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Background: Barriers to mealtime insulin include complexity, fear of injections, and lifestyle interference. This multicenter, randomized controlled trial evaluated efficacy, safety, and self-reported outcomes in adults with type 2 diabetes, inadequately controlled on basal insulin, initiating and managing mealtime insulin with a wearable patch versus an insulin pen. Methods: Adults with type 2 diabetes ( n  = 278, age: 59.2 ± 8.9 years), were randomized to patch ( n  = 139) versus pen ( n  = 139) for 48 weeks, with crossover at week 44. Baseline insulin was divided 1:1 basal: bolus. Using a pattern-control logbook, subjects adjusted basal and bolus insulin weekly using fasting and premeal glucose targets. Results: Glycated hemoglobin (HbA1c) change (least squares mean ± standard error) from baseline to week 24 (primary endpoint) improved ( P  < 0.0001) in both arms, -1.7% ± 0.1% and -1.6% ± 0.1% for patch and pen (-18.6 ± 1.1 and -17.5 ± 1.1 mmol/mol), and was maintained at 44 weeks. The coefficient of variation of 7-point self-monitoring blood glucose decreased more ( P  = 0.02) from baseline to week 44 for patch versus pen. There were no differences in adverse events, including hypoglycemia (three severe episodes per arm), and changes in weight and insulin doses. Subject-reported treatment satisfaction, quality of life, experience ratings at week 24, and device preferences at week 48 significantly favored the patch. Most health care providers preferred patch for mealtime insulin. Conclusions: Bolus insulin delivered by patch and pen using an algorithm-based weekly insulin dose titration significantly improved HbA1c in adults with type 2 diabetes, with improved subject and health care provider experience and preference for the patch.

Continuing use of medication is key to effective treatment and positive health outcomes, particularly in chronic conditions such as diabetes. However, in primary care, non-persistence (i.e. discontinuing or interrupting treatment) with insulin therapy is a common problem among patients with type 2 diabetes. To help primary care physicians manage patients who are non-persistent or likely not to be persistent, this review aimed to provide an overview of modifiable and non-modifiable factors associated with insulin non-persistence as well as practical strategies to address them. Data were extracted from published studies evaluating factors associated with non-persistence among patients with type 2 diabetes. A targeted literature review was performed using PubMed to identify recent studies (2000-2016) reporting measures of non-persistence with insulin therapy. Practical strategies to identify and prevent non-persistence were based on the authors' direct experience in primary care. Non-modifiable factors associated with non-persistence included gender, age, prior treatments, and cost of therapy. Before/at insulin initiation, modifiable factors included patients' perception of diabetes, preference for oral medication, and concerns/expectations about treatment complexity, inconvenience, or side effects. After initiation, modifiable factors included syringe use, difficulties during the first week of therapy, side effects, and insufficient glycemic control. Open-ended and patient-centered questions and a blame-free environment can help physicians identify, prevent, and reduce non-persistence behaviors. Possible questions to start a conversation with patients are provided. Effective physician-patient communication is essential to the management of diabetes. Primary care physicians should be familiar with the most common reasons for insulin non-persistence.

Background and Objective: People with type 2 diabetes mellitus (T2DM) often interrupt basal insulin treatment soon after initiation. This study aimed to describe the experiences during and after basal insulin initiation among people with T2DM with different persistence patterns., Methods: Adults with T2DM from France, Germany, Spain, UK, US, Brazil, and Japan were identified from consumer panels for an online survey. Respondents who initiated basal insulin 3-24 months prior to survey date were categorized as continuers (no gaps of ≥7 days in insulin treatment); interrupters (first gap ≥7 days within 6 months of initiation and restarted insulin); and discontinuers (stopped insulin for ≥7 days within 6 months of initiation without restarting)., Results: Among 942 participants, continuers were older than interrupters and discontinuers (46, 37, and 38 years, respectively, p < .01). Continuers reported having fewer concerns before and after insulin initiation than interrupters and discontinuers, while interrupters had the most concerns. Continuers also reported fewer challenges during the first week of insulin use. Continuers were more likely to respond that insulin use had a positive impact on specific aspects of life than interrupters and discontinuers, for example on glycemic control (73.0%, 63.0%, and 61.8%, respectively; p < .01 vs. continuers)., Conclusion: Among people with T2DM with different persistence patterns after basal insulin initiation there were significant differences in patient characteristics and experience during and after insulin initiation. Interrupters and discontinuers more frequently reported having concerns and challenges during the initiation process, negative impacts after initiation, and less improvement in glycemic control than continuers.

Background and Objective: People with T2DM who initiate basal insulin therapy often stop therapy temporarily or permanently soon after initiation. This study analyzes the reasons for and correlates of stopping and restarting basal insulin therapy among people with T2DM., Methods: An online survey was completed by 942 insulin-naïve adults with self-reported T2DM from Brazil, France, Germany, Japan, Spain, UK, and US. Respondents had initiated basal insulin therapy within the 3-24 months before survey participation and met criteria for one of three persistence groups: continuers had no gaps of ≥7 days in basal insulin treatment; interrupters had at least one gap in insulin therapy of ≥7 days within the first 6 months after initiation and had since restarted basal insulin; and discontinuers stopped using basal insulin within the first 6 months after initiation and had not restarted., Results: Physician recommendations and cost were strongly implicated in patients stopping and not resuming insulin therapy. Continuous persistence was lower for patients with more worries about insulin initiation, greater difficulties and weight gain while using insulin, and higher for those using pens and perceiving their diabetes as severe. Repeated interruption of insulin therapy was associated with hyperglycemia and treatment burden while using insulin. Resumption and perceived likelihood of resumption were associated with hyperglycemia upon insulin cessation. Perceived likelihood of resumption among discontinuers was associated with perceived benefits of insulin., Conclusion: Better understanding of the risk factors for patient cessation and resumption of basal insulin therapy may help healthcare providers improve persistence with therapy.

Aims: To examine the associations among fear of hypoglycaemia, diabetes-related quality of life and psychological well-being, and determine whether diabetes-related quality of life is a mediator of the relationship between fear of hypoglycaemia and psychological well-being in adults with Type 1 diabetes., Methods: A total of 235 of 319 invited adults (18-69years) with Type 1 diabetes agreed to participate. Hierarchical linear regression was applied to 188 individuals with complete data. Mediation analysis was used to determine whether diabetes-related quality of life mediated the relationship between fear of hypoglycaemia and psychological well-being., Results: Fear of hypoglycaemia was significantly associated with diabetes-related quality of life and psychological well-being. The behaviour and worry components of fear of hypoglycaemia were significantly associated with diabetes-related quality of life (behaviour component: unstandardised coefficient=-0.04, p<0.001, standardised coefficient=-0.40; worry component: unstandardised coefficient=-0.01, p=0.041, standardised coefficient=-0.18). Fear of hypoglycaemia worry had a significant independent association with psychological well-being (unstandardised coefficient=-0.28, p=0.009, standardised coefficient=-0.25), whereas fear of hypoglycaemia behaviour did not. Diabetes-related quality of life mediated approximately half of the association between fear of hypoglycaemia worry and psychological well-being., Conclusions: Hypoglycaemic episodes can have serious consequences, and assessing fear of hypoglycaemia might help health care providers offer suitable care strategies to individuals with Type 1 diabetes., (Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.)

Aims: To conduct a second Diabetes Attitudes, Wishes and Needs (DAWN2(™) ) study, examining the experiences of family members caring for adults with diabetes in order to identify correlates of family member psychological outcomes (generic psychological well-being, perceived quality of life, and diabetes-related burden, impact and distress)., Methods: A total of 2057 family members living with a person with diabetes and involved in their care participated in an online, telephone or in-person survey. Samples of 120 respondents were recruited in each of 17 countries. Significant (P < 0.05) correlates of psychological outcomes were identified by multi-level multiple regression., Results: Outcomes were worse for family members not working because of diabetes or those who had other competing obligations. Outcomes were worse if the person with diabetes was not a partner or parent, used injected diabetes medication, or had more frequent hypoglycaemia. Outcomes were worse for family members who believed that diabetes was more severe, were more involved in diabetes care, had more conflict over diabetes care or were frustrated about not knowing how to help the person with diabetes. Outcomes were better for those who had greater support from others and felt they found good ways to help the person with diabetes. There were significant differences in outcomes among countries before and after adjustment for individual characteristics, and correlates of outcomes varied by country., Conclusions: Several modifiable risk and protective factors for family member psychological outcomes were identified in this study. Diabetes education and social support were associated with improved outcomes, especially if they were helpful in supporting people with diabetes., (© 2016 Diabetes UK.)

Aims: To develop and validate a short form of the 54-item Diabetes Medication System Rating Questionnaire that maintains the domains and performance characteristics of the long-form questionnaire., Methods: Data from the Diabetes Medication System Rating Questionnaire validation study were analysed to select items representing the nine scales (convenience, negative events, interference, self-monitoring of blood glucose burden, efficacy, social burden, psychological well-being, treatment satisfaction and treatment preference). The resulting 20-item Diabetes Medication System Rating Questionnaire Short-Form was administered online, with validated criterion measures of treatment satisfaction and medication adherence, with a retest within 2 weeks. Participants were US adults (N = 413) with Type 2 diabetes using oral agents alone; insulin by syringe and/or pen with or without oral agents; or glucagon-like peptide-1 agents. Most participants (82%) completed the retest., Results: The median inter-item agreement of scales was 0.76 and the total composite (mean of all items except treatment preference) was 0.88. The median test-retest reliability of scales was 0.86, and of the total composite was 0.95. All statistically significant correlations between Diabetes Medication System Rating Questionnaire Short-Form scales and criterion measures of treatment satisfaction and adherence were in the expected direction. The median correlation of the Diabetes Medication System Rating Questionnaire Short-Form with corresponding criterion measures of treatment satisfaction was 0.59; the mean correlation of the same Diabetes Medication System Rating Questionnaire Short-Form measures with adherence was 0.42. The Diabetes Medication System Rating Questionnaire Short-Form scales were more powerful predictors of adherence than were the criterion measures of treatment satisfaction. The Diabetes Medication System Rating Questionnaire Short-Form scales differentiated between those taking different medications and between those using different insulin delivery devices., Conclusions: This study suggests that the Diabetes Medication System Rating Questionnaire Short-Form provides a comprehensive set of measures with acceptable reliability and validity and a reduced burden of administration., (© 2014 The Authors. Diabetic Medicine published by John Wiley & Sons Ltd on behalf of Diabetes UK.)

Aim: To identify insulin delivery system perceptions that contributed to improvements in overall satisfaction with insulin therapy (treatment satisfaction) that were larger in those using sensor-augmented pump therapy than those using multiple daily injections with self monitoring of blood glucose., Methods: The Sensor-Augmented Pump Therapy for A1C Reduction 3 (STAR 3), a randomized 12-month clinical trial, compared sensor-augmented pump therapy to multiple daily injections + self monitoring of blood glucose in adult and paediatric patients. The Insulin Delivery System Rating Questionnaire measured perceptions of convenience, problems, interference with daily activities, blood glucose monitoring burden, social burden, clinical efficacy, diabetes worries and psychological well-being, as well as treatment satisfaction. We conducted separate multiple regression analyses for the 334 adult patients and 147 paediatric patients and their caregivers to assess the independent associations (P < 0.05) between change from baseline to follow-up in user perceptions and treatment satisfaction., Results: Increased convenience was associated with improved treatment satisfaction in all user groups. Reduced interference with daily activities (caregivers), reduced social burden (adults) and increased efficacy (both) also were associated with improved treatment satisfaction., Conclusions: Treatment satisfaction among children was primarily a function of convenience, while perceived clinical efficacy was also a primary determinant among adults, reflecting different emphases on the treatment process itself vs. treatment consequences. Among adult patients and caregivers, improved treatment satisfaction was also a function of reductions in social burden and interference with daily activities (respectively), reflecting concern with the broader psychosocial impact of sensor-augmented pump therapy on their lives., (© 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.)

Aim: To examine factors associated with insulin injection omission/non-adherence on a global basis., Methods: Telephone survey of 1530 insulin-treated adults with self-reported diabetes (110 type 1 and 1420 type 2) in China, France, Japan, Germany, Spain, Turkey, UK or USA. Participants had a mean age of ∼60 years, ∼15 years duration of diabetes and ∼9 years duration of insulin treatment. Regression analysis assessed the independent associations (p < 0.05) of country, participant characteristics and treatment-related beliefs/perceptions with number of days in the past month that an insulin injection was missed or not taken as prescribed., Results: One third (35%) of respondents reported one or more days (mean: ∼3 days) of insulin omission/non-adherence. Insulin omission/non-adherence differed widely across countries (range = 20-44%); differences in days of insulin omission/non-adherence were maintained after adjustment for other risk factors. Most risk factors had similar relationships with insulin omission/non-adherence across countries (few interactions with country). Insulin omission/non-adherence was more frequent among respondents who were male, younger, had type 2 diabetes or more frequent hypoglycaemia, were less successful with other treatment tasks, regarded insulin adherence as less important, had more practical/logistical barriers and difficulties with insulin adherence, were concerned that insulin treatment required lifestyle changes or were dissatisfied with the flexibility of injection timing., Conclusions: The results of this large-scale study suggest that insulin omission/non-adherence is common and associated with several modifiable risk factors (including practical barriers, injection difficulties, lifestyle burden and regimen inflexibility). Additional efforts to address these risk factors might reduce the frequency of insulin omission/non-adherence and lead to improved clinical outcomes., (© 2012 Blackwell Publishing Ltd.)

Aim: To assess the reliability and validity of the Diabetes Medication System Rating Questionnaire among 537 US adults with Type 2 diabetes using five different diabetes medication regimens (oral agents with and without insulin; insulin only by syringe and by pen; glucagon-like peptide 1 agents)., Methods: The Diabetes Medication System Rating Questionnaire assesses the treatment experience of patients using any diabetes medication system that uses nine measures (Convenience, Negative Events, Interference, Self-Monitoring of Blood Glucose Burden, Efficacy, Social Burden, Psychological Well-Being, Treatment Satisfaction, Treatment Preference). It was administered via an initial online survey, along with other validated measures of treatment satisfaction and medication adherence, with a retest administered within 2 weeks. Participants were 52.5% male, 57.4% aged 40-64 years, 83.6% white and 95.2% non-Hispanic. Most (75.6%) had attended college and 58.3% had been diagnosed with diabetes for more than 10 years., Results: Median inter-item agreement was 0.86. Median test-retest reliability was also 0.86. All correlations between Diabetes Medication System Rating Questionnaire measures and criterion measures of treatment satisfaction and adherence were statistically significant (P<0.01) in the expected direction. Correlations between Diabetes Medication System Rating Questionnaire and the corresponding criterion measures of treatment satisfaction ranged from 0.349 to 0.629 (absolute values; interpolated median 0.568); correlations of the same measures with adherence ranged from 0.384 to 0.450 (absolute values; mean 0.411). Diabetes Medication System Rating Questionnaire measures differentiated among groups taking different medications and those using different delivery systems for the same medication., Conclusions:   This study suggests that the Diabetes Medication System Rating Questionnaire has good reliability and validity and provides a more comprehensive set of measures than existing medication satisfaction questionnaires., (© 2011 The Authors. Diabetic Medicine © 2011 Diabetes UK.)

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.

Aims: To examine patient and physician beliefs regarding insulin therapy and the degree to which patients adhere to their insulin regimens., Methods: Internet survey of 1250 physicians (600 specialists, 650 primary care physicians) who treat patients with diabetes and telephone survey of 1530 insulin-treated patients (180 with Type 1 diabetes, 1350 with Type 2 diabetes) in China, France, Japan, Germany, Spain, Turkey, the UK or the USA., Results: One third (33.2%) of patients reported insulin omission/non-adherence at least 1 day in the last month, with an average of 3.3 days. Three quarters (72.5%) of physicians report that their typical patient does not take their insulin as prescribed, with a mean of 4.3 days per month of basal insulin omission/non-adherence and 5.7 days per month of prandial insulin omission/non-adherence. Patients and providers indicated the same five most common reasons for insulin omission/non-adherence: too busy; travelling; skipped meals; stress/emotional problems; public embarrassment. Physicians reported low patient success at initiating insulin in a timely fashion and adjusting insulin doses. Most physicians report that many insulin-treated patients do not have adequate glucose control (87.6%) and that they would treat more aggressively if not for concern about hypoglycaemia (75.5%). Although a majority of patients (and physicians) regard insulin treatment as restrictive, more patients see insulin treatment as having positive than negative impacts on their lives., Conclusions: Glucose control is inadequate among insulin-treated patients, in part attributable to insulin omission/non-adherence and lack of dose adjustment. There is a need for insulin regimens that are less restrictive and burdensome with lower risk of hypoglycaemia., (© 2012 The Authors. Diabetic Medicine © 2012 Diabetes UK.)

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.

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.

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.

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.

Background: This study assessed patient-reported outcomes (PRO) for patients with type 2 diabetes treated by insulin pump therapy., Methods: This 16-week, open-label, multicenter study was conducted with adults (averaging 57 years old, 50% women, 68% white non-Hispanic, with duration of diabetes of 13 years) treated at baseline with oral antidiabetes agents (OAD) only (OAD cohort, n = 17), basal insulin with or without OAD (Basal cohort, n = 17), or multiple daily injections (MDI) with or without OAD (MDI cohort, n = 20). All diabetes medications except metformin were discontinued at baseline, and insulin pump therapy was initiated. PRO were measured at baseline and end of study using two measures of health-related quality of life (QOL)--the Diabetes Symptom Checklist-Revised (DSC-R) and the EuroQol-5 Dimensions (EQ-5D)--and a measure of treatment satisfaction--the Insulin Delivery System Rating Questionnaire (IDSRQ)., Results: The combined study population (n = 54) experienced significant reductions in DSC-R total symptoms, as well as a significant increase in the EQ-5D Visual Analog Scale score. The OAD cohort experienced no changes in any QOL measure; the Basal and MDI cohorts each experienced significant improvements in several QOL measures. The combined study population experienced significant improvements in all IDSRQ measures except treatment interference, for which change was not significant. The OAD cohort experienced significant improvements in perceived clinical efficacy and overall treatment preference; the Basal and MDI cohorts each experienced significant improvements in five of the seven IDSRQ measures., Conclusions: Insulin pump therapy improved QOL and treatment preference in patients with type 2 diabetes.

Objective: To determine whether treatment satisfaction and quality of life were affected by adding mealtime pramlintide or rapid-acting insulin analogs (RAIAs) to basal insulin therapy for patients with inadequately controlled type 2 diabetes., Research Design and Methods: In this 24-week open-label, multicenter study of adults with type 2 diabetes, mealtime pramlintide (PRAM) (120 microg fixed dose; n = 56) or titrated RAIAs (n = 56) was added to basal insulin therapy with or without oral antidiabetic medications., Clinical Trial Registration: ClinicalTrials.Gov NCT00467649., Main Outcome Measures: Quality of life (Diabetes Distress Scale - DDS, and Pittsburgh Sleep Quality Index - PSQI), and treatment satisfaction (Diabetes Treatment Satisfaction Questionnaire - DTSQ, and Pramlintide Treatment Satisfaction Questionnaire - PRAM-TSQ) were assessed at baseline and week 24. Mixed-effect models estimated mean group changes from baseline to week 24 (adjusted for baseline scores) in patient reported outcomes., Results: PRAM patients experienced significant improvement in total diabetes distress, while RAIA patients did not; both groups experienced significant improvement in regimen-related distress and physician-related distress. Between-group differences in DDS measures were not significant. PRAM patients experienced significant improvement in sleep latency and daytime dysfunction, while RAIA patients did not; the difference between groups was significant for daytime dysfunction. Both treatment groups experienced significant improvement in most individual DTSQ items and total diabetes treatment satisfaction, while only PRAM patients experienced significant improvement in perceived hypoglycemia. Between-group differences in DTSQ measures were not significant. Both treatment groups experienced significant improvement in most individual PRAM-TSQ items and total treatment satisfaction; RAIA patients experienced increased eating flexibility and reduced perceived weight control. PRAM patients experienced significantly better perceived weight and appetite control than RAIA patients., Limitations: The sample size was relatively small and there were few non-white subjects. The schedule for implementation of change in therapy may have affected study outcomes., Conclusions: Adding pramlintide on a background of basal insulin improved some aspects of treatment satisfaction and quality of life relative to adding rapid-acting insulin analogs.

Type 2 diabetes is progressive in nature and many people with the condition will inevitably require insulin therapy to attain and maintain adequate glycaemic control. In clinical practice, insulin initiation is delayed in many patients who would benefit from such treatment. Patients' and physicians' beliefs and perceptions regarding insulin therapy are known to create barriers contributing to the delay in its initiation. This article explores the nature of these barriers and offers suggestions and practical solutions for addressing and overcoming these hurdles so that insulin can be initiated confidently and appropriately in order to improve diabetes care., (2010 Primary Care Diabetes Europe. Published by Elsevier Ltd.. All rights reserved.)

Background: Along with general measures of treatment satisfaction, treatment-specific and device-specific treatment satisfaction should be assessed in clinical trials, because these latter measures may be more strongly correlated with clinical outcomes., Methods: Study participants were 1076 adults (type 1 = 509, type 2 = 567) in clinical trials of Technosphere Insulin(R), who completed the SF-36 health-related quality of life questionnaire and the Inhaled Insulin Treatment Questionnaire (IITQ), a new instrument assessing diabetes worries, perceptions of insulin therapy, treatment satisfaction, treatment preference, and inhaler performance. The IITQ was administered twice prior to treatment initiation in the clinical trials, 1-2 weeks apart, and several times during the trials. Inhaler performance was assessed at follow-up visits, after participants had used the device., Results: IITQ subscales had acceptable reliability (alpha = 0.68-0.87, median 0.83) and test-retest correlations (intra-class correlation coefficient = 0.67-0.90, median 0.82); floor effects (0.2-2.8%) and ceiling effects (0-9.3%) were minimal. Reliabilities for inhaler performance measures were acceptable (alpha = 0.73-0.90, median 0.85); there were no floor effects (0.0%) and ceiling effects (4.9-39.0%) were moderate. There were several modest associations between IITQ scores and measures of health status. Diabetes worries were lower for participants who had better mental health (type 2) and for those with higher BMI; perceptions of insulin therapy were more favorable for participants who had better physical and mental health; treatment satisfaction was higher for patients who had lower BMI (type 2), lower A1c levels, and better physical health (type 2); treatment preference was higher for patients with lower BMI (type 2) and better mental health (type 1). CONCLUSIONS -: Preliminary findings suggest that the IITQ is a comprehensive, reliable measure of the experience of patients treated with inhaled insulin.

Background: Little is known about how the most advanced technology affects treatment satisfaction and health-related quality of life (HRQOL) in adults with diabetes. This study was designed to assess treatment satisfaction and HRQOL among users of an integrated real-time (RT) continuous glucose monitoring (CGM)/continuous subcutaneous insulin infusion (CSII) system compared with those using self-monitoring of blood glucose (SMBG) with CSII., Methods: Participants were 311 adult respondents to an Internet survey, 162 using RT-CGM/CSII, 149 using SMBG + CSII (median age 43 years; type 1 diabetes 94%; diabetes duration >15 years 61%; median insulin use 15 years). Respondents completed instruments assessing glucose monitoring system and insulin delivery system convenience, interference, burden, glucose control efficacy, cost satisfaction, overall satisfaction, and treatment preference, as well as quality of life (diabetes-related worries, social burden, and psychological well-being). Real-time CGM/CSII users also assessed specific elements of the RT-CGM/CSII system. Group differences were assessed using analysis of covariance controlling for respondent characteristics., Results: The RT-CGM/CSII group gave significantly better ratings than the SMBG + CSII group for their glucose monitoring system's glucose control efficacy, overall satisfaction, desire to switch, and willingness to recommend, and significantly worse ratings for interference with daily activities. The RT-CGM/CSII group gave significantly better ratings than the SMBG + CSII group for their insulin delivery system's convenience and glucose control efficacy, overall satisfaction, desire to switch, and willingness to recommend. Real-time CGM/CSII users gave positive ratings of all system features., Conclusions: Users of the integrated RT-CGM/CSII system reported more benefits of treatment, higher treatment satisfaction and quality of life, and greater preference for this system than SMBG + CSII users.

OBJECTIVE This study tested a model hypothesizing that treatment affects objective clinical outcomes, which in turn affect perceived consequences, which in turn affect satisfaction and preference judgments. RESEARCH DESIGN AND METHODS The model was tested in a double-blind, randomized clinical trial in which 266 patients with type 1 diabetes added active or placebo pramlintide to their insulin regimens. Objective clinical outcomes included changes in glucose and weight control, insulin requirements, incidence of hypoglycemia, and study drug tolerance. At the end of the trial, patients completed the validated PRAM-TSQ questionnaire measuring treatment satisfaction and preference and perceived medication benefits and side effects. RESULTS Statistical modeling demonstrated that active pramlintide was significantly associated with greater treatment satisfaction, preference, and perceived benefits (all except hypoglycemia prevention), as well as objective clinical outcomes (weight loss, lower postprandial glucose [PPG], lower medication tolerance, more hypoglycemia). Perceptions of treatment consequences were sensitive and specific to their cognate objective clinical outcomes (no halo effects). Clinical outcomes (especially PPG) accounted for almost half of the effect of the study medication on treatment satisfaction and preference. Treatment satisfaction and preference were strongly related to the perceived benefits/side effects of the study medication, and these perceptions (especially glucose control) mediated most of the association of clinical outcomes with satisfaction and preference. CONCLUSIONS This model received substantial empirical support. Improvements in objective clinical outcomes accounted for a large part of the association of pramlintide treatment with higher treatment satisfaction and preference. Perceived treatment consequences mediated the effect of objective clinical benefits on satisfaction with and preference for the study medication.

Aims: To assess treatment satisfaction and weight-related quality of life (QOL) in subjects with Type 2 diabetes treated with exenatide once weekly (QW) or twice daily (BID)., Methods: In this 52-week randomized, multi-centre, open-label study, 295 subjects managed with diet and exercise and/or oral glucose-lowering medications received either exenatide QW or BID during weeks 1-30; thereafter, subjects receiving exenatide BID were switched to exenatide QW, with 258 total subjects receiving exenatide QW during weeks 30-52. Diabetes Treatment Satisfaction Questionnaire-status (DTSQ-s) and Impact of Weight on Quality of Life-Lite (IWQOL-Lite) were assessed at baseline and weeks 30 and 52. Mean group changes from baseline to week 30 were estimated by ancova; changes from week 30 to week 52 were assessed by Student's t-test., Results: Statistically significant improvements from baseline to week 30 were observed in both treatment groups for DTSQ-s and IWQOL-Lite measures, with significantly greater reduction in perceived frequency of hyperglycaemia and greater satisfaction with continuing treatment in the QW group compared with the BID group. Effect sizes for change in DTSQ-s total scores were 0.84 QW, 0.64 BID; for IWQOL-Lite: 0.96 QW, 0.82 BID. Treatment satisfaction and QOL improved significantly between weeks 30 and 52 for those switching from BID to QW. Occurrence of adverse events did not affect patients' improvements in treatment satisfaction and QOL., Conclusions: Patients treated with exenatide QW or BID experienced significant and clinically meaningful improvements in treatment satisfaction and QOL. Patients who switched from exenatide BID to exenatide QW administration reported further significant improvements.

Background: The clinical benefits of any new treatment depend substantially on patient acceptance and treatment satisfaction, because only well-accepted treatments will be widely used. Thus, it is important to understand how patients experience a new treatment., Objective: This study assessed the psychometric properties of a questionnaire (PRAM-TSQ) designed to measure treatment satisfaction in patients using pramlintide (an analog of amylin, a glucoregulatory hormone co-secreted with insulin), which is designed to improve glucose control., Methods: Patients with diabetes completed the 14-item PRAM-TSQ at the end of 2 separate placebo-controlled, double-blind, randomized clinical trials in which they added active or placebo pramlintide to their established insulin regimen. Factor analysis was used to assess item clustering for the PRAM-TSQ, and the Cronbach's alpha measure of inter-item agreement was used to assess scale reliability. PRAM-TSQ validity was assessed by comparing scores between treatment arms, and effect sizes were measured by the eta statistic. Validity was also assessed by associations (Pearson correlations) between the PRAM-TSQ and clinical study outcomes (end of study values and during study changes in clinical measures: postprandial glucose [PPG], A1C, weight, and insulin requirements)., Results: Scaling revealed 4 PRAM-TSQ components: Global Benefits, Specific Benefits, Absence of Side Effects, Treatment Preference. The total composite PRAM-TSQ had good reliability in both studies (type 1 alpha = .93; type 2 alpha = .94); subscale reliabilities ranged from .65 to 94. Composite scores differed for pramlintide-treated and placebo-treated patients (type 1 P < .01; type 2 P < .05), and were associated with lower PPG, weight, and insulin requirements (all P < .05). Results were similar for PRAM-TSQ subscales assessing Global Benefits and Treatment Preference; Specific Benefits subscale scores were associated with lower PPG and weight (all P < .05)., Conclusions: The PRAM-TSQ shows evidence of being a valid, reliable instrument for assessing treatment satisfaction in patients using pramlintide. The subscales are comprehensive and sensitive to the known potential effects of pramlintide treatment. Diabetes educators can use patient responses to the PRAM-TSQ to facilitate treatment adherence by reminding patients of treatment benefits they experience and by helping patients overcome negative effects they report.

Objective: This study was designed to assess diabetes-related distress and its association with clinical outcomes in patients with type 2 diabetes using basal insulin who were treated with pramlintide., Methods: In a 16-week, double-blind, placebo-controlled study 211 patients using insulin glargine with or without oral antidiabetes agents were randomized to addition of pramlintide or placebo. Clinical outcomes (change in A1C, postprandial glucose, daily basal insulin dose, and weight) and during-trial hypoglycemia were assessed, along with the Diabetes Distress Scale (DDS). The DDS assesses overall diabetes distress and four subdomains: regimen distress (RD), emotional burden (EB), interpersonal distress (ID), and physician-related distress (PD). Hierarchical, stepwise multiple regression was used to assess the association of clinical outcomes and during-trial hypoglycemia with DDS score changes during the study., Results: Pramlintide use was associated with a significant reduction in total DDS and RD, but only among those above the median of distress at baseline. Across treatment groups, reduction in basal insulin dose was linked to a drop in total DDS, RD, EB, and ID, reduction in postprandial glucose was associated with reduced total DDS and ID, and reduction in A1C was associated with reduced EB and RD. PD was not associated with hypoglycemia or any clinical outcome. Reduction in weight and incidence of hypoglycemia were not associated with any DDS measure., Conclusions: Pramlintide use reduced diabetes-related distress among those with high levels of distress at baseline, and better clinical outcomes were associated with improvements in several domains of diabetes-related distress. Efforts should be made to enhance these potential benefits of treatment.

Objective: To assess the association between elevated depression symptoms or antidepressant medicine use on entry to the Diabetes Prevention Program (DPP) and during the study and the risk of developing diabetes during the study., Research Design and Methods: DPP participants (n = 3,187) in three treatment arms (intensive lifestyle [ILS], metformin [MET], and placebo [PLB]) completed the Beck Depression Inventory (BDI) and reported their use of antidepressant medication at randomization and throughout the study (average duration in study 3.2 years)., Results: When other factors associated with the risk of developing diabetes were controlled, elevated BDI scores at baseline or during the study were not associated with diabetes risk in any arm. Baseline antidepressant use was associated with diabetes risk in the PLB (hazard ratio 2.25 [95% CI 1.38-3.66]) and ILS (3.48 [1.93-6.28]) arms. Continuous antidepressant use during the study (compared with no use) was also associated with diabetes risk in the same arms (PLB 2.60 [1.37-4.94]; ILS 3.39 [1.61-7.13]), as was intermittent antidepressant use during the study in the ILS arm (2.07 [1.18-3.62]). Among MET arm participants, antidepressant use was not associated with developing diabetes., Conclusions: A strong and statistically significant association between antidepressant use and diabetes risk in the PLB and ILS arms was not accounted for by measured confounders or mediators. If future research finds that antidepressant use independently predicts diabetes risk, efforts to minimize the negative effects of antidepressant agents on glycemic control should be pursued.

Objective: This study was designed to assess treatment satisfaction in patients using pramlintide who had not previously achieved glycemic targets with insulin therapy alone. Assessment included the association between treatment satisfaction and clinical outcomes (changes in post-prandial glucose [PPG], glycosylated hemoglobin [HbA(1c)], weight, and insulin requirements)., Research Design and Methods: In this open-label study 240 participants with type 1 diabetes and 160 participants with type 2 diabetes added pramlintide to their established insulin regimen. Mealtime insulin doses were subsequently adjusted to optimize glycemic control., Main Outcome Measures: Seven-point glucose profiles, weight, and insulin requirements were obtained at baseline and months 1, 3, and 6; HbA(1c) levels were obtained at baseline and months 3 and 6. Participants completed a treatment satisfaction questionnaire (TSQ) at months 1, 3, and 6., Results: Participants rated the study treatment regimen including pramlintide significantly (p < 0.001) superior to their pre-study regimens in terms of 'glucose control', 'eating-weight control', and 'general benefits' at all three TSQ administrations. Regression analysis of treatment satisfaction at 6 months revealed several independent predictors (p < 0.05). Participants who were able to reach the maximum dosage of pramlintide per protocol, and those who experienced more reduction in PPG and insulin requirements during the study, reported higher satisfaction with glucose control and general benefits; those who lost more weight reported higher treatment satisfaction on all three TSQ measurements., Conclusions: Greater satisfaction with the study regimen was reported on all treatment satisfaction factors at all three TSQ administrations, with all advantages representing large treatment effects. Treatment satisfaction was higher for patients who experienced better clinical outcomes (decreases in weight, insulin dose requirements, and PPG levels). Study limitations include the fact this was an open-label study.

Objective: To examine the correlates of patient and provider attitudes toward insulin therapy., Research Design and Methods: Data are from surveys of patients with type 2 diabetes not taking insulin (n = 2,061) and diabetes care providers (nurses = 1,109; physicians = 2,681) in 13 countries in Asia, Australia, Europe, and North America. Multiple regression analysis is used to identify correlates of attitudes toward insulin therapy among patients, physicians, and nurses., Results: Patient and provider attitudes differ significantly across countries, controlling for individual characteristics. Patients rate the clinical efficacy of insulin as low and would blame themselves if they had to start insulin therapy. Self-blame is significantly lower among those who have better diet and exercise adherence and less diabetes-related distress. Patients who are not managing their diabetes well (poor perceived control, more complications, and diabetes-related distress) are significantly more likely to see insulin therapy as potentially beneficial. Most nurses and general practitioners (50-55%) delay insulin therapy until absolutely necessary, but specialists and opinion leaders are less likely to do so. Delay of insulin therapy is significantly less likely when physicians and nurses see their patients as more adherent to medication or appointment regimens, view insulin as more efficacious, and when they are less likely to delay oral diabetes medications., Conclusions: Patient and provider resistance to insulin therapy is substantial, and for providers it is part of a larger pattern of reluctance to prescribe blood glucose-lowering medication. Interventions to facilitate timely initiation of insulin therapy will need to address factors associated with this resistance.

Aims To conduct a second Diabetes Attitudes, Wishes and Needs ( DAWN2™) study, examining the experiences of family members caring for adults with diabetes in order to identify correlates of family member psychological outcomes (generic psychological well-being, perceived quality of life, and diabetes-related burden, impact and distress). Methods A total of 2057 family members living with a person with diabetes and involved in their care participated in an online, telephone or in-person survey. Samples of 120 respondents were recruited in each of 17 countries. Significant ( P < 0.05) correlates of psychological outcomes were identified by multi-level multiple regression. Results Outcomes were worse for family members not working because of diabetes or those who had other competing obligations. Outcomes were worse if the person with diabetes was not a partner or parent, used injected diabetes medication, or had more frequent hypoglycaemia. Outcomes were worse for family members who believed that diabetes was more severe, were more involved in diabetes care, had more conflict over diabetes care or were frustrated about not knowing how to help the person with diabetes. Outcomes were better for those who had greater support from others and felt they found good ways to help the person with diabetes. There were significant differences in outcomes among countries before and after adjustment for individual characteristics, and correlates of outcomes varied by country. Conclusions Several modifiable risk and protective factors for family member psychological outcomes were identified in this study. Diabetes education and social support were associated with improved outcomes, especially if they were helpful in supporting people with diabetes. [ABSTRACT FROM AUTHOR]