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Wilding J.P.H.,University of Liverpool | Charpentier G.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | Hollander P.,Baylor University | Gonzalez-Galvez G.,Instituto Jalisciense Of Investigacion En Diabetes Y Obesidad | And 7 more authors.
International Journal of Clinical Practice | Year: 2013

Aims: Canagliflozin is a sodium glucose co-transporter 2 inhibitor developed for the treatment of type 2 diabetes mellitus (T2DM). This randomised, double-blind, placebo-controlled, Phase 3 study evaluated the efficacy and safety of canagliflozin as an add-on to metformin plus sulphonylurea in patients with T2DM. Methods: Patients (N = 469) received canagliflozin 100 or 300 mg or placebo once daily during a 26-week core period and a 26-week extension. Prespecified primary end-point was change in HbA1c at 26 weeks. Secondary end-points included change in HbA1c at week 52 as well as proportion of patients achieving HbA1c < 7.0%, change in fasting plasma glucose (FPG) and systolic blood pressure, and per cent change in body weight, high-density lipoprotein cholesterol, and triglycerides (weeks 26 and 52). Results: HbA1c was significantly reduced with canagliflozin 100 and 300 mg vs. placebo at week 26 (-0.85%, -1.06%, and -0.13%; p < 0.001); these reductions were maintained at week 52 (-0.74%, -0.96%, and 0.01%). Both canagliflozin doses reduced FPG and body weight vs. placebo at week 26 (p < 0.001) and week 52. Overall adverse event (AE) rates were similar across groups over 52 weeks, with higher rates of genital mycotic infections and osmotic diuresis-related AEs seen with canagliflozin vs. placebo; these led to few discontinuations. Increased incidence of documented, but not severe, hypoglycaemia episodes was seen with canagliflozin vs. placebo. Conclusions: Canagliflozin improved glycaemic control, reduced body weight, and was generally well tolerated in T2DM patients on metformin plus sulphonylurea over 52 weeks. © 2013 The Authors International Journal of Clinical Practice Published by John Wiley & Sons Ltd. Source


Franc S.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | Daoudi A.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | Mounier S.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | Boucherie B.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | And 7 more authors.
Diabetes and Metabolism | Year: 2011

The Health Authorities have huge expectations of telemedicine (TM): improved patient access to healthcare, a solution to the shortage of doctors in the face of an exponentially expanding disease, and reduced healthcare costs with improved quality. There are a host of applications for TM in the area of diabetes. TM has been validated and has been widely used to screen for diabetic retinopathy, and a number of studies are currently underway for the follow-up of diabetic foot ulcers. However, the main indication of TM remains the follow-up and control of blood glucose. In this area, many studies have been conducted to improve glycaemic control. While most of these studies have failed to show any benefits vs. conventional care, a small number have demonstrated great efficacy of this approach with regard to glycaemia. Using these studies, we attempt to define the key qualities of a successful TM system. How can we extend the results of these experiments beyond the framework of clinical studies and integrate them in daily practice so as to improve diabetes management? This is the key challenge for TM, implementation of which will require reorganization of healthcare, given the evolution of medical demographics. This reorganization will involve healthcare providers specialized in diabetes that may intervene in assigning physicians for especially distressed patients. However, such reorganization will require medico-economic evaluation before it can be implemented on a larger scale. © 2011 Elsevier Masson SAS. Source


Franc S.,Sud Francilien Hospital | Franc S.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | Dardari D.,Sud Francilien Hospital | Dardari D.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | And 13 more authors.
Diabetes Care | Year: 2010

OBJECTIVE- We investigated the relationship between carbohydrate intake and postprandial blood glucose (BG) levels to determine the most influential meal for type 2 diabetic subjects treated with basal insulin and needing prandial insulin. RESEARCH DESIGN AND METHODS- Three-day BG profiles for 37 type 2 diabetic subjects, with A1C levels of 7.7%, treated with sulfonylurea and metformin, and well titrated on insulin glargine, were analyzed using a continuous glucose monitoring system. Food intake from 680 meals was recorded and quantified during continuous glucose monitoring. RESULTS- The median BG excursion (ΔBG) was higher at breakfast than at lunch or dinner (111 [81; 160] vs. 69.5 [41.5; 106] and 82.5 mg/dl [53; 119] mg/dl, P < 0.0001). There was a weak overall correlation between ΔBG and carbohydrate intake. Correlation improved when mealtime was taken into account. Simple relationships were established: ΔBG (mg/dl) = 65 X carbohydrate/body weight + 73 for breakfast (R2 = 0.20, P < 0.0001); the slope was reduced by half at lunch and by one-third at dinner. Twelve relevant variables likely to affect ΔBG were integrated into a polynomial equation. This model accounted for 49% of ΔBG variability. Two groups of patients were identified: responders, in whom ΔBG was well correlated with carbohydrate intake (R2 ≥ 0.30, n = 8), and nonresponders (R2 < 0.30, n = 29). Responders exhibited a greater insulinopenic profile than nonresponders. CONCLUSIONS- The carbohydrate intake in responders clearly drives ΔBG, whereas, in nonresponders, other factors predominate. This sort of characterization should be used to guide therapeutic choices toward more targeted care with improved type 2 diabetes management. © 2010 by the American Diabetes Association. Source


Franc S.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | Daoudi A.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | Mounier S.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | Boucherie B.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | And 6 more authors.
Diabetes and Metabolism | Year: 2011

Health authorities currently have high expectations for telemedicine (TM), as it addresses several major challenges: to improve access to healthcare (especially for patients in underserved or remote areas); to overcome the scarcity of specialists faced with epidemic disease; and to reduce the costs of healthcare while improving quality. The aims of TM in the field of diabetes differ according to the type of diabetes. In type 1 diabetes (T1DM) associated with complex insulin regimens, the goal of TM is to help patients achieve better control of their blood glucose levels through accurate adjustment of insulin doses. In type 2 diabetes (T2DM), while therapeutic adjustments may be necessary, improvement in blood glucose control is based primarily on behavioural changes (reduced calorie and carbohydrate intakes, increased physical activity). Many TM studies focusing on management of blood glucose levels have been published, but most failed to demonstrate any superiority of TM vs traditional care. While previously published meta-analyses have shown a slight advantage at best for TM, these meta-analyses included a mix of studies of varying durations and different populations (both T1DM and T2DM patients, adults and children), and tested systems of inconsistent quality. Studies published to date on TM suggest two currently promising approaches. First, handheld communicating devices, such as smartphones, loaded with software to apply physicians' prescriptions, have been shown to improve glycaemic control. These systems provide immediate assistance to the patient (such as insulin-dose calculation and food choice optimization at meals), and all data stored in the smartphone can be transmitted to authorized caregivers, enabling remote monitoring and even teleconsultation. These systems, initially developed for T1DM, appear to offer many possibilities for T2DM, too. Second, systems combining an interactive Internet system (or a mobile phone coupled to a remote server) with a system of communication between the healthcare provider and the patient by e-mail, texting or phone calls have also shown certain benefits for glycaemic control. These systems, primarily aimed at T2DM patients, generally provide motivational support as well. Although the individual benefits of these systems for glycaemic control are fewer than with smartphones, their widespread use should be of particular value for overcoming the relative shortage of doctors and reducing the health costs associated with a disease of such epidemic proportions. © 2011 Elsevier Masson SAS. Source


Franc S.,Sud Francilien Hospital Center | Franc S.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | Dardari D.,Center Detudes Et Of Recherche Pour Lintensification Du Traitement Du Diabete Ceritd | Biedzinski M.,Sud Francilien Hospital Center | And 6 more authors.
Diabetes and Metabolism | Year: 2012

Aim: For patients with type 1 diabetes (T1D) using multiple insulin injections (MII), there are currently no guidelines for insulin dose adjustments in the event of physical activity (PA) and no simple algorithms that can be applied directly. Thus, the objective of this study was to assess the relevance of simple algorithms based on assessments of PA intensity by T1D patients themselves. Methods: This 4-month observational study was conducted in 35 patients using the Diabeo software system. Algorithms for insulin dose adjustments aimed to reduce the insulin dose of the meal closest to PA by 30 and 50% for moderate and intense PA, respectively. A 50% reduction plus extra carbohydrates was proposed for intense PA of long duration. These algorithms were entered into the Diabeo system. Results: The mean blood glucose (BG) profile in the event of PA (n=151 triple BG values) was compared with that when no PA was performed (n=3606). The initial mean FBG values were similar in both groups (7.58 ± 2.70. mmol/L vs. 7.80 ± 3.49. mmol/L; P=0.36), whereas there was a slight, but significant, increase in 2-hours postprandial BG (PPBG) values related to PA, with a return to similar values before the next meal. The incidence of mild hypoglycaemia was similar, whether PA was undertaken or not, for the 2-hour PPBG and the next fasting/premeal glucose values. Conclusion: This appears to be a pragmatic and efficient method for T1D patients using MII to adjust insulin doses in the event of PA that only requires an assessment of PA intensity by the patients themselves to anticipate the magnitude of the reduction in insulin doses. © 2012. Source

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