Artificial pancreas (AP) clinical trial participants' acceptance of future AP technology.

BACKGROUND: Artificial pancreas (AP) systems are currently an active field of diabetes research. This pilot study examined the attitudes of AP clinical trial participants toward future acceptance of the technology, having gained firsthand experience. SUBJECTS AND METHODS: After possible influencers of AP technology adoption were considered, a 34-question questionnaire was developed. The survey assessed current treatment satisfaction, dimensions of clinical trial participant motivation, and variables of the technology acceptance model (TAM). Forty-seven subjects were contacted to complete the survey. The reliability of the survey scales was tested using Cronbach's α. The relationship of the factors to the likelihood of AP technology adoption was explored using regression analysis. RESULTS: Thirty-six subjects (76.6%) completed the survey. Of the respondents, 86.1% were either highly likely or likely to adopt the technology once available. Reliability analysis of the survey dimensions revealed good internal consistency, with scores of >0.7 for current treatment satisfaction, convenience (motivation), personal health benefit (motivation), perceived ease of use (TAM), and perceived usefulness (TAM). Linear modeling showed that future acceptance of the AP was significantly associated with TAM and the motivation variables of convenience plus the individual item benefit to others (R(2)=0.26, P=0.05). When insulin pump and continuous glucose monitor use were added, the model significance improved (R(2)=0.37, P=0.02). CONCLUSIONS: This pilot study demonstrated that individuals with direct AP technology experience expressed high likelihood of future acceptance. Results support the factors of personal benefit, convenience, perceived usefulness, and perceived ease of use as reliable scales that suggest system adoption in this highly motivated patient population.

Impact of intensive lifestyle intervention on depression and health-related quality of life in type 2 diabetes: the Look AHEAD Trial.

OBJECTIVE: We examined the effects of an intensive lifestyle intervention (ILI), compared with a diabetes support and education (DSE) control intervention, on long-term changes in depression symptoms, antidepressant medication (ADM) use, and health-related quality of life (HRQoL) in overweight/obese individuals with type 2 diabetes. RESEARCH DESIGN AND METHODS: Look AHEAD was a multisite randomized controlled trial of 5,145 overweight/obese participants assigned to ILI (designed to produce weight loss) or DSE and followed for a median of 9.6 years. The Beck Depression Inventory (BDI) was administered at baseline, annually at years 1-4, and again at year 8. Mean BDI scores and incidence of BDI scores ≥10, indicative of likely mild or greater depression, were examined. Annually through year 10, participants reported their ADM use and completed the Medical Outcomes Study Short Form 36 (SF-36) questionnaire, which yields physical component summary (PCS) and mental component summary (MCS) scores. RESULTS: ILI significantly reduced the incidence of mild or greater depression symptoms (BDI scores ≥10) compared with DSE (hazard ratio [HR] = 0.85; 95% CI 0.75-0.97; P = 0.0145). Although SF-36 PCS scores worsened over time in both groups, ILI participants reported better physical function than DSE throughout the first 8 years (all P values <0.01). There were no significant differences between treatment arms in the proportion of participants who used ADMs or in SF-36 MCS scores. CONCLUSIONS: ILI for overweight/obese patients with type 2 diabetes may reduce the risk of developing clinically significant symptoms of depression and preserve physical HRQoL. These findings should be considered when evaluating the potential benefits of ILIs.

Examining behavioral processes through which lifestyle interventions promote weight loss: results from PREMIER.

OBJECTIVE: To examine the behavioral processes through which lifestyle interventions impacted weight loss. METHODS: The analyses were limited to overweight and obese Black and White adults randomized to a PREMIER lifestyle intervention (N = 501). Structural equation modeling was conducted to test the direct and indirect relationships of session attendance, days of self-monitoring diet and exercise, change in diet composition and exercise, and 6-month weight change. RESULTS: Greater session attendance was associated with increased self-monitoring, which was in turn significantly related to reduction in percent energy from total fat consumed. Change in percent energy from fat and self-monitoring was associated with 6-month percent change in weight. Both a decrease in fat intake and increase in self-monitoring are potential mediators of the relationship between attendance and weight change. CONCLUSIONS: The findings provide a reasonable model that suggests regular session attendance and use of behavioral strategies like self-monitoring are associated with improved behavioral outcomes that are associated with weight loss.

Four-year analysis of cardiovascular disease risk factors, depression symptoms, and antidepressant medicine use in the Look AHEAD (Action for Health in Diabetes) clinical trial of weight loss in diabetes.

OBJECTIVE: To study the association of depressive symptoms or antidepressant medicine (ADM) use with subsequent cardiovascular disease (CVD) risk factor status in the Look AHEAD (Action for Health in Diabetes) trial of weight loss in type 2 diabetes. RESEARCH DESIGN AND METHODS: Participants (n = 5,145; age [mean ± SD] 58.7 ± 6.8 years; BMI 35.8 ± 5.8 kg/m(2)) in two study arms (intensive lifestyle [ILI], diabetes support and education [DSE]) completed the Beck Depression Inventory (BDI), reported ADM use, and were assessed for CVD risk factors at baseline and annually for 4 years. Risk factor-positive status was defined as current smoking, obesity, HbA1c >7.0% or insulin use, and blood pressure or cholesterol not at levels recommended by expert consensus panel or medicine to achieve recommended levels. Generalized estimating equations assessed within-study arm relationships of elevated BDI score (≥11) or ADM use with subsequent year CVD risk status, controlled for demographic variables, CVD history, diabetes duration, and prior CVD risk status. RESULTS: Prior year elevated BDI was associated with subsequent CVD risk factor-positive status for the DSE arm (A1C [odds ratio 1.30 (95% CI 1.09-1.56)]; total cholesterol [0.80 (0.65-1.00)]; i.e., protective from high total cholesterol) and the ILI arm (HDL [1.40 (1.12-1.75)], triglyceride [1.28 (1.00-1.64)]). Prior year ADM use predicted subsequent elevated CVD risk status for the DSE arm (HDL [1.24 (1.03-1.50)], total cholesterol [1.28 (1.05-1.57)], current smoking [1.73 (1.04-2.88)]) and for the ILI arm (A1C [1.25 (1.08-1.46)], HDL [1.32 (1.11-1.58)], triglycerides [1.75 (1.43-2.14)], systolic blood pressure [1.39 (1.11-1.74)], and obesity [1.46 (1.22-2.18)]). CONCLUSIONS: Aggressive monitoring of CVD risk in diabetic patients with depressive symptoms or who are treated with ADM may be warranted.

Depression as a predictor of weight regain among successful weight losers in the diabetes prevention program.

OBJECTIVE: To determine whether depression symptoms or antidepressant medication use predicts weight regain in overweight individuals with impaired glucose tolerance (IGT) who are successful with initial weight loss. RESEARCH DESIGN AND METHODS: A total of 1,442 participants who successfully lost at least 3% of their baseline body weight after 12 months of participation in the randomized controlled Diabetes Prevention Program (DPP) continued in their assigned treatment group (metformin, intensive lifestyle, or placebo) and were followed into the Diabetes Prevention Program Outcome Study (DPPOS). Weight regain was defined as a return to baseline DPP body weight. Participant weight and antidepressant medication use were assessed every 6 months. Depression symptoms (Beck Depression Inventory [BDI] score ≥11) were assessed every 12 months. RESULTS: Only 2.7% of the overall cohort had moderate to severe depression symptoms at baseline; most of the participants with BDI score ≥11 had only mild symptoms during the period of observation. In unadjusted analyses, both depression symptoms (hazard ratio 1.31 [95% CI 1.03-1.67], P = 0.03) and antidepressant medication use at either the previous visit (1.72 [1.37-2.15], P < 0.0001) or cumulatively as percent of visits (1.005 [1.002-1.008], P = 0.0003) were predictors of subsequent weight regain. After adjustment for multiple covariates, antidepressant use remained a significant predictor of weight regain (P < 0.0001 for the previous study visit; P = 0.0005 for the cumulative measure), while depression symptoms did not. CONCLUSIONS: In individuals with IGT who do not have severe depression and who initially lose weight, antidepressant use may increase the risk of weight regain.

The impact of treatment non-compliance on mortality in people with type 1 diabetes.

AIMS: To determine if a diagnostic record of poor treatment compliance (medication non-compliance and/or non-attendance at medical appointments) was associated with all-cause mortality in people with type 1 diabetes. METHODS: This is an observational cohort study of data extracted from The Health Improvement Network (THIN) database, comprising data on patients served by over 350 primary care practices in the U.K. Participants were included in the study if they had diagnostic codes indicative of type 1 diabetes. Treatment non-compliance was defined as missing one or more scheduled appointment, or one or more codes indicating medication non-compliance. RESULTS: Of 2946 patients with type 1 diabetes, 867 (29.4%) had a record of either appointment non-attendance or medication non-compliance in the 30 month compliance assessment period. The crude, unadjusted mortality rate for those patients who were treatment non-compliant was 1.462 (95% CI 0.954-2.205). Following adjustment for confounding factors, treatment non-compliance was associated with increased all-cause mortality (HR=1.642; 95% CI 1.055-2.554). CONCLUSIONS: Treatment non-compliance was associated with increased all-cause mortality in patients with type 1 diabetes. Understanding and addressing factors that contribute to patient treatment non-compliance will be important in improving the life expectancy of patients with type 1 diabetes.

Impact of lifestyle intervention and metformin on health-related quality of life: the diabetes prevention program randomized trial.

BACKGROUND: Adults at high risk for diabetes may have reduced health-related quality of life (HRQoL). OBJECTIVE: To assess changes in HRQoL after interventions aimed at diabetes risk reduction. DESIGN, SETTING, AND PARTICIPANTS: A randomized clinical trial, the Diabetes Prevention Program, was conducted in 27 centers in the United States, in 3,234 non-diabetic persons with elevated fasting and post-load plasma glucose, mean age 51 years, mean BMI 34 Kg/m(2); 68 % women, and 45 % members of minority groups. INTERVENTIONS: Intensive lifestyle (ILS) program with the goals of at least 7 % weight loss and 150 min of physical activity per week, metformin (MET) 850 mg twice daily, or placebo (PLB). MEASUREMENTS: HRQoL using the 36-Item Short-Form (SF-36) health survey to evaluate health utility index (SF-6D), physical component summaries (PCS) and mental component summaries (MCS). A minimally important difference (MID) was met when the mean of HRQoL scores between groups differed by at least 3 %. RESULTS: After a mean follow-up of 3.2 years, there were significant improvements in the SF-6D (+0.008, p=0.04) and PCS (+1.57, p<0.0001) scores in ILS but not in MET participants (+0.002 and +0.15, respectively, p=0.6) compared to the PLB group. ILS participants showed improvements in general health (+3.2, p<0.001), physical function (+3.6, p<0.001), bodily pain (+1.9, p=0.01), and vitality (+2.1, p=0.01) domain scores. Treatment effects remained significant after adjusting sequentially for baseline demographic factors, and for medical and psychological comorbidities. Increased physical activity and weight reduction mediated these ILS treatment effects. Participants who experienced weight gain had significant worsening on the same HRQoL specific domains when compared to those that had treatment-related (ILS or MET) weight loss. No benefits with ILS or MET were observed in the MCS score. CONCLUSION: Overweight/obese adults at high risk for diabetes show small improvement in most physical HRQoL and vitality scores through the weight loss and increased physical activity achieved with an ILS intervention.

Bidirectional association between depression and metabolic syndrome: a systematic review and meta-analysis of epidemiological studies.

OBJECTIVE: Epidemiological studies have repeatedly investigated the association between depression and metabolic syndrome (MetS). However, the results have been inconsistent. This meta-analysis aimed to summarize the current evidence from cross-sectional and prospective cohort studies that evaluated this association. RESEARCH DESIGN AND METHODS: MEDLINE, EMBASE, and PsycINFO databases were searched for articles published up to January 2012. Cross-sectional and cohort studies that reported an association between the two conditions in adults were included. Data on prevalence, incidence, unadjusted or adjusted odds ratio (OR), and 95% CI were extracted or provided by the authors. The pooled OR was calculated separately for cross-sectional and cohort studies using random-effects models. The I(2) statistic was used to assess heterogeneity. RESULTS: The search yielded 29 cross-sectional studies (n = 155,333): 27 studies reported unadjusted OR with a pooled estimate of 1.42 (95% CI 1.28-1.57; I(2) = 55.1%); 11 studies reported adjusted OR with depression as the outcome (1.27 [1.07-1.57]; I(2) = 60.9%), and 12 studies reported adjusted OR with MetS as the outcome (1.34 [1.18-1.51]; I(2) = 0%). Eleven cohort studies were found (2 studies reported both directions): 9 studies (n = 26,936 with 2,316 new-onset depression case subjects) reported adjusted OR with depression as the outcome (1.49 [1.19-1.87]; I(2) = 56.8%), 4 studies (n = 3,834 with 350 MetS case subjects) reported adjusted OR with MetS as the outcome (1.52 [1.20-1.91]; I(2) = 0%). CONCLUSIONS: Our results indicate a bidirectional association between depression and MetS. These results support early detection and management of depression among patients with MetS and vice versa.

The impact of treatment noncompliance on mortality in people with type 2 diabetes.

OBJECTIVE: To assess the association of compliance with treatment (medication and clinic appointments) and all-cause mortality in people with insulin-treated type 2 diabetes. RESEARCH DESIGN AND METHODS: Data were extracted from U.K. general practice records and included patients (N = 15,984) who had diagnostic codes indicative of type 2 diabetes or who had received a prescription for an oral antidiabetic agent and were treated with insulin. Records in the 30 months before the index date were inspected for clinical codes (recorded at consultation) indicating medication noncompliance or medical appointment nonattendance. Noncompliance was defined as missing more than one scheduled visit or having at least one provider code for not taking medications as prescribed. Relative survival postindex date was compared by determining progression to all-cause mortality using Cox proportional hazards models. RESULTS: Those identified as clinic nonattenders were more likely to be smokers, younger, have higher HbA(1c), and have more prior primary care contacts and greater morbidity (P < 0.001). Those identified as medication noncompliers were more likely to be women (P = 0.001), smokers (P = 0.014), and have higher HbA(1c), more prior primary care contacts, and greater morbidity (all P < 0.001). After adjustment for confounding factors, medication noncompliance (hazard ratio 1.579 [95% CI 1.167-2.135]), clinic nonattendance of one or two missed appointments (1.163 [1.042-1.299]), and clinic nonattendance of greater than two missed appointments (1.605 [1.356-1.900]) were independent risk factors for all-cause mortality. CONCLUSIONS: Medication noncompliance and clinic nonattendance, assessed during routine care by primary care physicians or their staff, were independently associated with increased all-cause mortality in patients with type 2 diabetes receiving insulin.

Health-related quality of life and treatment satisfaction in the Sensor-Augmented Pump Therapy for A1C Reduction 3 (STAR 3) trial.

OBJECTIVE: This study assessed health-related quality of life (HRQOL) and treatment satisfaction in sensor-augmented pump therapy (SAPT) compared with optimal conventional therapy-multiple daily injection (MDI) therapy with self-monitoring of blood glucose (SMBG)-in adults and children with type 1 diabetes and children's caregivers. Patient acceptance of new therapies is essential to their adoption and effective use. RESEARCH DESIGN AND METHODS: STAR 3, a randomized 12-month clinical trial, compared SAPT with MDI+SMBG in 485 adult and pediatric patients. Within- and between-treatment arm changes in generic HRQOL, diabetes-specific HRQOL (fear of hypoglycemia), and treatment satisfaction were assessed (significance criterion P<0.01). RESULTS: In adults, children, and caregivers, there were no significant between-arm changes in generic HRQOL: SF-36 Physical Component Summary and Mental Component Summary scores in adults and the PedsQL Physical Health Summary and Psychosocial Health Summary scores in children or caregivers. Diabetes-specific HRQOL (Hypoglycemia Fear Survey Worry and Behavior subscale scores) improved more in SAPT than in MDI adults. Hypoglycemia Behavior scores improved more in SAPT caregivers. Key treatment satisfaction measures (Insulin Delivery System Rating Questionnaire measures of Convenience, Efficacy, and Overall Preference) improved more in SAPT adults, children, and caregivers (all P<0.001); all exceeded the criterion for minimal detectable difference. CONCLUSIONS: In the first-ever large-scale study of SAPT compared with optimal conventional therapy, SAPT had significant advantages for hypoglycemia fear in adults and caregivers and for treatment satisfaction in adults, children, and caregivers.

One-year changes in symptoms of depression and weight in overweight/obese individuals with type 2 diabetes in the Look AHEAD study.

Depressed individuals are frequently excluded from weight loss trials because of fears that weight reduction may precipitate mood disorders, as well as concerns that depressed participants will not lose weight satisfactorily. The present study examined participants in the Look AHEAD study to determine whether moderate weight loss would be associated with incident symptoms of depression and suicidal ideation, and whether symptoms of depression at baseline would limit weight loss at 1 year. Overweight/obese adults with type 2 diabetes (n = 5,145) were randomly assigned to an Intensive Lifestyle Intervention (ILI) or a usual care group, Diabetes Support and Education (DSE). Of these, 5,129 participants completed the Beck Depression Inventory (BDI) and had their weight measured at baseline and 1 year. Potentially significant symptoms of depression were defined by a BDI score ≥10. Participants in ILI lost 8.6 ± 6.9% of initial weight at 1 year, compared to 0.7 ± 4.8% for DSE (P < 0.001, effect size = 1.33), and had a reduction of 1.4 ± 4.7 points on the BDI, compared to 0.4 ± 4.5 for DSE (P < 0.001, effect size = 0.23). At 1 year, the incidence of potentially significant symptoms of depression was significantly lower in the ILI than DSE group (6.3% vs. 9.6%) (relative risk (RR) = 0.66, 95% confidence interval (CI) = 0.5, 0.8; P < 0.001). In the ILI group, participants with and without symptoms of depression lost 7.8 ± 6.7% and 8.7 ± 6.9%, respectively, a difference not considered clinically meaningful. Intentional weight loss was not associated with the precipitation of symptoms of depression, but instead appeared to protect against this occurrence. Mild (or greater) symptoms of depression at baseline did not prevent overweight/obese individuals with type 2 diabetes from achieving significant weight loss.

Comparative effectiveness of weight-loss interventions in clinical practice.

BACKGROUND: Obesity and its cardiovascular complications are extremely common medical problems, but evidence on how to accomplish weight loss in clinical practice is sparse. METHODS: We conducted a randomized, controlled trial to examine the effects of two behavioral weight-loss interventions in 415 obese patients with at least one cardiovascular risk factor. Participants were recruited from six primary care practices; 63.6% were women, 41.0% were black, and the mean age was 54.0 years. One intervention provided patients with weight-loss support remotely--through the telephone, a study-specific Web site, and e-mail. The other intervention provided in-person support during group and individual sessions, along with the three remote means of support. There was also a control group in which weight loss was self-directed. Outcomes were compared between each intervention group and the control group and between the two intervention groups. For both interventions, primary care providers reinforced participation at routinely scheduled visits. The trial duration was 24 months. RESULTS: At baseline, the mean body-mass index (the weight in kilograms divided by the square of the height in meters) for all participants was 36.6, and the mean weight was 103.8 kg. At 24 months, the mean change in weight from baseline was -0.8 kg in the control group, -4.6 kg in the group receiving remote support only (P<0.001 for the comparison with the control group), and -5.1 kg in the group receiving in-person support (P<0.001 for the comparison with the control group). The percentage of participants who lost 5% or more of their initial weight was 18.8% in the control group, 38.2% in the group receiving remote support only, and 41.4% in the group receiving in-person support. The change in weight from baseline did not differ significantly between the two intervention groups. CONCLUSIONS: In two behavioral interventions, one delivered with in-person support and the other delivered remotely, without face-to-face contact between participants and weight-loss coaches, obese patients achieved and sustained clinically significant weight loss over a period of 24 months. (Funded by the National Heart, Lung, and Blood Institute and others; ClinicalTrials.gov number, NCT00783315.).

Patient-reported outcomes in adults with type 2 diabetes using mealtime inhaled technosphere insulin and basal insulin versus premixed insulin.

AIMS: This study assessed patient-reported outcomes in a multicenter study of adults with type 2 diabetes taking mealtime Technosphere(®) inhaled insulin (MannKind Corp., Valencia, CA) and basal insulin (insulin glargine) or premixed aspart insulin 70/30. METHODS: Subjects were 618 non-smoking adults with starting hemoglobin A1c >7.0%: 302 in the Technosphere+glargine (TI+G) arm and 316 in the biphasic rapid-acting insulin arm (premixed aspart insulin 70/30). Subjects (47% male; mean age, 56 years; mean duration of diagnosed diabetes, 13.4 years) completed a measure of health-related quality of life (the SF-36) and a measure of treatment satisfaction (the Inhaled Insulin Treatment Questionnaire [IITQ]) before starting insulin treatment and approximately 45 weeks later. RESULTS: There were no significant changes in either treatment arm for SF-36 Physical or Mental Component Summary measures. IITQ Diabetes Worries declined significantly in the TI+G arm (P=0.008), and Perceptions of Insulin Therapy, Treatment Satisfaction, and Treatment Preference improved in both arms (all P<0.001); there were no significant between-arm differences in change on any of these measures. CONCLUSIONS: Treatment with inhaled Technosphere insulin was implemented without a negative impact on health-related quality of life and with a reduction in diabetes worries. Improvements in perceptions of insulin therapy, treatment satisfaction, and treatment preference did not differ from treatment with premixed aspart insulin.

An observational study to validate the Satisfaction Measure of the Injection of Growth Hormone Therapy (SMIGHTy) questionnaire.

OBJECTIVE: The objective of this study was to psychometrically evaluate a tool to measure adult caregivers' level of satisfaction with the delivery device used to administer injections of recombinant human growth hormone (rhGH) to a child - the Satisfaction Measure of the Injection of Growth Hormone Therapy (SMIGHTy*) questionnaire. RESEARCH DESIGN AND METHODS: One hundred caregivers who administer rhGH to a child using an injection device completed the SMIGHTy questionnaire at baseline and 7-14 days later, and also completed other measures of treatment adherence and treatment satisfaction at baseline. MAIN OUTCOME MEASURES: SMIGHTy reliability (inter-item and test-retest) and external validity (association with other study measures) were assessed. RESULTS: Analyses revealed good inter-item agreement and test-retest reliability for the SMIGHTy questionnaire. External validity, measured by associations with adherence and other measures of treatment satisfaction, was high. STUDY LIMITATIONS: This study assessed only adult caregivers; the instrument was not validated for use by young or adult patients. CONCLUSIONS: The SMIGHTy instrument is more comprehensive than existing instruments for assessing the growth hormone treatment experience. It is multidimensional, assesses both positive and negative aspects of the treatment experience (Device Satisfaction, Negative Events, Benefits), and has separate measures of overall satisfaction and preference.

Perceived medication benefits and their association with interest in using inhaled insulin in type 2 diabetes: a model of patients' cognitive framework.

OBJECTIVE: To examine predictors of patient perceived relevance of different diabetes medication benefits, and to determine how medication benefit ratings of an inhaled insulin were associated with evaluation of, and interest in that inhaled insulin. METHODS: The study was an Internet survey of a US sample (n = 1094) of adults with type 2 diabetes using different medication regimens. Patients were given a brief description of potential clinical benefits and administration procedures for the inhaled insulin described in this study (based on MannKind Corporation's Technosphere insulin). Measures included indicators of medication benefits, needs and relevance, benefit ratings and overall evaluation of the studied inhaled insulin relative to current medication, and interest in the study medication. Multivariate regression assessed significant (P < 0.05) independent associations, controlling for demographic and disease characteristics. RESULTS: Relevance of potential medication benefits (avoidance of hyperglycemia, hypoglycemia, weight gain, discomfort/inconvenience) was significantly associated with objective and subjective indicators of patients' needs. Most need indicators were associated only with the specific benefit to which they apply; concerns about weight and lifestyle were associated with multiple benefits. Ratings of the studied inhaled insulin for avoiding postprandial hyperglycemia and discomfort/inconvenience were associated with overall evaluation of and interest in the inhaled insulin described in this study; rating of this medication for avoiding weight gain was associated with overall evaluation ratings. CONCLUSIONS: Relevance of different potential benefits was based on objective and subjective indicators of need. Perceived efficacy of the inhaled insulin described in this study for avoiding postprandial hyperglycemia and discomfort/inconvenience were the benefits most strongly related to the evaluation of and interest in this medication.

Associations between improved glucose control and patient-reported outcomes after initiation of insulin pump therapy in patients with type 2 diabetes mellitus.

BACKGROUND: This study assessed the relationship between changes in glucose control and changes in patient-reported outcomes (PRO)--health-related quality of life (HR-QoL) and treatment satisfaction (TxSat)--in patients with type 2 diabetes initiating insulin pump therapy. METHODS: Patients (n = 54) initiating insulin pump therapy (Animas(®) 2020, Animas Corp., West Chester, PA) were studied for 16 weeks. Glucose control was measured with patient-blinded continuous glucose monitoring (CGM) (SEVEN(™), DexCom, San Diego, CA) and unblinded glycosylated hemoglobin (A1C) and seven-point self-monitored blood glucose (SMBG) profiles. HR-QoL was measured using the Diabetes Symptom Checklist-Revised (DSC-R) and the EuroQol-5 Dimensions (EQ-5D). TxSat was measured using the Insulin Delivery System Rating Questionnaire (IDSRQ) clinical efficacy and treatment preference scales. Bivariate correlations assessed associations between measures of change from baseline. RESULTS: Decreased A1C was associated only with improvement in IDSRQ clinical efficacy. For CGM and SMBG, reductions in mean glucose concentrations were associated with decreased DSC-R symptoms, improved EQ-5D health utility, and increased IDSRQ perceived clinical efficacy and treatment preference. Reduced glycemic variability was associated with improved EQ-5D health utility and increased IDSRQ treatment preference. CGM and SMBG readings from different times of day/night were differentially associated with all PRO. CONCLUSIONS: Findings suggest that A1C, representing an "average" of both high and low blood glucose values throughout the day, may not capture aspects of glucose control with the greatest impact on HR-QoL. Although TxSat was more strongly associated with A1C and mean glucose readings than with glycemic variability, HR-QoL was more strongly associated with glycemic variability.

Weight-related quality of life, health utility, psychological well-being, and satisfaction with exenatide once weekly compared with sitagliptin or pioglitazone after 26 weeks of treatment.

OBJECTIVE: To assess change in patient-reported outcomes in subjects with type 2 diabetes treated with exenatide once weekly compared with those treated with sitagliptin or pioglitazone. RESEARCH DESIGN AND METHODS: In this 26-week randomized, multicenter, double-dummy study, 491 subjects received 2 mg of exenatide once weekly or maximum daily doses of sitagliptin (100 mg) or pioglitazone (45 mg) on a background of metformin. Weight-related quality of life, health utility, psychological well-being, and diabetes treatment satisfaction were assessed at baseline and week 26. Mean group changes from baseline to week 26 were estimated by ANCOVA. RESULTS: Weight-related quality of life total scores improved significantly in the exenatide once weekly and sitagliptin arms only; the exenatide once weekly group experienced significantly greater improvement than the pioglitazone group in weight-related quality of life total scores and in several domain scores. Health utility scores improved significantly for exenatide once weekly and sitagliptin groups (P < 0.05) with no significant difference between the exenatide once weekly group and either comparison group. All groups experienced significant improvements on the psychological well-being global scale and all six domain scores, with no significant difference between the exenatide once weekly group and either comparator. All groups experienced significant improvements in total diabetes treatment satisfaction scores. The exenatide once weekly group experienced greater improvement than the sitagliptin group in treatment satisfaction total scores. CONCLUSIONS: In combination with clinical outcomes from this study, these results indicate it is possible for patients treated with metformin to initiate exenatide therapy with potential benefits in both clinical and patient-reported outcomes.

Crossing the technology divide: practical strategies for transitioning patients from multiple daily insulin injections to sensor-augmented pump therapy.

PURPOSE: To describe the benefits of continuous glucose monitoring (CGM) and continuous subcutaneous insulin infusion (CSII) systems compared with self-monitoring of blood glucose (SMBG) and multiple daily injection (MDI) therapy; to assess the benefits of sensor-augmented pump therapy (SAPT) in patients with type 1 diabetes; and to present an evidence-based practical protocol for introducing SAPT in patients with no prior pump or CGM experience. CONCLUSION: Continuous glucose monitoring and CSII have advantages over SMBG and MDI, respectively, in terms of A1C and hypoglycemia reduction. The Sensor-Augmented Pump Therapy for A1C Reduction (STAR) 3 trial demonstrated that initiating both CGM and CSII in selected adult and pediatric patients with type 1 diabetes unable to meet glycemic goals with intensive insulin injection therapy significantly improved glucose control. In all subjects using SAPT, A1C levels fell rapidly from baseline to 3 months and remained significantly lower than among subjects in the SMBG+MDI group for 1 year. A distinguishing feature of the STAR 3 study was its stepwise protocol for systematizing education and self-management support using Web-based training modules and therapy management software. The demonstrated strengths of this education protocol recommend it as a model for implementing SAPT in the broader population of patients with type 1 diabetes who have not achieved their glycemic goals with optimized MDI therapy.

Factors associated with persistence and resumption of insulin pen use for patients with type 2 diabetes.

OBJECTIVE: this study assessed patient-related factors associated with persistence and resumption of using pens as insulin delivery devices. METHODS: patients (n = 549; 300 current pen users, 249 former pen users) were recruited from national panels to participate in computer-assisted telephone interviews. Measures included demographic characteristics, diabetes treatment and self-care factors, physician recommendation for pen use, perceptions of pen convenience, clinical efficacy, facilitation of self-care, cost, patient reasons for terminating pen use, and likelihood of resuming pen use among those who had terminated use. RESULTS: current and former pen users rated the pen higher (P < 0.05) than vial and syringe on convenience, efficacy, facilitation of self-care, and cost, except for former users' ratings of cost. Current pen users rated pens higher (P < 0.05) than former users on all these measures. In addition to more positive pen perceptions, multivariate analysis showed that current users were more likely (P < 0.05) than former users to have received a pen recommendation from their physician, have better insurance coverage, and be working. Cost was the major reason reported for terminating pen use. Self-assessed likelihood of resuming pen use was higher (P < 0.05) among those with longer duration of pen use and more positive perceptions of pen cost and convenience. CONCLUSIONS: results suggest that physician recommendations of pen use, patient perceptions of pens, and cost and insurance coverage of pens may play an important role in persistence of pen use. Among former pen users, duration of pen use and perceptions of pens may be important factors in likelihood of patients' resuming pen use.