Changes In HbA1c Values Research Articles

Therapy Optimization with Once Daily Glargine Gla-300–Based Therapy in Patients Insufficiently Controlled on Premixed Insulins or Twice Daily Basal Regimens—Real-Life Data

Introduction: In Slovenia, as in many Central Europe countries, there is a high share of patients with T2D treated with human basal and premixed insulins. Many of them are often sub optimally controlled. One barrier to the achievement of optimal glycaemic control is the risk of hypoglycaemia, a common side effect of insulin therapy. Gla-300 is a new formulation of insulin glargine delivering the same amount of insulin as insulin glargine 100 units/mL (Gla-100) in a 1/3 volume. Pharmacokinetic and pharmacodynamic action profiles of Gla-300 are more constant and prolonged compared with Gla-100, due to a more gradual and extended release of glargine from the subcutaneous depot which allows continued blood glucose control beyond 24 hours. Study Design: We performed a retrospective, observational study. We have obtained data from medical charts of T2D and T1D patients, who initiated Gla-300 in the period from May 1st, 2016 to June 1st, 2017. The primary objective was to evaluate a real-life efficacy of once daily Gla-300 basal insulin therapy in patients insufficiently controlled on premixed insulins or twice- daily basal regimens, defined as the mean change in HbA1c value 3 or 6 months after the switch. The secondary objective was relationship between the occurrence of hypoglycaemia before and after the switch. Results: Data from 107 patients on Gla-300 have been analysed. Switching to insulin Gla-300 significantly reduced HbA1c (∆ -1.0%, p=0.000), FPG (∆ - 1.7mmol/l, p=0.000) and PPG (∆ -2.8mmol/l, p=0.000). More patients achieved target HbA1c concentrations (≤ 7%) after the switch to Gla-300 (8.4% before vs. 32% after the switch). 90.2% of subjects reported reduced number of hypoglycaemic events after switching to Gla-300. Conclusion: Switching to insulin Gla-300 proved to be safe and effective for patients with both, T1D and T2D. Disclosure J. Komel: Research Support; Self; Novo Nordisk Inc.. Other Relationship; Self; Sanofi, AstraZeneca, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company. D. Fabcic: None. K. Vukelic: None.

HbA1c and retinal sensitivity in diabetics using microperimetry

PurposeThe purpose of this study was to determine the relationship between HbA1c values and retinal sensitivity at central 10° using the MP-1 microperimeter. MethodsA prospective study was carried out on 32 healthy subjects (control group) and 60 diabetic patients. The diabetic patients were divided into 2 groups. Group 1 comprised of 30 patients without diabetic retinopathy (DR) and group 2 had 30 patients with mild non-proliferative DR. A full-threshold microperimetry of the central 10° of retina (the macula) was performed on all subjects, utilizing 32 points with the MP-1. The relationship between light sensitivity and HbA1c value was calculated using linear regression analysis. ResultsTotal mean sensitivity at 10° for group 1 without DR, group 2 with mild NPDR and control group were 18.67±0.83, 17.98±1.42 and 19.45±0.34 (dB), respectively. There was a significant difference in total mean retinal sensitivity at 10° between the 3 groups (F(2,89)=18.14, p=0.001). A simple linear regression was calculated to predict HbA1c based on retinal sensitivity. A significant regression equation was found (F(1,90)=107.61, p=0.0001, with an R2 of 0.545). The linear regression analysis revealed that there was a 0.64dB decline in mean retinal sensitivity within the central 10° diameter with an increase of 1mmHg of HbA1c. ConclusionRetinal sensitivity at the central 10° of the macula is affected by changes in HbA1c values.

Reducing the Risk of Type 2 Diabetes in Nonselected Outpatients With Schizophrenia: A 30-Month Program.

Type 2 diabetes is 2- to 3-fold more common in patients with schizophrenia than in the general population. A lifestyle with a focus on diet, exercise, and medication is required to prevent complications from type 2 diabetes, but patients with schizophrenia frequently have trouble maintaining such a lifestyle because of factors related to their illness, such as cognitive disturbances, negative and positive symptoms, and side effects of psychotropic medications. To measure and reduce risk factors for type 2 diabetes in patients with schizophrenia and examine characteristics associated with positive outcomes. This study, which was conducted in clinics treating both newly diagnosed and long-term (LT) patients with schizophrenia, evaluated the effects of a 30-month naturalistic intervention on improvement in the physical health of patients treated for schizophrenia and reduction in their risk factors for type 2 diabetes. The clinical intervention incorporated individual guidance, group sessions, and treatment as usual. Patients newly diagnosed with schizophrenia were found to have high consumption of soft drinks and low physical activity at their index evaluation. At follow-up, the physical profile of these patients had worsened, with increased weight, waist circumferences, visceral adiposity index (P=0.030), and glycosylated hemoglobin (HbA1c; P=0.010). Average HbA1c values increased in newly diagnosed male patients by 0.24 mmol/l (P=0.007). At follow-up, LT patients improved with regard to their consumption of soft drinks (P=0.001) and fast food (P=0.009). The LT patients also reduced their weight and waist circumferences and became more physically active. No changes in HbA1c values were found in the LT patients during the intervention period. The study found that positive outcomes were associated with female sex and a longer duration of illness. Negative outcomes with worsening of risk factors were associated with being newly diagnosed with schizophrenia and male sex. It was possible to produce improvements in some risk factors through individual health-oriented lifestyle interventions, especially in LT patients.

Association Between Neighborhood Supermarket Presence and Glycated Hemoglobin Levels Among Patients With Type 2 Diabetes Mellitus.

We estimated associations between neighborhood supermarket gain or loss and glycemic control (assessed by glycated hemoglobin (HbA1c) values) in patients from the Kaiser Permanente Northern California Diabetes Registry (n=434,806 person-years; 2007-2010). Annual clinical measures were linked to metrics from a geographic information system for each patient's address of longest residence. We estimated the association between change in supermarket presence (gain, loss, or no change) and change in HbA1c value, adjusting for individual- and area-level attributes and according to baseline glycemic control (near normal, <6.5%; good, 6.5%-7.9%; moderate, 8.0%-8.9%; and poor, ≥9.0%). Supermarket loss was associated with worse HbA1c trajectories for those with good, moderate, and poor glycemic control at baseline, while supermarket gain was associated with marginally better HbA1c outcomes only among patients with near normal HbA1c values at baseline. Patients with the poorest baseline HbA1c values (≥9.0%) had the worst associated changes in glycemic control following either supermarket loss or gain. Differences were not clinically meaningful relative to no change in supermarket presence. For patients with type 2 diabetes mellitus, gaining neighborhood supermarket presence did not benefit glycemic control in a substantive way. The significance of supermarket changes on health depends on a complex interaction of resident, neighborhood, and store characteristics.

An Audit of Clinical Practice in a Single Centre in Kuwait: Management of Children on Continuous Subcutaneous Insulin Infusion and Cardiovascular Risk Factors Screening.

Objectives:To audit the current clinical practice of continuous subcutaneous insulin infusion (CSII) for the treatment of type 1 diabetes mellitus (T1D) in children and adolescents attending a single centre in Kuwait.Methods:A one year retrospective audit was performed in children and adolescents with T1D on CSII, who attended the paediatric diabetes clinic, Dasman Diabetes Institute during 2012. The primary outcome measure was glycaemic control as evidenced by glycated haemoglobin (HbA1c) level and the secondary outcome measures were the frequency of monitoring of the risk for microvascular complications and occurrence of acute complications and adverse events.Results:58 children and adolescents (mean age ± SD: 12.6 ± 4.1 years) were included. Mean HbA1c at baseline was 8.8% (72.7 mmol/mol) and 8.9% (73.8 mmol/mol) at the end of a 12 months observation period. Children with poor control (HbA1c >9.5% (80 mmol/mol) had a significant 1.4% reduction in HbA1c compared with the overall reduction of 0.1% (p=0.7). Rate of screening for cardiovascular risk factors and for long term complications were well documented. However, there was underreporting of acute complications such as severe hypoglycaemia and diabetic ketoacidosis. Only 1.7% of patients discontinued the pump.Conclusion:There was no significant change in HbA1c values at the end of 12 months follow up. However, HbA1c values in poorly controlled children improved. CSII requires care by skilled health professionals as well as education and selection of motivated parents and children.

Examining the relationship between HbA1c and diabetes risk models in a European population indicates a lower threshold to identify 'high risk' is required.

This study examined whether changes in HbA1c values are reflected in the risk scores and categories of four validated risk-assessment tools (QDiabetes, Leicester Risk Assessment, Finnish Diabetes Risk Score and Cambridge Risk Score). Retrospective analysis was performed on 651 individuals with no prior diagnosis of cardiovascular disease or diabetes who participated in a UK workplace-based risk-assessment initiative. There were significant positive correlations (p < 0.01) revealed between HbA1c values and predicted risk scores: QDiabetes (r = 0.362), Leicester Risk Assessment (r = 0.315), Finnish Diabetes Risk Score (r = 0.202) and Cambridge Risk Score (r = 0.335). HbA1c values increased within risk prediction categories, and at 'high-risk' categories, median HbA1c values were at least 39 mmol mol(-1) (5.7%) irrespective of gender or risk-assessment model. Overall, an association is present between increases in HbA1c scores and predicted risk of type 2 diabetes. Furthermore, the 'high-risk' median HbA1c values in each of the risk assessments are more akin to the lower American recommendations rather than those suggested by the UK expert group.

A randomized trial of abiraterone acetate (AA) administered with 1 of 4 glucocorticoid (GC) regimens in metastatic castration-resistant prostate cancer (mCRPC) patients (pts).

261 Background: AA is approved for mCRPC, coadministered with prednisone (P) (5 mg BID) to prevent adverse events (AEs) associated with mineralocorticoid excess (ME). Lower GC doses had not previously been formally evaluated in combination with AA. Methods: This was an open-label, multicenter, phase 2 trial (NCT01867710) of asymptomatic chemotherapy-naïve mCRPC pts randomized 1:1:1:1 to AA (1000 mg QD) plus P 5 mg BID or P 5 mg QD or P 2.5 mg BID or dexamethasone (DEX) 0.5 mg QD. Pts who had previously received GC or ketoconazole were excluded. The primary end point was no ME (% of pts experiencing neither hypokalemia nor hypertension during the first 24 weeks of treatment).Secondary end points included additional safety, as well as response rate in the first 24 weeks, defined as a decline in prostate-specific antigen (PSA) ≥ 50% confirmed after 4 weeks. Results: 164 pts were randomized; 133 (81.6%) completed 24 weeks’ treatment. Median age: 70 years. Table 1 shows the rates of ME, hypertension, hypokalemia and PSA response. Changes in HbA1c values were minimal and observed in 16 (10.7%) pts. Conclusions: These data suggest that P 5 mg BID, which is approved in combination with AA, and DEX 0.5 mg QD, are effective in preventing ME-associated AEs, and that P 2.5 mg BID and P 5 mg QD can be safely used with appropriate monitoring. The suggestion of a higher PSA response rate with DEX 0.5 mg QD arm warrants further validation. Clinical trial information: NCT01867710. [Table: see text]

The Effects of Transition from Bedtime to Morning Glargine Administration in Patients with Poorly Regulated Type 1 Diabetes Mellitus: Croatian Pilot Study.

IntroductionThe objective of this study was to compare differences in glucoregulation, frequency of hypoglycemic episodes, glucose variability and lipid profiles of inpatients with poorly regulated type 1 diabetes mellitus (T1DM) after evening versus morning glargine application.MethodsEighteen patients with poorly regulated T1DM, glycated hemoglobin (Hba1c) levels ≥7% and frequent nocturnal and/or morning hypoglycemic episodes were included in this study. There was a 12-week screening phase where patients continued their usual insulin regimen and were encouraged to achieve optimal glycemic control; however, all patients maintained HbA1c values ≥7% and continued to have frequent nocturnal and/or morning hypoglycemic events and were therefore transitioned to morning application of insulin glargine for 12 weeks. The primary outcome was to investigate changes in HbA1c values 12 weeks after the transition. The secondary outcome was to evaluate the effect of transition on glucose variability, incidence of hypoglycemic episodes, insulin doses, lipid profile and weight. Data were analyzed using paired Student’s t test and Pearson correlation.ResultsAfter the transition, there was no significant change in total daily dose of basal insulin (p 0.114) and the average body weight remained unchanged, while significant reduction of HbA1c was present (8.02 ± 0.5 vs. 7.4 ± 0.3%) (p < 0.01) resulting in a decrease in nocturnal and daytime hypoglycemic episodes per month per person (p < 0.01). Parameters of glucose variability (glycemic standard deviations and J-index) were also improved after transition period (p < 0.01). As for the lipid profile, increase of high-density lipoprotein cholesterol and decrease of triglycerides (p < 0.01) were noticed, while other lipid parameters remained unaffected. Furthermore, insignificant association of basal insulin dose with HbA1c values regardless of the time of administration was observed.ConclusionIn patients with poorly regulated T1DM, transition to morning application of glargine improved glucoregulation (including a decrease in HbA1c, glucose variability and number of nocturnal hypoglycemic episodes), followed by favorable changes in lipid profile without affecting body weight. These effects were associated with the time of application, but not with the insulin dose.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-015-0130-2) contains supplementary material, which is available to authorized users.

Evolution of glycated haemoglobin in adults on growth hormone replacement therapy

ObjectivesTo evaluate the effects of GH replacement therapy (GHR) for 3 years on glycated haemoglobin (HbA1c) and on the presence of dysglycaemia at any time during follow-up in Spanish adult patients with growth hormone deficiency (GHD). Study designA retrospective study of 41 patients with GHD was conducted using baseline and long-term data. Changes in HbA1c values during the first 3 years of GHR were studied in both the overall population and patients with or without dysglycaemia during follow-up. Dysglycaemia was defined as FPG≥100mg/dl and/or HbA1c≥5.7%. ResultsMean HbA1c value (5.4±0.4% at baseline) increased during the first and second years of GHR (HbA1c 5.5±0.4%, p=0.05, and 5.5±0.4%, p=0.006 respectively). This increase was not maintained during the third year (HbA1c 5.4±0.3%, p=0.107) of GHR. Twenty-eight patients (68.2%) had dysglycaemia during follow-up, 9 of them since baseline. In the 19 patients without baseline dysglycaemia, HbA1c increased during the first year and remained stable in the next 2 years (mean HbA1c 5.2±0.4% at baseline; 5.5±0.4% at 1 year, p<0.050; 5.4±0.4% at 2 years, p=0.004, and 5.4±0.4% at 3 years, p=0.016). In the 9 patients with baseline dysglycaemia, HbA1c did not significantly change during the 3 years of GHR therapy. ConclusionsHbA1c values increased during the first 2 years of GHR therapy. In patients with no dysglycaemia before treatment, HbA1c steadily increased over the 3 years. However, it did not change in patients with baseline dysglycaemia.

Sitagliptin: Is It Effective in Routine Clinical Practice?

Aim. The present study was conducted to determine the glycaemic effects of sitagliptin in type 2 diabetes patients. Methods. Data was collected from patient medical records of a major teaching hospital in Malaysia, from 2009 to 2012. Glycated hemoglobin (HbA1c) values prior to and up to 12 months after the initiation of sitagliptin were analysed. The change in HbA1c values was accounted for based on a generalized linear model generated using the Generalized Estimating Equations (GEE) method. Results and Discussion. Of the 457 patients, 53.6% were elderly and 81.4% were overweight. The mean HbA1c (standard deviation) before initiation of sitagliptin was 8.5 (1.4)%. This dropped to 7.7 (1.4)%, 3 to 6 months after initiation of sitagliptin, with a mean difference of 0.8% (95% confidence interval (CI): 0.7–1.0; P < 0.001). However, this value increased to 8.0 (1.7)% after 7 to 12 months on sitagliptin (P = 0.002) with a mean difference from baseline of 0.6% (95% CI: 0.4–0.7; P < 0.001). Conclusion. In routine clinical practice, sitagliptin produces a significant reduction in mean HbA1c (0.8%) within the first 6 months of use which corresponds to efficacy data obtained in controlled clinical trials. However, this reduction was lesser, 7 to 12 month later.

Longitudinal change in HbA1c after insulin initiation in primary care patients with type 2 diabetes: A database analysis in UK and Germany

AimsTo evaluate the 3-year change in HbA1c values after start of insulin therapy among patients with type 2 diabetes in primary care practices in UK and Germany. MethodsLongitudinal data from general practices in Germany and UK (Disease Analyser, IMS HEALTH) from 2005 to 2009 were analysed, including 779 patients (mean age±SD: 63±11yrs, HbA1c: 8.1±1.3%) in Germany and 646 patients (55±12yrs; 9.3±1.5%) in UK with first time insulin prescriptions in 2005 (index date). The mean individual relative changes in HbA1c over 3 years after index date were adjusted for age, sex, diabetes duration, oral antidiabetics, insulin type, comorbidity and visits using general linear models. ResultsThe average adjusted HbA1c improvements in the first 12 months in primary care patients were 0.5% (95%CI: 0.4–0.6%) in Germany and 1.0% (0.7–1.3%) in UK. Between 12 and 36 months these improvements in glycemic control were maintained in both patient groups. DiscussionInitiation of insulin therapy in primary care patients in Germany and UK was associated with a similar moderate improvement in glycemic control over the first 12 months. After this period, insulin therapy only maintained HbA1c values without additional improvement in glycemic control.

A Pilot Trial of Pramlintide Home Usage in Adolescents With Type 1 Diabetes

The objective of this study was to evaluate the safety and efficacy of home pramlintide use in adolescents with type 1 diabetes. This was a randomized, 28-day pilot trial of pramlintide (maximum dose: 30 microg per meal) in 10 adolescents aged 13 to 17 years. End points included changes in hemoglobin A1c (HbA1c) values, body weight, and postprandial peak blood glucose levels and area under the curve on continuous glucose monitoring. Changes in HbA1c values, body weight, and total insulin dose declined in the treatment group compared with the control group (bootstrapped, P <or= .02 for each). The treatment group also demonstrated lower average dinner area under the curve (P = .02) and lower maximum breakfast (P = .03) and dinner (P = .02) postprandial blood glucose values. Pramlintide can help some adolescents to decrease postprandial hyperglycemia, HbA1c values, body weight, and insulin dosages. Additional large-scale trials should now be considered.

Longitudinal Change in HbA1c in Patients with Type 2 Diabetes: Comparison of Short-acting, Biphasic and Basal Insulin

To evaluate the annual change in HbA1c values among patients with type 2 diabetes in primary care practices comparing different insulin regimens. Longitudinal data from 666 nationwide general and internal medicine practices in Germany (Disease Analyser, IMS HEALTH) from 7/2004 to 6/2006 were analysed, including 348 patients (mean age+/-SD: 61+/-11 years) with continuous short-acting (regular insulin or analogues), 1 906 with biphasic (72+/-9 years), 439 with basal-bolus (68+/-10 years), and 1 719 with basal insulin therapy (65+/-10 years). The mean of the individual relative changes in HbA1c (level in 2006 divided by level in 2005) were compared between insulin groups, adjusting for age, sex, BMI, diabetes duration, oral antidiabetics, comorbidity, health insurance, visits, hospitalisations, and practice type using general linear models. There was only a small difference in baseline HbA1c values (range 7.3-7.5%) between the four insulin groups (p=0.008). Substantial group differences were observed for age, diabetes duration, and additional prescriptions of oral antidiabetics (p<0.0001). After adjusting for potential confounders, the relative annual increase in HbA1c was highest for biphasic insulin (1.021; 95%CI 1.016-1.025), followed by basal-bolus therapy (1.017; 1.012-1.022), and basal insulin (monotherapy) (1.012; 1.002-1.021). No significant change in HbA1c was found for short-acting insulin (1.006; 0.996-1.016). Although many options for insulin therapy are now available, a progression of glycemia still occurs in the majority of insulin-treated type 2 diabetic patients in primary care.

Brisk walking compared with an individualised medical fitness programme for patients with type 2 diabetes: a randomised controlled trial

Aims/hypothesisStructured exercise is considered a cornerstone in type 2 diabetes treatment. However, adherence to combined resistance and endurance type exercise or medical fitness intervention programmes is generally poor. Group-based brisk walking may represent an attractive alternative, but its long-term efficacy as compared with an individualised approach such as medical fitness intervention programmes is unknown. We compared the clinical benefits of a 12-month exercise intervention programme consisting of either brisk walking or a medical fitness programme in type 2 diabetes patients.MethodsWe randomised 92 type 2 diabetes patients (60 ± 9 years old) to either three times a week of 60 min brisk walking (n = 49) or medical fitness programme (n = 43). Primary outcome was the difference in changes in HbA1c values at 12 months. Secondary outcomes were differences in changes in blood pressure, plasma lipid concentrations, insulin sensitivity, body composition, physical fitness, programme adherence rate and health-related quality of life.ResultsAfter 12 months, 18 brisk walking and 19 medical fitness participants were still actively participating. In both programmes, 50 and 25% of the dropout was attributed to overuse injuries and lack of motivation, respectively. Intention-to-treat analyses showed no important differences between brisk walking and medical fitness programme in primary or secondary outcome variables.Conclusions/interpretationThe prescription of group-based brisk walking represents an equally effective intervention to modulate glycaemic control and cardiovascular risk profile in type 2 diabetes patients when compared with more individualised medical fitness programmes. Future exercise intervention programmes should anticipate the high attrition rate due to overuse injuries and motivation problems.Electronic supplementary materialThe online version of this article (doi:10.1007/s00125-008-0950-y) contains supplementary material, which is available to authorised users.

Use of CoZmonitor®in youth with type 1 diabetes

The purpose of this study was to evaluate the effectiveness of directly integrating self-monitoring blood glucose (BG) information with insulin pump therapy on overall glycemic control. In this randomized trial, 34 youth with type 1 diabetes using insulin pump therapy were trained on the use of the Deltec Cozmo Insulin Pump. Seventeen were randomized to use the CoZmonitor Blood Glucose Module, a device that attaches to the back of the pump using FreeStyle technology to perform BG tests which read directly on the pump screen. The remaining 17 (control group) used a FreeStyle Flash meter, a stand-alone BG meter, for their BG testing. At baseline, 3 and 6 months, the subjects filled out a questionnaire, had a hemoglobin A1c (HbA1c) test, and had pumps and meters downloaded. After 3 months of study, there were no changes in mean HbA1c (+/- SD) values for the experimental (8.7 +/- 1.1 to 8.6 +/- 1.1) or the control groups (9.1 +/- 1.4 to 9.2 +/- 1.5). There were also no significant differences in HbA1c values after 6 months. The average number of BG tests per day did not change significantly in either group during the study. After 3 and 6 months, the experimental group rated satisfaction with the use of the CoZmonitor at 4.4 and 3.8 (respectively) on a five-point Likert scale, with 5 being the most satisfied. Although significant changes in HbA1c values or the number of BG tests were not found, use of the BG module had a positive level of satisfaction.

Low intense physical exercise in normobaric hypoxia leads to more weight loss in obese people than low intense physical exercise in normobaric sham hypoxia.

Training in mild to moderate hypoxia (14–17% O2 in breathing air) and extended resting in moderate hypoxia (9–13% O2) have been shown to have effects in animals and humans on lipid and glucose metabolism, appetite loss, and, in part, on body weight. The causality for these effects is not yet known in detail, and the available data in humans from high-altitude and low-pressure chamber studies are scarce. New technical developments by German companies in the production of artificial climates with normobaric hypoxic conditions in larger rooms at reasonable energy costs allow now to perform hypoxia weight loss studies in obese humans with stable experimental conditions and protocols with a sham hypoxia control. Thirty-two obese people were recruited for a mild intense training study in normobaric hypoxia (15 vol.% O2) and normoxia/sham hypoxia (20.1 vol.% O2). Twenty of these [mean age 47.6 years, mean body mass index (BMI) 33.1, 16 m, 4 f) were willing to follow up on an 8-week, three times per week, 90-min low intense physical exercise in their individual fat burning mode, which has been determined by an exercise testing with spiro-ergometry upfront. The subjects were evenly randomized into a hypoxia and sham hypoxia group. The difference of the two groups in weight loss and changes in HBa1C values were analyzed before and after the training period. No nutritional diet was applied. Subjects in the hypoxia group in mean lost significantly more weight than in the sham hypoxia group (Δ1.14 kg vs Δ0.03 kg; p = 0.026). This resulted in a tendency to reduce the BMI more in the hypoxia group (p = 0.326). In the mean, there was no HbA1C exceeding normal values (mean 5.67 and 5.47%), and the HbA1C stayed basically unchanged after the 8-week training. Mild physical exercise three times per week for 90 min in normobaric hypoxia for 8 weeks led to significantly greater weight loss in obese persons than the exercise in sham hypoxia in this, to our knowledge, first sham hypoxia controlled study.

Treatment of type 2 diabetes with a combination regimen of repaglinide plus pioglitazone

The efficacy and safety of combination therapy (repaglinide plus pioglitazone) was compared to repaglinide or pioglitazone in 24-week treatment of type 2 diabetes. This randomized, multicenter, open-label, parallel-group study enrolled 246 adults (age 24–85) who had shown inadequate response in previous sulfonylurea or metformin monotherapy (HbA 1c > 7%). Prior therapy was withdrawn for 2 weeks, followed by randomization to repaglinide, pioglitazone, or repaglinide/pioglitazone. In the first 12 weeks of treatment, repaglinide doses were optimized, followed by 12 weeks of maintenance therapy. Pioglitazone dosage was fixed at 30 mg per day. Baseline HbA 1c values were comparable (9.0% for repaglinide, 9.1% for pioglitazone, 9.3% for combination). Mean changes in HbA 1c values at the end of treatment were −1.76% for repaglinide/pioglitazone, −0.18% for repaglinide, +0.32% for pioglitazone. Fasting plasma glucose reductions were −82 mg/dl for combination therapy, −34 mg/dl for repaglinide, −18 mg/dl for pioglitazone. Minor hypoglycemia occurred in 5% of patients for the combination, 8% for repaglinide, and 3% for pioglitazone. Weight gains for combination therapy were correlated to individual HbA 1c reductions. In summary, for patients who had previously failed oral antidiabetic monotherapy, the combination repaglinide/pioglitazone had acceptable safety, with greater reductions of glycemic parameters than therapy using either agent alone.

Stress management training as related to glycemic control and mood in adults with Type 1 diabetes mellitus

Relationships between attending a stress management and relaxation-training program, glycemic control (HbA 1c) and mood were examined in two randomised groups of 31 persons with Type 1 diabetes. The program involved group-education 2 h a week for 14 weeks. Whereas one group received the program, the other acted as a control group and received the program later. HbA 1c was measured and subjects filled out a mood adjective checklist before the start of intervention and both 1 month and 1 year after completing it. In both groups, significant positive mood changes were obtained, but no significant changes in HbA 1c values occurred. No significant relationship was found between measures of change in HbA 1c and of changes in mood. For those attending the group-sessions less frequently, the HbA 1c values were significantly worse on each of the three measurement occasions than the values of those attending more frequently. The effectiveness of the program, with its failure to improve glycemic control but enhancing the mood of participants, is discussed in terms of characteristics of the sample and various methodological issues as well as in comparison with results of similar studies involving Type 1 and Type 2 diabetes.

A multifaceted intervention in support of diabetes treatment guidelines: a cont trial

Objective: in an academic family practice clinic, we performed a controlled trial of a multifaceted intervention versus usual care for managing diabetes. Providers received didactic training and computerized compliance feedback to support staged diabetes management, an evidenced-based approach to diabetes care. Research design and methods: one firm of the clinic practice received the intervention, the other served as the control group during a 14-month baseline period and a 14-month study period. HbA1c was the principal outcome measure. Results: there was a significant 0.71% difference in change in HbA1c values between the intervention and control firms (P=0.02). The subgroup with the greatest improvement in HbA1c was those subjects who started the intervention with a HbA1c above 8%. The overall improvement in glycemic control could not be explained by differences in visit frequency or the aggressiveness of drug therapy. There were no changes in healthcare utilization or costs between the two firms. Conclusion: in an academic family practice clinic, a multifaceted intervention in support of diabetes treatment guidelines modestly improved glycemic control without incurring additional costs. The improvement was mostly due to mitigation of the natural deterioration in control usually seen. Further efforts are required to involve all patients in co-managing their diabetes.

Strong in Body and Spirit

To determine the effects of a culturally appropriate diabetes lifestyle intervention for Native Americans on risk factors for complications of diabetes. A nonrandomized, community-based diabetes intervention trial was conducted in three Native American sites in New Mexico from 1993-1997. Participants were assigned to intervention or control based on community of residence. Intervention sessions were held approximately 6 weeks apart over approximately 10 months. The intervention was delivered in site A in family and friends (FF) groups (n = 32); site B received the same intervention in one-on-one (OO) appointments (n = 39); and site C received usual medical care (UC) (n = 33) (total participants, n = 104). Primary change in HbA(1c) level was assessed at 1 year. Adjusted mean change in HbA(1c) value varied significantly across the three arms at 1 year (P = 0.05). The UC arm showed a statistically significant increase in adjusted mean HbA(1c) change (1.2%, P = 0.001), whereas both intervention arms showed a small nonsignificant (P > 0.05) increase in the adjusted mean change (0.5% and 0.2% for FF and OO arms, respectively). The increase was statistically significantly smaller in the combined intervention arms (0.4%) compared with the UC arm (1.2%, P = 0.02). Lifestyle intervention has the potential to substantially reduce microvascular complications, mortality, and health care utilization and costs if the change is sustained over time.