DreamTel; Diabetes risk evaluation and management tele-monitoring study protocol

<p>Abstract</p> <p>Background</p> <p>The rising prevalence of type 2 diabetes underlines the importance of secondary strategies for the prevention of target organ damage. While access to diabetes education centers and diabetes intensification management has been shown to improve blood glucose control, these services are not available to all that require them, particularly in rural and northern areas. The provision of these services through the Home Care team is an advance that can overcome these barriers. Transfer of blood glucose data electronically from the home to the health care provider may improve diabetes management.</p> <p>Methods and design</p> <p>The study population will consist of patients with type 2 diabetes with uncontrolled A1c levels living on reserve in the Battlefords region of Saskatchewan, Canada. This pilot study will take place over three phases. In the first phase over three months the impact of the introduction of the Bluetooth enabled glucose monitor will be assessed. In the second phase over three months, the development of guidelines based treatment algorithms for diabetes intensification will be completed. In the third phase lasting 18 months, study subjects will have diabetes intensification according to the algorithms developed.</p> <p>Discussion</p> <p>The first phase will determine if the use of the Bluetooth enabled blood glucose devices which can transmit results electronically will lead to changes in A1c levels. It will also determine the feasibility of recruiting subjects to use this technology. The rest of the Diabetes Risk Evaluation and Management Tele-monitoring (DreamTel) study will determine if the delivery of a diabetes intensification management program by the Home Care team supported by the Bluetooth enabled glucose meters leads to improvements in diabetes management.</p> <p>Trial Registration</p> <p>Protocol NCT00325624</p

Epoetin Alfa Resistance: Valuation of a Management Algorithm

ABSTRACT Background: Patients who require large doses of epoetin alfa to achieve and maintain a target hemoglobin of 110 to 120 g/L are usually considered epoetin alfa–resistant. The Kidney Disease Outcomes Quality Initiative guidelines suggest that epoetin alfa resistance be considered when subcutaneous epoetin alfa doses exceed 300 IU kg-1 week-1.Objective: The objective of this project was to develop and validate an algorithm to guide the identification and management of patients on chronic dialysis with suspected epoetin alfa resistance.Methods: The algorithm developed was used for 3 consecutive months to identify patients who did not respond to epoetin alfa; to identify the causes of nonresponse, including epoetin alfa resistance; and to guide the management of their cases. Patients were excluded from the final analysis if they did not complete the 3-month follow-up.Results: Of the 212 patients screened, the algorithm identified 21 who were resistant to epoetin alfa. Of the 16 evaluable patients, 11 achieved their target hemoglobin during the followup period. Mean hemoglobin concentrations improved from 92.8 ± 11.0 to 106.9 ± 14.7 g/L (p = 0.0009). The most common causes of epoetin alfa resistance were iron deficiency, chronic infection, inflammation, and dialysis inadequacy. Many patients had more than one cause of epoetin alfa resistance.Conclusion: The algorithm used in this project can be successfully used to identify epoetin alfa resistance and to manage epoetin alfa therapy for patients on hemodialysis.RÉSUMÉ Historique : Les patients qui ont besoin de fortes doses d’époétine alfa pour atteindre et maintenir des taux d’hémoglobine cibles de 110 à 120 g/L sont habituellement réputés être résistants à l’époétine alfa. Les lignes directrices de l’Initiative sur la qualité des résultats pour la maladie rénale (Kidney Disease Outcomes Quality Initiative) suggèrent d’envisager une résistance à l’époétine alfa lorsque les doses nécessaires d’époétine alfa sous-cutanée chez un patient dépassent 300 UI kg-1 semaine-1.Objectif : L’objectif de ce projet était d’élaborer et de valider un algorithme permettant de dépister et de prendre en charge les patients sous dialyse à répétition, chez qui l’on soupçonne une résistance à l’époétine alfa.Méthodes : L’algorithme mis au point a été utilisé pendant trois mois consécutifs pour dépister les patients qui n’ont pas répondu à l’administration d’époétine alfa, identifier les causes de l’absence de réponse, y compris la résistance à l’époétine alfa, et aiguiller la prise en charge de ces cas. Les patients étaient exclus de l’analyse finale s’ils n’achevaient pas la période de suivi de trois mois.Résultats : Parmi les 212 patients sélectionnés, l’algorithme a permis de dépister 21 patients résistants à l’époétine alfa. Des 16 patients évaluables, 11 ont atteint leur taux d’hémoglobine cible au cours de la période de suivi. Les concentrations moyennes d’hémoglobine ont augmenté, passant de 92,8 ± 11,0 à 106,9 ± 14,7 g/L (p = 0,0009). Les causes les plus fréquentes de résistance à l’époétine alfa étaient les suivantes : carence en fer, infection chronique, inflammation et dialyse insuffisante. Chez de nombreux patients, la résistance à l’époétine alfa était due à plus d’une cause.Conclusion : L’algorithme auquel on a eu recours dans le cadre de ce projet peut être utilisé avec succès pour dépister la résistance à l’époétine alfa et prendre en charge le traitement par l’époétine alfa chez les patients hémodialysés

The 2009 Canadian Hypertension Education Program recommendations for the management of hypertension: Part 2 – therapy

OBJECTIVE: To update the evidence-based recommendations for the prevention and management of hypertension in adults for 2009. OPTIONS AND OUTCOMES: For lifestyle and pharmacological interventions, evidence from randomized controlled trials and systematic reviews of trials was preferentially reviewed. Changes in cardiovascular morbidity and mortality were the primary outcomes of interest. However, for lifestyle interventions, blood pressure lowering was accepted as a primary outcome given the lack of long-term morbidity and mortality data in this field. Progression of kidney dysfunction was also accepted as a clinically relevant primary outcome among patients with chronic kidney disease. EVIDENCE: A Cochrane collaboration librarian conducted an independent MEDLINE search from 2007 to August 2008 to update the 2008 recommendations. To identify additional published studies, reference lists were reviewed and experts were contacted. All relevant articles were reviewed and appraised independently by both content and methodological experts using prespecified levels of evidence. RECOMMENDATIONS: For lifestyle modifications to prevent and treat hypertension, restrict dietary sodium to less than 2300 mg (100 mmol)/day (and 1500 mg to 2300 mg [65 mmol to 100 mmol]/day in hypertensive patients); perform 30 min to 60 min of aerobic exercise four to seven days per week; maintain a healthy body weight (body mass index 18.5 kg/m(2) to 24.9 kg/m(2)) and waist circumference (smaller than 102 cm for men and smaller than 88 cm for women); limit alcohol consumption to no more than 14 units per week in men or nine units per week in women; follow a diet that is reduced in saturated fat and cholesterol, and that emphasizes fruits, vegetables and low-fat dairy products, dietary and soluble fibre, whole grains and protein from plant sources; and consider stress management in selected individuals with hypertension. For the pharmacological management of hypertension, treatment thresholds and targets should be predicated on by the patient\u27s global atherosclerotic risk, target organ damage and comorbid conditions. Blood pressure should be decreased to lower than 140/90 mmHg in all patients, and to lower than 130/80 mmHg in those with diabetes mellitus or chronic kidney disease. Most patients will require more than one agent to achieve these target blood pressures. Antihypertensive therapy should be considered in all adult patients regardless of age (caution should be exercised in elderly patients who are frail). For adults without compelling indications for other agents, initial therapy should include thiazide diuretics. Other agents appropriate for first-line therapy for diastolic and/or systolic hypertension include angiotensin- converting enzyme (ACE) inhibitors (in patients who are not black), long-acting calcium channel blockers (CCBs), angiotensin receptor antagonists (ARBs) or beta-blockers (in those younger than 60 years of age). A combination of two first-line agents may also be considered as the initial treatment of hypertension if the systolic blood pressure is 20 mmHg above the target or if the diastolic blood pressure is 10 mmHg above the target. The combination of ACE inhibitors and ARBs should not be used. Other agents appropriate for first-line therapy for isolated systolic hypertension include long- acting dihydropyridine CCBs or ARBs. In patients with angina, recent myocardial infarction or heart failure, beta-blockers and ACE inhibitors are recommended as first-line therapy; in patients with cerebrovascular disease, an ACE inhibitor/diuretic combination is preferred; in patients with proteinuric nondiabetic chronic kidney disease, ACE inhibitors or ARBs (if intolerant to ACE inhibitors) are recommended; and in patients with diabetes mellitus, ACE inhibitors or ARBs (or, in patients without albuminuria, thiazides or dihydropyridine CCBs) are appropriate first-line therapies. All hypertensive patients with dyslipidemia should be treated using the thresholds, targets and agents outlined in the Canadian Cardiovascular Society position statement (recommendations for the diagnosis and treatment of dyslipidemia and prevention of cardiovascular disease). Selected high-risk patients with hypertension who do not achieve thresholds for statin therapy according to the position paper should nonetheless receive statin therapy. Once blood pressure is controlled, acetylsalicylic acid therapy should be considered. VALIDATION: All recommendations were graded according to strength of the evidence and voted on by the 57 members of the Canadian Hypertension Education Program Evidence-Based Recommendations Task Force. All recommendations reported here achieved at least 95% consensus. These guidelines will continue to be updated annually