2) then added a sulfonylurea (SU) to existing MET; and (3) initiated insulin (INS) after MET or SU. We used the date of the initiation of each stage of therapy to calculate time between A1C ≥7% and TI, pre-TI A1C, post-TI A1C, and achievement of A1C goal ≤7% within one year of TI. We also measured time to intensification within 6 months prior to TI. Mean or median cumulative measures were summed across the three TI stages. Among patients who experienced each stage of MET, SU, and INS intensification, the mean A1C percentage points outside of goal summed to 5.9 (Table). These patients accrued a median of 191 days of TI delays in the 3 6-month periods preceding TI. Although A1C was lowered after each stage of TI, a minority of patients achieved A1C goals of ≤7% resulting in accumulation of a mean of 3.3 excess A1C percentage points over the 3 one year periods after TI of MET, SU, and INS. TI delays occur at every stage of diabetes therapy. Glycemic burden accumulates over the life course of diabetes and may result in differential complication risks. However, further study is needed. Cumulative TI ExposuresMET initiationSU add-onINS add-onCumulativeMean distance from goal measured during 1 year after TI1.7%1.7%2.5%5.9 %Median days to intensification measured during 6 months prior to TI27.967.795.3190.9Mean Pre-TI A1c8.7%8.7%9.5%--Mean Post-TI A1c7.7%8.5%8.1%--Post-A1c minus A1c goal measured during 1 year after TI0.7%1.5%1.1%3.3%Achieved A1C goal ≤7%35.1%16.9%26.6%-- Disclosure S. Vupputuri: Research Support; Self; Sanofi US.

Delay in treatment intensification increases the risks of cardiovascular events in patients with type 2 diabetes.

BackgroundThe aim of the study was to evaluate the effect of delay in treatment intensification (IT; clinical inertia) in conjunction with glycaemic burden on the risk of macrovascular events (CVE) in type 2 diabetes (T2DM) patients.MethodsA retrospective cohort study was carried out using United Kingdom Clinical Practice Research Datalink, including T2DM patients diagnosed from 1990 with follow-up data available until 2012.ResultsIn the cohort of 105,477 patients mean HbA1c was 8.1% (65 mmol/mol) at diagnosis, 11% had a history of cardiovascular disease, and 7.1% experienced at least one CVE during 5.3 years of median follow-up. In patients with HbA1c consistently above 7/7.5% (53/58 mmol/mol, n = 23,101/11,281) during 2 years post diagnosis, 26/22% never received any IT. Compared to patients with HbA1c <7% (<53 mmol/mol), in patients with HbA1c ≥7% (≥53 mmol/mol), a 1 year delay in receiving IT was associated with significantly increased risk of MI, stroke, HF and composite CVE by 67% (HR CI: 1.39, 2.01), 51% (HR CI: 1.25, 1.83), 64% (HR CI: 1.40, 1.91) and 62% (HR CI: 1.46, 1.80) respectively. One year delay in IT in interaction with HbA1c above 7.5% (58 mmol/mol) was also associated with similar increased risk of CVE.ConclusionsAmong patients with newly diagnosed T2DM, 22% remained under poor glycaemic control over 2 years, and 26% never received IT. Delay in IT by 1 year in conjunction with poor glycaemic control significantly increased the risk of MI, HF, stroke and composite CVE.

Comment on Khunti et al. Clinical inertia in people with type 2 diabetes: a retrospective cohort study of more than 80,000 people. Diabetes care 2013;36:3411-3417.

We read with interest the article by Khunti et al. (1) reporting delays in treatment intensification in people with type 2 diabetes, approaching 6.9 years (median) in those with a starting HbA1c level ≥8% (64 mmol/mol) and taking two oral antidiabetes drugs. Moreover, median time to intensification with insulin was 7.1, 6.1, or 6.0 years for those taking one, two, or three oral antidiabetes drugs, respectively. Although their findings support current knowledge about the protracted failure for intensification of treatment despite suboptimal glycemic control, and despite some limitations inherent to this type of analysis, the large patient population of this retrospective cohort study …

Clinical Inertia in People With Type 2 Diabetes

OBJECTIVETo determine time to treatment intensification in people with type 2 diabetes treated with one, two, or three oral antidiabetes drugs (OADs) and associated levels of glycemic control.RESEARCH DESIGN AND METHODSThis was a retrospective cohort study based on 81,573 people with type 2 diabetes in the U.K. Clinical Practice Research Datalink between January 2004 and December 2006, with follow-up until April 2011.RESULTSIn people with HbA1c ≥7.0, ≥7.5, or ≥8.0% (≥53, ≥58, or ≥64 mmol/mol), median time from above HbA1c cutoff to intensification with an additional OAD was 2.9, 1.9, or 1.6 years, respectively, for those taking one OAD and >7.2, >7.2, and >6.9 years for those taking two OADs. Median time to intensification with insulin was >7.1, >6.1, or 6.0 years for those taking one, two, or three OADs. Mean HbA1c at intensification with an OAD or insulin for people taking one, two, or three OADs was 8.7, 9.1, and 9.7%. In patients taking one, two, or three OADs, median time from treatment initiation to intensification with an OAD or insulin exceeded the maximum follow-up time of 7.2 years. The probability of patients with poor glycemic control taking one, two, or three OADs, intensifying at end of follow-up with an OAD, was 21.1–43.6% and with insulin 5.1–12.0%.CONCLUSIONSThere are delays in treatment intensification in people with type 2 diabetes despite suboptimal glycemic control. A substantial proportion of people remain in poor glycemic control for several years before intensification with OADs and insulin.