The differential impact of a 6-versus 12-month pharmacist-led interprofessional medication adherence program on medication adherence in patients with diabetic kidney disease: the randomized PANDIA-IRIS study.

Background: For every 100 patients with diabetes, 40 will develop diabetic kidney disease (DKD) over time. This diabetes complication may be partly due to poor adherence to their prescribed medications. In this study, we aimed to evaluate the differential impact of a 6- versus 12-month pharmacist-led interprofessional medication adherence program (IMAP) on the components of adherence (i.e., implementation and discontinuation) in patients with DKD, during and after the intervention. Methods: All included patients benefited from the IMAP, which consists in face-to-face regular motivational interviews between the patient and the pharmacist based on the adherence feedback from electronic monitors (EMs), in which the prescribed treatments were delivered. Adherence reports were available to prescribers during the intervention period. Patients were randomized 1:1 into two parallel arms: a 12-month IMAP intervention in group A versus a 6-month intervention in group B. Adherence was monitored continuously for 24 months post-inclusion during the consecutive intervention and follow-up phases. In the follow-up phase post-intervention, EM data were blinded. Blood pressure was measured by the pharmacist at each visit. The repeated measures of daily patient medication intake outcomes (1/0) to antidiabetics, antihypertensive drugs, and statins were modeled longitudinally using the generalized estimated equation in both groups and in both the intervention and the follow-up phases. Results: EM data of 72 patients were analyzed (34 in group A and 38 in group B). Patient implementation to antidiabetics and antihypertensive drugs increased during the IMAP intervention phase and decreased progressively during the follow-up period. At 12 months, implementation to antidiabetics was statistically higher in group A versus group B (93.8% versus 86.8%; Δ 7.0%, 95% CI: 5.7%; 8.3%); implementation to antihypertensive drugs was also higher in group A versus B (97.9% versus 92.1%; Δ 5.8%, 95% CI: 4.8%; 6.7%). At 24 months, implementation to antidiabetics and antihypertensive drugs remained higher in group A versus B (for antidiabetics: 88.6% versus 85.6%; Δ 3.0%, 95% CI: 1.7%; 4.4% and for antihypertensive drugs: 94.4% versus 85.9%; Δ 8.5%, 95% CI: 6.6%; 10.7%). No difference in pharmacy-based blood pressure was observed between groups. Implementation to statins was comparable at each time point between groups. Three patients discontinued at least one treatment; they were all in group B. In total, 46% (16/35) of patients in the 12-month intervention versus 37% (14/38) of patients in the 6-month intervention left the study during the intervention phase, mainly due to personal reasons. Conclusion: The IMAP improves adherence to chronic medications in patients with DKD. The longer the patients benefit from the intervention, the more the implementation increases over time, and the more the effect lasts after the end of the intervention. These data suggest that a 12-month rather than a 6-month program should be provided as a standard of care to support medication adherence in this population. The impact on clinical outcomes needs to be demonstrated. Clinical Trial Registration: Clinicaltrials.gov, identifier NCT04190251_PANDIA IRIS.

Blood pressure and vascular determinants of glomerular filtration rate decline in diabetic kidney disease.

Objective: In patients with type 2 diabetes and diabetic kidney disease (DKD), explore the relationship between estimated glomerular filtration rate decline (eGFR-d) and simultaneously assessed vascular risk markers including office, ambulatory or central blood pressure, pulse pressure, carotid-femoral pulse wave velocity (PWV), carotid intima-media thickness (IMT) and renal resistive indexes (RRI). Research design and methods: At baseline, vascular risk markers were measured in addition to the routine clinical workup. The eGFR-d was based on 2000-2019 creatinine values. Parameters were compared by eGFR-d quartiles. Regression models of eGFR-d and vascular markers were assessed. Results: In total, 135 patients were included. Mean age was 63.8 ± 10.8y, baseline eGFR 60.2 ± 26.4 ml/min/1.73 m2 and urine albumin-creatinine ratio (ACR) 49 ± 108 mg/mmol. Mean eGFR-d was based on 43 ± 39 creatinine values within a time span of 7.0 ± 1.9y. The average yearly eGFR decline was -1.8 ± 3.0 ml/min/1.73 m2 ranging from -5.8 ± 2.3 in the first quartile to +1.4 ± 1.7 in the fourth quartile. Mean 24 h systolic (SBP) and diastolic (DBP) blood pressure were 126 ± 17 and 74 ± 9 mmHg. Mean PWV was 11.8 ± 2.8 m/s, RRI 0.76 ± 0.07 and IMT 0.77 ± 0.21 mm. SBP and pulse pressure correlated with eGFR-d but not DBP. 24 h SBP stood out as a stronger predictor of eGFR-d than office or central SBP. PWV and RRI correlated with eGFR decline in univariate, but not multivariate regression models including 24 SBP and ACR. Conclusions: In this study, eGFR decline was highly variable in patients with type 2 diabetes and DKD. Twenty-four hour SBP provided an added value to the routine measurement of ACR in predicting eGFR decline, whereas PWV and RRI did not.

Translation of the Diabetes Knowledge Questionnaire into French and its validation / Traduction et validation en langue française de l'instrument « Diabetes Knowledge Questionnaire ¼

Introduction: Improving patients' knowledge of diabetes would support adherence to treatment, prevent complications, and promote shared decision-making. Healthcare professionals need to assess patients' knowledge using a validated questionnaire in the local language. Objective: The aim of the study was to translate the Diabetes Knowledge Questionnaire from English to French and assess the psychometric properties of the translated version. Methods: A cross-sectional method was used. Individuals with diabetes were recruited from diabetes clinics, as well as dialysis units, since approximately 30 percent of dialysis patients have diabetes. Participants with type 1 or type 2 diabetes completed the translated questionnaire. The questionnaire targeted both groups, with additional questions for those with type 1 diabetes. Reliability and validity were assessed according to COSMIN approach. Results: Analysis of the translated questionnaire (n=102) showed good internal consistency (α=0.77), similar to the original questionnaire. The removal of an item on the self-monitoring of blood glucose increased the α Cronbach coefficient by 0.03. Discussion: Despite its validation, the questionnaire should be updated according to new clinical and medical recommendations to ensure consistency between the desired knowledge and the intended goals of care. Conclusion: The French version of the Diabetes Knowledge Questionnaire demonstrated good validity and reliability. It can be used in practice and research, after deleting item 9.

Introduction: L'amélioration des connaissances des patients sur le diabète pourrait soutenir leur adhésion au traitement, prévenir les complications et favoriser la prise de décision partagée. Les professionnels de la santé ont besoin d'évaluer les connaissances des patients à l'aide d'un questionnaire validé dans la langue locale. Objectif: L'étude avait pour but de traduire le Diabetes Knowledge Questionnaire en français et d'évaluer les qualités psychométriques de la version traduite. Méthodes: Dans cette étude transversale, les personnes diabétiques ont été recrutées dans les services de diabétologie, ainsi que dans les services de dialyse, car environ 30 % des patients dialysés sont diabétiques. Les participants diabétiques de type 1 ou 2 ont répondu au questionnaire traduit, le questionnaire s'adressant aux deux populations, avec des questions supplémentaires pour les diabétiques de type 1. La fidélité et la validité ont été évaluées selon la démarche COSMIN. Résultats: L'analyse du questionnaire traduit (n = 102) a montré une bonne cohérence interne (α = 0,77), similaire au questionnaire d'origine. La suppression d'un item portant sur les autocontrôles de glycémie a augmenté le coefficient α Cronbach de 0,03. Discussion: Malgré sa validation, le questionnaire mériterait une mise à jour selon les nouvelles pratiques et recommandations médicales, pour garantir une cohérence entre les connaissances souhaitées et les objectifs de soins visés. Conclusion: La version française du Diabetes Knowledge Questionnaire a démontré une bonne validité et fidélité, et peut être utilisée dans la pratique et la recherche, après la suppression de l'item n° 9.

Interprofessional Medication Adherence Program for Patients With Diabetic Kidney Disease: Protocol for a Randomized Controlled and Qualitative Study (PANDIA-IRIS).

BACKGROUND: Despite effective treatments, more than 30% of patients with diabetes will present with diabetic kidney disease (DKD) at some point. Patients with DKD are among the most complex as their care is multifactorial and involves different groups of health care providers. Suboptimal adherence to polypharmacy is frequent and contributes to poor outcomes. As self-management is one of the keys to clinical success, structured medication adherence programs are crucial. The PANDIA-IRIS (patients diabétiques et insuffisants rénaux: un programme interdisciplinaire de soutien à l'adhésion thérapeutique) study is based on a routine medication adherence program led by pharmacists. OBJECTIVE: The aim of this study is to define the impact of the duration of this medication adherence program on long-term adherence and clinical outcomes in patients with DKD. METHODS: This monocentric adherence program consists of short, repeated motivational interviews focused on patients' medication behaviors combined with the use of electronic monitors containing patients' medications. When patients open the electronic monitor cap to take their medication, the date and hour at each opening are registered. In total, 73 patients are randomized as 1:1 in 2 parallel groups; the adherence program will last 6 months in the first group versus 12 months in the second group. After the intervention phases, patients continue using their electronic monitors for a total of 24 months but without receiving feedback. Electronic monitors and pill counts are used to assess medication adherence. Persistence and implementation will be described using Kaplan-Meier curves and generalized estimating equation multimodeling, respectively. Longitudinal adherence will be presented as the product of persistence and implementation and modelized by generalized estimating equation multimodeling. The evolution of the ADVANCE (Action in Diabetes and Vascular disease: Preterax and Diamicron Modified-Release Controlled Evaluation) and UKPDS (United Kingdom Prospective Diabetes Study) clinical scores based on medication adherence will be analyzed with generalized estimating equation multimodeling. Patients' satisfaction with this study will be assessed through qualitative interviews, which will be transcribed verbatim, coded, and analyzed for the main themes. RESULTS: This study was approved by the local ethics committee (Vaud, Switzerland) in November 2015. Since then, 2 amendments to the protocol have been approved in June 2017 and October 2019. Patients' recruitment began in April 2016 and ended in October 2020. This study was introduced to all consecutive eligible patients (n=275). Among them, 73 accepted to participate (26.5%) and 202 (73.5%) refused. Data collection is ongoing and data analysis is planned for 2022. CONCLUSIONS: The PANDIA-IRIS study will provide crucial information about the impact of the medication adherence program on the adherence and clinical outcomes of patients with DKD. Monitoring medication adherence during the postintervention phase is innovative and will shed light on the duration of the intervention on medication adherence. TRIAL REGISTRATION: Clinicaltrials.gov NCT04190251_PANDIA IRIS; https://clinicaltrials.gov/ct2/show/NCT04190251. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/25966.

[Challenges in managing diabetes in chronic hemodialysis]. / Défis dans la prise en charge du diabète en hémodialyse chronique.

Hemodialysis (HD) centers are facing an increasing number of patients with diabetes. These cases require an intensive multidisciplinary approach of the consequences of renal failure, glycemic control and nutrition and the management of frequent co-morbidities, in particular the diabetic foot. A major challenge is to decrease glycemic variability and the risk of hypoglycemia. Because of increased risk of hypoglycemia-associated mortality, the HbA1C target is loosened in the majority of HD patients. Continuous glucose monitoring technology has identified important glycemic fluctuations during and after dialysis. However, their reliability in HD needs to be improved. New therapeutic pathways that decrease glucose excursions and hypoglycemia, such as GLP1 receptor agonists and sensor-coupled insulin pumps, have yet to be validated in HD.

Les centres d'hémodialyse (HD) sont confrontés à un nombre croissant de patients diabétiques. Leur prise en charge multidisciplinaire tient compte de l'insuffisance rénale, du contrôle glycémique, de la nutrition et des comorbidités fréquentes, en particulier le pied diabétique. La réduction de la variabilité glycémique et des hypoglycémies qui sont associées à une mortalité accrue reste un défi. La cible de l'HbA1C est assouplie chez la majorité des patients. L'usage du contrôle en continu de la glycémie permet d'identifier les fluctuations glycémiques per et interdialytiques importantes. Sa fiabilité doit cependant être améliorée en HD. Les nouvelles voies thérapeutiques qui diminuent les excursions glycémiques et le risque d'hypoglycémie comme les GLP1 agonistes et les pompes à insuline couplées aux sensors restent à valider en HD.

Changing trends in end-stage renal disease patients with diabetes.

BACKGROUND: Worldwide, diabetes has become the most common cause of end-stage renal disease (ESRD), yet Swiss data are largely lacking. METHODS: This observational study examined ESRD patients with diabetes mellitus (ESRD-DM) at end of 2009 and 2014. The prevalence and characteristics of ESRD-DM patients were collected in all dialysis facilities in the Canton of Vaud of Switzerland in 2009 and in 2014, and the 5-year mortality rate was assessed. RESULTS: A total of 107 and 140 ESRD-DM patients underwent dialysis at end of 2009 and 2014, respectively. Within the 5-year period a total of 167 incidental ESRD-DM patients required dialysis, corresponding to an estimated incidental rate of 0.84/1000 person-years in the diabetic population. In 2009, all patients with ESRD-DM underwent haemodialysis, decreasing to 96.2% in 2014, with 3.8% on peritoneal dialysis. Age, sex, body mass index, type of diabetes, duration of diabetes, cause of ESRD, dialysis duration, dialysis frequency, vascular access, and glycosylated haemoglobin levels did not differ between 2009 and 2014. In 2014, macrovascular comorbidity was reported more often than in 2009, but not amputations. Haemoglobin level decreased significantly from 117.9 g/l to 112.3 g/l. Calcium-containing phosphate binder and angiotensin-converting enzyme inhibitor use significantly decreased, whereas iron therapy significantly increased with time. The 5-year mortality rate was 61.7%. Five-year survivors were significantly younger and had a higher body mass index. CONCLUSIONS: The growing prevalence of ESRD-DM emphasises that prevention of chronic kidney disease and its progression should be a public health priority in Switzerland.