Diabetes Treatment Intensification Research Articles

Therapeutic patient education and treatment intensification of diabetes and hypertension in subjects with newly diagnosed type 2 diabetes mellitus: a longitudinal study.

The aim of this study is to prospectively evaluate whether individual and group Therapeutic Patient Education (TPE) can reduce the need to intensify treatment of diabetes and hypertension in newly diagnosed type 2 diabetic patients. A total of 937 patients were recruited and followed-up for 42.7 ± 21.5 months. TPE was a structured comprehensive education delivered by trained nurses: 322 patients received individual TPE (ITPE), 291 underwent group TPE (GTPE), and 324 were in Usual Care (UC). The primary endpoints were intensification of diabetes treatment and intensification of hypertension treatment. The rate of diabetes treatment intensification was 40.1% in patients receiving ITPE, 47.8% in patients undergoing GTPE, and 64.2% in patients in UC (p < 0.001). The rate of hypertension treatment intensification was 24.2% in patients following ITPE, 31.3% in patients receiving GTPE, and 41.0% in patients in UC (p < 0.001). Multivariate analysis showed that both ITPE and GTPE were associated with reduced intensification of diabetes (ITPE: HR:0.51; 95% IC:0.40-0.64; p < 0.001 - GTPE: HR:0.46; 95% IC:0.44-0.70; p < 0.001) and hypertension medication (ITPE: HR:0.45; 95% IC:0.34-0.61; p < 0.001 - GTPE: HR:0.49; 95% IC:0.38-0.65; p < 0.001). The association was independent of age, sex, BMI, HbA1c, and presence of hypertension at baseline. TPE, delivered as both individual and group sessions, represents an effective tool to reduce the need to intensify treatment of both diabetes and hypertension. Therefore, it can ensure better control of diabetes and hypertension with fewer medications. This could reduce adverse effects and costs and improve quality of life and medication taking in patients with type 2 diabetes.

COX2 Inhibitor Use and Type 2 Diabetes Treatment Intensification: a Registry-based Cohort Study

AimThis study examined the association between cyclooxygenase-2 inhibitor (COX2i) use and diabetes progression in people with type 2 diabetes. MethodsWe conducted a nation-wide cohort study using an Australian diabetes registry linked to medication dispensing data. We assessed time to diabetes treatment intensification among new users of COX2i compared to mild opioids. Inverse probability of treatment-weighted Cox regression models were used to adjust for age, sex, time since diabetes diagnosis, comorbidities, and socio-economic disadvantage. We conducted several sensitivity analyses, including per-protocol analyses and comparing use of any NSAID to mild opioids. ResultsThere were 8,071 new users of COX2i and 7,623 of mild opioid with 4,168 diabetes treatment intensifications over a median follow-up of 1.6 years. Use of COX2i was associated with decreased risk of treatment intensification when compared to mild opioid (HR 0.91, 95%CI 0.85-0.96). The results were not significant in the per-protocol analyses. Use of any NSAID was associated with a lower risk of treatment intensification compared to mild opioid (HR 0.90, 95%CI 0.85-0.96). ConclusionsTreatment with COX2i may be associated with a modest decreased risk of diabetes treatment intensification compared to mild opioids. Future clinical studies are required to confirm whether COX2 inhibition has clinically significant benefits for glycaemic control.

Hospital stays and costs of telemedical monitoring versus standard follow-up for diabetic foot ulcer: an open-label randomised controlled study.

Two randomised controlled trials (RCTs) have previously shown that telemedical monitoring of diabetic foot ulcer (DFU) reduces the number of visits to the outpatient clinic, without losing treatment efficacy or increasing costs. Here we present the results of an open-label, randomised controlled trial designed to investigate whether telemonitoring, provided by an expert nurse (with extensive experience in DFU and trained in remote monitoring), reduces the hospital stay and the associated costs for a patient with DFU (TELEPIED trial). Eligible patients (n= 180) were randomly allocated to: (i) a control group, in which they received standard care, and (ii) an intervention group, in which they received asynchronous telemedicine follow-up by the expert nurse. The primary outcome was the cumulative hospital days over 12 months. The main secondary outcomes were (i) direct healthcare costs (estimated in a collective perspective), (ii) wound healing and (iii) amputation rates. ITT (intention-to-treat) population was analysed. In the ITT population, cumulative hospital days were significantly higher in the control group (13.4 days [95% CI 9.0-17.8]) than in the intervention group (7.1 days [2.8-11.5]) (p= 0.0458, ANCOVA model). Cumulative direct costs over 12 months were 7185 € (95% CI 5144-9226) in the control group and 3471 € (95% CI 1430-5512) in the intervention group (p= 0.0120). The percentage of wounds healed and amputation rate were not significantly different between groups. Similar results were found with the PP population. The implementation of a telemedical intervention with an expert nurse could lead to a length of hospitalization and direct costs that were two times lower compared to conventional follow-up. This lower medical and economic burden was obtained without losing effectiveness on the rate of healing, nor increasing the amputation rate. Additional studies are required to confirm these findings. This study was designed, funded and conducted by CERITD (Study and Research Centre for Intensification of Diabetes Treatment, Evry, France), Genopole GIP, 20 rue Henri Desbruères, 91030 EVRY Cedex and Laboratoires URGO, 15 Avenue d'Iéna, 75116 Paris Cedex, France. The findings and conclusions in this study are those of the authors and do not necessarily represent the views of the sponsor. The corresponding author (DD) certify that authors were not precluded from accessing data in the study, and they accept responsibility to submit for publication.

Early type 2 diabetes treatment intensification with glucagon-like peptide-1 receptor agonists in primary care: An Australian perspective on guidelines and the global evidence.

Early and intensive management of type 2 diabetes has been shown to delay disease progression, reduce the risk of cardiorenal complications and prolong time to treatment failure. Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are being increasingly recognized for their potential in early disease management, with recent guideline updates recommending second-line use of this injectable drug class alongside oral glucose-lowering drugs. GLP-1RAs target at least six of the eight core defects implicated in the pathogenesis of type 2 diabetes and offer significant glycaemic and weight-related improvements over other second-line agents in head-to-head trials. In addition, placebo-controlled clinical trials have shown cardiovascular protection with GLP-1RA use. Even so, this therapeutic class is underused in primary care, largely owing to clinical inertia and patient-related barriers to early intensification with GLP-1RAs. Fortunately, clinicians can overcome barriers to treatment acceptance through patient education and training, and management of treatment expectations. In this review we comment on global and Australian guideline updates and evidence in support of early intensification with this therapeutic class, and provide clinicians with practical advice for GLP-1RA use in primary care.

Trends in Timing of and Glycemia at Initiation of Second-line Type 2 Diabetes Treatment in U.S. Adults.

Therapeutic inertia threatens the potential long-term benefits of achieving early glycemic control after type 2 diabetes diagnosis. We evaluated temporal trends in second-line diabetes medication initiation among individuals initially treated with metformin. We included data from 199,042 adults with type 2 diabetes in the U.S. Department of Veterans Affairs health care system initially treated with metformin monotherapy from 2005 to 2013. We used multivariable Cox proportional hazards and linear regression to estimate associations of year of metformin monotherapy initiation with time to second-line diabetes treatment over 5 years of follow-up (primary outcome) and with hemoglobin A1c (HbA1c) at the time of second-line diabetes treatment initiation (secondary outcome). The cumulative 5-year incidence of second-line medication initiation declined from 47% among metformin initiators in 2005 to 36% in 2013 counterparts (P < 0.0001) despite a gradual increase in mean HbA1c at the end of follow-up (from 6.94 ± 1.28% to 7.09 ± 1.42%, Ptrend < 0.0001). In comparisons with metformin monotherapy initiators in 2005, adjusted hazard ratios for 5-year initiation of second-line diabetes treatment ranged from 0.90 (95% CI 0.87, 0.92) for 2006 metformin initiators to 0.68 (0.66, 0.70) for 2013 counterparts. Among those receiving second-line treatment within 5 years of metformin initiation, HbA1c at second-line medication initiation increased from 7.74 ± 1.66% in 2005 metformin initiators to 8.55 ± 1.92% in 2013 counterparts (Ptrend < 0.0001). We observed progressive delays in diabetes treatment intensification consistent with therapeutic inertia. Process-of-care interventions early in the diabetes disease course may be needed to reverse adverse temporal trends in diabetes care.

1080-P: Trends in Clinical Inertia in Diabetes Treatment Intensification in the U.S. Veterans Affairs Health Care System (VA)

Despite mounting clinical trial evidence to guide second-line diabetes treatment, clinical inertia could be a persistent barrier to improved care. We analyzed secular trends in second-line diabetes prescribing and timing of intensification in the largest integrated healthcare system in the US. We studied 93,317 Veterans in VA primary care with type 2 diabetes incidence and initial metformin monotherapy from 2004-2015 who were subsequently newly started on add-on therapy from 2010-2015 with a sulfonylurea (SU, n=78,924), insulin (INS, n=10,251), thiazolidinedione (TZD, n=737), or dipeptidyl peptidase 4 inhibitor (DPP4i, n=3405). We used linear and logistic regression to analyze temporal trends of second-line drug choice, of hemoglobin A1c (HbA1c) at metformin initiation and at initiation of add-on therapy, and of the time to initiating second-line therapy. Over the 6 years, SU use declined (86 to 78%, p=0.003), and INS (9 to 14%, p&amp;lt;0.001) and DPP4i (1.8 to 7.2%, p=0.02) use increased. In the full sample, mean HbA1c remained 7.6% at metformin initiation from 2010-2015 (p=0.2 for trend), but time to add a second drug rose (2.6 to 3.7 years) as did HbA1c at the time of add-on therapy (7.8 to 8.1%) (both p&amp;lt;0.001). Mean HbA1c at initiation of add-on therapy was higher in SU (7.9%) and INS (8.9%) users than in TZD (7.1%) and DPP4i (7.2%) users (p&amp;lt;0.001 for difference between groups). HbA1c at initiation of add-on therapy increased from 2010-2015 among SU (7.8 to 8.0%, p&amp;lt;0.001), INS (8.7 to 8.9%, p&amp;lt;0.001), and DPP4i users (6.8 to 7.4%, p&amp;lt;0.001). The time to treatment intensification increased from 2010 to 2015 for users of each medication class (2.5 to 3.7 years for SU; 2.5 to 3.5 years for INS; 2.9 to 4.0 years for TZD; 3.1 to 4.1 years for DPP4i; all p&amp;lt;0.001). Conclusions: Inertia in diabetes treatment intensification may be worsening in real-world care potentially blunting the impact of accumulating clinical trial evidence to guide optimal second-line diabetes treatment. Disclosure S. Raghavan: None. L. S. Phillips: Other Relationship; Self; Diasyst Inc., Research Support; Self; AbbVie Inc., Eli Lilly and Company, GlaxoSmithKline plc., Janssen Pharmaceuticals, Inc., Kowa Pharmaceuticals America, Inc., Novartis Pharmaceuticals Corporation, Novo Nordisk Pharma Ltd., Pfizer Inc., Sanofi-Aventis. L. Caplan: None. J. E. Reusch: Advisory Panel; Self; Medtronic. Funding U.S. Department of Veterans Affairs (IK2-CX001907-01)

Patient-physician interpersonal processes of care at the time of diabetes treatment intensification and their links to patient outcomes

ObjectiveTo investigate how patient-physician interpersonal processes of care are related to levels of diabetes-related distress, diabetes medication-taking behavior, and HbA1c during conversations with patients about intensifying medication. MethodsWe randomly recruited 1270 patients from diabetes specialty clinics in Tehran, Iran who were taking an additional oral diabetes medication or starting insulin during the prior 3 months. This interviewer-administered cross-sectional survey assessed multiple aspects of patient-physician interpersonal processes, diabetes-related distress, and diabetes medication-taking. Clinical history and HbA1c were collected from electronic medical records. Regression estimates and Structural Equation Modeling were used to test associations. ResultsSome communication scales indicated a significant relationship with total diabetes distress (P < 0.001). Diabetes medication-taking was associated with less diabetes distress (adjusted odds ratio [aOR]=0.45, P < 0.001), lower Hurried Communication (aOR=0.72, P = 0.013), higher Elicited Concerns (aOR=1.30, P = 0.012), and higher Explained Results (aOR=1.41, P < 0.001) scores. SEM analyses showed medication-taking behavior was associated with a 0.68 decrease in HbA1c. Hurried Communication and diabetes distress were directly associated with HbA1c. ConclusionAspects of patient-physician interpersonal processes at the time of intensifying diabetes treatment may be related to experiencing less distress, effective medication-taking, and improved HbA1c. Practice implicationsThe results are intended to inform communication strategies that physicians might incorporate into practice.

Use of biologic or targeted-synthetic disease-modifying anti-rheumatic drugs and risk of diabetes treatment intensification in patients with rheumatoid arthritis and diabetes mellitus.

ObjectivesGiven that RA treatment might affect the severity of diabetes mellitus (DM), we compared the risk of DM treatment intensification in patients with both RA and DM newly initiating a biologic DMARD or tofacitinib.MethodsUsing claims data from the IBM MarketScan database (2005–2016), we identified patients aged ≥18 years with RA who initiated abatacept, a TNF inhibitor (TNFi), rituximab, tocilizumab or tofacitinib. Patients were required to have type 1 or type 2 DM and to use at least one antidiabetic drug at baseline. We assessed DM treatment intensification (i.e. addition of a new insulin or non-insulin antidiabetic medication). We also assessed non-insulin antidiabetic medication switching events.ResultsWe included 10 019 patients with RA and DM initiating a biologic DMARD or tofacitinib. Baseline insulin use was the highest in rituximab initiators (44%) and lowest in tofacitinib initiators (35%). The incidence rate per 1000 person-years for DM treatment intensification ranged from 148.2 (tofacitinib) to 198.0 (rituximab). The risk of DM treatment intensification was similar between abatacept and TNFi [hazard ratio (HR) 0.97, 95% CI: 0.82, 1.15], rituximab (HR 0.99, 95% CI: 0.79, 1.23) and tocilizumab (HR 0.94, 95% CI: 0.74, 1.19), but lower for tofacitinib compared with abatacept (HR 0.67, 95% CI: 0.50, 0.90). The risk of non-insulin DM treatment switching was not different between abatacept and other biologic DMARDs.ConclusionIn patients with both RA and DM, we found no difference in the risk of DM treatment switching or intensification after initiating abatacept vs TNFi, rituximab and tocilizumab, whereas the risk appeared to be lower for tofacitinib.

164-LB: Lower Pediatric HbA1c in Sweden during Recent Years Is Associated with a Lower HbA1c Nadir during the First Year after Onset

Background: There is a large variation in mean HbA1c levels even between high-income countries, with a decrease over time in HbA1c in some countries but an increase in others. Sweden has experienced a steady decrease in HbA1c over the past 10 years. The aim of this study was to illustrate how changes in HbA1c during the first two years after diagnosis in children and adolescents is related to calendar year for diagnosis of type 1 diabetes from 2010 to 2017. Methods:The Swedish SWEDIABKIDS registry collects data every ~3 months and has &amp;gt; 95% coverage up to age 18 years. We plotted all available HbA1c data vs. diabetes duration, presented as separate Loess curves per 2 consecutive year groups. Results: In total, 5,102 patients contributed with 51,550 HbA1c values over 8 years. HbA1c at onset has slightly increased from 93.9 to 95.0 mmol/mol (10.7 to 10.8 %) between 2010 and 2017. The HbA1c nadir (lowest level during first year) is around 4 months, and has become lower over the years. Early HbA1c tracking is apparent and is established with a difference between the groups from 1 year’s diabetes duration. Conclusions: Intensification of early diabetes treatment, resulting in a lower HbA1c nadir at 4 months and lower HbA1c from 1 year onwards is related to HbA1c two years after diagnosis. Thus, a modifiable factor for a long-term improvement in metabolic control has been identified. Disclosure R. Hanas: Advisory Panel; Self; Abbott, Novo Nordisk A/S. Speaker’s Bureau; Self; Sanofi. Other Relationship; Self; AstraZeneca. I.I. Steineck: None. J. Anderzén: None. K. Eeg-Olofsson: None. J. Ekelund: Employee; Spouse/Partner; AstraZeneca. S. Gudbjörnsdottir: None. L. Hanberger: None. J. Nåtman: None. A. Pundziute Lyckå: None. A. Svensson: None. S. Särnblad: Advisory Panel; Self; Novo Nordisk A/S. Other Relationship; Self; Novo Nordisk A/S. K. Akesson: None.

Ethnic disparities in initiation and intensification of diabetes treatment in adults with type 2 diabetes in the UK, 1990-2017: A cohort study.

Type 2 diabetes mellitus (T2DM) disproportionately affects individuals of nonwhite ethnic origin. Timely and appropriate initiation and intensification of glucose-lowering therapy is key to reducing the risk of major vascular outcomes. Given that ethnic inequalities in outcomes may stem from differences in therapeutic management, the aim of this study was to identify ethnic differences in the timeliness of initiation and intensification of glucose-lowering therapy in individuals newly diagnosed with T2DM in the United Kingdom. An observational cohort study using the Clinical Practice Research Datalink was conducted using 162,238 adults aged 18 and over diagnosed with T2DM between 1990 and 2017 (mean age 62.7 years, 55.2% male); 93% were of white ethnicity (n = 150,754), 5% were South Asian (n = 8,139), and 2.1% were black (n = 3,345). Ethnic differences in time to initiation and intensification of diabetes treatment were estimated at three time points (initiation of noninsulin monotherapy, intensification to noninsulin combination therapy, and intensification to insulin therapy) using multivariable Cox proportional hazards regression adjusted for factors a priori hypothesised to be associated with initiation and intensification: age, sex, deprivation, glycated haemoglobin (HbA1c), body mass index (BMI), smoking status, comorbidities, consultations, medications, calendar year, and clustering by practice. Odds of experiencing therapeutic inertia (failure to intensify treatment within 12 months of HbA1c >7.5% [58 mmol/mol]), were estimated using multivariable logistic regression adjusted for the same hypothesised confounders. Noninsulin monotherapy was initiated earlier in South Asian and black groups (South Asian HR 1.21, 95% CI 1.08-1.36, p < 0.001; black HR 1.29, 95% CI 1.05-1.59, p = 0.017). Correspondingly, no ethnic differences in therapeutic inertia were evident at initiation. Intensification with noninsulin combination therapy was slower in both nonwhite ethnic groups relative to white (South Asian HR 0.80, 95% CI 0.74-0.87, p < 0.001; black HR 0.79, 95% CI 0.70-0.90, p < 0.001); treatment inertia at this stage was greater in nonwhite groups relative to white (South Asian odds ratio [OR] 1.45, 95% CI 1.23-1.70, p < 0.001; black OR 1.43, 95% CI 1.09-1.87, p = 0.010). Intensification to insulin therapy was slower again for black groups relative to white groups (South Asian HR 0.49, 95% CI 0.41-0.58, p < 0.001; black HR 0.69, 95% CI 0.53-0.89, p = 0.012); correspondingly, treatment inertia was significantly higher in nonwhite groups at this stage relative to white groups (South Asian OR 2.68, 95% CI 1.89-3.80 p < 0.001; black OR 1.82, 95% CI 1.13-2.79, p = 0.013). At both stages of treatment intensification, nonwhite groups had fewer HbA1c measurements than white groups. Limitations included variable quality and completeness of routinely recorded data and a lack of information on medication adherence. In this large UK cohort, we found persuasive evidence that South Asian and black groups intensified to noninsulin combination therapy and insulin therapy more slowly than white groups and experienced greater therapeutic inertia following identification of uncontrolled HbA1c. Reasons for delays are multifactorial and may, in part, be related to poorer long-term monitoring of risk factors in nonwhite groups. Initiatives to improve timely and appropriate intensification of diabetes treatment are key to reducing disparities in downstream vascular outcomes in these populations.

Unnecessary Intensification of Diabetes Treatment in U.S. Veterans

When diabetic patients are admitted to the hospital, their outpatient medication regimens often are modified, even when admissions are for reasons

Development of a Patient Decision Aid on the Choice of Diabetes Medication for Filipino Patients with Type 2 Diabetes Mellitus.

ObjectiveTo develop a locally adapted patient decision aid (PtDA) on treatment intensification among Filipino patients with Type 2 Diabetes Mellitus and to test the feasibility of using PtDAs in a low middle-income countryMethodologyA qualitative approach and an iterative process of development of a PtDA were employed for this study. We describe the process of developing a Filipino version of the Diabetes Medication Decision Aid. This PtDA was designed to help the patient choose the appropriate treatment intensification based on his own values and preferences, in consultation with his physician. The process involved decisional needs assessment through focus group discussions and key informant interviews, systematic literature review, iterative process of the development of a PtDA with clinical encounters (pilot testing), and preliminary field testing.ResultsDecisional needs assessment revealed that Filipino patients are open to participate in shared decision-making if given the opportunity, including those with low socioeconomic status who likely have low health literacy. Physicians prefer to have visual aid tools to help them support their patient’s decision-making. A PtDA prototype of a set of flash cards in Filipino was created and revised in an iterative method. We developed a more visually appealing tool after inputs from the expert panel and patient advisory group. Its use during clinical encounters provided additional insights from patients and clinicians on how to improve the PtDA. Preliminary field testing showed that its use is feasible in the target patient population.ConclusionFilipino patients, clinicians, and diabetes nurse educators have contributed to the creation of the first Filipino PtDA for diabetes treatment intensification.

World Health Organization Guidelines on Medicines for Diabetes Treatment Intensification: Commentary From the American College of Physicians High Value Care Committee.

This commentary from the American College of Physicians High Value Care Committee discusses the World Health Organization guideline on managing diabetes mellitus, the nuances of clinical decision m...

Assessment of the relationship between diabetes treatment intensification and quality measure performance using electronic medical records.

AimsAssess the relationship between timely treatment intensification and hemoglobin A1C (HbA1C) control quality-of-care performance measures, i.e., HbA1C levels, among patients with uncontrolled type 2 diabetes.Materials and methodsElectronic medical records and diabetes registry data from a large, accountable care organization (ACO) were used to isolate a sample of adult patients with type 2 diabetes who received at least one oral antidiabetes agent and had at least one HbA1C level measurement ≥8.0% (64 mmol/mol; i.e., uncontrolled diabetes) between 7/1/2011 and 6/30/2015. Treatment intensification status was evaluated for each patient during a 120-day treatment intensification window following the index HbA1c measure. Two-level hierarchical generalized linear models, with patients aggregated at the physician level, were used to assess the association between treatment intensification and achieving HbA1C quality performance measures.Results547 patients met study selection criteria and 480 patients had at least one HbA1C test after the treatment intensification window and were used for the statistical analyses. About 40% of patients who had uncontrolled diabetes received treatment intensification during the 120-day window. Greater index HbA1C, greater patient body mass index, and fewer unique pre-index oral antidiabetes agents were significantly associated with greater likelihood of receiving timely treatment intensification. The odds of receiving treatment intensification were about 1.8 times higher (P = 0.0027) among patients with poor index HbA1C control (HbA1c level >9.0% [75 mmol/mol]) compared to other patients (index HbA1c 8.0% - 9.0%). Hispanic patients (compared to White patients) were significantly more likely to exhibit poor control after treatment intensification (odds ratio [OR] 2.91, P = 0.0304), underscoring the difficulty of controlling diabetes in this vulnerable group. In contrast, being male and being treated primarily by an internist (compared to primary treatment by a family medicine specialist) were both significantly associated with achieving superior control (HbA1c level <8.0%) after treatment intensification (OR 0.53 [P = 0.0165]; OR 0.41 [P = 0.0275], respectively).ConclusionsTimely treatment intensification was significantly associated with greater likelihood of patients achieving superior HbA1C control (<8.0%) and better HbA1C control quality performance for the practice. Even in an ACO with resources dedicated to diabetes control, it is incumbent upon clinicians to readily identify and open dialogues with patients who may benefit from closely supervised, individualized attention.

Risk of Diabetes Hospitalization or Diabetes Drug Intensification in Patients With Depression and Diabetes Using Second-Generation Antipsychotics Compared to Other Depression Therapies.

Use of second-generation antipsychotics (SGAs) for treatment of depression has increased, and patients with depression and comorbid diabetes or cardiovascular disease are more likely to use SGAs than those without these conditions. We compared SGA and non-SGA depression pharmacotherapies on the risk of diabetes hospitalization or treatment intensification in adults with depression and preexisting diabetes. This was a retrospective cohort study of US commercially insured adults (2009-2015 Truven MarketScan Commercial Claims and Encounters Database) aged 18-64 years old with type 2 diabetes mellitus and unipolar depression previously treated with a selective serotonin reuptake inhibitor or serotonin-norepinephrine reuptake inhibitor. New users of SGAs versus non-SGAs, as well as specific treatments (aripiprazole, quetiapine, bupropion, mirtazapine, and tricyclic antidepressants [TCAs]) were matched on class/medication-specific high-dimensional propensity score. Cox proportional hazard models were used to compare the risk of diabetes-related hospitalization or treatment intensification. We identified 6,625 SGA (aripiprazole = 3,461; quetiapine = 1,977; other = 1,187) and 23,921 non-SGA patients for inclusion (bupropion = 15,511; mirtazapine = 1,837; TCAs = 5,989; other = 584) with a mean age of 51 years. In the matched cohort, the rate of diabetes-related hospitalization or drug intensification was 47.9 per 100 person-years in the SGA group and 43.5 per 100 person-years in the non-SGA group (adjusted hazard ratio [aHR] = 1.03; 95% CI, 0.96-1.11). When comparing treatment subgroups, the risk of events was lower for bupropion versus TCAs (aHR = 0.85; 95% CI, 0.76-0.98), quetiapine versus mirtazapine (aHR = 0.82; 95% CI, 0.67-0.99), and quetiapine versus TCAs (aHR = 0.84; 95% CI, 0.72-0.98). For other comparisons, differences were small and not statistically significant. While drug-specific effects on risk of diabetes hospitalization or treatment intensification most likely guide clinical decision making, we observed only modest differences in risk. The overall impact of SGAs on diabetes control depends not only on direct effects on glucose metabolism but also on effectiveness of depression symptom relief. Future studies evaluating other diabetes outcomes (glycosylated hemoglobin, diabetes complications) are needed.

Stepping Up Implementation Project

Introduction (context and problem statement): Most people with type 2 diabetes have their clinical care based in primary care, where evidence-based clinical management can help achieve target levels for glucose levels (glycaemia). However, many people remain out of glycaemic target range, leading to downstream vascular complications. Optimising glycated haemoglobin to minimise risk of long-term complications among people with type 2 diabetes is a global priority. Supporting timely treatment intensification, particularly insulin initiation, through innovation in primary care could have a major impact. Short description of practice change implemented: The project is based on the original Stepping Up randomised trial in general practice which found that with appropriate support and reorientation of roles, General Practitioners and Practice Nurses can manage commencement of insulin as part of routine care of people with Type 2 diabetes in their general practices.(1) For this project, two Registered Nurse Credentialed Diabetes Educators based in community health are trained to undertake mentoring roles supporting Practice Nurses in their areas to play a more active role in the initiation of insulin and other injectable therapies in General Practice. Aim and theory of change: The Stepping Up Implementation project is a community and primary-care led approach to integrated care that is seeking to build the capacity of general practice in the north western Melbourne region to better manage the intensification of diabetes treatment in the community. Our approach to professional behaviour change was informed by Normalisation Process Theory and developed through pilot studies. Targeted population and stakeholders, timeline: The project is a collaboration between North Western Melbourne Primary Health Network, the University of Melbourne Department of General Practice, Merri Health, cohealth, and the Royal Melbourne Hospital. Having commenced in May 2017, the project is seeking to implement the model of care in 20 general practices in inner north western Melbourne by June 2018. Innovation, Impact and outcomes: It is anticipated that enabling primary care practitioners to work to their full scope will make better use of resources and provide patients with more timely local care. Additionally, the role of community health staff will build linkages between general practice and community health. Greater integration driven by this stronger relationship may offer access to a range services offered in community health that is currently elusive to many patients. Conclusion, Sustainability and transferability: There is opportunity to scale-up the number of general practices participating and potential to transfer the project to other community health organisations. As a practice-nurse led model, the enhanced capacity built through mentoring is self-sustaining and utilises existing funding streams available through the Medicare Benefits Scheme. The sustainability of the mentoring element of the project is reliant upon the commitment of funding for the CDE position, which, while not assured, could be justified by the benefits of increased integration. Refrences: 1- Furler J, O’Neal D, Speight J, Manski-Nankervis JA, Gorelik A, Holmes-Truscott E et al. Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial BMJ 2017; 356 :j783

Use of GLP-1 receptor agonists for type 2 diabetes treatment intensification after basal insulin failure

Glucagon-like peptide-1 receptor agonists (GLP-1RAs) are part of the armamentarium for the treatment of type 2 diabetes (T2D), although recent guidelines have mainly recommended their use on top of oral treatments when a single or combination of two or three oral hypoglycaemic agents has failed to lower HbA1c levels below the individualized target range. In such situations, the decision to use GLP-1RAs is mostly driven by their high level of efficacy, their effect on body weight balance and their safety considerations, such as low hypoglycaemic risk. According to the current guidelines, GLP-1RAs may also be used in T2D patients in addition to basal insulin, following specialist-care advice, in patients who are more severely obese or who may not have the capacity to handle the complexities of a multiple daily injection (MDI) insulin regimen. The present review looks at the scientific evaluations performed in this context as well as the clinical trials assessing the use of GLP-1RAs in combination with intensive insulin therapy as further step-up therapy.

Lower and higher-potency statins on glycemic control in type 2 diabetes: A retrospective cohort study

AimsEvidences showed a link between statins and new-onset diabetes and large clinical trials in type 2 diabetes (T2DM) suggested a mild glycemic progression in statin treated. Since this effect has not yet elucidated in real world, we investigated the effects of different statins on glycemia in T2DM clinic outpatients. MethodsIn a retrospective cohort study, we recorded at 6 and 12months modifications of fasting glucose (FPG), HbA1c, diabetes intensification therapy and target rate for HbA1c in 421 T2DM non-users and new statin users. Statins were categorized with low or high potency. ResultsCompared to statin users, no statin group showed a significant HbA1c reduction from 52.8±14.0mmol/mol to 48.2±8.5 (p=0.003) at 6months and 48.6±8.8 (p=0.007) at 12months. This trend without statins was also observed in FPG starting from 7.1±2.0mmol/l to 6.7±1.6 (p=0.12) at 6months and 6.6±1.5 (p=0.032) at 12months. Statins determined a significant diabetes treatment intensification: 48.7% vs 27.4% (p=0.002) with hazard ratio 2.4 [95% CI 1.14–5.2], p=0.022. HbA1c target was significantly lower in statin users 62.0% vs 75.4%, p=0.042. Only lower-potency statins showed a significant reduction of HbA1c from 52.0±11.1mmol/mol to 50.7±9.0 (p=0.017) and 50.7±9.5 (p=0.038) at 6 and 12months, respectively. The same effect for these statins was registered in FPG from 7.5±2.2mmol/l to 7.0±1.6 (p=0.021) at 6months and 7.2±1.5 (p=0.026) at 12months. ConclusionsIn patients receiving statin therapy a greater intensification diabetes therapy is need. This impact seems to be less pronounced by statins with lower potency.

Diabetes treatment intensification and associated changes in HbA1c and body mass index: a cohort study.

BackgroundTo describe common type 2 diabetes treatment intensification regimens, patients’ characteristics and changes in glycated hemoglobin (HbA1c) and body mass index (BMI).MethodsWe constructed a national retrospective cohort of veterans initially treated for diabetes with either metformin or sulfonylurea from 2001 through 2008, using Veterans Health Administration (VHA) and Medicare data. Patients were followed through September, 2011 to identify common diabetes treatment intensification regimens. We evaluated changes in HbA1c and BMI post-intensification for metformin-based regimens.ResultsWe identified 323,857 veterans who initiated diabetes treatment. Of these, 55 % initiated metformin, 43 % sulfonylurea and 2 % other regimens. Fifty percent (N = 89,057) of metformin initiators remained on metformin monotherapy over a median follow-up 58 months (interquartile range [IQR] 35, 74). Among 80,725 patients who intensified metformin monotherapy, the four most common regimens were addition of sulfonylurea (79 %), thiazolidinedione [TZD] (6 %), or insulin (8 %), and switch to insulin monotherapy (2 %). Across these regimens, median HbA1c values declined from a range of 7.0–7.8 % (53–62 mmol/mol) at intensification to 6.6–7.0 % (49–53 mmol/mol) at 1 year, and remained stable up to 3 years afterwards. Median BMI ranged between 30.5 and 32 kg/m2 at intensification and increased very modestly in those who intensified with oral regimens, but 1–2 kg/m2 over 3 years among those who intensified with insulin-based regimens.ConclusionsBy 1 year post-intensification of metformin monotherapy, HbA1c declined in all four common intensification regimens, and remained close to 7 % in subsequent follow-up. BMI increased substantially for those on insulin-based regimens.Electronic supplementary materialThe online version of this article (doi:10.1186/s12902-016-0101-2) contains supplementary material, which is available to authorized users.

Effectiveness of insulin glargine in type 2 diabetes mellitus patients failing glycaemic control with premixed insulin: Adriatic countries data meta-analysis.

Type 2 diabetes mellitus (T2DM) is a progressive disease, often requiring exogenous insulin therapy and treatment intensification. Despite new therapies, most patients do not reach the recommended HbA1c targets, among them a significant proportion of patients on premixed insulins. The aim was to summarize published data in Adriatic countries on effectiveness of insulin glargine based therapy in type 2 diabetic patients suboptimally controlled on premix insulin. A meta-analysis was carried out in major medical databases up to April 2014, focusing on Adriatic region. We searched observational studies with duration of at least 6 months, evaluating effectiveness and safety of insulin glargine (IGlar), in combination with OAD or bolus insulin in patients with T2 failing premixed insulin therapy. Outcomes included values of HbA1c, fasting blood glucose and two hours post-prandial glucose concentration as well as changes in body mass index after at least 6 months of study duration. Three prospective, observational, multicentric trials (698 patients in total) were included. The basal bolus regimen with glargine significantly reduced HbA1c (Mean Difference, MD=2.27, CI [1.76, 2.78]), fasting glucose (MD=5.15, CI [4.86, 5.44]) and 2-hours postprandial glucose concentration (MD=6.94, CI [6.53, 7.34]). No significant changes were found in BMI after switching from premixes to IGlar based treatment. Insulin glargine based therapy following premix failure is efficacious and safe option of type 2 diabetes treatment intensification.