Home About us Contact
|
Home About us Contact | ||
|
|
||
Baseline HbA1c (baseline + hba1c)
Selected AbstractsEvaluation of glargine group-start sessions in patients with type 2 diabetes as a strategy to deliver the serviceINTERNATIONAL JOURNAL OF CLINICAL PRACTICE, Issue 2 2007A. A. Tahrani Summary Improving glycaemic control in patients with type 2 diabetes reduces microvascular complications. The national service framework for diabetes and the new general medical service contract have been aiming to direct more focus on improving HbA1c. These measures have resulted in increasing number of patients being initiated on insulin therapy, which increases the workload of diabetes specialist nurses (DSNs). Initiating insulin on a one-to-one basis is time consuming. As a result DSN-led insulin group-start sessions were introduced. To evaluate DSN-led glargine group-start and self-titration as a strategy of providing service. We assessed the impact of this method on the use of DSNs time, HbA1c and on patients' satisfaction. A prospective audit in a district general hospital. Groups of 5,7 patients received two 2-h sessions at weeks 0 and 2. During these sessions, patients were initiated on insulin glargine and received an educational package and a self-titration protocol. DSNs did not see patients after week 2. Patients were able to phone the DSNs for advice till the end of the titration period. Patients completed Diabetes Treatment Satisfaction Questionnaire (DTSQ) at baseline, week 2 and 12 months. Weight and HbA1c were assessed at base line and 12 months later. Twenty-nine consecutive patients were included. Baseline HbA1c improved at 6 months and remained stable at 12 months (medians 10.0, 8.7 and 8.9 respectively, p < 0.001). DTSQ score improved between week 0 and 2 and this was maintained at 12 months (medians 26, 35 and 34 respectively, p < 0.001). After week 2, the DSNs spent a median of 21 min advising patients by phone during the titration period. Weight did not increase significantly. In our centre, DSN-led insulin group-start sessions and self-titration improved glycaemic control. Patients were satisfied with this method of starting insulin. This was achieved with minimal DSNs time and input and proved to be effective, yet less time consuming. [source] Vildagliptin plus metformin combination therapy provides superior glycaemic control to individual monotherapy in treatment-naive patients with type 2 diabetes mellitusDIABETES OBESITY & METABOLISM, Issue 5 2009E. Bosi Aim:, To compare the efficacy and safety of vildagliptin and metformin initial combination therapy with individual monotherapies in treatment-naive patients with type 2 diabetes mellitus (T2DM). Methods:, This was a 24-week, randomized, double-blind, active-controlled study. Treatment-naive patients with T2DM who had a glycated haemoglobin (HbA1c) of 7.5,11% (N = 1179) were randomized equally to receive vildagliptin plus high-dose metformin combination therapy (50 mg + 1000 mg twice daily), vildagliptin plus low-dose metformin combination therapy (50 mg + 500 mg twice daily), vildagliptin monotherapy (50 mg twice daily) or high-dose metformin monotherapy (1000 mg twice daily). The primary objective was to demonstrate that HbA1c reduction from baseline with either combination therapy is superior to both monotherapies at the week 24 endpoint. Patients who failed glycaemic-screening criteria [HbA1c >11% or fasting plasma glucose (FPG) >15 mmol/l (270 mg/dl)] could enter a 24-week, single-arm substudy. These patients (N = 94) received open-label vildagliptin plus high-dose metformin combination therapy (100 mg + 1000 mg twice daily). Results:, From comparable baseline values (8.6,8.7%), HbA1c decreased in all four treatment groups, to the greatest extent with vildagliptin plus high-dose metformin combination therapy. Mean (SE) HbA1c change from baseline was ,1.8% (0.06%), ,1.6% (0.06%), ,1.1% (0.06%) and ,1.4% (0.06%) with vildagliptin plus high-dose metformin combination therapy, vildagliptin plus low-dose metformin combination therapy, and vildagliptin and metformin monotherapies respectively. The between-group difference was superior with vildagliptin plus high-dose metformin combination therapy (p < 0.001 vs. both monotherapies) and vildagliptin plus low-dose metformin combination therapy (p < 0.001 and p = 0.004, vs. vildagliptin and metformin monotherapies, respectively). Higher baseline HbA1c values were linked to greater HbA1c reductions, with changes of ,3.2% (0.22%), ,2.7% (0.22%), ,1.5% (0.24%) and ,2.6% (0.26%) respectively, occurring in patients with baseline HbA1c,10%. Reductions in FPG were superior with vildagliptin plus high-dose metformin combination therapy [change from baseline ,2.63 (0.13) mmol/l] compared with both monotherapies [,1.26 (0.13) mmol/l and ,1.92 (0.13) mmol/l, respectively; p < 0.001]. There was no incidence of hypoglycaemia or severe hypoglycaemia with either combination therapy, and neither was associated with weight gain. All treatments were well tolerated and displayed a comparable incidence of adverse events overall. Despite superior HbA1c lowering, the vildagliptin plus low-dose metformin combination therapy group demonstrated a favourable gastrointestinal (GI) tolerability profile compared with metformin monotherapy. Conclusions:, In treatment-naive patients, combinations of vildagliptin and both high-dose and low-dose metformin provide superior efficacy to monotherapy treatments with a comparable overall tolerability profile and low risk of hypoglycaemia. The potential dose-sparing effect of adding vildagliptin to low-dose metformin in preference to the up-titration of metformin may allow patients to achieve equivalent or superior HbA1c lowering without the GI tolerability issues associated with higher doses of metformin. [source] Fifty-two-week efficacy and safety of vildagliptin vs. glimepiride in patients with type 2 diabetes mellitus inadequately controlled on metformin monotherapyDIABETES OBESITY & METABOLISM, Issue 2 2009E. Ferrannini Aim:, To examine the efficacy and safety of vildagliptin vs. glimepiride as add-on therapy to metformin in patients with type 2 diabetes mellitus in a 52-week interim analysis of a large, randomized, double-blind, multicentre study. The primary objective was to demonstrate non-inferiority of vildagliptin vs. glimepiride in glycosylated haemoglobin (HbA1c) reduction at week 52. Methods:, Patients inadequately controlled on metformin monotherapy (HbA1c 6.5,8.5%) and receiving a stable dose of metformin (mean dose 1898 mg/day; mean duration of use 36 months) were randomized 1:1 to receive vildagliptin (50 mg twice daily, n = 1396) or glimepiride (titrated up to 6 mg/day; mean dose 4.5 mg/day, n = 1393). Results:, Non-inferiority of vildagliptin was demonstrated (97.5% confidence interval 0.02%, 0.16%) with a mean (SE) change from baseline HbA1c (7.3% in both groups) to week 52 endpoint of ,0.44% (0.02%) with vildagliptin and ,0.53% (0.02%) with glimepiride. Although a similar proportion of patients reached a target HbA1c level of <7% with vildagliptin and glimepiride (54.1 and 55.5%, respectively), a greater proportion of patients reached this target without hypoglycaemia in the vildagliptin group (50.9 vs. 44.3%; p < 0.01). Fasting plasma glucose (FPG) reductions were comparable between groups (mean [SE] ,1.01 [0.06] mmol/l and ,1.14 [0.06] mmol/l respectively). Vildagliptin significantly reduced body weight relative to glimepiride (mean [SE] change from baseline ,0.23 [0.11] kg; between-group difference ,1.79 kg; p < 0.001) and resulted in a 10-fold lower incidence of hypoglycaemia than glimepiride (1.7 vs. 16.2% of patients presenting at least one hypoglycaemic event; 39 vs. 554 hypoglycaemic events, p < 0.01). No severe hypoglycaemia occurred with vildagliptin compared with 10 episodes with glimepiride (p < 0.01), and no patient in the vildagliptin group discontinued because of hypoglycaemia compared with 11 patients in the glimepiride group. The incidence of adverse events (AEs), serious AEs and adjudicated cardiovascular events was 74.5, 7.1 and 0.9%, respectively, in patients receiving vildagliptin, and 81.1, 9.5 and 1.6%, respectively, in patients receiving glimepiride. Conclusions:, When metformin alone fails to maintain sufficient glycaemic control, the addition of vildagliptin provides comparable efficacy to that of glimepiride after 52 weeks and displays a favourable AE profile, with no weight gain and a significant reduction in hypoglycaemia compared with glimepiride. [source] Insulin therapy in type 2 diabetes patients failing oral agents: cost-effectiveness of biphasic insulin aspart 70/30 vs. insulin glargine in the US,DIABETES OBESITY & METABOLISM, Issue 1 2007J. A. Ray Objectives:, To project the long-term clinical and economic outcomes of treatment with biphasic insulin aspart 30 (BIAsp 70/30, 30% soluble and 70% protaminated insulin aspart) vs. insulin glargine in insulin-naïve type 2 diabetes patients failing to achieve glycemic control with oral antidiabetic agents alone (OADs). Methods:, Baseline patient characteristics and treatment effect data from the recent ,INITIATE' clinical trial served as input to a peer-reviewed, validated Markov/Monte-Carlo simulation model. INITIATE demonstrated improvements in HbA1c favouring BIAsp 70/30 vs. glargine (,0.43%; p < 0.005) and greater efficacy in reaching glycaemic targets among patients poorly controlled on OAD therapy. Effects on life expectancy (LE), quality-adjusted life expectancy (QALE), cumulative incidence of diabetes-related complications and direct medical costs (2004 USD) were projected over 35 years. Clinical outcomes and costs were discounted at a rate of 3.0% per annum. Sensitivity analyses were performed. Results:, Improvements in glycaemic control were projected to lead to gains in LE (0.19 ± 0.24 years) and QALE (0.19 ± 0.17 years) favouring BIAsp 70/30 vs. glargine. Treatment with BIAsp 70/30 was also associated with reductions in the cumulative incidences of diabetes-related complications, notably in renal and retinal conditions. The incremental cost-effectiveness ratio was $46 533 per quality-adjusted life year gained with BIAsp 70/30 vs. glargine (for patients with baseline HbA1c , 8.5%, it was $34 916). Total lifetime costs were compared to efficacy rates in both arms as a ratio, which revealed that the lifetime cost per patient treated successfully to target HbA1c levels of <7.0% and , 6.5% were $80 523 and $93 242 lower with BIAsp 70/30 than with glargine, respectively. Conclusions:, Long-term treatment with BIAsp 70/30 was projected to be cost-effective for patients with type 2 diabetes insufficiently controlled on OADs alone compared to glargine. Treatment with BIAsp 70/30 was estimated to represent an appropriate investment of healthcare dollars in the management of type 2 diabetes. [source] Flexible, intensive insulin therapy and dietary freedom in adolescents and young adults with Type 1 diabetes: a prospective implementation studyDIABETIC MEDICINE, Issue 5 2008A. Sämann Abstract Aims To assess the outcome of a Diabetes Treatment and Teaching Programme (DTTP) on glycated haemoglobin (HbA1c), severe hypoglycaemia (SH) and severe ketoacidosis (SKA) in adolescents and young adults with Type 1 diabetes. Methods Quality-assurance project with assessment of participants 1 year after participation in a DTTP (5-day inpatient course, groups , 10 patients, fixed curriculum of education/training, introduction of dietary freedom). Before,after analyses of participants aged 12,15, 15,18, 18,21 and 21,24 years. Main outcome measures were HbA1c, SH and SKA. Results For the 1592 participants, aged 12 to 24 years, mean age at enrolment was 19 ± 3 years, mean duration of diabetes was 7.3 ± 5.4 (range 0.3,24) years, mean baseline HbA1c declined from 8.8 ± 2.3% to 8.1 ± 2.0%. The incidence of SH was 0.31 vs. 0.11 events/patient/year; the incidence of SKA 0.17 vs. 0.07 events/patient/year. In mixed effects models taking into account effects of centres, age and diabetes duration, the mean difference was ,0.64%[P < 0.001, 95% confidence interval (CI) ,0.79 to ,0.5] for HbA1c, ,0.2 events/patient/year (P < 0.0001, 95% CI ,0.28 to ,0.12) for SH and ,0.1 events/patient/year (P < 0.0001, 95% CI ,0.14 to ,0.06) for SKA. Conclusions Adolescents and young adults with Type 1 diabetes benefit from participation in a standard DTTP for flexible, intensive insulin therapy and dietary freedom. [source] Improved glycaemic control with insulin glargine plus insulin lispro: a multicentre, randomized, cross-over trial in people with Type 1 diabetesDIABETIC MEDICINE, Issue 3 2006S. G. Ashwell Abstract Aims To compare blood glucose control using insulin glargine + insulin lispro with that on NPH insulin + unmodified human insulin in adults with Type 1 diabetes managed with a multiple injection regimen. Methods In this 32-week, five-centre, two-way cross-over study, people with Type 1 diabetes (n = 56, baseline HbA1c 8.0 ± 0.8%) were randomized to evening insulin glargine + mealtime insulin lispro or to NPH insulin (once- or twice-daily) + mealtime unmodified human insulin. Each 16-week period concluded with a 24-h inpatient plasma glucose profile. Results HbA1c was lower with glargine + lispro than with NPH + human insulin [7.5 vs. 8.0%, difference ,0.5 (95% CI ,0.7, ,0.3) %, P < 0.001]. This was confirmed by an 8% lower 24-h plasma glucose area under the curve (AUC) (187 vs. 203 mmol l,1 h,1, P = 0.037), a 24% reduction in plasma glucose AUC > 7.0 mmol/l1 (47 vs. 62 mmol l,1 h,1, P = 0.017) and a 15% lower post-prandial plasma glucose AUC (75 vs. 88 mmol l,1 h,1, P = 0.002). There was no reduction in night-time plasma glucose AUC or increase in plasma glucose area < 3.5 mmol/l. Monthly rate of nocturnal hypoglycaemia was reduced by 44% with glargine + lispro (0.66 vs. 1.18 episodes/month, P < 0.001). Conclusions Compared with NPH insulin + unmodified human insulin, the combination of insulin glargine with a rapid-acting insulin analogue as multiple-injection therapy for Type 1 diabetes improves overall glycaemic control as assessed by HbA1c and 24-h plasma glucose monitoring to a clinically significant degree, together with a reduction in nocturnal hypoglycaemia. [source] Evaluation of a holistic treatment and teaching programme for patients with Type 1 diabetes who failed to achieve their therapeutic goals under intensified insulin therapyDIABETIC MEDICINE, Issue 9 2000U. Bott SUMMARY Aims To evaluate a treatment and teaching programme including psychosocial modules for patients with Type 1 diabetes mellitus on intensified insulin therapy who failed to achieve their treatment goals despite participation in standard programmes. Methods The 5-day inpatient programme comprises small groups of 4,6 patients, focusing on individual needs and problems. Beyond the teaching lessons (most topics are deliberately chosen by the patients), the programme provides intensive group discussions and offers individual counselling concerning motivational aspects, psychosocial problems and coping strategies. Of the first consecutive 83 participants, 76 were re-examined after 17.5 ± 5.5 months (range 9,31 months). Results At follow-up, HbA1c was not improved compared to baseline (8.0 ± 1.3% vs. 8.1 ± 1.5%). However, the incidence of severe hypoglycaemia per patient/year (glucose i.v., glucagon injection) was substantially decreased: 0.62 ± 1.5 episodes at baseline compared to 0.16 ± 0.9 at follow-up (P < 0.001). Twenty-six per cent of the patients at baseline, and 4% at re-examination had experienced at least one episode of severe hypoglycaemia during the preceding year (P < 0.001). Sick leave days per patient/year decreased from 17.0 ± 38.5,7.7 ± 13.6 days (P < 0.05). Patients improved their perceptions of self-efficacy, their relationship to doctors and felt less externally controlled (P < 0.001). The majority of patients perceived an improved competence regarding diet (80.6%) and adaptation of insulin dosage (82.4%), an improved knowledge (82.2%), and a renewed motivation for the treatment (84.5%). Treatment success was significantly associated with baseline HbA1c, stability of motivation, frequency of blood glucose self-monitoring, control beliefs and change in subsequent outpatient care. Conclusions The programme improved glycaemic control mainly as a result of a substantial reduction in the incidence of severe hypoglycaemia. Patients with persistent poor glycaemic control may benefit from structured follow-up care focusing on motivational aspects of self-management and psychosocial support. [source] | ||||||||||