Diabetes-specific Quality Of Life Research Articles

Program ACTIVE II—Glycemic Improvements Are Sustained over 12 Months with Combination Therapy for MDD in Adults with T2DM

Few studies have evaluated the long-term comparative effects of behavioral treatments for major depressive disorder (MDD) on glycemic and psychological outcomes. Program ACTIVE II was a multi-state randomized controlled comparative effectiveness trial of cognitive behavioral therapy (CBT), community-based exercise (EXER), combination treatment (CBT+EXER) or usual care (UC) for adults with MDD and type 2 diabetes (T2DM). CBT+EXER had a lasting A1c benefit at 6-months (-1.27%; SE: 0.6; p=0.04) and 12 months (-1.42%; SE: 0.6; p=0.03) compared to UC in those with baseline A1c ≥ 7.0%, after controlling for baseline covariates. At 6-month (N=74) and 12-month (N=64) follow-up assessments, all groups had high rates of MDD full remission (range: 63-93%; NS) and minimal depressive symptoms (BDI total score range: 10.7-15.6; NS). At 6 months, CBT+EXER had significant improvements in diabetes-related distress regimen burden (p=0.05); and personal support for health (p=0.05) compared to UC. EXER had improvements in negative thoughts (p=0.005), community social support (p=0.005), diabetes-specific quality of life (DQoL; p=0.04) and satisfaction with T2DM (p=0.01) compared to UC. CBT had improvements over UC in personal support for health (p=0.04) and DQoL (p=0.047). At 12 months, all 3 treatment groups reported improved support from health care providers (p=0.03 CBT, EXER and CBT+EXER) compared to UC. CBT+EXER had improved SF-12 Physical Component Scores (p=0.04) compared to UC. The Program ACTIVE II CBT+EXER intervention had a sustained benefit for A1c beyond the effect of MDD full remission. All 3 behavioral interventions sustained improvements in psychological well-being over 1 year. These findings highlight durable benefits of community-based depression interventions delivered by behavioral health and exercise professionals, which could allow expanded access to depression treatment for T2DM patients in rural and urban areas. Disclosure M. de Groot: Consultant; Self; Johnson &Johnson Diabetes Institute, LLC., Eli Lilly and Company.W. Hornsby: None.C.K. Saha: None.Z. Yang: None.Y. Pillay: None.K.M. Fitzpatrick: None. K.J. Mather: Research Support; Self; Merck &Co., Inc., Sanofi-Aventis, Novo Nordisk A/S, Abbott. Advisory Panel; Self; Merck & Co., Inc.J.H. Shubrook: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk Inc., Intarcia Therapeutics, Inc..

Family adjustment to diabetes diagnosis in children: Can participation in a study on type 1 diabetes genetic risk be helpful?

Diagnosis of type 1 diabetes often causes a negative psychological impact on families. We examined whether parents and children enrolled in The Environmental Determinants of Diabetes in the Young (TEDDY) study differ in their psychological adjustment to diabetes diagnosis compared to children diagnosed with diabetes in the community. TEDDY follows 8676 children at genetic risk for type 1 diabetes from birth. Fifty-four TEDDY children diagnosed with diabetes and 54 age-matched community control children diagnosed with diabetes were enrolled. Participants were aged 3 to 10 years and study visits occurred at 3, 6, and 12 months postdiagnosis. Psychological measures included an adapted diabetes-specific State Anxiety Inventory, the Pediatric Quality of Life Inventory-Diabetes Module, and the Pediatric Inventory for Parents, which measures frequency and difficulty of parenting stress. A generalized estimating equation analysis based on a difference score between TEDDY children and community controls found no significant differences between TEDDY parents and community controls on parent diabetes-specific anxiety (P = .30). However, TEDDY children exhibited better diabetes-specific quality of life (P = .03) and TEDDY parents reported lower frequency (P = .004) and difficulty (P = .008) of parenting stress compared to community controls. Children diagnosed with at-risk for type 1 diabetes who have previously enrolled in research monitoring have improved diabetes quality of life and lower parenting stress postdiagnosis compared to children diagnosed in the community. Families in follow-up studies may be more prepared if their child is diagnosed with diabetes.

Vitamin D deficiency is associated with poorer satisfaction with diabetes-related treatment and quality of life in patients with type 2 diabetes: a cross-sectional study

BackgroundIn this cross-sectional study, we assessed the possible association of vitamin D deficiency with self-reported treatment satisfaction and health-related quality of life in patients with type 2 diabetes.MethodsWe performed a sub-analysis of a previous study and included a total of 292 type 2 diabetic patients. We evaluated treatment satisfaction and health-related quality of life through specific tools: the Diabetes Treatment Satisfaction Questionnaire and the Audit of Diabetes-Dependent Quality of Life. Vitamin D deficiency was defined as 25 (OH) D serum levels < 15 ng/mL.ResultsMultivariable linear regression models were used to estimate the relationship of vitamin D deficiency with both outcomes once adjusted for self-reported patient characteristics. Vitamin D deficiency was significantly associated with the final score of the Diabetes Treatment Satisfaction Questionnaire and the single “diabetes-specific quality of life” dimension of the Audit of Diabetes-Dependent Quality of Life (p = 0.0198 and p = 0.0070, respectively). However, lower concentrations of 25-OH vitamin D were not associated with the overall quality of life score or the perceived frequency of hyperglycaemia and hypoglycaemia.ConclusionsOur study shows the association between vitamin D deficiency and both the self-reported diabetes treatment satisfaction and the diabetes-specific quality of life in patients with type 2 diabetes.

The impact of non-severe hypoglycemia on quality of life in patients with type 2 diabetes

AimsTo determine the impact of frequency of non-severe hypoglycemic events (NSHE) and the perceived burden of NSHE on quality of life (QOL) over time. MethodsT2D adults (n = 424) were re-contacted two years after initial QOL assessment. Responding subjects (n = 290) reported the frequency and burden of NSHE over time and completed six generic and diabetes-specific QOL measures. ResultsMost subjects (86%) reported ≥ one NSHE over time. Higher frequency of NSHE was significantly associated with decrements in QOL. Greater perceived burden of NSHE was significantly linked to decreases in QOL over time for all six QOL measures. Interaction terms indicated that participants with a higher frequency of NSHE and higher perceived burden reported the greatest decrease in QOL; participants who experienced frequent NSHE but did not perceive these events as burdensome evidenced little worsening in QOL over time. ConclusionsNSHE have a negative impact on QOL over time in T2D adults. However, it is not just the occurrence of NSHE that affects QOL; it is the individual's felt burden of these events that is critical. The greatest reductions in QOL are seen among those subjects reporting a higher frequency of NSHE and indicating that such events are burdensome.

Camp-based multi-component intervention for families of young children with type 1 diabetes: A pilot and feasibility study

Managing type 1 diabetes mellitus (T1DM) in preschool-aged children has unique challenges that can negatively impact glycemic control and parental coping. To evaluate the impact of a camp-based multi-component intervention on glycated hemoglobin A1c (HbA1c) in young children with T1DM and psychosocial measures for their parents. Two separate cohorts of 18 children (ages 3-5 years) and their families participated in a camp-based intervention that included didactic and interactive parent education, child-centered education and family-based recreational activities. In Camp 1.0, measures of HbA1c, parental fear of hypoglycemia, mealtime behaviors and quality of life (QOL) were compared before and after an initial session (I) and follow-up booster session (II) 6 months later. Based on these results, the intervention was consolidated into 1 session (Camp 2.0) and repeated with additional measures of parental stress and parental self-efficacy with diabetes management tasks. Participants in Camp 2.0 exhibited a significant decrease in mean HbA1c level (-0.5%, P = .002) before and after camp. Mothers exhibited a significant improvement in diabetes-specific QOL (Camp 1.0/Session I and Camp 2.0) and reduction in stress as measured on the Pediatric Inventory for Parent (PIP) assessment (Camp 2.0). The booster session in Camp 1.0 showed no added benefit. A family centered, camp-based multi-component intervention in young children with T1DM improved HbA1c and perceived QOL and stress in their mothers.

Effect of "321" health education model on uncertainty of disease in patients with diabetic retinopathy

Objective To explore the influence of 321 health education model on the quality of life, physiological and psychological treatment and uncertainty of disease in patients with diabetic retinopathy. Methods From January to December 2016, 104 patients with fundus surgery in the hospital for the treatment of diabetic retinopathy were selected as the research object. They were randomly divided into observation group and control group by the random number table method. Patients in the control group received routine health education and the patients in the observation group received the 321 model of health education. Patients in the two groups were tested with Mishel's uncertainty in illness scale (MUIS) before and after receiving education. The uncertainty of disease between two groups before and after education was compared, and two groups were assessed by using SF-36 scale and diabetes specific quality of life (DSQL) . Results Before the education, the scores of disease uncertainty in the control group and the observation group were (104.9±6.7) and (105.1±6.5) points, and the difference was not statistically significant (t=-0.154, P=0.878) ; After receiving education, the scores of disease uncertainty in the control group and the observation group were (92.6±6.2) and (82.2±6.1) points, and the difference was statistically significant (t=8.622, P<0.001) ; The scores of psychological/mental health and treatment were significantly different between the two groups after receiving education (P<0.05) . Conclusions The 321 health education model for diabetic retinopathy can significantly reduce the uncertainty of disease, and has positive significance for the psychological/mental health and treatment of the patients. Key words: Diabetic retinopathy; Health education; Uncertainty of disease

Decreased quality of life and treatment satisfaction in patients with latent autoimmune diabetes of the adult.

ObjectivesOur main aim was to assess the quality of life (QoL) and treatment satisfaction (TS) of subjects with LADA (latent autoimmune diabetes of the adult) and compare these measures with those of patients with other diabetes types, i.e., type 1 (T1DM) and type 2 diabetes mellitus (T2DM).MethodsThis was a cross-sectional study with a total of 48 patients with LADA, 297 patients with T2DM and 124 with T1DM. The Audit of Diabetes-Dependent Quality of Life (ADDQoL-19) questionnaire and the Diabetes Treatment Satisfaction Questionnaire (DTSQ) were administered. Relevant clinical variables were also assessed. The data analysis included comparisons between groups and multivariate linear models.ResultsThe LADA patients presented lower diabetes-specific QoL (p = 0.045) and average weighted impact scores (p = 0.007) than the T2DM patients. The subgroup of LADA patients with diabetic retinopathy (DR) who were treated with insulin had a lower ADDQoL average weighted impact score than the other diabetic groups. Although the overall measure of TS was not different between the LADA and T2DM (p = 0.389) and T1DM (p = 0.091) groups, the patients with LADA showed a poorer hyperglycemic frequency perception than the T2DM patients (p < 0.001) and an improved frequency of hypoglycemic perception compared with the T1DM patients (p = 0.021).ConclusionsThe current findings suggest a poorer quality of life, especially in terms of DR and insulin treatment, among patients with LADA compared with those with T1DM and T2DM. Hyperglycemia frequency perception was also poorer in the LADA patients than in the T1DM and T2DM patients. Further research with prospective studies and a large number of patients is necessary.

Examining diabetes distress, medication adherence, diabetes self-care activities, diabetes-specific quality of life and health-related quality of life among type 2 diabetes mellitus patients

AimsHealth-Related Quality of Life (HRQoL) has been increasing attention in health outcome studies. Factors that individually influence HRQoL, diabetes self-care behaviors, and medication adherence have been widely investigated; however, most previous studies have not tested an integrated association between multiple health outcomes. The purpose of this study was to formulate a hypothetical structural equation model linking HRQoL, diabetes distress, diabetes self-care activities, medication adherence and diabetes-dependent QoL in patients with Type 2 Diabetes Mellitus (T2DM). MethodsA cross-sectional study design was employed, and 497 patients with T2DM were recruited from outpatient clinics in three public hospitals and one government clinic. The patients completed a series of questionnaires. The hypothetical model was tested using Structural Equation Modeling (SEM) analysis. ResultsThe values of the multiple fit indices indicated that the proposed model provided a good fit to the data. SEM results showed that medication adherence (MMAS) had a significant direct effect on diabetes distress (PAID) (Beta=−0.20). The self-care activities (SDSCA) construct was significantly related to PAID (Beta=−0.24). SDSCA was found to have a significant relationship with HRQoL (SF-36) (Beta=0.11). Additionally, diabetes distress had a significant effect (Beta=−0.11) on HRQoL of patients. Finally, ADDQoL had a significant effect on HRQoL (Beta=0.12). ConclusionsThe various health outcome indicators such as self-care behaviors, diabetes distress, medication adherence and diabetes-dependent QoL need to be considered in clinical practice for enhancing HRQoL in those patients.

General and diabetes-specific stress in adolescents with type 1 diabetes.

Type 1 diabetes (T1D) is one of the most common chronic health conditions in adolescents in the United States. Adherence to the recommended treatment regimen has been reported as a source of stress for adolescents. The purpose of this study was to examine the associations among general and diabetes-specific stress and glycemic control (HbA1c), self-management, and diabetes-specific quality of life (QOL) in adolescents with T1D. A secondary analysis of baseline data (N=320) from a randomized controlled trial was conducted. Adolescents completed validated measures of general and diabetes-specific stress, self-management, and diabetes-specific QOL. HbA1c levels were obtained from medical records. Over 50% of the sample scored at or above criteria for high general and diabetes-specific stress. Higher general and diabetes-specific stress was significantly associated with higher HbA1c, poorer self-management activities, and lower diabetes-specific QOL. Diabetes-specific stress accounted for a significant proportion of the variance in HbA1c, while general stress did not. General and diabetes-specific stress accounted for 40% of the variance in diabetes-specific QOL. General and diabetes-specific stress are common in adolescents with T1D. Healthcare providers must be mindful of the sources of stress that adolescents with T1D face on a daily basis. General stress and diabetes-specific stress should be differentiated and may require different interventions to improve coping and outcomes.

The Impact of Continuous Glucose Monitoring on Markers of Quality of Life in Adults With Type 1 Diabetes: Further Findings From the DIAMOND Randomized Clinical Trial

Continuous glucose monitoring (CGM) improves glycemic control, but data are inconclusive about its influence on quality of life (QOL). We investigated the impact of 24 weeks of CGM use on QOL in adults with type 1 diabetes (T1D) who use multiple daily insulin injections. DIAMOND (Multiple Daily Injections and Continuous Glucose Monitoring in Diabetes) was a prospective randomized trial that assessed CGM versus self-monitoring of blood glucose (SMBG) only in 158 adults with poorly controlled T1D. At baseline and study end, participants completed QOL measures that assessed overall well-being (WHO-5), health status (EQ-5D-5L), diabetes distress (DDS), hypoglycemic fear (worry subscale of the HFS-II), and hypoglycemic confidence (HCS). At study end, CGM participants completed the CGM Satisfaction Survey. Linear regression analyses compared treatment group changes in QOL outcomes over time. Associations between CGM satisfaction and change in QOL outcomes and in glycemic control indices were assessed. The CGM group demonstrated a greater increase in hypoglycemic confidence (P = 0.01) and a greater decrease in diabetes distress (P = 0.01) than the SMBG group. No significant group differences in well-being, health status, or hypoglycemic fear were observed. CGM satisfaction was not significantly associated with glycemic changes but was associated with reductions in diabetes distress (P < 0.001) and hypoglycemic fear (P = 0.02) and increases in hypoglycemic confidence (P < 0.001) and well-being (P = 0.01). CGM contributes to significant improvement in diabetes-specific QOL (i.e., diabetes distress, hypoglycemic confidence) in adults with T1D, but not with QOL measures not specific to diabetes (i.e., well-being, health status). CGM satisfaction was associated with most of the QOL outcomes but not with glycemic outcomes.

A cluster randomised trial, cost-effectiveness analysis and psychosocial evaluation of insulin pump therapy compared with multiple injections during flexible intensive insulin therapy for type 1 diabetes: the REPOSE Trial.

Insulin is generally administered to people with type 1 diabetes mellitus (T1DM) using multiple daily injections (MDIs), but can also be delivered using infusion pumps. In the UK, pumps are recommended for patients with the greatest need and adult use is less than in comparable countries. Previous trials have been small, of short duration and have failed to control for training in insulin adjustment. To assess the clinical effectiveness and cost-effectiveness of pump therapy compared with MDI for adults with T1DM, with both groups receiving equivalent structured training in flexible insulin therapy. Pragmatic, multicentre, open-label, parallel-group cluster randomised controlled trial, including economic and psychosocial evaluations. After participants were assigned a group training course, courses were randomly allocated in pairs to either pump or MDI. Eight secondary care diabetes centres in the UK. Adults with T1DM for > 12 months, willing to undertake intensive insulin therapy, with no preference for pump or MDI, or a clinical indication for pumps. Pump or MDI structured training in flexible insulin therapy, followed up for 2 years. MDI participants used insulin analogues. Pump participants used a Medtronic Paradigm® VeoTM (Medtronic, Watford, UK) with insulin aspart (NovoRapid, Novo Nordisk, Gatwick, UK). Primary outcome - change in glycated haemoglobin (HbA1c) at 2 years in participants whose baseline HbA1c was ≥ 7.5% (58 mmol/mol). Key secondary outcome - proportion of participants with HbA1c ≤ 7.5% at 2 years. Other outcomes at 6, 12 and 24 months - moderate and severe hypoglycaemia; insulin dose; body weight; proteinuria; diabetic ketoacidosis; quality of life (QoL); fear of hypoglycaemia; treatment satisfaction; emotional well-being; qualitative interviews with participants and staff (2 weeks), and participants (6 months); and ICERs in trial and modelled estimates of cost-effectiveness. We randomised 46 courses comprising 317 participants: 267 attended a Dose Adjustment For Normal Eating course (132 pump; 135 MDI); 260 were included in the intention-to-treat analysis, of which 235 (119 pump; 116 MDI) had baseline HbA1c of ≥ 7.5%. HbA1c and severe hypoglycaemia improved in both groups. The drop in HbA1c% at 2 years was 0.85 on pump and 0.42 on MDI. The mean difference (MD) in HbA1c change at 2 years, at which the baseline HbA1c was ≥ 7.5%, was -0.24% [95% confidence interval (CI) -0.53% to 0.05%] in favour of the pump (p = 0.098). The per-protocol analysis showed a MD in change of -0.36% (95% CI -0.64% to -0.07%) favouring pumps (p = 0.015). Pumps were not cost-effective in the base case and all of the sensitivity analyses. The pump group had greater improvement in diabetes-specific QoL diet restrictions, daily hassle plus treatment satisfaction, statistically significant at 12 and 24 months and supported by qualitative interviews. Blinding of pump therapy was not possible, although an objective primary outcome was used. Adding pump therapy to structured training in flexible insulin therapy did not significantly enhance glycaemic control or psychosocial outcomes in adults with T1DM. To understand why few patients achieve a HbA1c of < 7.5%, particularly as glycaemic control is worse in the UK than in other European countries. Current Controlled Trials ISRCTN61215213. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 21, No. 20. See the NIHR Journals Library website for further project information.

Diabetes camp matters: Assessing families’ views of their diabetes camp experience

Camp offers a safe and fun environment for learning new information about diabetes care and for trying new self-care skills. It is a place where children and teens are able to meet with others who also have diabetes and who share their experiences. This study assessed self-reports before and after attending diabetes camp on diabetes-specific emotional distress, diabetes-specific quality of life, and self-care behaviors by surveying campers and their parents from over 42 diabetes-specific summer camps across the United States. Parents (N = 413), Teenagers (N = 154), and Children (N = 116) completed both pre- and post-camp surveys. Parents reported higher levels of diabetes-specific emotional distress than their campers did. Both parents and children reported significant improvements in their own distress after camp. Teens reported improvements in distress but they were not statistically significant. Youth report higher levels of self-care skills than parents believe their children possess. Parents, Teens, and Children all reported significant improvements in the camper's self-care skills after camp. First time campers' and their parents' perspectives regarding self-care skills are consistent with veteran campers after attending camp. Self-reports post-camp reveals that campers and their parents see camp as a place where youth feel they are with others who really understand what it is like to live with diabetes. Respondents also report that camp is a place where youth are exposed to new technologies and where campers can try new self-care tasks.

Medication Adherence Contributes to an Improved Quality of Life in Type 2 Diabetes Mellitus Patients: A Cross-Sectional Study.

IntroductionDiabetes mellitus is a chronic disease with a high prevalence world wide. This disease has also been reported to affect the quality of life (QOL) of the patient and their family due to its chronic nature and multi organ involvement. The aim of this study was to analyze the association between adherence to prescribed diabetes medication and diabetes-specific QOL in patients attending Secondary Health Care Facility in Bandung City, Indonesia.MethodsA cross-sectional survey was conducted in the Secondary Health Care Facility in Bandung City, Indonesia. Data were collected between February and April 2014 using consecutive sampling. Adherence was assessed using the eight-item Morisky Medication Adherence Scale while diabetes-specific-QOL was assessed using the Diabetes 39 instrument.ResultsThe results showed that among the patients, 49.4% exhibited low adherence, 29.7% exhibited medium adherence, and 20.9% exhibited high adherence to diabetes medication. Diabetes-specific QOL proved to be highly affected in the sexual functioning domain. Social-burden domain scores were better than overall QOL scores. There was a significant association between adherence and diabetes-specific QOL (p = 0.009) using The Kruskall-Wallis test of significance. The results of the post hoc Mann–Whitney tests (high vs medium adherence, p = 0.084; medium vs low adherence, p = 0.86; and high vs low adherence, p = 0.001) indicated that higher adherence to prescribed diabetes medication contributed to an improved QOL. Multiple regression analysis showed that the predictors of diabetes-specific QOL were adherence and patient income.ConclusionsAdherence to prescribed medication showed a positive effect on diabetes-specific QOL in patients. Patients with a high adherence to medication had an improved QOL. This result is important not only in developing intervention programs for patients but also in improving their QOL through sustainable health promotion.

Quality of Life in Type 1 Diabetes and Celiac Disease: Role of the Gluten-Free Diet

To evaluate quality of life (QoL) and glycemic control in youth with type 1 diabetes (T1D) and celiac disease vs T1D only. We hypothesized that QoL scores would be lower in youth with T1D and celiac disease and those nonadherent to the gluten-free diet (GFD). This case control study included 35 youth with T1D and 35 with T1D and celiac disease matched for age, sex, diabetes duration, and hemoglobin A1c level. QoL was assessed in participants and parents using the Pediatric Quality of Life Inventory Generic Core Scale, Pediatric Quality of Life Inventory Diabetes Module. and the General Well-Being Scale; youth with T1D and celiac disease also completed the celiac disease-specific DUX questionnaire and parents completed the Pediatric Quality of Life Inventory Family Impact Scale. Questionnaires were scored from 0 to 100; higher scores indicate better QoL or well-being. Scores were compared between T1D vs T1D with celiac disease, with subgroup analysis by GFD adherence vs nonadherence and therapy (continuous subcutaneous insulin infusion vs multiple daily injections). Youth with T1D and celiac disease reported similar generic and diabetes-specific QoL to T1D only. GFD nonadherent vs adherent youth reported lower diabetes-specific QoL (mean score 58 vs 75, P = .003) and lower general well-being (57 vs 76, P = .02), as did their parents (50 vs 72, P = .006), and hemoglobin A1c was higher (9.6% vs 8.0%, P = .02). Youth with T1D and celiac disease using continuous subcutaneous insulin infusion vs multiple daily injections had similar generic and diabetes-specific QoL and A1C (8.6 vs 8.2%, P = .44), but were less happy having to follow a lifelong diet (59 vs 29, P = .007). Youth with T1D and celiac disease who do not adhere to the GFD have lower QoL and worse glycemic control. Novel strategies are required to understand and improve adherence in those with both conditions.

Correlation of quality of life of Children with type 1 diabetes between their patents′coping and parenting style

Objective To analyze the correlation of quality of life of children with type 1 diabetes and their patents′ coping and parenting style. Methods A total of 67 children with type 1 diabetes and their parents were recruited from 6 Third Class A hospitals and 2 Third Class-B hospitals in Fujian province by convenience sampling method. Diabetes specific quality of life scale, coping style questionnaire and EMBU were used. Results The total score of diabetes specific quality of life was(54.64±14.21). The sorting of each dimension′s ratio was psychology, therapy, society, physiology from high to low. All parents adopted coping style of solving problem. Mothers′rationalization in coping style was positively correlated with overall quality of life and therapy dimension in children(r=2.191-2.319, P<0.05). Fathers′ overprotection in parenting style was negatively correlated with therapy dimension in quality of life in children(r=-2.282, P<0.05). Mathers′ rationalization in coping style had predicted effect to overall quality of life and therapy dimension in children. Conclusions Parents should be sensible to accept and face the fact that children have type 1 diabetes. Reasonable coping style and avoiding overprotection positively impacted on quality of life of children with type 1 diabetes. Key words: Diabetes, type 1; Quality of life; Coping style; Parenting style

A randomised trial of the effect and cost-effectiveness of early intensive multifactorial therapy on 5-year cardiovascular outcomes in individuals with screen-detected type 2 diabetes: the Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care (ADDITION-Europe) study.

Intensive treatment (IT) of cardiovascular risk factors can halve mortality among people with established type 2 diabetes but the effects of treatment earlier in the disease trajectory are uncertain. To quantify the cost-effectiveness of intensive multifactorial treatment of screen-detected diabetes. Pragmatic, multicentre, cluster-randomised, parallel-group trial. Three hundred and forty-three general practices in Denmark, the Netherlands, and Cambridge and Leicester, UK. Individuals aged 40-69 years with screen-detected diabetes. Screening plus routine care (RC) according to national guidelines or IT comprising screening and promotion of target-driven intensive management (medication and promotion of healthy lifestyles) of hyperglycaemia, blood pressure and cholesterol. The primary end point was a composite of first cardiovascular event (cardiovascular mortality/morbidity, revascularisation and non-traumatic amputation) during a mean [standard deviation (SD)] follow-up of 5.3 (1.6) years. Secondary end points were (1) all-cause mortality; (2) microvascular outcomes (kidney function, retinopathy and peripheral neuropathy); and (3) patient-reported outcomes (health status, well-being, quality of life, treatment satisfaction). Economic analyses estimated mean costs (UK 2009/10 prices) and quality-adjusted life-years from an NHS perspective. We extrapolated data to 30 years using the UK Prospective Diabetes Study outcomes model [version 1.3; (©) Isis Innovation Ltd 2010; see www.dtu.ox.ac.uk/outcomesmodel (accessed 27 January 2016)]. We included 3055 (RC, n = 1377; IT, n = 1678) of the 3057 recruited patients [mean (SD) age 60.3 (6.9) years] in intention-to-treat analyses. Prescription of glucose-lowering, antihypertensive and lipid-lowering medication increased in both groups, more so in the IT group than in the RC group. There were clinically important improvements in cardiovascular risk factors in both study groups. Modest but statistically significant differences between groups in reduction in glycated haemoglobin (HbA1c) levels, blood pressure and cholesterol favoured the IT group. The incidence of first cardiovascular event [IT 7.2%, 13.5 per 1000 person-years; RC 8.5%, 15.9 per 1000 person-years; hazard ratio 0.83, 95% confidence interval (CI) 0.65 to 1.05] and all-cause mortality (IT 6.2%, 11.6 per 1000 person-years; RC 6.7%, 12.5 per 1000 person-years; hazard ratio 0.91, 95% CI 0.69 to 1.21) did not differ between groups. At 5 years, albuminuria was present in 22.7% and 24.4% of participants in the IT and RC groups, respectively [odds ratio (OR) 0.87, 95% CI 0.72 to 1.07), retinopathy in 10.2% and 12.1%, respectively (OR 0.84, 95% CI 0.64 to 1.10), and neuropathy in 4.9% and 5.9% (OR 0.95, 95% CI 0.68 to 1.34), respectively. The estimated glomerular filtration rate increased between baseline and follow-up in both groups (IT 4.31 ml/minute; RC 6.44 ml/minute). Health status, well-being, diabetes-specific quality of life and treatment satisfaction did not differ between the groups. The intervention cost £981 per patient and was not cost-effective at costs ≥ £631 per patient. Compared with RC, IT was associated with modest increases in prescribed treatment, reduced levels of risk factors and non-significant reductions in cardiovascular events, microvascular complications and death over 5 years. IT did not adversely affect patient-reported outcomes. IT was not cost-effective but might be if delivered at a reduced cost. The lower than expected event rate, heterogeneity of intervention delivery between centres and improvements in general practice diabetes care limited the achievable differences in treatment between groups. Further follow-up to assess the legacy effects of early IT is warranted. ClinicalTrials.gov NCT00237549. This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 20, No. 64. See the NIHR Journals Library website for further project information.

The Association of Mindful Parenting with Glycemic Control and Quality of Life in Adolescents with Type 1 Diabetes: Results from Diabetes MILES-The Netherlands.

The objective of this study was to examine associations between the mindful parenting style of parents of adolescents (aged 12–18) with type 1 diabetes mellitus (T1DM), and the glycaemic control and quality of life (QoL) of the adolescents. Chronic health conditions, such as T1DM, that require demanding treatment regimens, can negatively impact adolescents’ quality of life. Therefore, it is important to determine whether mindful parenting may have a positive impact in these adolescents. Age, sex and duration of T1DM were examined as potential moderators. Parents (N = 215) reported on their own mindful parenting style (IM-P-NL) and the adolescents’ glycaemic control. Parents and the adolescents with T1DM (N = 129) both reported on adolescents’ generic and diabetes-specific QoL (PedsQL™). The results showed that a more mindful parenting style was associated with more optimal hemoglobin A1c (HbA1c) values for boys. For girls, a more mindful parenting style was associated with not having been hospitalized for ketoacidosis. For both boys and girls, a more mindful parenting style was associated with better generic and diabetes-specific proxy-reported QoL. In conclusion, mindful parenting style may be a factor in helping adolescents manage their T1DM. Mindful parenting intervention studies for parents of adolescents with T1DM are needed to examine the effects on adolescents’ glycaemic control and their quality of life.

The Burden of Structured Self-Monitoring of Blood Glucose on Diabetes-Specific Quality of Life and Locus of Control in Patients with Noninsulin-Treated Type 2 Diabetes: The PRISMA Study.

Background: To evaluate whether structured self-monitoring of blood glucose (SMBG) is associated with changes in diabetes-specific quality of life (DSQoL) and locus of control (LOC) in patients with noninsulin-treated type 2 diabetes (T2DM).Study Design and Methods: In this analysis of the PRISMA (Prospective Randomized Trial on Intensive SMBG Management Added Value in Noninsulin-Treated T2DM Patients) Study psychosocial data, we evaluated the impact of 12 months of structured SMBG on the individual domains of DSQoL and LOC questionnaires, including the role of selected confounders.Results: The score for Satisfaction, Impact, and Worry domains (DSQoL) improved when compared with baseline, without significant differences between structured SMBG regimen (intervention group, n = 501) and active control group (n = 523). Scores for Internal, Chance, and Powerful Others domains (LOC) improved compared with baseline, with a significant between-group change in Chance (P = 0.0309). For DSQoL domain score, improvements were associated with higher number of SMBG measurements (P = 0.007), older age (P = 0.013), and male sex (P = 0.0133) for Satisfaction and with male sex (P < 0.0001) for Worry. Concerning LOC domain score, improvements were associated with longer diabetes duration (P = 0.0084) and younger age (P < 0.0001) for Chance and total number of SMBG measurements (P = 0.0036) for Internal, with the intervention group close to being significant (P = 0.06).Conclusions: Our analysis demonstrates that in patients with noninsulin-treated T2DM, structured SMBG is not associated with a deterioration of quality of life and LOC, which is strongly predicted by demographics and diabetes-related variables. These findings should be considered when tailoring educational support to SMBG for these patients.

Stress and Other Determinants of Diabetes-Specific Quality of Life in Low-Income African Americans with Uncontrolled Type 2 Diabetes Mellitus.

Understanding diabetes-specific quality of life (DSQOL) is important to improving lives of people with type 2 diabetes mellitus (T2DM). Despite the prevalence of T2DM among African Americans, there is scant evidence about DSQOL in this population. This study aims to understand relationships between DSQOL and demographics, clinical markers, psychosocial factors, and stress in African Americans. We hypothesize that: 1) predictors of DSQOL in African Americans will be consistent with predictors identified in prior studies with non-African Americans, and 2) greater stress will independently predict poorer DSQOL. Participants were 211 low-income African Americans with uncontrolled T2DM. The two hypotheses were tested using distinct linear regression models. Significant predictors of poorer DSQOL were: 1) fewer years of school, 2) fewer T2DM-related complications, 3) longer T2DM duration, and 4) more perceived stress. Findings suggest that interventions targeting stress could improve DSQOL in African Americans.

Modeling predictors of changes in glycemic control and diabetes-specific quality of life amongst adults with type 1 diabetes 1 year after structured education in flexible, intensive insulin therapy.

Few studies have identified determinants of glycemic control (HbA1c) and diabetes-specific quality of life (DSQoL) in adults with type 1 diabetes. To identify factors predicting outcomes following structured diabetes education. 262 participants completed biomedical and questionnaire assessments before, and throughout 1 year of follow-up. The proportion of variance explained ranged from 28 to 62 % (DSQoLS) and 14-20 % (HbA1c). When change in psychosocial variables were examined, reduced hypoglycemia fear, lower 'perceived diabetes seriousness', greater self-efficacy and well-being predicted QoL improvements from baseline to 3-months. Increased frequency of blood glucose testing predicted improvements in HbA1c from baseline to 6-months. Greater benefits may be achieved if programs focus explicitly on psychosocial factors. Self-care behaviours did not predict HbA1c suggesting existing assessment tools need refinement. Evaluation of treatment mechanisms in self-management programs is recommended.