Diabetes Worry Research Articles

South Asian Muslim individuals’ lived experiences of Type 2 Diabetes healthcare – ‘I just want someone to actually break it down for me’

Objective Type 2 Diabetes is highly prevalent across Aotearoa New Zealand, and South Asian people have a disproportionately high burden of disease. This research aimed to improve understanding of South Asian Muslim people’s experiences navigating New Zealand’s diabetes healthcare to promote cultural responsiveness and equitable outcomes. Method We conducted semi-structured interviews with 10 South Asian Muslim individuals with Type 2 Diabetes. Interviews explored how participants made sense of their diabetes in relational and cultural contexts, and the healthcare barriers and facilitators they experienced. Reflexive thematic analysis was used to develop themes from the interview transcripts. Results Three key themes were developed: the feeling, managing, and reflecting on diabetes worry in relational contexts; the cultural and relational challenges of enacting self-control and discipline; and how diabetes is a family experience, for better or for worse. Conclusion These themes illustrated the multifaceted relational dynamics of navigating diabetes healthcare. Several avenues to consider for developing culturally sensitive diabetes care were suggested. This included: practitioners exploring dynamics of worry, shame and self-blame, building upon family supports, supporting reducing family-facilitated health barriers, addressing power dynamics which facilitate institutional distrust, and funding culturally appropriate, accessible community health interventions.

An Evidence-Based Nurse-Led Intervention to Reduce Diabetes Distress Among Adults With Type 1 Diabetes and Diabetes Distress (REDUCE): Development of a Complex Intervention Using Qualitative Methods Informed by the Medical Research Council Framework.

Diabetes distress refers to the negative emotional reaction to living with the demands of diabetes; it occurs in >40% of adults with type 1 diabetes (T1D). However, no interventions to reduce diabetes distress are specifically designed to be an integral part of diabetes care. This study aims to modify and adapt existing evidence-based methods into a nurse-led group intervention to reduce diabetes distress among adults with T1D and moderate to severe diabetes distress. The overall framework of this study was informed by the initial phase of the Medical Research Council's complex intervention framework that focused on undertaking intervention identification and development to guide the adaptation of the intervention. This study took place at 2 specialized diabetes centers in Denmark from November 2019 to June 2021. A total of 36 adults with T1D participated in 10 parallel workshops. A total of 12 diabetes-specialized nurses were interviewed and participated in 1 cocreation workshop; 12 multidisciplinary specialists, including psychologists, educational specialists, and researchers, participated in 4 cocreation workshops and 14 feedback meetings. Data were analyzed by applying a deductive analytic approach. The intervention included 5 biweekly 2.5-hour small group sessions involving adults with T1D and diabetes distress. Guided by a detailed step-by-step manual, the intervention was delivered by 2 trained diabetes specialist nurses. The intervention material included visual conversation tools covering seven diabetes-specific sources derived from the 28-item Type 1 Diabetes Distress Scale for measuring diabetes distress: (1) powerlessness, (2) self-management, (3) fear of hypoglycemia, (4) food and eating, (5) friends and family, (6) negative social perception, and (7) physician distress. The tools are designed to kick-start awareness and sharing of diabetes-specific challenges and strengths, individual reflections, as well as plenary and peer-to-peer discussions about strategies to manage diabetes distress, providing new perspectives on diabetes worries and strategies to overcome negative emotions. Diabetes specialist nurses expressed a need for a manual with descriptions of methods and detailed guidelines for using the tools. To deliver the intervention, nurses need increased knowledge about diabetes distress, how to support diabetes distress reduction, and training and supervision to improve skills. This co-design study describes the adaptation of a complex intervention with a strong evidence base, including detailed reporting of the theoretical underpinnings and core mechanisms.

Diabetes-related distress and quality of life among people with type 2 diabetes at primary care level in Brazil.

Living with diabetes can be challenging, particularly when it comes to dealing with psychological distress and requiring self-care directives. Patients may feel frustrated, angry, overwhelmed, and discouraged. This study aimed to investigate the diabetes-related distress and quality of life among people with type 2 diabetes mellitus (T2DM). A cross-sectional study carried out at the Clinical Research Centre at the University of Campinas, Brazil, between September 2020 and April 2021. Patients answered data regarding demographic and clinical variables, the Brazilian version of the Diabetes Distress Scale and the Diabetes Quality of Life (QOL) Measure by telephone contact. The data were managed using the RedCap System. For statistical analysis of the data, the Mann-Whitney and Kruskal-Wallis tests were applied for comparisons, and the Chi-square test for associations. The correlations were evaluated using the Spearman correlation coefficient. Out of the 302 participants we recruited, 50.33% exhibited significant diabetes-related distress. Those with elevated diabetes-related distress scores had shorter education levels (p < 0.05), lower HbA1c levels (p < 0.05), and lower total scores in Diabetes QOL Measure (p < 0.0001), particularly in the QOL impact (p < 0.0001), social/vocational worry (p < 0.05), and diabetes worry (p < 0.0001) subscales compared to the group with the lowest diabetes-related distress. Elevated diabetes-related stress scores significantly affect patients' QOL. Therefore, early screening of individuals at risk for this condition, using well-coordinated protocols, could mitigate adverse QOL effects and enhance their overall experience during disease management.

COVID-19-specific worries among people with type 2 diabetes following the continuation of the pandemic and occurrence of multiple waves of COVID-19 in Iran.

PurposeTo assess COVID-19-specific diabetes worries, and to determine characteristics of people with high levels of these worries among people with type 2 diabetes (T2D) following the continuation of the pandemic and occurrence of multiple waves of COVID-19 in Iran.MethodsAn interviewer-based, cross-sectional study was conducted using 500 T2D people in a diabetes specialty clinic. The questionnaire package comprised five parts: sociodemographic and clinical characteristics, COVID-19-specific worries, diabetes-related distress, feelings of isolation and changes in diabetes-specific behaviors. Clinical history and serum measurements were collected from electronic medical records. Descriptive statistics and logistic regressions were performed in the study.ResultsWorries related to COVID-19 pandemic were highly prevalent in T2D people. Around 60% were worried about being severely affected due to diabetes if infected with COVID-19 and being described as a high-risk group for COVID-19, and more than half about being possibly faced with lack of diabetes medications. Logistic regressions demonstrated that being female, higher age, diabetes-related complications, duration of diabetes, insulin use, feeling isolation, diabetes-related distress and having changed self-management behaviors were associated with being more worried about diabetes and COVID-19.ConclusionDiabetes-related worries relating to the COVID-19 were strongly associated with poorer psychosocial status. Findings emphasize the importance of conveying up-to-date information regarding diabetes and COVID-19 that patients want and need to know, also of providing emotional support associated with COVID-19-specific diabetes worries.

COVID-19-specific diabetes worries amongst diabetic patients: The role of social support and other co-variates

BackgroundThe COVID-19 pandemic has impacted every individual’s life. It has been shown that mortality in people with underlying diseases including diabetes has been very high. The present study aimed to measure diabetes related worries (outcome) and their associations with social support and lifestyle (exposures) amongst people with diabetes during the COVID-19 pandemic. MethodsAn online cross-sectional survey was completed by 928 respondents (>18 years) between 15-11-2020 and 12-12-2020. The questionnaire comprised four sections: socio-demographic details, diabetic-related worries, social support, and behavioral changes due to COVID-19. Descriptive statistics, correlations and hierarchical regression analysis were performed in the study. ResultsData from 928 respondents (51.61% male; mean age = 52.48 [SD = 11.76]; age range = 18–86 years) were analyzed. The mean score for COVID-19 specific diabetes worries was 3.13 out of 8. Hierarchical regression analysis showed that the mean COVID-19-specific diabetes worries score was significantly associated with lower age, cigarette smoking, perceived poor health status, presence of other diabetic complications. Lack of social support from family, friends, work colleagues and diabetes care team and also eating more than usual were also significantly associated with COVID-19 specific diabetes worry. ConclusionsDiabetes related worries were strongly associated with a lack of social support during the COVID-19 pandemic. The findings suggest the need of social support as well as improving knowledge and guidelines is important for people with diabetes during the COVID-19 pandemic.

Effect of Disclosure on Receiving Spousal Support in Korean Immigrants With Type 2 Diabetes.

The purpose of this study was to investigate factors associated with receiving diabetes spousal support in a sample of Korean immigrants with type 2 diabetes (T2DM) and to test whether disclosure (culture-specific factor) is a significant predictor of spousal support receipt in this group. A cross-sectional survey was conducted with a convenience sample of 136 US community-dwelling Korean immigrants with T2DM ages 46 to 89 years old. Potential predictors were sociodemographic factors (age, gender, education, years in US), personal characteristics (quality of marriage and depression), diabetes severity (duration of diabetes, A1C, insulin use), diabetes self-management, diabetes worries/concerns (psychological factor), and disclosure of worries (cultural factor). The study used validated survey instruments including Diabetes Care Profile for spousal support received, Summary of Diabetes Self-Care Activities, Problem Area in Diabetes, and Diabetes Distress Disclosure Index. Descriptive statistics, correlations, and hierarchical multivariable linear regression models were conducted. Six predictors (education level, years spent in the US, glucose control status, diabetes self-management level, diabetes worries/concerns, and disclosure of diabetes worries) were significantly related to receiving spousal support. At least some college education, less time in the US, better glucose control (lower A1C), poor self-management, more diabetes worries, and more disclosure of diabetes worries/distress were associated with receiving higher level of spousal support. Disclosure was the strongest predictor. Receiving spousal support for diabetes self-management among Korean immigrants is influenced by 6 factors identified in this study. Disclosing diabetes worries (cultural factor) is most impactful.

The MiniMed™ 670G Hybrid Closed-Loop (HCL) System and Patient-Reported Outcomes Concerning Quality of Life Measures

Patient-reported outcomes are important in assessing the impact of new diabetes therapies on patient perceptions of quality of life (QoL). The QoL of patients using the Medtronic MiniMed™ 670G HCL system with SmartGuard™ technology, released for commercial use in March 2017, was examined. MiniMed™ 670G HCL system users (n=198) completed the validated Diabetes-39 (D-39) questionnaire prior to starting HCL system therapy and at 3-4 months post start. QoL was evaluated on a 7-point scale (1=Not Affected at All to 7=Extremely Affected) across 5 categories: energy and mobility, diabetes control, anxiety and worry, social burden, and sexual functioning. Paired t-test was used to compare the mean score for each attribute, and a two-tailed t-test determined statistical significance from baseline to 3-4 months after MiniMed™ 670G system use. All patients had responses indicating a positive experience after use of the system in Auto Mode. For all 5 categories, 160/198 patients (81%) experienced an outcome in the positive direction. The Table shows the top 10 criteria in which statistically significant improvement was observed. In addition to the previously reported improvements in glycemic control,1 these findings suggest that the MiniMed™ 670G system improves multiple domains in self-reported QoL measures, and particularly those concerning adherence to diabetes management. Disclosure S. Gopalakrishnan: Employee; Self; Medtronic. C. Fogel: Employee; Self; Medtronic. J. Mueckler: Employee; Self; Medtronic MiniMed, Inc..

Comparing diabetes mellitus risk perception among patients followed in primary and specialized healthcare: A cross-sectional study in Vaud, Switzerland

Purpose: The purpose of this study is to 1) evaluate perceived risk for diabetes among type 2 diabetes patients with different types of diabetes follow-up: diabetologist, general practitioner, or both (“combined follow-up”) in the community and university settings and 2) determine the prognostic factors for better/ higher risk perception of diabetes among these patients. Methods: In this cross-sectional study, we quantified diabetes risk perception using Walker’s RPS-DM survey. The PRIME-MD PHQ questionnaire was used to screen for mood and anxiety disorders. The global risk perception scores were coded in two categories (low/high) and compared across the various types of medical follow-up; univariate and multivariate logistic regression techniques were used to examine the association between perceived risk, patients’ sociodemographic factors, diabetes characteristics and psychological profile. Results: Univariate analysis in logistic regression showed that having combined diabetes follow-up in the university setting was significantly associated with higher composite risk perception (OR=14; 95% CI 3.56-55.05) compared to patients with either single provider type follow-up. Specifically, combined follow- up, was linked to diabetes worry (OR=6.45; 95% CI 1.68-24.7), but also higher perceived risk for diabetes complications (OR=3.55; 95% CI 1.12-11.2). These analyses also showed that perceived risk for diabetes complications was associated with longer diabetes duration (OR=1.05; 95% CI 1.01-1.09), higher number of drug therapies (OR=1.35; 95% CI 1.08-1.69), increased microvascular complications (OR=1.47; 95% CI 1.03- 2.10) and increased vascular complications (OR=1.31; 95% CI 1.02-1.71). Conclusions: Having combined follow-up in the same medical institution increases a patient’s perceived risk of the complications of his/her diabetic illness. Having a more accurate self-perception of potential diabetic complications may help patients make healthier and informed lifestyle choices. Future studies should further examine the association between combined provider follow-up and risk perception, and focus on how patient-provider relationships and follow-up impact diabetic patient outcomes.

Glycaemic control and quality of life among ethnically diverse Malaysian diabetic patients

To assess the relationship between glycaemic control and quality of life (QoL) among a sample of Malaysians with type 2 diabetes mellitus. This study is a cross-sectional hospital-based study involving 256 patients from three major ethnic groups in Malaysia. Data about QoL were collected with the 18-item Audit of Diabetes Dependent QoL questionnaire. Other data about putative predictors of QoL including personal characteristics and disease-related factors were also collected. Hierarchical multiple linear regression was used to determine factors associated with QoL and to control for confounding variables. The mean age of participants was 56.79 years. Participants were mostly women, employed and married and had attained secondary education. More than a third of the patients had a disease duration of more than 10 years, and about two-thirds had HbA1c ≥ 6.5 %. Those with desired glycaemic control had poorer QoL than those with less than desired glycaemic control moderated by the use of insulin. Hierarchical multiple linear regression showed that desired glycaemic control (HbA1c), diabetes worry, use of insulin, more than 10 years' duration of diabetes, neuropathy and retinopathy were associated with poor QoL, whereas being satisfied with waiting time for consultation was associated with better QoL. The results of this study show that diabetes was associated with negative impact on quality of life. The use of insulin to achieve desired glycaemic control was particularly associated with negative impact on QoL.

Psychometric analysis of the Spanish and Catalan versions of the Diabetes Self-Care Inventory-Revised version questionnaire

BackgroundThe purpose of this study was to validate the Spanish and Catalan versions of the Diabetes Self-Care Inventory-Revised Version (SCI-R) questionnaire to assess the degree of adherence to self-care among adults with diabetes.MethodsWe validated the Spanish and Catalan translation from, and back translation to, English and cultural adaptation of the SCI-R in type 1 diabetes patients on multiple insulin doses or continuous subcutaneous insulin infusion and in type 2 diabetes patients on oral agents and/or insulin. Internal reliability, structural validity, and external validity (correlation with glycated hemoglobin) were evaluated. Responsiveness to change was assessed in patients 1 year after onset of type 1 diabetes and following a structured education program.ResultsThe SCI-R presented good internal reliability Cronbach’s α: 0.75, test-retest reliability (r = 0.82) and structural validity (r > 0.40). The external validity was also good; the SCI-R correlated with HbA1c in patients with type 1 diabetes on multiple insulin doses (r = −0.50) or continuous subcutaneous insulin infusion (r = −0.66) and in patients with type 2 diabetes on multiple insulin doses (r = −0.62). However, it was not satisfactory in patients on oral agents (r = −0.20) and/or bedtime insulin (r = −0.35). Responsiveness to change was analyzed in 54 patients (age 27.3±7.4 years, 26% men, HbA1c 6.8% ±1.1%); the SCI-R score was 72.3% ±13.7% and correlated negatively with glycated hemoglobin (r = −0.42) and 3 scales of the Diabetes Quality of Life questionnaire (lower score indicating better perception): Impact (r = −0.37), Social Worry (r = −0.36) and Diabetes Worry (r = −0.38), all at P < 0.05.ConclusionThe Spanish and Catalan versions of the SCI-R questionnaire show good psychometric properties and both could be considered as useful tools for evaluating self-care behavior in patients with type 1 or type 2 diabetes. However, there are still some subgroups of patients with type 2 diabetes in which the validity of this questionnaire needs further evaluation.

Health-related quality of life and treatment preferences in adolescents with type 1 diabetes. The VIPKIDS study

A multi-centre, observational, cross-sectional study was carried out to determine whether the health-related quality of life (HRQOL) of adolescents with type 1 diabetes is affected by different insulin treatment systems, and which features of HRQOL are impacted by the respective insulin treatment. The study regarded 577 adolescents, aged 10-17 years, with type 1 diabetes treated with continuous subcutaneous insulin infusion (CSII) (n = 306) or multiple daily injections (MDI) (n = 271). The Insulin Delivery System Rating Questionnaire was validated in Italian and was self-completed by the subjects during a routine visit to the centres. Subjects were compared following the domains of the questionnaire. Good HRQOL was seen in subjects treated with either MDI or CSII. Significant differences were not found in the domains for general diabetes, including diabetes worries, social burden and psychological well-being. Multiple quantile regression analysis showed that CSII confers significant advantages in terms of HRQOL with improvements in treatment satisfaction, perceived clinical efficacy and reduction in treatment interference with daily activities. This favourable impact was more evident in subjects reporting lower HRQOL scores, suggesting that CSII may be especially useful for individuals perceiving a poor HRQOL. Analysis of the domains indicated that CSII was associated with a higher HRQOL than MDI. Life-course HRQOL evaluation using a standardised questionnaire can ensure better chronic disease management. This is particularly important when providing individualised care for adolescents, as they become increasingly responsible for managing their diabetes.

Treatment satisfaction in the Sensor‐Augmented Pump Therapy for A1C Reduction 3 (STAR 3) trial

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. 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. 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. 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.

Patient-Reported Outcomes in Adults with Type 2 Diabetes Using Mealtime Inhaled Technosphere Insulin and Basal Insulin Versus Premixed Insulin

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. 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. 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. 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.

Effect of short‐term intensive insulin therapy on quality of life in type 2 diabetes

Short-term intensive insulin therapy (IIT) early in the course of type 2 diabetes can improve pancreatic beta-cell function and even induce normoglycemia that persists post-therapy. In spite of this benefit, insulin is often delayed until late in the course of disease partly because of its perceived negative impact on quality of life (QOL). Therefore, we sought to examine the effect of early implementation of short-term IIT on patient-reported QOL and treatment satisfaction. A total of 34 patients with type 2 diabetes (5.9 ± 6.6 years duration, on zero to two oral antihyperglycaemic agents) underwent 4-8 weeks of IIT consisting of basal detemir and pre-meal insulin aspart. Patient-reported QOL, treatment satisfaction and symptom distress were assessed at baseline and post-IIT using the Medical Outcomes Study 36-item Short-Form Health Survey (SF-36), Diabetes Quality of Life Measure (DQOL), and Diabetes Symptoms Checklist-Revised (DSC-R). There was a significant improvement in glycated haemoglobin post-IIT (mean 6.5% vs. 7%; P < 0.001). All 34 patients tolerated IIT well with no severe hypoglycaemia. Following IIT, the SF-36 showed a significant improvement compared to baseline in reported physical functioning (mean 88.2 vs. 83.3, P = 0.009), general health (69.4 vs. 65.6, P = 0.03), and general mental health (85.2 vs. 82.2, P = 0.04). The DQOL demonstrated a significant improvement in global health perception (P = 0.02), diabetes worry (P = 0.006) and treatment satisfaction (P = 0.007). The DSC-R revealed a significant improvement in the diabetes-related total symptom score (P = 0.01). Contrary to popular perception, a short course of IIT resulted in significant improvements in QOL and treatment satisfaction, demonstrating the patient acceptability of early insulin therapy.

Built Environment Factors, Psychosocial Factors and Diabetes Mellitus: A South Indian Study

We assessed the contribution of selected built environment factors to body weight in a pilot study in urban Visakhapatnam, South India. Participants were 123 men and 60 women (age 16 to 69 years; BMI 17.3–30.5) who had lived in the area for at least 3 years. Individuals with lower BMI tended to be (a) working people (non-home based–-working away from home), (b) non-vegetarians, (c) physically active (activity mostly related to work), and (d) taking afternoon siestas. Psychological stress, quality of life and wellbeing data were used from an earlier study of individuals with diabetes mellitus. The measures included were depression, anxiety, energy, positive wellbeing, satisfaction, impact, and social worry and diabetes worry (Diabetes quality of life). Guttman's Smallest Space Analysis (SSA) suggested the relationships among the psychosocial measures can be accounted for by one facet with three axial sets of variables (a) positive wellbeing and energy, (b) satisfaction, impact, and social worry and diabetes worry, and (c) anxiety and depression. SSAs on male participants suggested that fasting blood glucose and weight were most closely associated with anxiety and energy levels. In female participants, weight and fasting glucose were most closely associated with energy and to a somewhat lesser extent with anxiety. In both sexes, age was closely associated with positive wellbeing. Also in both sexes, age, weight, and fasting glucose levels were closely associated with each other. The results support the importance of understanding the impact of built environment and psychosocial factors on body weight in diabetic individuals for designing prevention strategies.

Effect of Technosphere Inhaled Insulin on Quality of Life and Treatment Satisfaction

This randomized controlled trial assessed the impact of Technosphere insulin (MannKind Corp., Valencia, CA) delivered via the MedTone inhaler (MannKind Corp.) on quality of life and treatment satisfaction in adults with type 2 diabetes. Subjects were 119 insulin-naive subjects with starting hemoglobin A1c >6.5%: 58 in the active inhaled insulin arm and 61 in the inhaled placebo arm (67% male; mean age 55 years; mean duration of diagnosed diabetes 7 years). Subjects completed a measure of health-related quality of life (the SF-36) and a measure of treatment satisfaction (the Insulin Treatment Questionnaire [ITQ]) before starting insulin treatment and approximately 12 weeks later. The ITQ assesses Diabetes Worries, Perceptions of Insulin Therapy, and Inhaler Performance. There was no significant change in any SF-36 factor or Diabetes Worries during the trial in either arm, and there were no significant between-arm differences in change on any of these measures. Perceptions of Insulin Therapy improved significantly during the trial in the active medication arm (effect size for composite measure = 0.56, P = 0.002) but not in the placebo arm; there were no significant between-arm differences in change. The majority of subjects gave positive ratings of Inhaler Performance on all items (median = 93% positive ratings). In this study treatment with inhaled Technosphere insulin was well tolerated, clinically efficacious, and associated with positive patient-reported outcomes, including improved attitudes toward insulin therapy and high treatment satisfaction. This treatment strategy was implemented without a negative impact on health-related quality of life or worries about diabetes.

Psychometric properties of an instrument for assessing the experience of patients treated with inhaled insulin: the Inhaled Insulin Treatment Questionnaire (IITQ)

BackgroundAlong 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.MethodsStudy participants were 1076 adults (type 1 = 509, type 2 = 567) in clinical trials of Technosphere Insulin®, 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.ResultsIITQ 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.

A clinical decision support system using multi-layer perceptron neural network to predict quality of life in diabetes

Background In diabetes mellitus, quality of life is recognized to be an integral outcome measure of management. We have developed a neural network system which is trained to predict the measurements of quality of life in diabetes, using data generated in real life. Methods We developed a multi-layer perceptron neural network (NN) model, which had been trained by back propagation algorithm. Data was obtained from a cohort of 241 individuals with diabetes, which has been published. We used age, gender, weight, fasting plasma glucose as a set of inputs and predicted measures of quality of life (satisfaction, impact, social and diabetes worry). Results Using the NN model, men reported significantly higher levels of satisfaction with the treatment being provided to them than women. Women had greater social and diabetes worry. The results have been considered based on the observation of the normalized system error (NSE) values of the neural network and are consistent with results obtained from traditional statistical methods. Conclusion We have developed a prototype neural network model to measure the quality of life in diabetes, when biological or biographical variables are given as inputs.

Patient-Reported Outcomes for an Integrated Real-Time Continuous Glucose Monitoring/Insulin Pump System

A 16-week, two-site study evaluated outcomes for a new device (the Paradigm 722 System, Medtronic MiniMed, Northridge, CA) that combines a "smart" continuous subcutaneous insulin infusion (CSII) pump with real-time (RT) continuous glucose monitoring (CGM) and CareLinktrade mark data management software (DMS). CSII-naive adults with type 1 diabetes in suboptimal control (mean glycosylated hemoglobin [A1C] = 8.6%) were randomized to the control arm, consisting of multiple daily injections (MDI) and self-monitoring of blood glucose (SMBG), or the study arm (CSII with RT-CGM as an adjunct to SMBG). Participants (n = 28) completed the validated Insulin Delivery System Rating Questionnaire (IDSRQ) and the parallel Blood Glucose (BG) Monitoring System Rating Questionnaire (BGMSRQ) at study start and end. Participants in the study arm (n = 14) also completed newly developed User Acceptance Questionnaires (UAQs) for CSII, RT-CGM, and DMS at study end. A1C reduction from study start to end was significant (P < 0.05) in both arms (-1.7% for study arm;-1.0% for control arm); there was no significant change in weight in either arm. The IDSRQ showed significantly (P < 0.05) greater benefit for the study arm in convenience, acceptability of BG monitoring requirements, BG control efficacy, diabetes worries, and interpersonal hassles, as well as higher overall satisfaction/preference. The BGMSRQ showed significantly (P < 0.05) greater benefit for the study arm in the BG monitoring system's ability to help manage glycemic control and less interest in changing to another BG monitoring system. The Study Arm UAQs showed positive ratings of system features. Several patient-reported outcomes were significantly more positive in the study arm than the control arm; none was significantly more positive in the control arm. The features of the integrated RT-CGM/CSII system were frequently used and highly rated by participants, with high user satisfaction.

Concerns about hypoglycaemia and late complications in patients with insulin-treated diabetes

AbstractBackground: Diabetes-related anxiety influences the quality-of-life of people with diabetes.Aim: To compare diabetes-related concerns in insulin-treated patients with type 1 and type 2 diabetes.Method: A cross-sectional questionnaire survey was carried out in two cohorts of adult outpatients with type 1 diabetes (n=223) and insulin-treated type 2 diabetes (n=104). Assessment of concerns about mild and severe hypoglycaemia, blindness and kidney failure was carried out using the seven-point Likert scale.Results: Insulin-treated patients with type 1 or 2 diabetes worry mostly about late diabetic complications, less about severe hypoglycaemia and little about mild hypoglycaemia. Patients with type 1 diabetes worry more about severe hypoglycaemia than those with type 2 diabetes; no differences in levels of anxiety about mild hypoglycaemia, blindness and kidney failure exist. Severe hypoglycaemia in the preceding year is associated with more worry about severe hypoglycaemia in patients with type 1 or 2 ...