Mean Difference In HbA1c Research Articles

English

AIM: An Observational study Comparing sitagliptin to metformin as an initial monotherapy in type 2 diabetes mellitus patients. METHOD: In this observational study we have selected 100 patients which divided into two groups; first group was on sitagliptin and second group was on metformin. The criterion for inclusion in the study was 1) Age group of 18 - 78 years 2) HbA1c of 6.5 - 9.0%. Group A was started on sitagliptin 50 to 100 mg. Group B patients were started on Metformin, dosage of 500 mg once a day and the dose was increased to a of maximum of 2000 mg; and this study was done for 12 weeks. RESULTS AND STATISTICAL ANALYSIS: Group A comprises 50 patients whose baseline FBS, PPBS, HbA1C was determined, Group B comprises 50 patients whose baseline FBS, PPBS, HbA1C was determined. The results of HbA1c obtained before and after the sitagliptin and metformin therapy was analyzed using SPSS V 20 software using paired t test and chi square analysis. It was observed that the mean baseline hba1c in the group A patients was 7.8 % and in group B was 7.95% whereas the mean HbA1c after 12 weeks of therapy was 7.44% and 7.73% respectively in the Group A and B. There was a significant decrease in Hba1c in both groups with t (49) value Group A (7.89, p <0.001) Group B (3.48, p 0.001). There was a significantly positive correlation (p<0.001) in two groups, A (r = 0.903) having higher positive correlation than group B (r= 0.748), whereas the mean difference in Hba1c was higher for group A (0.36) compared to group B (0, 21) suggesting a greater decrease in Hba1c with sitagliptin compared to metformin, as the mean difference was significant the effect size (d) was calculated it was observed that the effect size for group A was (d= 1.16) larger than group B (d= 0.49). Occurrence of Various symptoms such as nausea, headache and diarrhoea were seen in two groups and it was observed that nausea was greater in group A (16%) compared to B (8%), the increase was observed to b non-significant at p = 0.35, headache was greater in group B (10%) compared to A (5%), the increase was observed to b non-significant at p = 1.0, Diarrhoea was greater in group B (18%) compared to A (2%), the increase was observed to b significant at p = 0.016 with a likelihood ratio of 8.0. CONCLUSION: In this 12 week study sitagliptin was not inferior compared to metformin in controlling the Hba1C in patients with type 2 diabetes mellitus. Both the group; patients well tolerated and the incidence of gastro- intestinal adverse effects were lower in the patients on sitagliptin.

Computer-based diabetes self-management interventions for adults with type 2 diabetes mellitus.

Diabetes is one of the commonest chronic medical conditions, affecting around 347 million adults worldwide. Structured patient education programmes reduce the risk of diabetes-related complications four-fold. Internet-based self-management programmes have been shown to be effective for a number of long-term conditions, but it is unclear what are the essential or effective components of such programmes. If computer-based self-management interventions improve outcomes in type 2 diabetes, they could potentially provide a cost-effective option for reducing the burdens placed on patients and healthcare systems by this long-term condition. To assess the effects on health status and health-related quality of life of computer-based diabetes self-management interventions for adults with type 2 diabetes mellitus. We searched six electronic bibliographic databases for published articles and conference proceedings and three online databases for theses (all up to November 2011). Reference lists of relevant reports and reviews were also screened. Randomised controlled trials of computer-based self-management interventions for adults with type 2 diabetes, i.e. computer-based software applications that respond to user input and aim to generate tailored content to improve one or more self-management domains through feedback, tailored advice, reinforcement and rewards, patient decision support, goal setting or reminders. Two review authors independently screened the abstracts and extracted data. A taxonomy for behaviour change techniques was used to describe the active ingredients of the intervention. We identified 16 randomised controlled trials with 3578 participants that fitted our inclusion criteria. These studies included a wide spectrum of interventions covering clinic-based brief interventions, Internet-based interventions that could be used from home and mobile phone-based interventions. The mean age of participants was between 46 to 67 years old and mean time since diagnosis was 6 to 13 years. The duration of the interventions varied between 1 to 12 months. There were three reported deaths out of 3578 participants.Computer-based diabetes self-management interventions currently have limited effectiveness. They appear to have small benefits on glycaemic control (pooled effect on glycosylated haemoglobin A1c (HbA1c): -2.3 mmol/mol or -0.2% (95% confidence interval (CI) -0.4 to -0.1; P = 0.009; 2637 participants; 11 trials). The effect size on HbA1c was larger in the mobile phone subgroup (subgroup analysis: mean difference in HbA1c -5.5 mmol/mol or -0.5% (95% CI -0.7 to -0.3); P < 0.00001; 280 participants; three trials). Current interventions do not show adequate evidence for improving depression, health-related quality of life or weight. Four (out of 10) interventions showed beneficial effects on lipid profile.One participant withdrew because of anxiety but there were no other documented adverse effects. Two studies provided limited cost-effectiveness data - with one study suggesting costs per patient of less than $140 (in 1997) or 105 EURO and another study showed no change in health behaviour and resource utilisation. Computer-based diabetes self-management interventions to manage type 2 diabetes appear to have a small beneficial effect on blood glucose control and the effect was larger in the mobile phone subgroup. There is no evidence to show benefits in other biological outcomes or any cognitive, behavioural or emotional outcomes.

Efficacy and safety of traditional chinese medicine for diabetes: a double-blind, randomised, controlled trial.

BackgroundTreatment of diabetes mellitus with Traditional Chinese Medicine has a long history. The aim of this study is to establish the safety and efficacy of traditional Chinese medicine combined with glibenclamide to treat type 2 diabetes mellitus.MethodsIn a controlled, double blind, multicentre non-inferiority trial, 800 patients with unsatisfactory glycemic control (fasting glucose 7–13 mmol/L and HbA1c 7–11%) were randomly assigned to receive Xiaoke Pill, a compound of Chinese herbs combined with glibenclamide, or Glibenclamide in two study groups – drug naive group, and patients previously treated with metformin monotherapy (metformin group). Outcome measures at 48 weeks were the incidence and rate of hypoglycemia, mean difference in HbA1c, and proportion of patients with HbA1c<6.5%.FindingsIn drug naïve group, the total hypoglycemia rate and the mild hypoglycemic episode in the Xiaoke Pill arm were 38% (p = 0.024) and 41% (p = 0.002) less compared to Glibenclamide arm; in Metformin group, the average annual rate of hypoglycemia was 62% lower in Xiaoke Pill arm (p = 0.003). Respective mean changes in HbA1c from baseline were −0.70% and −0.66% for Xiaoke Pill and Glibenclamide, with a between-group difference (95% CI) of −0.04% (−0.20, 0.12) in the drug naïve group, and those in metformin group were −0.45% and −0.59%, 0.14% (−0.12, 0.39) respectively. The respective proportions of patients with a HbA1c level <6.5% were 26.6% and 23.4% in the drug naïve group and 20.1% and 18.9% in the metformin group.InterpretationIn patients with type 2 diabetes and inadequate glycaemic control, treatment with Xiaoke Pill led to significant reduction in risk of hypoglycemia and similar improvements in glycemic control after 48 weeks compared to Glibenclamide.Trial RegistrationChinese Clinical Trial Register number, ChiCTR-TRC-08000074

Hemoglobin A1c May Be an Inadequate Diagnostic Tool for Diabetes Mellitus in Anemic Subjects

BackgroundRecently, a hemoglobin A1c (HbA1c) level of 6.5% has been determined to be a criterion for diabetes mellitus (DM), and it is a widely used marker for the diagnosis of DM. However, HbA1c may be influenced by a number of factors. Anemia is one of the most prevalent diseases with an influence on HbA1c; however, its effect on HbA1c varies based on the variable pathophysiology of anemia. The aim of this study was to determine the effect of anemia on HbA1c levels.MethodsAnemic subjects (n=112) and age- and sex-matched controls (n=217) who were drug naive and suspected of having DM were enrolled. The subjects underwent an oral glucose tolerance test and HbA1c simultaneously. We compared mean HbA1c and its sensitivity and specificity for diagnosing DM between each subgroup.ResultsClinical characteristics were found to be similar between each subgroup. Also, when glucose levels were within the normal range, the difference in mean HbA1c was not significant (P=0.580). However, when plasma glucose levels were above the diagnostic cutoff for prediabetes and DM, the mean HbA1c of the anemic subgroup was modestly higher than in the nonanemic group. The specificity of HbA1c for diagnosis of DM was significantly lower in the anemic subgroup (P<0.05).ConclusionThese results suggest that the diagnostic significance of HbA1c might be limited in anemic patients.

Psychological and pharmacological interventions for depression in patients with diabetes mellitus and depression

Depression occurs frequently in patients with diabetes mellitus and is associated with a poor prognosis. To determine the effects of psychological and pharmacological interventions for depression in patients with diabetes and depression. Electronic databases were searched for records to December 2011. We searched CENTRAL in The Cochrane Library, MEDLINE, EMBASE, PsycINFO, ISRCTN Register and clinicaltrials.gov. We examined reference lists of included RCTs and contacted authors. We included randomised controlled trials (RCTs) investigating psychological and pharmacological interventions for depression in adults with diabetes and depression. Primary outcomes were depression and glycaemic control. Secondary outcomes were adherence to diabetic treatment regimens, diabetes complications, death from any cause, healthcare costs and health-related quality of life (HRQoL). Two review authors independently examined the identified publications for inclusion and extracted data from included studies. Random-effects model meta-analyses were performed to compute overall estimates of treatment outcomes. The database search identified 3963 references. Nineteen trials with 1592 participants were included. Psychological intervention studies (eight trials, 1122 participants, duration of therapy three weeks to 12 months, follow-up after treatment zero to six months) showed beneficial effects on short (i.e. end of treatment), medium (i.e. one to six months after treatment) and long-term (i.e. more than six months after treatment) depression severity (range of standardised mean differences (SMD) -1.47 to -0.14; eight trials). However, between-study heterogeneity was substantial and meta-analyses were not conducted. Short-term depression remission rates (OR 2.88; 95% confidence intervals (CI) 1.58 to 5.25; P = 0.0006; 647 participants; four trials) and medium-term depression remission rates (OR 2.49; 95% CI 1.44 to 4.32; P = 0.001; 296 participants; two trials) were increased in psychological interventions compared to usual care. Evidence regarding glycaemic control in psychological intervention trials was heterogeneous and inconclusive. QoL did not improve significantly based on the results of three psychological intervention trials compared to usual care. Healthcare costs and adherence to diabetes and depression medication were examined in only one study and reliable conclusions cannot be drawn. Diabetes complications and death from any cause have not been investigated in the included psychological intervention trials.With regards to the comparison of pharmacological interventions versus placebo (eight trials; 377 participants; duration of intervention three weeks to six months, no follow-up after treatment) there was a moderate beneficial effect of antidepressant medication on short-term depression severity (all studies: SMD -0.61; 95% CI -0.94 to -0.27; P = 0.0004; 306 participants; seven trials; selective serotonin reuptake inhibitors (SSRI): SMD -0.39; 95% CI -0.64 to -0.13; P = 0.003; 241 participants; five trials). Short-term depression remission was increased in antidepressant trials (OR 2.50; 95% CI 1.21 to 5.15; P = 0.01; 136 participants; three trials). Glycaemic control improved in the short term (mean difference (MD) for glycosylated haemoglobin A1c (HbA1c) -0.4%; 95% CI -0.6 to -0.1; P = 0.002; 238 participants; five trials). HRQoL and adherence were investigated in only one trial each showing no statistically significant differences. Medium- and long-term depression and glycaemic control outcomes as well as healthcare costs, diabetes complications and mortality have not been examined in pharmacological intervention trials. The comparison of pharmacological interventions versus other pharmacological interventions (three trials, 93 participants, duration of intervention 12 weeks, no follow-up after treatment) did not result in significant differences between the examined pharmacological agents, except for a significantly ameliorated glycaemic control in fluoxetine-treated patients (MD for HbA1c -1.0%; 95% CI -1.9 to -0.2; 40 participants) compared to citalopram in one trial. Psychological and pharmacological interventions have a moderate and clinically significant effect on depression outcomes in diabetes patients. Glycaemic control improved moderately in pharmacological trials, while the evidence is inconclusive for psychological interventions. Adherence to diabetic treatment regimens, diabetes complications, death from any cause, health economics and QoL have not been investigated sufficiently. Overall, the evidence is sparse and inconclusive due to several low-quality trials with substantial risk of bias and the heterogeneity of examined populations and interventions.

A network meta‐analysis to compare glycaemic control in patients with type 2 diabetes treated with exenatide once weekly or liraglutide once daily in comparison with insulin glargine, exenatide twice daily or placebo

The glucagon-like peptide-1 receptor agonists (GLP-1 RAs) exenatide once weekly (ExQW) and liraglutide once daily (QD) are indicated to improve glycaemic control in patients with type 2 diabetes. Although glycaemic control with ExQW versus liraglutide QD 1.8 mg has been directly compared, no studies have compared ExQW with liraglutide QD 1.2 mg or determined the probable relative efficacies of various injectable therapies for glycaemic control; therefore, a network meta-analysis was performed to address these questions. A systematic review identified randomized controlled trials of ≥24 weeks that compared ExQW, liraglutide QD (1.2 mg, 1.8 mg), insulin glargine, exenatide twice daily (ExBID), or placebo. Twenty-two studies evaluating 11 049 patients were included in the network meta-analysis. Mean differences in HbA1c relative to placebo or each other and probability rankings were estimated. Estimated mean differences in HbA1c versus placebo were -1.15% (95% CrI: -1.31 to -1.00) for ExQW, -1.01% (95% CrI: -1.18 to -0.85) for liraglutide 1.2 mg, and -1.18% (95% CrI: -1.32 to -1.04) for liraglutide 1.8 mg. HbA1c differences for ExQW versus liraglutide 1.2 mg and 1.8 mg were -0.14% (95% CrI: -0.34 to 0.06) and 0.03% (95% CrI: -0.14 to 0.18), respectively. The estimated mean difference in HbA1c between liraglutide 1.2 mg and 1.8 mg was 0.17% (95% CrI: 0.02-0.30). Results were consistent when adjusted for background antihyperglycaemic medications and diabetes duration. This network meta-analysis did not identify meaningful differences in HbA1c lowering between ExQW and both liraglutide doses, suggesting that these GLP-1 RAs have similar glycaemic effects.

Linagliptin: A Novel Methylxanthin Based Approved Dipeptidyl Peptidase-4 Inhibitor

Chemically, methylxanthine nucleus based Linagliptin (BI-1356, BI-1356-BS) is a dipeptidyl peptidase-IV inhibitor, which has been developed by Boehringer Ingelheim in association with Lilly for the treatment of Type-II Diabetes. Linagliptin was marketed by Lilly under the trade name Tradjenta and Trajenta. Linagliptin was approved as the once-daily dose by USFDA on 2 May 2011, for the treatment of Type-II Diabetes. Linagliptin 5mg once daily dose was approved based on a clinical trial program, which was conducted on approximately 4,000 adults with Type-II Diabetes. Linagliptin demonstrated statistically significant mean difference in HbA1c from placebo of up to 0.72 percent, when it was used monotherapically. In patients, who were not adequately controlled on metformin or metformin plus sulphonylurea, the addition of Linagliptin resulted in a statistically significant mean difference in HbA1c from placebo of -0.6 percent. Linagliptin was observed to produce significant reduction in fasting plasma glucose (FPG) compared to placebo, when used as a monotherapy in combination with metformin, sulfonylurea and/or pioglitazone. Linagliptin demonstrated significant reduction post-prandial glucose (PPG) levels in two hours as compared with placebo in monotherapy as well as in combination with metformin. In vitro assays also anticipated that Linagliptin is a potent DPPIV inhibitor as well as it exhibits good selectivity for DPP-IV as compared with other DPPs. The in-vivo studies also demonstrated same anticipation with respect to Linagliptin. Consequently, increasing the GLP-1 levels so far improved glucose tolerance in both healthy animals. X-ray crystallography anticipates that Linagliptin complexes with human DPPIV enzyme, e.g. butynyl substituent occupies the S1 hydrophobic pocket of the enzyme; the aminopiperidine substituent in the xanthine scaffold occupies the S2 subsite and its primary amine interacts with the key amino acid residues, which involves in the recognition of peptide substrates. In the present review, we have tried to cover comparative study of DPPIV inhibitors, chemistry, physical properties, commercial synthesis, patent portfolio, crystalline polymorphic forms of Linagliptin and its receptor interaction, Pharmacophore rational, mechanism, clinical studies, preclinical, adverse effect, available formulations, dose regimen, co-therapy of Linagliptin, giving emphasis on the medicinal chemistry aspects.

Using Health Information Technology to Prevent and Treat Diabetes

Using Health Information Technology to Prevent and Treat Diabetes

New insulins and insulin therapy

New insulins and insulin therapy

Glycaemic control in type 1 diabetes during real time continuous glucose monitoring compared with self monitoring of blood glucose: meta-analysis of randomised controlled trials using individual patient data

Objective To determine the clinical effectiveness of real time continuous glucose monitoring compared with self monitoring of blood glucose in type 1 diabetes.Design Meta-analysis of randomised controlled trials.Data sources Cochrane...

Glucagon-like peptide-1 analog liraglutide in combination with sulfonylurea safely improves blood glucose measures vs sulfonylurea monotherapy in Japanese patients with type 2 diabetes: Results of a 52-week, randomized, multicenter trial.

Aims/Introduction: Sulfonylurea (SU) agents are the most effective drugs at lowering blood glucose when used alone. However, their effectiveness declines after a certain period. The addition of liraglutide to existing SU therapy might reverse some of the known drawbacks of SU. This multicenter, randomized, 52-week study assessed the long-term efficacy and safety of adding liraglutide at 0.6 or 0.9 mg/day to existing SU therapy in Japanese patients with inadequately controlled type 2 diabetes. In total, 264 patients were enrolled and received treatment. At week 52, HbA1c in the liraglutide 0.6 mg, liraglutide 0.9 mg and placebo groups was reduced from 9.00 to 7.91%, from 8.61 to 7.33%, and from 8.85 to 8.79%, respectively. The mean difference of HbA1c (95% CI) in the liraglutide 0.6 and 0.9 mg groups vs the placebo group was 0.96 (-1.25 to -0.67) and -1.33 (-1.62 to -1.04), respectively. For the liraglutide 0.6 mg, 0.9 mg and placebo groups, the Japanese Diabetes Society target HbA1c of <6.9% was achieved by 15.1, 39.1 and 4.5% of patients, respectively. Mean fasting plasma glucose at week 52 was lower in the liraglutide groups compared with the placebo group, and mean bodyweight remained unchanged in the liraglutide groups. Most subjects in all three treatment groups reported mild adverse events. No major hypoglycemic episode was reported. Once-daily administration of liraglutide in combination with SU for 52 weeks provided favorable metabolic control, a safety profile and did not alter bodyweight. This trial was registered with ClinicalTrial.gov (no. NCT00395746). (J Diabetes Invest,doi: 10.1111/j.2040-1124.2011.00103.x, 2011).

The effect of sitagliptin therapy in suboptimally controlled metformin-treated type 2 diabetes patients: A Middle Eastern experience

Because of the high cost of sitagliptin and its unknown long term effects, a retrospective study to evaluate its effectiveness was undertaken at our Abu Dhabi Medical Center after one year of treatment. Glycemic control and changes in body weight were analyzed in 53 UAE national patients (26 men, 27 women) with type 2 diabetes mellitus managed with a combination of sitagliptin and metformin. Sitagliptin 100mg once daily was added after inadequate glycemic control (HbA1c > 7%) on Metformin alone or with a Thiazolidinedione for > 3 months. Mean patient age 52 years; mean diabetes duration 8 years; mean HbA1c 8.2% at treatment start. Mean HbA1c difference between before and post treatment was 0.56% (95% CI 0.24% - 0.87%). This did not change with multivariable analysis of weight, body mass index and duration of diabetes. Weight reduction was not statistically significant. Side effects were minimal. The addition of sitagliptin in our patients who failed to achieve glycemic control with insulin sensitizers resulted in a minimal drop in HbA1c with neutral effect on weight reduction, similar to that reported in recent literature. Therefore to justify its high cost, sitagliptin should be used to its maximum potential.

Weak Evidence Suggests Scaling and Root Planing May Help People With Diabetes Improve Glycemic Control

Systematic review conclusion. Periodontal treatment may improve glycemic control in adults with poorly controlled diabetes, although the research basis for this statement is not robust.Critical summary assessment. This systematic review followed a clear protocol for locating and assessing all pertinent studies. The studies were of variable quality, with only one randomized controlled trial considered to be of high quality. The review does not provide a confident basis for determining whether scaling and root planing can improve glycemic control in people with diabetes.Evidence quality rating. Limited. Systematic review conclusion. Periodontal treatment may improve glycemic control in adults with poorly controlled diabetes, although the research basis for this statement is not robust. Critical summary assessment. This systematic review followed a clear protocol for locating and assessing all pertinent studies. The studies were of variable quality, with only one randomized controlled trial considered to be of high quality. The review does not provide a confident basis for determining whether scaling and root planing can improve glycemic control in people with diabetes. Evidence quality rating. Limited. Do adults with diabetes who receive periodontal therapy experience improved glycemic control compared with similar patients who do not receive periodontal treatment? The authors of this systematic review conducted a search of seven databases with no language restrictions and publication dates from January 1976 to December 2007; they also included unpublished research. They followed a clear protocol, with two independent reviewers identifying studies and extracting data. The authors considered studies for inclusion if they were original interventional investigations and involved human subjects for whom glycosylated hemoglobin (HbA1c) levels were reported. The authors reported the results of the systematic review and meta-analysis. They followed the Quality of Reporting of Meta-analyses (QUOROM) recommendations.1Moher D Cook DJ Eastwood S Olkin I Rennie D Stroup DF Improving the quality of reports of meta-analyses of randomised controlled trials: the QUOROM statement.Lancet. 1999; 354: 1896-1900Abstract Full Text Full Text PDF PubMed Scopus (3943) Google Scholar The authors of the systematic review included 25 studies with a total of 976 participants. Of these 25 studies, only nine were randomized controlled trials. These nine trials had sample sizes ranging from 22 to 165 participants, and investigators used varied treatment modalities. Overall, the meta-analysis demonstrated a moderate, statistically significant result favoring the therapeutic group (standardized mean difference in HbA1c, 0.46; 95 percent confidence interval [CI], 0.11–0.82; P = .01). This result may be interpreted as a small but statistically significant improvement in glycemic control (0.79 percent; 95 percent CI, 0.19–1.40). The best information available suggests that scaling and root planing can improve glycemic control. However, caution is advised, because despite the general trend of these results, the studies have shortcomings that may influence the findings.

Prevention of cardiovascular disease through glycemic control in type 2 diabetes: A meta-analysis of randomized clinical trials

Background and aims Randomized clinical trials (RCTs) aimed at the assessment of the efficacy of lowering blood glucose in the prevention of diabetic complications have always failed to detect a significant effect on cardiovascular events. Aim of this meta-analysis is the assessment of the effects of improvement of glycemic control on the incidence of cardiovascular diseases in patients with type 2 diabetes. Methods The RCTs were included in this meta-analysis if: a) the between-group difference in mean HbA1c during the trial was at least 0.5%, b) they had a planned duration of treatment of at least 3 years, c) if they had a cardiovascular endpoint. Data for analysis were extracted independently by two observers and potential contrasts were resolved by a senior investigator. Results Five studies (17,267 and 15,362 patients in the intensive and conventional therapy groups, respectively) were included. Intensive treatment, which reduced mean HbA1c by 0.9% on average, was associated with a significant reduction of incident cardiovascular events and myocardial infarction (OR 0.89 [0.83–0.95] and 0.86 [0.78–0.93], respectively), but not of stroke or cardiovascular mortality (OR 0.93 [0.81–1.07] and 0.98 [0.77–1.23], respectively). In meta-regression analysis, a higher BMI duration of diabetes, and incidence of severe hypoglycaemia were associated with greater risk for cardiovascular death in intensive treatment groups. Conclusion Intensified hypoglycaemic treatment in type 2 diabetic patients leads to a significant reduction of the incidence of myocardial infarction, while it does not affect the incidence of stroke and cardiovascular mortality. Hypoglycemia induced by intensified treatment could be associated with increased cardiovascular mortality.

Efficacy of periodontal treatment on glycaemic control in diabetic patients: A meta-analysis of interventional studies

Aim There is growing evidence that periodontal disease may favour the incidence or aggravation of diabetes and its complications. To investigate the issue, we conducted a meta-analysis of the effect of periodontal therapy on glycaemic control in diabetic patients. Methods A literature search was carried out using seven databases (Medline, EMBASE, LILACS, The Cochrane Library, Pascal, IADR Abstracts and Current Contents), with no language restrictions. We followed the QUOROM-recommended standards for improving the quality of reporting meta-analyses of interventional studies. Results Twenty-five studies, involving 976 subjects altogether, were included in the present systematic review. Of these, nine studies, involving a total of 485 patients, were controlled trials and were included in the meta-analysis. The standardized mean difference in HbA 1c with the treatment of periodontal disease was 0.46 (95% CI: 0.11, 0.82). These findings suggest that periodontal treatment could lead to a significant 0.79% (95% CI: 0.19, 1.40) reduction in HbA 1c level. Conclusion The present meta-analysis represents the best information available to date that addresses this issue, and suggests that periodontal treatment could improve glycaemic control. Nevertheless, these results need to be viewed with caution because of a lack of robustness, and deficiencies in the design of some of the studies included. A randomized controlled trial with sufficient statistical power would help to confirm the results of this meta-analysis.

A pragmatic cluster randomised controlled trial of a Diabetes REcall And Management system: the DREAM trial

BackgroundFollowing the introduction of a computerised diabetes register in part of the northeast of England, care initially improved but then plateaued. We therefore enhanced the existing diabetes register to address these problems. The aim of the trial was to evaluate the effectiveness and efficiency of an area wide 'extended,' computerised diabetes register incorporating a full structured recall and management system, including individualised patient management prompts to primary care clinicians based on locally-adapted, evidence-based guidelines.MethodsThe study design was a pragmatic, cluster randomised controlled trial, with the general practice as the unit of randomisation. Set in 58 general practices in three Primary Care Trusts in the northeast of England, the study outcomes were the clinical process and outcome variables held on the diabetes register, patient-reported outcomes, and service and patient costs. The effect of the intervention was estimated using generalised linear models with an appropriate error structure. To allow for the clustering of patients within practices, population averaged models were estimated using generalized estimating equations.ResultsPatients in intervention practices were more likely to have at least one diabetes appointment recorded (OR 2.00, 95% CI 1.02, 3.91), to have a recording of a foot check (OR 1.87, 95% CI 1.09, 3.21), have a recording of receiving dietary advice (OR 2.77, 95% CI 1.22, 6.29), and have a recording of blood pressure (BP) (OR 2.14, 95% CI 1.06, 4.36). There was no difference in mean HbA1c or BP levels, but the mean cholesterol level in patients from intervention practices was significantly lower (-0.15 mmol/l, 95% CI -0.25, -0.06). There were no differences in patient-reported outcomes or in patient-reported use of drugs, or uptake of health services. The average cost per patient was not significantly different between the intervention and control groups. Costs incurred in administering the system at the register and in general practice were in addition to these.ConclusionThis study has shown benefits from an area-wide, computerised diabetes register incorporating a full structured recall and individualised patient management system. However, these benefits were achieved at a cost. In future, these costs may fall as electronic data exchange becomes a reliable reality. Trial registration: International Standard Randomised Controlled Trial Number (ISRCTN) Register, ISRCTN32042030.

Efficacy and safety of preprandial human insulin inhalation powder versus injectable insulin in patients with type 1 diabetes

The efficacy and safety of human insulin inhalation powder (HIIP) plus insulin glargine were compared to subcutaneously injected insulin (SC insulin) plus insulin glargine in patients with type 1 diabetes. This was a randomised, open-label crossover study in which one group of patients received preprandial HIIP plus insulin glargine for 12 weeks, followed by the same duration with preprandial SC insulin (lispro or regular) plus insulin glargine. Another group of patients received the reverse treatment sequence. The trial was designed as a non-inferiority comparison of the two treatments for effect on HbA(1c); blood glucose levels were also monitored. Safety assessments included adverse event reporting and hypoglycaemic events. HbA(1c) at endpoint was 7.95+/-0.12% for the HIIP treatment and 8.06+/-0.12% for the SC insulin treatment; mean changes from baseline to endpoint were -0.08 and 0.00%, respectively, (p=NS). The upper limit of the 95% CI of mean difference in HbA(1c) between the two treatments was 0.02%, indicating that HIIP was not inferior relative to SC insulin, as measured against the pre-defined margin of 0.3%. Fasting blood glucose was significantly lower for HIIP treatment (8.09+/-0.33 mmol/l; n=117) than for SC insulin treatment (9.05+/-0.33 mmol/l; n=111) (p=0.01). Safety profiles were comparable between the two treatments. The rate of any hypoglycaemia (least-squares mean adjusted for 30 days+/-SE) was 8.9+/-0.7 and 8.2+/-0.8 for HIIP and SC insulin treatments, respectively, (p=0.29). The rate of nocturnal hypoglycaemia was greater for HIIP (4.2+/-0.4) than for SC insulin (2.7+/-0.4; p<0.001). HIIP was similar in efficacy to SC insulin for glycaemic control in type 1 diabetes mellitus. The two treatments had comparable safety profiles.

Nurse-based evaluation of point-of-care assays for glycated haemoglobin

Background Various devices are now available to measure glycated haemoglobin (HbA1c) outside of the laboratory. The aim of this study was to assess the performance of these point-of-care instruments in the hands of non-laboratory trained personnel. Methods Two nursing staff tested samples from patients attending a diabetes research clinic using the following point-of-care devices for HbA1c-Metrica A1C Now, Bayer DCA 2000, Cholestech GDX and Axis-Shield Nycocard HbA1c. In addition they performed regular analysis of quality control samples. The effects on analytical performance of multiple operators as well as laboratory-trained staff, were also assessed. All measurements were compared to a boronate-affinity HPLC method in the central laboratory. Results The mean HbA1c difference of the point-of-care devices compared to the laboratory reference method ranged from − 0.31% to + 0.39%. Only the DCA device had a between batch imprecision of less than 5%. The analytical performance obtained by laboratory staff was similar to nursing staff for 3 devices and better for the Nycocard device. Conclusions On the basis of the results obtained by nursing staff, only the DCA of the devices tested, can be recommended for measurement of HbA1c outside of the laboratory.

Haemoglobin A1c: Evaluation of three point of care analysers for use in a paediatric diabetes clinic

The measurement of haemoglobin A1c(HbA1c) by high-performance liquid chromatography (HPLC) is generally deemed unsuitable for point of care testing (POCT) due to its complexity and extended turnaround times (TAT). The aim of this project was to evaluate two new HPLC instruments, the Bio-Rad D10 and the Primus PDQ, as POCT instruments compared with Bayer's DCA2000 HbA1c immunoassay analyser in our paediatric diabetes clinic. A total of 228 samples were analysed, of which 160 analyses were performed in our paediatric diabetes clinic. HbA1c results were compared by the Passing-Bablok agreement test, the Bland-Altman difference analysis, within- and between-run imprecision, and TAT. : The agreement test and difference analysis showed a correlation of r2 = 0.96 and a mean HbA1c difference of < 0.1% between the three analysers. The PDQ and the D10 achieved the within-run target coefficient of variation (CV) of < 2% at an HbA1c of 7.5%. Between-run imprecision at an HbA1c of 10.8% produced CV of 3.5%, 2.4% and 1.6% for the D10, DCA2000 and PDQ, respectively. TAT studies confirmed that the PDQ was substantially faster than the DCA2000 and D10. The PDQ had the shortest TAT, afforded random access and exhibited acceptable imprecision, and hence is the preferred instrument for our POCT environment.

Epidemiology of Diabetes Interventions and Complications (EDIC). Design, implementation, and preliminary results of a long-term follow-up of the Diabetes Control and Complications Trial cohort.

The Diabetes Control and Complications Trial (DCCT) demonstrated the powerful impact of glycemic control on the early manifestations of microvascular complications. Contemporary prospective data on the evolution of macrovascular and late microvascular complications of type 1 diabetes are limited. The Epidemiology of Diabetes Interventions and Complications (EDIC) study is a multicenter, longitudinal, observational study designed to use the well-characterized DCCT cohort of > 1,400 patients to determine the long-term effects of prior separation of glycemic levels on micro- and macrovascular outcomes. Using a standardized annual history and physical examination, 28 EDIC clinical centers that were DCCT clinics will follow the EDIC cohort for 10 years. Annual evaluation also includes resting electrocardiogram. Doppler ultrasound measurements of ankle/arm blood pressure, and screening for nephropathy. At regular intervals, a timed 4-h urine is collected, lipid profiles are obtained, and stereoscopic fundus photographs are taken. In addition, dual B-mode Doppler ultrasound scans of the common and internal carotid arteries will be performed at years 1 and 6 and at study end. Written informed consent was obtained from 96% of the DCCT subjects. The participants, compared with nonparticipants, tended to have better glycemic control at the completion of the DCCT and were more likely to have their diabetes care provided by DCCT personnel. The EDIC baseline measurement stratified by sex delineates multiple cardiovascular disease risk factor differences such as age (older in men), waist-to-hip ratio (higher in men). HDL cholesterol (lower in men), hypertension (more prevalent in men), and maximum intimal-medial thickness of common and internal carotid arteries (thicker in men). Of the original conventional treatment group, 69% have changed to continuous subcutaneous insulin infusion or multiple daily injections. Although the mean HbA1c difference between the intensive and conventional treatment groups narrowed at EDIC years 1 and 2, HbA1c remained significantly lower in the intensive group. Of all expected clinic visits, 95% were completed, and the quality of EDIC data is very similar to that observed in the DCCT. Although obvious problems exist in extended follow-up studies of completed clinical trials, these are balanced by the value of continued systematic observation of the DCCT cohort. In contrast to other epidemiologic studies, EDIC will provide 1) definitive data on type 1 as distinct from type 2 diabetes; 2) reliance on prospective rather than on cross-sectional analysis; 3) long-term follow-up in a large population; 4) consistent use of objective, reliable measures of outcomes and glycemia; and 5) observation of patients from before the onset of complications.