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  • v.18(3); Jul-Sep 2020

Clinical pharmacists´ interventions in the management of type 2 diabetes mellitus: a systematic review

Sarah pousinho.

MSC. CICS-UBI – Health Sciences Research Centre, University of Beira Interior. Covilhã (Portugal). moc.liamg@ohnisuopharas

Manuel Morgado

PhD, PharmD. CICS-UBI – Health Sciences Research Centre, University of Beira Interior. Covilhã (Portugal). tp.ibu.eduascf@odagromm

Ana I. Plácido

PhD. Research Unit for Inland Development, Polytechnic of Guarda (UDI-IPG). Guarda (Portugal). tp.gpi@odicalpana

Fátima Roque

PhD, PharmD. CICS-UBI – Health Sciences Research Centre, University of Beira Interior. Covilhã (Portugal). tp.gpi@euqorf

Amílcar Falcão

PhD, PharmD. Centre for Neuroscience and Cell Biology, Laboratory of Pharmacology, Faculty of Pharmacy, University of Coimbra. Coimbra (Portugal). tp.cu.ff@oaclafca

Gilberto Alves

PhD, PharmD. CICS-UBI – Health Sciences Research Centre, University of Beira Interior. Covilhã (Portugal). tp.ibu.eduascf@otreblig

Associated Data

Background:.

Type 2 diabetes mellitus is a chronic disease that is reaching epidemic proportions worldwide. It is imperative to adopt an integrated strategy, which involves a close collaboration between the patient and a multidisciplinary team of which pharmacists should be integral elements.

This work aims to identify and summarize the main effects of interventions carried out by clinical pharmacists in the management of patients with type 2 diabetes, considering clinical, humanistic and economic outcomes.

PubMed and Cochrane Central Register of Controlled Trials were searched for randomized controlled trials assessing the effectiveness of such interventions compared with usual care that took place in hospitals or outpatient facilities.

This review included 39 studies, involving a total of 5,474 participants. Beneficial effects were observed on various clinical outcomes such as glycemia, blood pressure, lipid profile, body mass index and coronary heart disease risk. For the following parameters, the range for the difference in change from baseline to final follow-up between the intervention and control groups was: HbA1c, -0.05% to -2.1%; systolic blood pressure, +3.45 mmHg to -10.6 mmHg; total cholesterol, +10.06 mg/dL to -32.48 mg/dL; body mass index, +0.6 kg/m 2 to -1.94 kg/m 2 ; and coronary heart disease risk, -3.0% and -12.0% (among the studies that used Framinghan prediction method). The effect on medication adherence and health-related quality of life was also positive. In the studies that performed an economic evaluation, the interventions proved to be economically viable.

Conclusions:

These findings support and encourage the integration of clinical pharmacists into multidisciplinary teams, underlining their role in improving the management of type 2 diabetes.

INTRODUCTION

Type 2 diabetes mellitus (T2DM) is a complex metabolic disease characterized by several pathophysiologic alterations, including insulin resistance and a progressive decrease in insulin secretion, ultimately leading to increased blood glucose levels. 1 , 2 This multifactorial disease results from the interaction between genetic, epigenetic and lifestyle factors that act in a specific sociocultural environment. 1 Diabetes-related complications such microvascular and macrovascular alterations, resulting from uncontrolled glycemic levels are responsible for an increased morbidity and mortality, and reduced health-related quality of life. 3 , 4 The burden of diabetes and diabetic associated complications results in worrisome increased global health expenditure.

Evidences from the literature suggest that despite tighter control of blood glucose and other cardiovascular risk factors, such as blood pressure and serum lipids as well as the huge number therapies available, recommended targets are hardly achieved among patients with T2DM. 5 - 7 These unsatisfactory outcomes may result from inadequate intervention strategies by healthcare providers, or patient related problems, such as lack of compliance. 8 , 9

To achieve these targets and improves therapeutic outcomes, new healthcare models, based in a collaborative, proactive and integrated team work in which patients play an active role should be implemented. 1 , 10 - 12 Some systematic reviews have addressed this topic however they failed in critical review the economic outcomes. 13 - 17

The aim of this study is to review and investigate the effect of interventions performed by clinical pharmacists on the management of T2DM, considering clinical, humanistic and economic outcomes, and focusing solely on randomized controlled trials conducted in hospitals or ambulatory healthcare centers.

Search strategy and inclusion criteria

Two electronic databases (PubMed and Cochrane Central Register of Controlled Trials) were searched from inception to 13 th September 2017 and updated in 30 th June 2020.

The PubMed search strategy served as a template for the search strategy used in the Cochrane Central Register of Controlled Trials database. The search terms included medical subject headings and text terms combined with Boolean operators (

online Appendix 1

Studies were eligible for inclusion if they were in accordance with the following criteria: (1) randomized controlled trials evaluating the effectiveness of interventions provided by pharmacists for patients with T2DM in comparison to usual care were eligible; (2) Studies that took place in hospitals or outpatient centers (e.g. health care centers and clinics) and reported data on one or more of the following outcomes were suitable for this systematic review: glycosylated hemoglobin (HbA1c), blood glucose (fasting or postprandial), blood pressure, lipid profile [total cholesterol, low-density lipoprotein (LDL) cholesterol, high-density (HDL) cholesterol and triglycerides], body mass index, 10-year coronary heart disease (CHD) risk, medication adherence, health-related quality of life (HRQoL) and economic analysis; (3) papers published in English, French, Spanish, or Portuguese; (4) no limitation regarding publication year was imposed.

Study selection

Two reviewers independently screened all titles and abstracts retrieved from the electronic databases using the prespecified inclusion criteria. Then, the full-text of each potentially eligible article was obtained and screened independently by two reviewers to further assess its suitability for inclusion in this review. Preferred reporting items for systematic reviews (PRISMA) standard guidelines were followed when applicable as per recommended practice. 18 Any disagreement was resolved through discussion.

Data extraction and synthesis

A single reviewer extracted data from included studies. Subsequently, another reviewer independently checked the extracted data. The data extracted were summarized in

online Appendix 2

. The study results for each outcome were presented as change from baseline to final follow-up in both intervention and control groups. When not reported, the difference in change between groups was calculated (change from baseline in intervention group minus change from baseline in control group). To allow comparisons, when necessary, the units of measurement of the clinical results were standardized.

Risk of bias assessment

Two reviewers independently assessed the risk of bias in included studies using the Cochrane risk of bias tool. 19 Due to the allocation concealment methods and cross contamination between participants, the evaluation of bias (blinding) in the included studies was difficult. Given the nature of the interventions under analysis, the criteria concerning blinding of participants and personnel were not considered.

The databases search yielded a total of 748 citations. After screening titles and abstracts, 84 citations potentially met the inclusion criteria. After full-reading, 39 studies met the inclusion criteria and were included in this systematic review ( Figure 1 ). 20 - 58 Additionally, three study 59-61 reports found among the search results were also obtained and used to extract data as they contained relevant outcome information from some included studies.

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Among the included studies, nine were conducted in North America, five in South America, three in Europe, one in Africa, and twenty one in Asia. The settings in which the studies took place included hospitals, primary care health centers and outpatient medical clinics. Pharmacist interventions varied across the studies and were summarized in

. Globally, the included studies involved a total of 6,411 participants. The duration of follow-up ranged from 45 days to 24 months. A detailed description of the characteristics of included studies is presented in

Study risk of bias

The risk of bias varied among the 39 studies ( Figure 2 and

). In 18 (46.2%) of them, the allocation sequence was sufficiently generated. The allocation sequence was concealed, and outcome assessors were blinded in only a few studies (7.7% and 2.6%, respectively). In most studies (97.5%), there was or might have been a risk of bias due to selective outcome reporting. Only 13 studies (33.3%) reported outcome data completely, and 19 studies (48.7%) were free of other source of bias.

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HbA1c and blood glucose

The mean HbA1c value decreased from baseline to follow-up in the intervention group in all studies (

online Appendix 3

), but this decrease reached statistical significant for only sixteen studies (47%). 23 , 25 , 27 - 29 , 35 , 37 - 39 , 41 , 42 , 45 , 50 , 52 , 56 , 57 In these studies, the difference showed in HbA1c change from baseline to final follow-up between the intervention group and the control group ranged from -0.05% to -2.1%. Regarding blood glucose, 22 studies reported this parameter as an outcome measure (

). Only six studies (27%) reported a statistically significant decrease in blood glucose (fasting or postprandial). 39 , 40 , 42 , 45 , 46 , 56 Overall, the difference in change between both groups, which ranged from -7.74 mg/dL to -76.32 mg/dL.

Blood pressure

Twenty studies evaluated the change in systolic blood pressure (SBP) during the course of the study (

). The difference in change between the two groups ranged from +3.45 mmHg to -10.6 mmHg and was shown to be statistically significant in only seven studies (33.3%). 31 , 35 , 39 - 42 , 45 , 50 , 53 , 56 , 57 As for diastolic blood pressure (DBP), 15 studies reported data on this outcome (

). However, only three studies revealed a statistically significant difference in change from baseline to final follow-up between both groups. 39 , 41 , 53 The difference in change between the two groups ranged from +1.32 mmHg to -9.1 mmHg.

Lipid profile

Fifteen studies described total cholesterol as an outcome measure (

online Appendix 4

). However, only four studies (26.7%) reported as statistically significant in only three studies. 39 , 41 , 45 The difference in change between both groups, ranged from +10.06 mg/dL to -32.48 mg/dL. Regarding LDL cholesterol, 21 studies reported data on this outcome (

). For this parameter, the difference in change between both groups ranged from +2.1 mg/dL to -27 mg/dL, and was reported as statistically significant in only seven studies (33.3%). 27 , 29 , 35 , 39 , 40 , 45 , 57

Among the 15 studies that reported HDL cholesterol as an outcome measure (

), the difference in change between both groups was shown to be statistically significant in only one study (6.7%) 45. The difference in change between the two groups ranged from -5.8 mg/dL to +11 mg/dL. Finally, 16 studies reported data on triglycerides (

) and three studies (18.8%) 39, 40, 45, observed a statistical significance in change between the two groups, ranged from +21.26 mg/dL to -62.0 mg/dL.

Body mass index

Sixteen studies described body mass index (BMI) as an outcome measure (

). Although eleven studies reported a greater reduction in this group in comparison with the control group, Only one study (6.3%) revealed a statistically significant difference in change between both groups. 41 The difference in change between the two groups ranged from +0.6 kg/m 2 to -1.94 kg/m 2 .

10-year CHD risk

CHD risk was predicted among study participants in five studies. As observed in

, different methods were used to estimate this outcome. In comparison with the control group, the difference in change between the two groups was reported as statistically significant in only two studies (40%). 27 , 53 Because the methods used to assess this risk varied among studies, it is not possible to define a range for the difference in change between both groups across all studies. However, among the studies that used the Framingham prediction method, this difference was -3.0% and -12.0%, respectively.

Medication adherence and Health-related quality of life

Medication adherence was evaluated, using different methods, in 20 studies. In 12 studies, a greater improvement in medication adherence was observed in the intervention group when compared with the control group, but only four studies reported a statistically significant difference. 23 , 25 , 27 , 35 Regarding HRQoL, despite, the different tools used, only one 25 of the twelve studies that measures this outcome reported a statistically significant difference in change between the two groups (

online Appendix 5

Economic outcomes

Six studies performed an economic analysis, but only 2 provided the p-values, and only one of these was <0.05. Adibe et al . conducted a cost-utility analysis of the pharmaceutical care intervention implemented in their study. 59 This analysis was based on the followed resources: the “cost of the intervention,” the “cost of drugs,” and the “cost of other health care resource use” (including primary care, hospital care, and auxiliary health care). The total cost per patient per year was USD 326 for the control group and USD 394 for the intervention group (p=0.1009). In addition, quality-adjusted life-year (QALY) per patient per year was 0.64 for the control group and 0.76 for the intervention group p<0.0001). 59 Thus, the authors found that the intervention led to an incremental cost of USD 69 and an incremental effect of 0.12 QALY gained, with an associated incremental cost-utility ratio of USD 571 per QALY gained, demonstrating that the intervention was very cost-effective. 59

Chan et al . estimated the cost-effectiveness of the pharmacist care program based on based on projected cost savings anticipated due to CHD risk reduction. 27 The estimated potential saving in costs was USD 5,086.3 per patient. 27

Simpson et al . also conducted a cost-effectiveness analysis. 61 This analysis was based on followed resource costs: the pharmacist intervention, prescription medications, healthcare services provided by physician specialists and other healthcare professionals, emergency department visits and hospitalizations. The authors found that the total cost per patient per year was CAD 190.00 (USD 151.88) lower in the intervention group compared with the control group, and that the intervention group had a 0.26% greater reduction in the annualized risk of cardiovascular event in comparison with the control group. 61 The cost-effectiveness analysis showed that at a societal willingness-to-pay of CAD 4,000.00 (USD 3,196.22) per 1% reduction in annual cardiovascular risk, the probability that the intervention was cost-effective compared with usual care reached 95%. 61

In the study reported by Chen et al. , medical expenses were not significantly different between intervention and control groups (p=0.767). 28 However, regarding pharmacist intervention expenditure based on pharmacist’s salary, telephone fees and supplies cost, the mean cost per patient was NTD 1,336. 9 (USD 44.10) in the intervention group and NTD 132 (USD 4.35) in the control group, representing an increase of NTD 1,204.9 (USD 39.73) in cost per patient. 28 Since a decrease of 0.83% in HbA1c mean levels was achieved in the intervention group, the incremental cost per 1% reduction in HbA1c mean levels was NTD 1,451.69 (USD 47.87), which could in part be covered by health insurance reimbursement. 28

Siaw et al . also performed an economic evaluation by calculating direct outpatient medical costs, taking into account consultation visits, laboratory tests and procedures, and medications. 52 The mean cost for direct outpatient diabetes-related care was USD 516.77 in the intervention group and USD 607.78 in the control group, which translated into an average cost saving of USD 91.01 per patient. 52

Wu et al . performed an economic evaluation based on the costs of medical visits (only for the intervention arm), medications, hospitalizations, emergency department visits, laboratory testing, procedures, outsource referral or transfer to other facilities and outpatient clinic visits and observed a decreased by 6% for the group visit but increased by 13% for the standard care arm 13 months post-study (p<0.01). 58

This systematic review analyzed randomized controlled trials that investigated the effects of different interventions performed by clinical pharmacists on various outcomes related to T2DM care. It stands out from previous systematic reviews because besides demonstrating the positive contribution of clinical pharmacists in the metabolic control of patients with T2DM, it also includes economics and humanistic outcomes of pharmacist’s interventions. 13 - 16 , 62 Considering, that the role of pharmacists remains undervalued in the context of clinical interventions, specifically directed to patients, in contrast to what happens with other healthcare professional with this work, we also intend to underline that pharmacists are highly capacitated professional that are able to integrate multidisciplinary teams for improving practice strategies such patient’s educations, drug review and case management with routine follow up. Frequently, pharmacist interventions involved medication management, educational interventions and referrals to other healthcare professionals or services. The diversity of interventions observed may be related to the difference in roles and integration of pharmacists within healthcare systems in different countries, particularly concerning prescribing authority and autonomy to make medication changes. Evidences from the studies included in this review indicate that clinical pharmacists contribute positively to the management of patients with T2DM. For instance, these types of interventions could be even more effective if they were part of the routine follow-up of the patients. 63

Indeed, an improvement in HbA1c, blood glucose, blood pressure, lipid profile and BMI in the intervention group was reported in almost all studies.

Our findings are consistent with those of other systematic reviews on this topic. In their review on pharmacist interventions in primary care for patients with diabetes, Wubben et al . reported an overall improvement in HbA1c mean levels in the intervention group and the difference in change between intervention and control groups ranged from +0.2% to -2.1%. 16 The fact that pharmacist interventions resulted in a reduction in HbA1c and blood glucose is of great importance, since an improvement in glycemic control is linked to a decreased risk of diabetes-related microvascular complications namely a reduced risk of stroke by 12%, a reduced risk of myocardial infarction by 14% and a reduced risk of heart failure by 16%. 64 Inclusion of fasting or non-fasting blood glucose levels as a primary outcome is of far less clinical relevance than that of HbA1c, especially since so few of these studies showed a statistically significant difference.

Regarding blood pressure, lipid profile and BMI, our findings add to the evidence described in other studies. 15 - 17 , 62 For instance, in their review assessing the effects of pharmacist care among outpatients with cardiovascular risk factor in diabetes, Santschi et al . reported that pharmacist interventions were associated with significant reductions in SBP and DBP, total cholesterol, LDL cholesterol and BMI compared with usual care, but the same was not observed with HDL cholesterol. 15 Wubben et al . also found decreases in blood pressure, low-density cholesterol or triglycerides in the intervention group in most studies, although the difference in change between groups was not significant. 16

There are few studies assessing CHD risk, after pharmacist interventions, however these interventions have been associated with an improvement in CHD risk. Since the tools/formulas used to calculate this risk include some clinical outcomes mentioned above, such as HbA1c, SBP and cholesterol, the decrease in CHD risk can be in part attributable to an improvement in these parameters. 65 - 67 Pharmacist interventions also had a positive impact on medication adherence in most studies that included this outcome. Although adherence might have been subject to overestimation, since the majority of methods used to assess this outcome were based on self-reported adherence, the existing findings demonstrate that pharmacists have the potential to improve medication adherence among patients with T2DM, which in turn can translate into a beneficial effect on clinical outcomes, as observed in some studies. 68 , 69

The fact that pharmacist interventions did not result in a significant increase in HRQoL in the majority of the studies could be explained by the lack of sensitivity of the existing tools in detecting subtle changes on this outcome, since there is no tool specifically designed to determine the effect of pharmaceutical care on patient quality of life. 70

Although pharmacist interventions have shown to be cost-effective, evidence is limited by the small number of studies that carried out an economic analysis. However, in order to inform and influence the decision of policymakers regarding the widespread involvement of clinical pharmacists in the care of patients with T2DM, economic analyses are essential due to the current resource restraints in healthcare systems. Therefore, pharmacist interventions should be assessed in a comprehensive manner, considering clinical, humanistic and economic outcomes (ECHO approach). 71

Limitations

This review has some limitations. First, although randomized controlled trials have the most robust study design, the included studies presented some methodological weaknesses, as assessed by the Cochrane risk of bias tool. However, it should be highlighted that some risk of bias criteria, such as random sequence generation, allocation concealment and blinding of outcomes assessment, were rated as “unclear” in a large proportion of studies because the study reports did not provide sufficiently detailed information to enable a more precise evaluation of the risk of bias. Second, because pharmacist interventions were somehow heterogeneous, it is difficult to identify the most effective intervention. In this work, we observed that educational interventions and medication management performed by pharmacists could be a good approach to the management of type 2 diabetes mellitus.

Future prospective

Future studies evaluating the humanistic and economic outcomes of pharmacist interventions must be performed to facilitate policy makers to develop healthcare models, in which pharmacists have a proactive role in the improvement of the well-being of the patients.

Moreover, the evaluation of patient related-outcomes such medication adherence should be done using more accurate methods in order to provide more realistic data regarding the effect of pharmacist interventions. Finally and taking into account that the lack of a standard tool to evaluate some outcomes (e.g. medication adherence and HRQoL) limited the direct comparison of the results of different interventions, a well-validated tool to access the most relevant outcomes should be developed in order to identify the best assertive strategy in the management of T2DM.

CONCLUSIONS

The findings from this systematic review strengthen the evidence that pharmacist interventions contribute positively to the control and management of T2D. Patients suffering from this chronic disease often present other comorbidities, such as hypertension and dyslipidemia, and require complex drug regimens. By monitoring drug therapy, educating the patient and promoting medication adherence, pharmacists play an important role on achieving therapeutic outcomes. In fact, the results of the randomized controlled trials analyzed in this review demonstrated that several pharmacist interventions had a beneficial effect on metabolic control, cardiovascular risk factors, medication adherence and HRQoL among patients with T2DM. Therefore, these findings support the idea of considering the clinical pharmacist as an integral element of multidisciplinary health care teams in T2DM care, encouraging the implementation of this approach in health care systems around the world where pharmacists are still not actively involved in the management of this patient population.

CONFLICT OF INTEREST

None to declare.

This work was financially supported by the MedElderly project [SAICT-POL/23585/2016], funded by Portuguese Fundação para a Ciência e a Tecnologia (FCT/MCTES), Portugal 2020 and Centro 2020 grants; The funders had no role in the study design, data-collection and analysis, decision to publish, or preparation of the manuscript.

Contributor Information

Sarah Pousinho, MSC. CICS-UBI – Health Sciences Research Centre, University of Beira Interior. Covilhã (Portugal). moc.liamg@ohnisuopharas .

Manuel Morgado, PhD, PharmD. CICS-UBI – Health Sciences Research Centre, University of Beira Interior. Covilhã (Portugal). tp.ibu.eduascf@odagromm .

Ana I. Plácido, PhD. Research Unit for Inland Development, Polytechnic of Guarda (UDI-IPG). Guarda (Portugal). tp.gpi@odicalpana .

Fátima Roque, PhD, PharmD. CICS-UBI – Health Sciences Research Centre, University of Beira Interior. Covilhã (Portugal). tp.gpi@euqorf .

Amílcar Falcão, PhD, PharmD. Centre for Neuroscience and Cell Biology, Laboratory of Pharmacology, Faculty of Pharmacy, University of Coimbra. Coimbra (Portugal). tp.cu.ff@oaclafca .

Gilberto Alves, PhD, PharmD. CICS-UBI – Health Sciences Research Centre, University of Beira Interior. Covilhã (Portugal). tp.ibu.eduascf@otreblig .

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Case Study: Insulin Sensitizers as Enhancers in Diabetes Management

  • Marina Dykhne PharmD, BCACP, APh, CDCES

The objective of this study is to evaluate the use of low-dose pioglitazone, without relying on high doses of insulin, by enhancing sensitivity as a suitable, cost-effective strategy compared to larger insulin doses in patients with limited access to care.

Thiazolidinediones (TZDs) enhance insulin activity and reverse insulin resistance, a common characteristic of type 2 diabetes. 1 These agents are ligands for peroxisomal proliferator-activated receptor gamma (PPARγ), a nuclear receptor superfamily member and a transcription factor that is expressed at high levels in adipose tissues. 2

PPARγ is involved in modulating the insulin-responsive glucose transporter GLUT 4, which plays a crucial role in glucose uptake and metabolism in insulin target tissues. 3 These insulin sensitizers function on intracellular metabolic pathways.

As a result of this act, there will be an improvement in insulin action and an increase in insulin sensitivity in critical tissues. 4 These agents can facilitate glucose transport activity, enhance glycogen synthesis, and stimulate insulin-mediated glucose uptake and disposal in skeletal muscle tissue. 5 Despite the well-established benefits this class offers in glycemic control, they have fallen out of favor due to concerns over their adverse effects (AEs), such as edema and weight gain.

Studies have shown the AEs of this drug are diminished if low doses of pioglitazone are added to insulin therapy (i.e., 15 mg/day). 4,6 The objective of this study is to evaluate the use of low-dose pioglitazone, without relying on high doses of insulin, by enhancing sensitivity as a suitable, cost-effective strategy compared to larger insulin doses in patients with limited access to care.

The following studies support the benefits of combination therapy of thiazolidinedione and insulin. “Concomitant therapy with pioglitazone and insulin for the treatment of type 2 diabetes” is a study published in 2010 that showed a dramatic lowering effect in plasma glucose when low-dose pioglitazone is used in combination with insulin therapy. 4

Consistent with this observation, a study conducted by Berhanu et al. demonstrated pioglitazone administration in combination with insulin therapy improves glycemic control, reduces insulin dose requirements, and improves lipid profiles. 7 Analysis of another study by Rosenstock et al. demonstrated the addition of pioglitazone to stable insulin regimens significantly improves HbA1c and fasting plasma glucose (FPG) in patients with T2DM. 8

Two large prospective clinical trials have demonstrated that pioglitazone reduces cardiovascular incidents in association with enhanced insulin sensitivity. A decrease in plasma triglyceride and transformation of small dense low-density lipoprotein (LDL) particles to larger and less dense LDL particles are other characteristics of these agents that can lead to the correction of diabetic dyslipidemia and can decrease the risk of cardiovascular complications. 9

Both patients presented in this case report are covered under a formulary that only offers metformin, sulfonylureas, thiazolidinediones, and Neutral Protamine Hagedorn (NPH) insulin to treat diabetes. Due to limited accessible options, increasing insulin doses are, at points, the only feasible option for controlling diabetes in these patients. Addition of pioglitazone 15 mg daily significantly lowered HgA1c by 4% and 6%, respectively, in less than 6 weeks in 2 patients with T2DM and limited access to care who were already receiving insulin.

The first patient was a 52-year-old Hispanic male with uncontrolled diabetes who presented to the clinic to be seen by the primary care provider (PCP) and a clinical pharmacist. His random blood glucose performed by PCP was > 650 mg/dL. His laboratory value showed an HbA1c of 18.4%.

He reported blurry vision, excessive thirst, frequent urination, and tingling in the toes. He was started on short- and long-acting insulin (lispro and glargine), metformin, glimepiride, and pioglitazone. For a complete list of the therapeutic regimen for this patient, please refer to Table 1 .

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pharmacy case study diabetes

Polypharmacy in Type 2 Diabetes Mellitus: Insights from an Internal Medicine Department

Affiliations.

  • 1 "Carol Davila" University of Medicine and Pharmacy, 8 Eroii Sanitari Boulevard, Bucharest 050474, Romania.
  • 2 "Carol Davila" University of Medicine and Pharmacy, 8 Eroii Sanitari Boulevard, Bucharest 050474, Romania. [email protected].
  • 3 Emergency University Central Military Hospital, 88 Mircea Vulcanescu Street, Bucharest 010825, Romania.
  • 4 Academy of Romanian Scientists, 54 Splaiul Independentei Street, Bucharest 030167, Romania.
  • 5 Internal Medicine Clinic, Clinical Emergency Hospital of Bucharest, 8 Calea Floreasca Street, Bucharest 014461, Romania.
  • PMID: 31382651
  • PMCID: PMC6723949
  • DOI: 10.3390/medicina55080436

Background and objectives: Polypharmacy heavily impacts the quality of life of patients worldwide. It is a necessary evil in many disorders, and especially in type 2 diabetes mellitus, as patients require treatment both for this condition and its related or unrelated comorbidities. Thus, we aimed to evaluate the use of polypharmacy in type 2 diabetes mellitus vs. non-diabetes patients.

Materials and methods: A cross-sectional retrospective observational study was conducted. We collected the medical records of patients hospitalized in the Internal Medicine Clinic of the Clinical Emergency Hospital of Bucharest, Romania, for a period of two months (01/01/2018-28/02/2018). Patients diagnosed with type 2 diabetes mellitus were included in the study group, whereas patients who were not diabetic were used as controls.

Results: The study group consisted of 63 patients with type 2 diabetes mellitus (mean age 69.19 ± 9.67 years, range 46-89 years; 52.38% males). The control group included 63 non-diabetes patients (mean age 67.05 ± 14.40 years, range 42-93 years, 39.68% males). Diabetic patients had more comorbidities (10.35 ± 3.09 vs. 7.48 ± 3.59, p = 0.0001) and received more drugs (7.81 ± 2.23 vs. 5.33 ± 2.63, p = 0.0001) vs. non-diabetic counterparts. The mean number of drug-drug and food-drug interactions was higher in type 2 diabetes mellitus patients vs. controls: 8.86 ± 5.76 vs. 4.98 ± 5.04, p = 0.0003 (minor: 1.22 ± 1.42 vs. 1.27 ± 1.89; moderate: 7.08 ± 4.08 vs. 3.54 ± 3.77; major: 0.56 ± 0.74 vs. 0.37 ± 0.77) and 2.63 ± 1.08 vs. 2.19 ± 1.42 ( p = 0.0457), respectively.

Conclusions: Polypharmacy should be an area of serious concern also in type 2 diabetes mellitus, especially in the elderly. In our study, type 2 diabetes mellitus patients received more drugs than their non-diabetes counterparts and were exposed to more drug-drug and food-drug interactions.

Keywords: comorbidities; diabetes mellitus; drug-drug interactions; elderly; food-drug interactions; multimorbidity; polypharmacy.

Publication types

  • Observational Study
  • Aged, 80 and over
  • Cross-Sectional Studies
  • Diabetes Mellitus, Type 2 / drug therapy*
  • Diabetes Mellitus, Type 2 / psychology
  • Internal Medicine / methods*
  • Internal Medicine / standards
  • Middle Aged
  • Polypharmacy*
  • Quality of Life / psychology
  • Retrospective Studies

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Information Prescription Case studies

"The new information prescriptions developed by Diabetes UK are simple, clear and easy to understand. They are an additional resource that will allow the person with diabetes to monitor their progress, whilst supporting them to take more responsibility for their condition." Gail Pasquall, Diabetes Clinical Nurse Specialist

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Dr Farooq Ahmad, GP, South London

A 57-year-old Asian man who has had diabetes for eight years came to see me for a minor illness. After dealing with this I saw the pop up icon on the right of the screen suggesting I could print an information prescription about his diabetes and the fact that his diabetes control was not optimum. After setting some goals himself and handing over the printed personalised sheet to him, he was really grateful and commented that in his time as a diabetic patient this was the first time anyone did some goal setting with him and gave him a personalised plan for his health. Since then this patient has greatly improved his diabetes control and become more focused about his health.

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Dr Stephen Lawrence, GP, Medway

A 56-year-old woman with a six year history of Type 2 diabetes with reasonable glycaemic control but sub-optimal lipid profile and blood pressure levels. It is fair to say that over the six years since her diagnosis I, together with many other healthcare professionals, had contributed to her education regarding cardiovascular risk factors. However, it was is sobering revelation to me that, on issuing her with information prescriptions relating to her blood pressure and lipid profile to personalised interventions, she revealed to me that it was the first time that anyone had explained her results. Perhaps more accurately it was the first time that her results have been presented in the way that she could understand. I would highly recommend this tool to healthcare professionals seeking to optimise the care of their patients with diabetes.

pharmacy case study diabetes

Sandi Kendall, Practice Nurse, South London

A 42 year-old man with Type 2 diabetes diagnosed for about five years. He works night shifts at a packing factory and is currently living with his mother due to not being able to afford his own accommodation.

He has a history of poor compliance in taking his medication as he reports that he has adverse side effects with most of the medication he has been prescribed. He also finds it difficult to remember to take his medication, particularly since he has been doing night shift work.

His attendance at his six month reviews is unpredictable as he normally tends to be asleep during the day because of his job. It is difficult to contact him in order to invite to these reviews. He has a love for fizzy drinks and consumes large amounts even though he has been advised to cut down.

In the first three years of his diabetes he was treated with oral medication. Due to his rising HbA1c he agreed to start a mixed insulin to take twice daily. Due to poor compliance with the insulin regime this was discontinued after two months.

When he attended his review I gave him a copy of his Information Prescription. He was able to see in black and white how his blood glucose levels have risen over the last year. We focused on the need to comply with medication and on how keeping to a healthy diet and weight can effect blood glucose levels and cholesterol. The fact that he could actually make his own goals and write them down gave him something concrete and structured to aim for. This had more impact than just being given verbal advice. He was also able to take this home and have a reminder of the goals he had made.

This patient has started to make these small changes which have had an overall effect in improving his diabetes management, resulting in a reduction in his HbA1c from 82mmols to 65 mmols.

When people are enabled to be in the driving seat of their care they invariably make decisions that are right for them and enjoy better personal and health outcomes. Diabetes UK have developed some promising, desktop-accessible Information Prescriptions. When these are used as part of a caring therapeutic relationship, they will help promote shared decision making, goal setting and support self-management. They are likely to be a welcome tool to help people have more confidence, knowledge, understanding and skills to collaborate in their diabetes care”  

Graham Kramer, GP and The Scottish Government's Clinical Lead for Self Management and Health Literacy

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© The British Diabetic Association operating as Diabetes UK, a   charity registered in England and Wales (no. 215199) and in Scotland (no. SC039136). A company limited by guarantee registered in England and Wales with (no.00339181) and registered office at Wells Lawrence House, 126 Back Church Lane London E1 1FH

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Title: knowledge-infused llm-powered conversational health agent: a case study for diabetes patients.

Abstract: Effective diabetes management is crucial for maintaining health in diabetic patients. Large Language Models (LLMs) have opened new avenues for diabetes management, facilitating their efficacy. However, current LLM-based approaches are limited by their dependence on general sources and lack of integration with domain-specific knowledge, leading to inaccurate responses. In this paper, we propose a knowledge-infused LLM-powered conversational health agent (CHA) for diabetic patients. We customize and leverage the open-source openCHA framework, enhancing our CHA with external knowledge and analytical capabilities. This integration involves two key components: 1) incorporating the American Diabetes Association dietary guidelines and the Nutritionix information and 2) deploying analytical tools that enable nutritional intake calculation and comparison with the guidelines. We compare the proposed CHA with GPT4. Our evaluation includes 100 diabetes-related questions on daily meal choices and assessing the potential risks associated with the suggested diet. Our findings show that the proposed agent demonstrates superior performance in generating responses to manage essential nutrients.

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Case study: a patient with uncontrolled type 2 diabetes and complex comorbidities whose diabetes care is managed by an advanced practice nurse.

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Geralyn Spollett; Case Study: A Patient With Uncontrolled Type 2 Diabetes and Complex Comorbidities Whose Diabetes Care Is Managed by an Advanced Practice Nurse. Diabetes Spectr 1 January 2003; 16 (1): 32–36. https://doi.org/10.2337/diaspect.16.1.32

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The specialized role of nursing in the care and education of people with diabetes has been in existence for more than 30 years. Diabetes education carried out by nurses has moved beyond the hospital bedside into a variety of health care settings. Among the disciplines involved in diabetes education, nursing has played a pivotal role in the diabetes team management concept. This was well illustrated in the Diabetes Control and Complications Trial (DCCT) by the effectiveness of nurse managers in coordinating and delivering diabetes self-management education. These nurse managers not only performed administrative tasks crucial to the outcomes of the DCCT, but also participated directly in patient care. 1  

The emergence and subsequent growth of advanced practice in nursing during the past 20 years has expanded the direct care component, incorporating aspects of both nursing and medical care while maintaining the teaching and counseling roles. Both the clinical nurse specialist (CNS) and nurse practitioner (NP) models, when applied to chronic disease management, create enhanced patient-provider relationships in which self-care education and counseling is provided within the context of disease state management. Clement 2 commented in a review of diabetes self-management education issues that unless ongoing management is part of an education program, knowledge may increase but most clinical outcomes only minimally improve. Advanced practice nurses by the very nature of their scope of practice effectively combine both education and management into their delivery of care.

Operating beyond the role of educator, advanced practice nurses holistically assess patients’ needs with the understanding of patients’ primary role in the improvement and maintenance of their own health and wellness. In conducting assessments, advanced practice nurses carefully explore patients’ medical history and perform focused physical exams. At the completion of assessments, advanced practice nurses, in conjunction with patients, identify management goals and determine appropriate plans of care. A review of patients’ self-care management skills and application/adaptation to lifestyle is incorporated in initial histories, physical exams, and plans of care.

Many advanced practice nurses (NPs, CNSs, nurse midwives, and nurse anesthetists) may prescribe and adjust medication through prescriptive authority granted to them by their state nursing regulatory body. Currently, all 50 states have some form of prescriptive authority for advanced practice nurses. 3 The ability to prescribe and adjust medication is a valuable asset in caring for individuals with diabetes. It is a crucial component in the care of people with type 1 diabetes, and it becomes increasingly important in the care of patients with type 2 diabetes who have a constellation of comorbidities, all of which must be managed for successful disease outcomes.

Many studies have documented the effectiveness of advanced practice nurses in managing common primary care issues. 4 NP care has been associated with a high level of satisfaction among health services consumers. In diabetes, the role of advanced practice nurses has significantly contributed to improved outcomes in the management of type 2 diabetes, 5 in specialized diabetes foot care programs, 6 in the management of diabetes in pregnancy, 7 and in the care of pediatric type 1 diabetic patients and their parents. 8 , 9 Furthermore, NPs have also been effective providers of diabetes care among disadvantaged urban African-American patients. 10 Primary management of these patients by NPs led to improved metabolic control regardless of whether weight loss was achieved.

The following case study illustrates the clinical role of advanced practice nurses in the management of a patient with type 2 diabetes.

A.B. is a retired 69-year-old man with a 5-year history of type 2 diabetes. Although he was diagnosed in 1997, he had symptoms indicating hyperglycemia for 2 years before diagnosis. He had fasting blood glucose records indicating values of 118–127 mg/dl, which were described to him as indicative of “borderline diabetes.” He also remembered past episodes of nocturia associated with large pasta meals and Italian pastries. At the time of initial diagnosis, he was advised to lose weight (“at least 10 lb.”), but no further action was taken.

Referred by his family physician to the diabetes specialty clinic, A.B. presents with recent weight gain, suboptimal diabetes control, and foot pain. He has been trying to lose weight and increase his exercise for the past 6 months without success. He had been started on glyburide (Diabeta), 2.5 mg every morning, but had stopped taking it because of dizziness, often accompanied by sweating and a feeling of mild agitation, in the late afternoon.

A.B. also takes atorvastatin (Lipitor), 10 mg daily, for hypercholesterolemia (elevated LDL cholesterol, low HDL cholesterol, and elevated triglycerides). He has tolerated this medication and adheres to the daily schedule. During the past 6 months, he has also taken chromium picolinate, gymnema sylvestre, and a “pancreas elixir” in an attempt to improve his diabetes control. He stopped these supplements when he did not see any positive results.

He does not test his blood glucose levels at home and expresses doubt that this procedure would help him improve his diabetes control. “What would knowing the numbers do for me?,” he asks. “The doctor already knows the sugars are high.”

A.B. states that he has “never been sick a day in my life.” He recently sold his business and has become very active in a variety of volunteer organizations. He lives with his wife of 48 years and has two married children. Although both his mother and father had type 2 diabetes, A.B. has limited knowledge regarding diabetes self-care management and states that he does not understand why he has diabetes since he never eats sugar. In the past, his wife has encouraged him to treat his diabetes with herbal remedies and weight-loss supplements, and she frequently scans the Internet for the latest diabetes remedies.

During the past year, A.B. has gained 22 lb. Since retiring, he has been more physically active, playing golf once a week and gardening, but he has been unable to lose more than 2–3 lb. He has never seen a dietitian and has not been instructed in self-monitoring of blood glucose (SMBG).

A.B.’s diet history reveals excessive carbohydrate intake in the form of bread and pasta. His normal dinners consist of 2 cups of cooked pasta with homemade sauce and three to four slices of Italian bread. During the day, he often has “a slice or two” of bread with butter or olive oil. He also eats eight to ten pieces of fresh fruit per day at meals and as snacks. He prefers chicken and fish, but it is usually served with a tomato or cream sauce accompanied by pasta. His wife has offered to make him plain grilled meats, but he finds them “tasteless.” He drinks 8 oz. of red wine with dinner each evening. He stopped smoking more than 10 years ago, he reports, “when the cost of cigarettes topped a buck-fifty.”

The medical documents that A.B. brings to this appointment indicate that his hemoglobin A 1c (A1C) has never been <8%. His blood pressure has been measured at 150/70, 148/92, and 166/88 mmHg on separate occasions during the past year at the local senior center screening clinic. Although he was told that his blood pressure was “up a little,” he was not aware of the need to keep his blood pressure ≤130/80 mmHg for both cardiovascular and renal health. 11  

A.B. has never had a foot exam as part of his primary care exams, nor has he been instructed in preventive foot care. However, his medical records also indicate that he has had no surgeries or hospitalizations, his immunizations are up to date, and, in general, he has been remarkably healthy for many years.

Physical Exam

A physical examination reveals the following:

Weight: 178 lb; height: 5′2″; body mass index (BMI): 32.6 kg/m 2

Fasting capillary glucose: 166 mg/dl

Blood pressure: lying, right arm 154/96 mmHg; sitting, right arm 140/90 mmHg

Pulse: 88 bpm; respirations 20 per minute

Eyes: corrective lenses, pupils equal and reactive to light and accommodation, Fundi-clear, no arteriolovenous nicking, no retinopathy

Thyroid: nonpalpable

Lungs: clear to auscultation

Heart: Rate and rhythm regular, no murmurs or gallops

Vascular assessment: no carotid bruits; femoral, popliteal, and dorsalis pedis pulses 2+ bilaterally

Neurological assessment: diminished vibratory sense to the forefoot, absent ankle reflexes, monofilament (5.07 Semmes-Weinstein) felt only above the ankle

Lab Results

Results of laboratory tests (drawn 5 days before the office visit) are as follows:

Glucose (fasting): 178 mg/dl (normal range: 65–109 mg/dl)

Creatinine: 1.0 mg/dl (normal range: 0.5–1.4 mg/dl)

Blood urea nitrogen: 18 mg/dl (normal range: 7–30 mg/dl)

Sodium: 141 mg/dl (normal range: 135–146 mg/dl)

Potassium: 4.3 mg/dl (normal range: 3.5–5.3 mg/dl)

Lipid panel

    • Total cholesterol: 162 mg/dl (normal: <200 mg/dl)

    • HDL cholesterol: 43 mg/dl (normal: ≥40 mg/dl)

    • LDL cholesterol (calculated): 84 mg/dl (normal: <100 mg/dl)

    • Triglycerides: 177 mg/dl (normal: <150 mg/dl)

    • Cholesterol-to-HDL ratio: 3.8 (normal: <5.0)

AST: 14 IU/l (normal: 0–40 IU/l)

ALT: 19 IU/l (normal: 5–40 IU/l)

Alkaline phosphotase: 56 IU/l (normal: 35–125 IU/l)

A1C: 8.1% (normal: 4–6%)

Urine microalbumin: 45 mg (normal: <30 mg)

Based on A.B.’s medical history, records, physical exam, and lab results, he is assessed as follows:

Uncontrolled type 2 diabetes (A1C >7%)

Obesity (BMI 32.4 kg/m 2 )

Hyperlipidemia (controlled with atorvastatin)

Peripheral neuropathy (distal and symmetrical by exam)

Hypertension (by previous chart data and exam)

Elevated urine microalbumin level

Self-care management/lifestyle deficits

    • Limited exercise

    • High carbohydrate intake

    • No SMBG program

Poor understanding of diabetes

A.B. presented with uncontrolled type 2 diabetes and a complex set of comorbidities, all of which needed treatment. The first task of the NP who provided his care was to select the most pressing health care issues and prioritize his medical care to address them. Although A.B. stated that his need to lose weight was his chief reason for seeking diabetes specialty care, his elevated glucose levels and his hypertension also needed to be addressed at the initial visit.

The patient and his wife agreed that a referral to a dietitian was their first priority. A.B. acknowledged that he had little dietary information to help him achieve weight loss and that his current weight was unhealthy and “embarrassing.” He recognized that his glucose control was affected by large portions of bread and pasta and agreed to start improving dietary control by reducing his portion size by one-third during the week before his dietary consultation. Weight loss would also be an important first step in reducing his blood pressure.

The NP contacted the registered dietitian (RD) by telephone and referred the patient for a medical nutrition therapy assessment with a focus on weight loss and improved diabetes control. A.B.’s appointment was scheduled for the following week. The RD requested that during the intervening week, the patient keep a food journal recording his food intake at meals and snacks. She asked that the patient also try to estimate portion sizes.

Although his physical activity had increased since his retirement, it was fairly sporadic and weather-dependent. After further discussion, he realized that a week or more would often pass without any significant form of exercise and that most of his exercise was seasonal. Whatever weight he had lost during the summer was regained in the winter, when he was again quite sedentary.

A.B.’s wife suggested that the two of them could walk each morning after breakfast. She also felt that a treadmill at home would be the best solution for getting sufficient exercise in inclement weather. After a short discussion about the positive effect exercise can have on glucose control, the patient and his wife agreed to walk 15–20 minutes each day between 9:00 and 10:00 a.m.

A first-line medication for this patient had to be targeted to improving glucose control without contributing to weight gain. Thiazolidinediones (i.e., rosiglitizone [Avandia] or pioglitizone [Actos]) effectively address insulin resistance but have been associated with weight gain. 12 A sulfonylurea or meglitinide (i.e., repaglinide [Prandin]) can reduce postprandial elevations caused by increased carbohydrate intake, but they are also associated with some weight gain. 12 When glyburide was previously prescribed, the patient exhibited signs and symptoms of hypoglycemia (unconfirmed by SMBG). α-Glucosidase inhibitors (i.e., acarbose [Precose]) can help with postprandial hyperglycemia rise by blunting the effect of the entry of carbohydrate-related glucose into the system. However, acarbose requires slow titration, has multiple gastrointestinal (GI) side effects, and reduces A1C by only 0.5–0.9%. 13 Acarbose may be considered as a second-line therapy for A.B. but would not fully address his elevated A1C results. Metformin (Glucophage), which reduces hepatic glucose production and improves insulin resistance, is not associated with hypoglycemia and can lower A1C results by 1%. Although GI side effects can occur, they are usually self-limiting and can be further reduced by slow titration to dose efficacy. 14  

After reviewing these options and discussing the need for improved glycemic control, the NP prescribed metformin, 500 mg twice a day. Possible GI side effects and the need to avoid alcohol were of concern to A.B., but he agreed that medication was necessary and that metformin was his best option. The NP advised him to take the medication with food to reduce GI side effects.

The NP also discussed with the patient a titration schedule that increased the dosage to 1,000 mg twice a day over a 4-week period. She wrote out this plan, including a date and time for telephone contact and medication evaluation, and gave it to the patient.

During the visit, A.B. and his wife learned to use a glucose meter that features a simple two-step procedure. The patient agreed to use the meter twice a day, at breakfast and dinner, while the metformin dose was being titrated. He understood the need for glucose readings to guide the choice of medication and to evaluate the effects of his dietary changes, but he felt that it would not be “a forever thing.”

The NP reviewed glycemic goals with the patient and his wife and assisted them in deciding on initial short-term goals for weight loss, exercise, and medication. Glucose monitoring would serve as a guide and assist the patient in modifying his lifestyle.

A.B. drew the line at starting an antihypertensive medication—the angiotensin-converting enzyme (ACE) inhibitor enalapril (Vasotec), 5 mg daily. He stated that one new medication at a time was enough and that “too many medications would make a sick man out of me.” His perception of the state of his health as being represented by the number of medications prescribed for him gave the advanced practice nurse an important insight into the patient’s health belief system. The patient’s wife also believed that a “natural solution” was better than medication for treating blood pressure.

Although the use of an ACE inhibitor was indicated both by the level of hypertension and by the presence of microalbuminuria, the decision to wait until the next office visit to further evaluate the need for antihypertensive medication afforded the patient and his wife time to consider the importance of adding this pharmacotherapy. They were quite willing to read any materials that addressed the prevention of diabetes complications. However, both the patient and his wife voiced a strong desire to focus their energies on changes in food and physical activity. The NP expressed support for their decision. Because A.B. was obese, weight loss would be beneficial for many of his health issues.

Because he has a sedentary lifestyle, is >35 years old, has hypertension and peripheral neuropathy, and is being treated for hypercholestrolemia, the NP performed an electrocardiogram in the office and referred the patient for an exercise tolerance test. 11 In doing this, the NP acknowledged and respected the mutually set goals, but also provided appropriate pre-exercise screening for the patient’s protection and safety.

In her role as diabetes educator, the NP taught A.B. and his wife the importance of foot care, demonstrating to the patient his inability to feel the light touch of the monofilament. She explained that the loss of protective sensation from peripheral neuropathy means that he will need to be more vigilant in checking his feet for any skin lesions caused by poorly fitting footwear worn during exercise.

At the conclusion of the visit, the NP assured A.B. that she would share the plan of care they had developed with his primary care physician, collaborating with him and discussing the findings of any diagnostic tests and procedures. She would also work in partnership with the RD to reinforce medical nutrition therapies and improve his glucose control. In this way, the NP would facilitate the continuity of care and keep vital pathways of communication open.

Advanced practice nurses are ideally suited to play an integral role in the education and medical management of people with diabetes. 15 The combination of clinical skills and expertise in teaching and counseling enhances the delivery of care in a manner that is both cost-reducing and effective. Inherent in the role of advanced practice nurses is the understanding of shared responsibility for health care outcomes. This partnering of nurse with patient not only improves care but strengthens the patient’s role as self-manager.

Geralyn Spollett, MSN, C-ANP, CDE, is associate director and an adult nurse practitioner at the Yale Diabetes Center, Department of Endocrinology and Metabolism, at Yale University in New Haven, Conn. She is an associate editor of Diabetes Spectrum.

Note of disclosure: Ms. Spollett has received honoraria for speaking engagements from Novo Nordisk Pharmaceuticals, Inc., and Aventis and has been a paid consultant for Aventis. Both companies produce products and devices for the treatment of diabetes.

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