Problem Areas In Diabetes Score Research Articles

Implications of Patient-Reported Outcome Measures among patients with recently diagnosed type 2 diabetes

BackgroundFor the past two decades, the assessment of the quality of diabetes care has mostly relied on clinical quality indicators. These have not included Patient-Reported Outcome Measures (PROMs) which provide information on outcomes deemed valuable by patients. We aimed to examine the potential utility of PROMs in type 2 diabetes care and to study the association of PROMs with patients' characteristics and clinical quality indicators.MethodsA cross-sectional survey of recently (≤ 4 years) diagnosed patients with type 2 diabetes (n = 392) in the setting of a large health plan. PROMs were based on two well-validated questionnaires, the Problem Areas in Diabetes (PAID) one-page questionnaire that measures diabetes-related distress, and the ten item PROMIS-10 global health questionnaire that measures general health. Additional items were added following a previous qualitative study among Israeli patients with diabetes. The survey was carried out using phone interviews, and data collected were linked to the electronic medical records. Multivariable regression models were used to assess the associations of socio-demographic variables and clinical quality indicators with the PROMs.ResultsAbout a fifth of participants (22%) had high diabetes-related distress (PAID score ≥ 40), a third reported that they did not feel confident in self-management of diabetes and about a third reported having sexual dysfunction. Women, younger patients, and those with a low education level (≤ 12 years) reported worse general health, were more likely to experience high diabetes-related distress, and to have low confidence in diabetes self-management. Interestingly, performance of all seven diabetes quality indicators was associated with worse general health and high diabetes-related distress. Of note, levels of glycated hemoglobin, LDL-cholesterol, or blood pressure were not associated with PROMs.ConclusionsPROMs provide important information on patient self-reported health status and are likely to reflect aspects of the quality of care that are not otherwise available to clinicians. Thus, the use of PROMs has the potential to expand the evaluation of diabetes care and promote patient-centered care. We recommend that policy-makers in the Ministry of Health and health maintenance organizations implement PROMs for assessing and improving the care for patients with type 2 diabetes.

Association between glycemic control and patient-reported outcomes in adults with type 1 diabetes in Japan: the SAGE study subanalysis.

Psychosocial aspects and the quality of life (QOL) of individuals with diabetes are important for achieving glycemic control and treatment goals. Here, we describe patient-reported outcomes (PROs) of Japanese adults with type 1 diabetes (T1D) and evaluate the association thereof with glycemic control. This subanalysis of a subgroup of 528 Japanese participants in the SAGE study of adults with T1D used data on glycosylated hemoglobin (HbA1c) and PRO scores [Hypoglycemia Fear Survey-II (HFS-II), Problem Areas In Diabetes (PAID), Insulin Treatment Satisfaction Questionnaire (ITSQ), and Audit of Diabetes-Dependent QOL (ADDQoL)] and summarized the score by the predefined age groups (26-44-years: n = 208, 45-64-years: n = 217, and ≥ 65-years: n = 103). The association between PROs, achieving HbA1c < 7.0%, and individualized targets was explored using multivariate logistic regression analysis. The HFS-II and PAID scores were lower, and the ITSQ score was higher in the ≥ 65-years group than in the younger groups with a linear trend of better scores with increasing age (P for trend < 0.05). ADDQoL scores were similar across the age groups, and present QOL (ADDQoL subscale) tended to improve with age (P for trend < 0.05). Achieving HbA1c < 7.0% and individualized targets were associated with satisfaction with insulin treatment regarding glycemic control. In Japanese adults with T1D, the impact on psychosocial aspects and QOL varied across age groups, with a trend of improving scores with age, potentially in relation to the less stringent glycemic control targets adopted in older individuals. Glycemic control was significantly associated with treatment satisfaction. The online version contains supplementary material available at 10.1007/s13340-023-00668-4.

Effectiveness of a dietician-led intervention in reducing glycated haemoglobin among people with type 2 diabetes in Nepal: a single centre, open-label, randomised controlled trial

Nutrition education and counselling are considered a cornerstone for the management of type 2 diabetes (T2D). However, there is limited research related to the management of T2D through dietary approach, particularly in low-income and middle-income countries (LMICs) like Nepal. This study assessed the effectiveness of a dietician-led dietary intervention in reducing glycated haemoglobin (HbA1c) levels among people with T2D. An open-label, two-armed, hospital-based, randomised controlled trial was conducted at Tribhuvan University Teaching Hospital, Kathmandu, Nepal. Participants were randomly assigned to either dietician-led dietary intervention group (n=78) or usual care control group (n=78). People with type 2 diabetes with HbA1c >6.5% and aged 24-64 years were included in the study. The primary outcome was a change in HbA1c level over six months, and secondary outcomes included changes in biochemical and clinical parameters, Problem Areas in Diabetes (PAID) score, diabetic knowledge, dietary adherence, and macronutrient intake level. Data were analysed using an intention-to-treat approach. This trial is registered with ClinicalTrials.gov, NCT04267367. Between August 15, 2021 and February 25, 2022, 156 people with type 2 diabetes were recruited for the study, of which 136 participants completed the trial. At six months of follow-up, compared to baseline values, the mean HbA1c (%) level decreased in the intervention group by 0.48 (95% CI:-0.80 to-0.16), while it increased in the control group by 0.22 (95% CI:-0.21 to 0.66). In an adjusted model, the reduction in HbA1c (%) levels for the intervention was 0.61 (95% CI:-1.04 to-0.17; p=0.006). In addition, fasting blood glucose was decreased by 18.96mg/dL (95% CI:-36.12 to-1.81; p=0.031) after the intervention. The intervention resulted in the reduction of BMI, waist and hip circumference, PAID score, dietary adherence, and macronutrient intake in the intervention group compared to the control group. The dietician-led intervention improved glycaemic control, improved macronutrient intake, and clinical outcomes among people with type 2 diabetes. The dietician-led intervention may be considered for diabetes management in LMICs. The research was funded by the University Grants Commission (UGC), Nepal.

The Japanese version of Problem Areas in Diabetes Scale: a clinical and research tool to assess emotional functioning among people with diabetes.

The purpose of this study was to develop the Japanese version of the Problem Areas in Diabetes (PAID) scale, a measure of emotional adjustment to diabetes that has been translated into Japanese by our group. A total of 418 Japanese people with diabetes attending our outpatient clinic participated (n = 65 type 1 and n = 353 type 2). We assessed the internal reliability of the PAID, examined correlations of the PAID with conceptually related psychosocial constructs, evaluated mean differences in the PAID between diabetes treatment groups, and examined correlations of the PAID with diabetes self-care behaviours and selected treatment outcomes. Results showed that the PAID had excellent reliability (Cronbach alpha = 0.934). The PAID correlated significantly with the Diabetes Treatment Satisfaction Questionnaire (r = -0.593, p < 0.0001) and the positive wellbeing (r = -0.396, p < 0.0001), negative wellbeing (r = -0.640, p < 0.0001) and energy (r = -0.444, p < 0.0001) subscales of the Wellbeing Questionnaire. Adherence to diet was negatively correlated with PAID score (r = -0.263, p < 0.0001). The frequency of recent hypoglycemia and number of chronic complications (retinopathy, nephropathy and neuropathy) were positively correlated with PAID scores. PAID was weakly correlated with HbA1c (r = 0.13, p = 0.01). In conclusion, the Japanese version of the PAID demonstrated good internal reliability and evidence of concurrent and discriminant validity. The PAID measures the impact of diabetes, diabetes treatment and treatment outcomes on the emotions of people with diabetes. The results provide encouraging evidence for the clinical utility of the PAID in Japanese people with diabetes.

664-P: Efficacy of a Digital Diabetes Logbook for Reducing Treatment Burden—Results of a Randomized Controlled Trial

The digital diabetes logbook mySugr is designed to help people with diabetes manage their diabetes and to reduce burden of diabetes management. To test the efficacy of the app, a randomized controlled trial (RCT) was conducted. The RCT was designed as a multi-center, open-label, parallel study with a 3-month follow-up in Germany. Participants were randomized to either using the mySugr app or to the treatment-as-usual control group in a 2:1 ratio. Primary outcome was change in diabetes distress using the Problem Areas in Diabetes (PAID) questionnaire. Based on the power analysis, the recruitment goal was 396 participants, anticipating 15% drop-out it was planned to recruit 466 participants. Robust regression was used to analyze the data with follow-up scores as dependent variable, group as independent variable and controlled for respective baseline scores. Primary analysis was based on the intention-to-treat population with jump-to-reference approach for multiple imputation of missing data. A total of 424 people with diabetes were randomized, 282 to the intervention and 142 to the control group (12.5% type 1 diabetes, 68.2% type 2 diabetes, 18.9% gestational diabetes, age: 51.7±15.2 years, 50% female, diabetes duration: 9.5±10.8 years, A1c: 7.1±1.5%, PAID: 21.6±17.4); 397 completed the 3-month follow-up. Intention-to-treat analysis revealed a significant between-group difference in the primary outcome (p = 0.0182). PAID scores at follow-up in the mySugr group were significantly lower than in the control group (Δ -2.20, 95% CI: -4.02 to -0.38). This was corroborated by the per-protocol analysis (Δ -2.43, 95% CI: -4.49 to -0.37, p = 0.0211). Recruitment was successful and could be stopped earlier due to the very low drop-out rate (6.4%). Use of mySugr led to a significant improvement in diabetes distress after 3 months compared to the treatment-as-usual control group. Thus, the efficacy of mySugr regarding the reduction of diabetes distress could be demonstrated in the RCT. Disclosure D.Ehrmann: Advisory Panel; Roche Diabetes Care, mySugr, Dexcom, Inc., Speaker's Bureau; Berlin-Chemie AG, Dexcom, Inc. N.Hermanns: Advisory Panel; Insulet Corporation, Research Support; Sanofi-Aventis Deutschland GmbH, Roche Diagnostics, Becton, Dickinson and Company, Speaker's Bureau; Dexcom, Inc., Berlin-Chemie AG. S.Silbermann: Employee; Roche Diabetes Care. J.Kober: Employee; mySugr. K.Finke-groene: None. T.Roos: None. I.Vesper: None. V.L.Schaefer: Employee; Roche Diabetes Care. B.Kulzer: Advisory Panel; Berlin-Chemie AG, Abbott Diabetes, Bayer Inc., Dexcom, Inc., Novo Nordisk, Insulet Corporation, embecta, Research Support; Sanofi, Roche Diabetes Care. Funding Roche Diabetes Care GmbH (DC000097)

Differences in positive expectancy of hybrid closed loop (HCL) insulin delivery systems do not explain racial differences in HCL use

AimsHybrid closed loop (HCL) insulin delivery systems improve glycemia and quality of life among youth with type 1 diabetes (T1D), however there are inequities in use. We aimed to evaluate whether differences in positive expectancy of HCL systems may explain differences in use. MethodsFifteen publicly-insured, non-Hispanic Black (NHB) youth with hemoglobin A1C (HbA1c) ≥ 10% enrolled in a study exploring changes in glycemia and person reported outcomes (PRO) during 6 months of Tandem t:slim X2 insulin pump with Control-IQ technology. At baseline youth and parents completed PROs, including Insulin Delivery Systems: Perceptions, Ideas, Reflections and Expectations (INSPIRE) survey assessing positive expectancy of HCL use, and Problem Areas in Diabetes (PAID) survey assessing diabetes-related distress. Differences between this cohort and the Tandem Control-IQ pediatric pivotal trial (DCLP5) cohort were assessed. ResultsAs compared to the DCLP5 cohort (0% NHB, 10% publicly-insured), baseline glycemic indicators were suboptimal (MHbA1c 11.9 ± 1.4% vs 7.6 ± 0.9%, p < 0.0001; continuous glucose monitor (CGM) time-above-range > 180 mg/dL 82 ± 15% vs 45 ± 18%, p < 0.0001). INSPIRE scores in both cohorts were equally high among youth (80 ± 10 vs 77 ± 13, p = 0.41) and parents (88 ± 14 vs 85 ± 11, p = 0.37). PAID scores were higher among parents (68 ± 19 vs 43 ± 16, p < 0.0001), but not youth (43 ± 16 vs 35 ± 16, p = 0.09) in the historically marginalized cohort as compared to the DCLP5 cohort. ConclusionsDespite differences in glycemic control and diabetes related burden, positive expectancy of HCL systems is comparable among historically marginalized youth with T1D and the predominantly non-Hispanic White, privately insured DCLP5 cohort. These findings suggest that differences in perceptions of HCL technology may not explain inequities in use.

Diabetes Distress Is Associated With Future Risk of Progression of Diabetic Nephropathy in Adults With Type 2 Diabetes: A Prospective Cohort Study (Diabetes Distress and Care Registry at Tenri [DDCRT23

ObjectivesOur aim in this study was to investigate the prospective association between diabetes distress assessed with Problem Areas in Diabetes (PAID) survey scores at baseline and the subsequent risk of development or progression of diabetic nephropathy in people with type 2 diabetes. MethodsLongitudinal data were acquired from 2,845 individuals with type 2 diabetes registered in a Japanese diabetes registry. A Cox proportional hazards model was used to adjust for possible confounders to examine the prospective association between baseline diabetes distress (PAID score ≥40) and the development or progression of albuminuria. ResultsMean patient age, body mass index, and glycated hemoglobin level were 64.8 years, 24.5 kg/m2, and 57.4 mmol/mol (7.5%), respectively. We did not observe a significant association between diabetes distress and the subsequent risk of diabetic nephropathy development from normoalbuminuria to microalbuminuria/macroalbuminuria (multivariable-adjusted hazard ratio [HR]=0.95 over 4.2 years, 95% confidence interval [CI] 0.77 to 1.17, p=0.640); however, we identified a significant association for progression from microalbuminuria to macroalbuminuria (multivariable-adjusted HR=1.34 over 7.0 years, 95% CI 1.01 to 1.80, p=0.045). Stratification by sex revealed a significant association between diabetes distress and the subsequent risk of progressing diabetic nephropathy (HR=1.45, 95% CI 1.06 to 1.98, p=0.019) in males, but not females (HR=1.42, 95% CI 0.95 to 2.14, p=0.087). ConclusionsDiabetes distress at baseline, assessed using the PAID survey, was associated with a subsequent risk of progressing diabetic nephropathy independent of possible confounders in males, but not females, with type 2 diabetes.

Severe distress & denial among Asian patients with Type 2 Diabetes Mellitus in the primary care: A prospective, multicentre study

AimsTo determine the point-prevalence and distribution of diabetes distress among primary care Asians with Type 2 Diabetes Mellitus (T2DM) and evaluate its association with cardiovascular risk. MethodsThis was a prospective, multicentre study conducted in two outpatient clinics. Patients aged ≥ 21 years with uncontrolled T2DM (HbA1c > 7.0 % [53 mmol/mol]) and polypharmacy were stratified based on their Framingham Risk Score (FRS–high ≥ 10 %, low < 10 %) and matched in accordance to their baseline HbA1c. Cardiovascular risk was estimated using FRS while diabetes distress was measured using Problem Areas in Diabetes (PAID) scale (denial 0–10, severe distress ≥ 40). ResultsOf 1940 patients approached, 210 were recruited. A final 132 (62.9 %) participants were eligible for analysis. Median PAID score was 17.5 (IQR 6.25–41.56), with an even distribution in each distress category. There was no significant difference in PAID scores between the high and low FRS groups (20.00vs13.75, p = 0.446). Additionally, PAID score distribution within each group was similar (McNemar-Bowker test, p = 0.477). However, a high prevalence of severe distress (31.4 %) and denial (33.8 %) was detected. Among those in denial, 58.7 % had accompanying intermediate-high 10-year cardiovascular risk. ConclusionIn our sample of Asian primary care patients, a high prevalence of severe diabetes distress and denial was detected although no clear association between cardiovascular risk and diabetes distress was found. Future studies should assess the longitudinal changes and impact of other risk factors in diabetes distress.(Abstract: 199 words)

Impact of anxiety, depression and disease-related distress on long-term glycaemic variability among subjects with Type 1 diabetes mellitus

BackgroundAnxiety, depression, and disease-related distress are linked to worse overall glycaemic control, in terms of HbA1c. This study was aimed to evaluate whether traits of these emotional disorders are associated with long-term glycaemic variability in subjects with Type 1 diabetes.MethodsLongitudinal retrospective study. Six-year HbA1c data (2014–2019) from 411 subjects with Type 1 diabetes who had participated in a previous study to design a diabetes-specific quality of life questionnaire in the year 2014 were included. Scores for Spanish versions of the Hospital Anxiety and Depression Scale (HADS) and Problem Areas in Diabetes (PAID) scale were obtained at baseline, along with sociodemographic and clinical data. Long-term glycaemic variability was measured as the coefficient of variation of HbA1c (HbA1c-CV). The association between HADS and PAID scores and HbA1c-CV was analysed with Spearman correlations and multiple regression models, both linear and additive, including other covariates (age, sex, diabetes duration time, type of treatment, baseline HbA1c, use of anxiolytic or antidepressant drugs, education level and employment status).ResultsScores of depression, anxiety and distress were positively and significantly correlated to HbA1c-CV in univariate analyses. Multiple regression study demonstrated an independent association only for diabetes distress score (p < 0.001). Age, diabetes duration time, baseline HbA1c, education level and employment status were also significantly associated with HbA1c-CV. However, when subjects were analyzed separately in two age groups, distress scores were associated with HbA1c-CV only among those aged 25 years or older, while anxiety scores, but not distress, were associated with HbA1c-CV among those younger than 25 years.ConclusionsPsychological factors, particularly disease-related distress and anxiety, are associated with long-term glycaemic variability in subjects with Type 1 diabetes.

Effects of very low-carbohydrate vs. high-carbohydrate weight loss diets on psychological health in adults with obesity and type 2 diabetes: a 2-year randomized controlled trial.

Very low-carbohydrate (LC) diets are popular for type 2 diabetes (T2DM) management; however, long-term effects on psychological health remain largely unknown. This study reports the effects of a LC diet on mood and cognitive function after 2 years and explores the potential predictors of changes in psychological health. 115 adults (57% males; age: 58.5 ± 7.1years) with obesity and T2DM were randomized to consume an energy reduced (~ 500 to 1000kcal/day deficit), LC diet [14% energy as carbohydrate, 28% protein, 58% fat (< 10% saturated fat)] or an isocaloric high unrefined carbohydrate, low-fat diet [HC: 53% carbohydrate, 17% protein, 30% fat (< 10% saturated fat)] for 2 years. Both diets were combined with aerobic/resistance exercise (1h, 3days/week). Mood/well-being [Beck Depression Inventory (BDI), Spielberger State Anxiety Inventory (SAI), Profile of Mood States (POMS)], diabetes-related quality of life [Diabetes-39 (D-39)] and distress [Problem Areas in Diabetes (PAID) Questionnaire], and cognitive function were assessed during and post-intervention. 61 (LC: 33, HC: 28) participants completed the study. Weight loss was 9.1% after 12months and 6.7% after 2years with no difference between diet groups. There were no differences between the groups for the changes in any psychological health outcome (smallest p ≥ 0.19 for all time x diet interactions). Overtime, improvements in BDI, POMS [Total Mood Disturbance (TMD); four subscales], PAID, and D-39 (three subscales) scores occurred (p ≤ 0.05, time). Stepwise regression analysis showed improvements in BDI, POMS (TMD; two subscales), D-39, SAI, and PAID scores were significantly (p < 0.05) correlated with reductions in body weight and glycated hemoglobin. In adults with obesity and T2DM, energy-restricted LC and HC diets produced comparable long-term improvements on a comprehensive range of psychological health outcomes. The findings suggest both diets can be used as a diabetes management strategy as part of a holistic lifestyle modification program without concern of negative effects on mental well-being or cognition. ACTRN12612000369820, https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=362168&isReview=true . Data described in the manuscript, code book, and analytic code will not be made available because approval has not been granted by participants.

Association between attendance at an American diabetes camp and improvements in glycaemic control and treatment satisfaction.

IntroductionFew studies have evaluated glycaemic control using continuous glucose monitoring (CGM) in individuals before and after attendance at a diabetes camp or by comparing control groups at home to control groups at camp.MethodsYouth (6–17 years) with T1D and receiving insulin therapy were enrolled at a week‐long diabetes camp. They participated in three clinic visits: at the start of a week at home, by initiating a Dexcom G6 CGM system; at the start of a week at camp, where the home week G6 was removed and a camp week G6 was inserted; and after camp, where the camp week G6 was removed. We administered Problem Areas in Diabetes (PAID) surveys at the second and third visits. Participants with <80% CGM data coverage or who did not complete all PAID surveys were excluded from analysis. We compared glycaemic control and PAID scores between the week at home and week at camp.ResultsOf 76 enrolled campers, 69 completed the study and 52 had results that qualified for analysis. The mean participant age was 12.5 ± 2.2 years. Camp was associated with significantly improved treatment satisfaction, time in desired glucose range and insulin sensitivity. Time in hyperglycaemia and basal insulin requirements decreased significantly.ConclusionsDiabetes camp is associated with significant improvements in diabetes treatment satisfaction and glycaemic control compared to home care.

661 Chronotype, Mood, and Diabetes-Related Distress in Adults with Type 2 Diabetes

Abstract Introduction Chronotype refers to an individual’s preferred timing of sleep and wakefulness, which can be classified as ‘normal’ or ‘late’ chronotypes. The purpose of this study was to examine whether late sleep timing was associated with impaired mood and diabetes-related distress in persons with type 2 diabetes (T2D). Methods The study is a secondary analysis of pooled cross-sectional baseline data from two studies of treatment of obstructive sleep apnea (R01-DK96028) and insomnia (K24-NR016685) in persons with T2D. Sleep timing was measured by the bedtime from a 7-day sleep diary. “Normal” sleep timing was defined as bedtime between 9PM to 12AM ≥ 85% per week. “Late” sleep timing as bedtime after 12AM with normal sleep timing &amp;lt; 85% per week. Other sleep variables evaluated were sleep duration, daytime sleepiness (Epworth Sleepiness Scale [ESS]), and OSA severity (apnea-hypopnea index [AHI]). The Profiles of Mood States measured Total Mood Disturbance (TMD) and the subscales of Tension-Anxiety (T-A), Depression-Dejection (D-D), Anger-Hostility (A-H), Vigor-Activity (V-A), Fatigue-Inertia (F-I), and Confusion-Bewilderment (C-B). Diabetes-related distress was measured by the Problem Areas in Diabetes (PAID). Hierarchical multiple regression was performed to determine whether sleep timing was associated with mood and diabetes-related distress. Results The sample (N=296) had 61% with late sleep timing (n=181). Persons with normal vs late sleep timing were similar in age, sex, race, and education (p &amp;gt;.05). Persons with late sleep timing were less likely to be partnered, had shorter sleep duration and greater mood impairment (TMD and T-A, D-D, A-H, C-B subscales) than those with normal timing (all p values &amp;lt;.05); there was no significant difference by sleep timing in PAID scores (p=.256). Hierarchical regression analyses adjusting for demographics (age, sex, race, marital status, education level), clinical (HbA1c, BMI), and sleep variables (sleep duration, ESS, AHI) revealed that late sleep timing was not significantly associated with impaired mood (TMD and subscales) or PAID. However, ESS was statistically significant in predicting greater TMD (β=.310, p &amp;lt;.001), mood subscales (all p-values &amp;lt;.05) and PAID (β =.222, p &amp;lt;.001). Conclusion Daytime sleepiness, not late sleep timing, is a significant sleep-related symptom for increased mood impairment and diabetes-related distress in persons with T2D. Support (if any):

Effect of Voluntary Participation on Mobile Health Care in Diabetes Management: Randomized Controlled Open-Label Trial.

BackgroundThe role of mobile health care (mHealth) in glycemic control has been investigated, but its impact on self-management skills and its psychological aspects have not been studied.ObjectiveWe evaluated the efficacy of mHealth-based diabetes self-management education and the effect of voluntary participation on its effects.MethodsThis study was a randomized controlled open-label trial conducted for 6 months at Kangbuk Samsung Hospital. Participants in the control group (n=31) maintained their previous diabetes management strategies. Participants in the intervention group (n=41) additionally received mHealth-based diabetes self-management education through a mobile app and regular individualized feedback from health care professionals. The primary outcome was change in glycated hemoglobin (HbA1c) level over 6 months between the 2 groups (intervention versus control) and within each group (at 6 months versus baseline). The secondary outcomes were changes in body mass index, blood pressure, lipid profile, and questionnaire scores (the Korean version of the Summary of Diabetes Self-Care Activities Questionnaire, an Audit of Diabetes Dependent Quality of Life, the Appraisal of Diabetes Scale, and Problem Areas in Diabetes) over 6 months between groups and within each group.ResultsA total of 66 participants completed this study. HbA1c (P=.04), total cholesterol level (P=.04), and Problem Areas in Diabetes scores (P=.02) significantly decreased; total diet (P=.03) and self-monitoring of blood glucose level scores (P=.01), based on the Summary of Diabetes Self-Care Activities Questionnaire, markedly increased within the intervention group. These significant changes were observed in self-motivated participants who were recruited voluntarily via advertisements.ConclusionsmHealth-based diabetes self-management education was effective at improving glycemic control and diabetes self-management skills and lowering diabetes-related distress in voluntary participants.Trial RegistrationClinicalTrials.gov NCT03468283; http://clinicaltrials.gov/ct2/show/NCT03468283

13-OR: Piloting the Problem Areas in Diabetes Scale in Clinical Practice: The DiaPROM Pilot Trial

Background: Diabetes distress is a potential barrier to self-management and satisfactory glycaemic control. A structured focus on diabetes distress using the Problem Areas in Diabetes (PAID) scale may improve the health of people with diabetes. We designed the DiaPROM trial, evaluating the effect of using electronically captured PAID in clinical practice, to reduce diabetes distress among adults with type 1 diabetes. Methods: In this pilot trial, we aimed to evaluate PAID scores pre and post intervention and identify patients with elevated scores. We randomly assigned participants (18-≤40 yrs) at an outpatient clinic to standard care or an intervention were physicians referred individuals with a PAID score ≥30 or single item(s) ≥3 (moderately high distress) to minimum two nurse appointments. Following a communication manual based on empowerment and self-determination theory, reported problem areas were reviewed and discussed. Results: We recruited 79 adults with type 1 diabetes (age 27.2 ±5.0 yrs, diabetes duration 13.7 ±7.0 yrs, HbA1c 65.4 ±14.5 mmol/mol). In the intervention group (n=39), baseline PAID score was 27.7 ±16.8; 23 (59%) participants qualified for additional follow up and 17 (44%) accepted referral, attending a mean of 2.2 ±1.1 appointments. At 12 month follow up, the intervention group (n=31) mean score was 21.7 ±14.4 (mean change 3.7 ±13.0), with 13 (42%) reporting moderately high distress. The control group (n=40) scored 24.1 ±14.3 at baseline and 26.2 ±14.5 at 12 months (n=36), with respectively 19 (48%) and 20 (56%) patients reporting moderately high distress. Between-group difference at 12 months was 5.5 (95% CI 0.25, 10.7). Conclusion: Half of the participants reported diabetes distress levels qualifying for additional follow up, which has consequences for scaling a future RCT. Although the study was not powered to estimate intervention effects, we identified a promising PAID score reduction in the intervention group which was not observed for the controls. Disclosure I. Hernar: None. M. Graue: None. D. Richards: None. R.B. Strandberg: None. K.F. Løvaas: None. T. Madsen: None. G.S. Tell: None. A. Haugstvedt: None.

769-P: Diabetes Distress Screening in an Academic Young Adult Diabetes Transition Program

Background: The transition from pediatric to adult care is a high risk time for young adults with diabetes associated with poor glycemic control and psychosocial challenges. However, little is known about how to prospectively identify patients most at risk during transition. Thus, we screened young adults for diabetes distress as part of a multidisciplinary diabetes transition program and identified correlations between distress and patient outcomes. Methods: Diabetes distress was measured during enrollment in the Michigan Medicine Diabetes Transition Program (MMDTP) using the Problem Areas in Diabetes (PAID) questionnaire, a validated diabetes distress screening tool. Patients with high distress were referred to the program social worker. We performed a retrospective chart review on MMDTP participants who were screened from 7/2017 to 12/2018. Results: Fifty-eight young adults (age 17-23 years) completed distress screening, with PAID scores ranging from 0 to 82.5 (median 11.9). 13.8% of patients had high distress (PAID&amp;gt;40). Mean HbA1c prior to transition was 9.7 ± 2.3% and did not correlate with PAID scores nor did distress correlate with insulin pump or continuous glucose monitor use. Among 48 patients &amp;gt;1 year from first adult endocrine visit, those attending at least 3 visits in the first year (n=35) had lower median PAID scores than those attending 2 or fewer visits (10.0 vs. 26.2, p=0.02). Those attending at least 3 visits also had significantly lower mean HbA1c prior to transition (9.0% vs. 12.2%, p&amp;lt;0.01). Discussion: Here we report the successful implementation of diabetes distress screening for young adults during the transition to adult care. While distress scores were lower than anticipated based on prior studies, we still found 13.8% of our patients had high distress levels. High distress and HbA1c levels at program entry both correlated with reduced visit frequency in the first year post-transition. Future interventions will aim to improve clinic attendance in patients with high distress. Disclosure K. Rodeman: None. A. Rao: None. A. Konigsberg: None. L. Ang: None. I.H. Thomas: None. S. Soleimanpour: None. J.J. Iyengar: None.

823-P: Diabetes Camp Experience Associated with Improved Glycemia and Treatment Satisfaction

We compared glycemic metrics using continuous glucose monitoring (CGM) and quality of life between diabetes camp and the preceding home week. Insulin-treated youth (6-17 years) with T1D were enrolled at Barton Diabetes Camp and participated in 3 clinic visits: at the start of home week, where a Dexcom G6 CGM system was initialized; at the start of camp week, where the home week G6 was removed and a camp week G6 was inserted; and after camp, where the camp week G6 was removed. Problem areas in diabetes (PAID) surveys were administered at visits 2 and 3. Data from campers who did not complete all surveys were excluded. At camp, treatment decisions were informed by G6 as per FDA guidelines; interventions were prompted by daytime glucose levels ≤55 mg/dL or ≥350 mg/dL and for nighttime glucose levels ≤80 mg/dL or ≥300 mg/dL. Glycemic control and PAID scores were compared between home and camp weeks. Of 76 enrolled campers, 69 completed the study and 52 had results that qualified for analysis. Mean (SD) age was 12.5 (2.2) years. Most campers used insulin pumps (87.2%) and had experience with CGM (86.6%). Camp was associated with significant improvements in treatment satisfaction, time in range and in hyperglycemia, decreased basal insulin requirements, and improved insulin sensitivity (Table). Diabetes camp is associated with significant improvements in diabetes treatment satisfaction and glycemia compared to home care. Disclosure A. Darukhanavala: None. K.V. Dinunno: None. S. Puhr: Employee; Self; Dexcom, Inc. J.B. Welsh: Employee; Self; CSL Behring. L. Butler: None. D. Alfego: None. K.L. Magyar: None. Funding Dexcom, Inc.

1629-P: Association of Patient-Reported Outcomes (PROs) Scores with Glycemic Target Achievement in Type 1 Diabetes (T1D) in the SAGE Study

T1D is a chronic disease affecting both physical and psychosocial health. SAGE was a multinational, cross-sectional observational study using data from medical records and interviews of people (N=3858) aged ≥26 years with T1D for ≥1 year. The association between the achievement of general (HbA1c &amp;lt;7 %) or individualized HbA1c targets and PRO scores was analyzed by multivariate logistic regression, adjusted for region and age group. The following PROs are reported: Hypoglycemia Fear Survey (HFS-II) worry subscore, Problem Areas in Diabetes (PAID), Insulin Treatment Satisfaction Questionnaire (ITSQ), Audit of Diabetes-Dependent Quality of Life (ADDQoL). Overall, 24.3% of people achieved the general HbA1c target; 20.9% achieved individualized targets (most common target, HbA1c 7 % to &amp;lt;7.5 %). Lower emotional distress (PAID score) and higher treatment satisfaction (all ITSQ scores except Lifestyle domain) were associated with achievement of general and individualized HbA1c targets (Table). Lower HFS-II worry score and higher ADDQoL total scores were associated with achievement of HbA1c general target, but neither was associated with achieving individualized HbA1c targets. In people with T1D, lower diabetes-related emotional distress and higher treatment satisfaction appear to be associated with achievement of both general and individualized HbA1c targets. Disclosure E.G. Wilmot: Advisory Panel; Self; Abbott, Dexcom, Inc., Eli Lilly and Company, Insulet Corporation, Medtronic. Speaker’s Bureau; Self; Abbott, Eli Lilly and Company, Insulet Corporation, Novo Nordisk Inc., Sanofi. F. Ampudia Blasco: None. L. Berard: Consultant; Self; Abbott, AstraZeneca, Bayer Healthcare Pharmaceuticals Inc., Becton, Dickinson and Company, Eli Lilly and Company, Janssen Pharmaceuticals, Inc., Montméd, Novo Nordisk Inc., Sanofi. Speaker’s Bureau; Self; Boehringer Ingelheim (Canada) Ltd. S. Brette: Other Relationship; Self; Sanofi. L.P. Calliari: Board Member; Self; Abbott, Medtronic, Novo Nordisk A/S, Sanofi. Speaker’s Bureau; Self; Lilly Diabetes. E. Fitts: Other Relationship; Self; N/A. K.L. Close: Other Relationship; Self; Abbott, Air Liquide, American Diabetes Association, AstraZeneca, Dexcom, Inc., Janssen Pharmaceuticals, Inc., JDRF, Leona M. and Harry B. Helmsley Charitable Trust, Lilly Diabetes, Merck &amp; Co., Inc. J.J. Gagliardino: None. F. Lauand: Employee; Self; Sanofi. A.L. Peters: Advisory Panel; Self; Abbott, Bigfoot Biomedical, Boehringer Ingelheim Pharmaceuticals, Inc., Eli Lilly and Company, MannKind Corporation, Medscape, Novo Nordisk Inc., Sanofi US. Consultant; Self; Livongo Health. Research Support; Self; Dexcom, Inc., vTv Therapeutics. Other Relationship; Self; Livongo Health, Mellitus Health, Omada Health, Stability Healthcare, Whole Biome Inc. E. Renard: Board Member; Self; Abbott, Insulet Corporation, Novo Nordisk A/S, Roche Diabetes Care. Consultant; Self; Air Liquide, Eli Lilly and Company, Sanofi. Research Support; Self; Dexcom, Inc., Tandem Diabetes Care. A. Roborel de Climens: Employee; Self; Sanofi. J. Seufert: Research Support; Self; Sanofi. Speaker’s Bureau; Self; Sanofi.

Development and Validation of the Continuous Subcutaneous Insulin Infusion-Related Quality-of-Life (CSII-QOL) Scale.

Background: Continuous subcutaneous insulin infusion (CSII) is associated with improved glycemic control, a reduced incidence of hypoglycemia, and improved quality of life (QOL). To date, however, there has been no QOL scale specific to CSII. The objective of this study was to develop and validate a scale to measure CSII-QOL for people with type 1 diabetes (T1D). Methods: A total of 50 people with T1D aged ≥15 years who used CSII (28% males; age, 47.6 ± 17.0 years; duration of diabetes, 14.7 ± 9.7 years; duration of CSII use, 6.1 ± 3.3 years; HbA1c, 7.4% ± 0.8%) took part in the CSII-QOL study. Twenty-eight potential CSII-QOL items were developed in a combined approach consisting of semistructured patient interviews, expert input, and a literature search. The resulting CSII-QOL was tested for factor analysis, validity, reliability, and influencing factors. Results: The final 25-item questionnaire had a 3-domain structure ("convenience," "social restriction," and "psychological problems"), high internal consistency (Cronbach's alpha = 0.870), and substantial test-retest reliability (intraclass correlation coefficient = 0.65). The CSII-QOL score was correlated negatively with the Problem Areas in Diabetes score. Conclusion: The CSII-QOL is the first CSII-related QOL scale for people with T1D. This short, validated, and reliable instrument might potentially be useful in future clinical studies and routine clinical patient care. Further validation is required to confirm these issues because of the small and potentially biased sample (UMIN-CTR: UMIN000031595).

Large-Scale Cross-Sectional Study of the Problem Areas in Diabetes Survey among Japanese Patients with Type 2 Diabetes Mellitus

Introduction: Diabetes treatment has unique aspects that require behavior modification among patients in terms of food consumption, exercise and others. The emotional burden among patients that is caused by diabetes treatment and diabetes-related morbidity in itself often causes patients to have trouble carrying out daily activities and makes the maintenance of glycemic control difficult. The aim of this study was to investigate the association between glycemic control and the Problem Areas in Diabetes (PAID) scores which is an indicator of emotional burden among Japanese patients with type 2 diabetes mellitus (T2DM) on a large scale. Methods: Data from 3511 patients with T2DM were obtained from the Diabetes Registry in Kanagawa. We used PAID scores to evaluate diabetes-related emotional distress. For 3432 patients who answered completely, we assessed the association between PAID scores and HbA1c and other background factors, while adjusting for possible confounding factors. Results: The mean age, body mass index, disease duration and HbA1c level were 63.2 years, 25.3 kg/m2, 12.5 years, and 7.53%, respectively. The mean PAID score was 43.3 points. Five point five percent were severely burdened patients who scored more than 70 points. There was a significant correlation between PAID scores and HbA1c (ρ=0.025, p&amp;lt;0.001), and higher HbA1c levels were associated with higher PAID scores. Sex (female; p&amp;lt;0.0001), younger age (p&amp;lt;0.0001), higher BMI (p&amp;lt;0.0001), diabetic neuropathy (p&amp;lt;0.0001), diabetic retinopathy (p&amp;lt;0.0001), and diabetic foot (p&amp;lt;0.0037) were all associated with higher PAID scores. In the multiple regression analysis, HbA1c level (p&amp;lt;0.0001), diabetic retinopathy (p=0.003) and injection therapy (p=0.0001) were independent factors affecting PAID scores. Conclusions: Treatment to maintain normal levels of HbA1c may prevent the onset of diabetic retinopathy; moreover, it will reduce the emotional burden among patients with diabetes. Disclosure K. Takahashi: None. M. Shinoda: None. R. Sakamoto: None. J. Suzuki: None. T. Yamakawa: None. Y. Terauchi: Research Support; Self; MSD K.K.. Speaker's Bureau; Self; MSD K.K.. Advisory Panel; Self; MSD K.K.. Research Support; Self; Ono Pharmaceutical Co., Ltd.. Speaker's Bureau; Self; Ono Pharmaceutical Co., Ltd.. Research Support; Self; Novartis Pharma K.K., Boehringer Ingelheim GmbH. Speaker's Bureau; Self; Boehringer Ingelheim GmbH. Advisory Panel; Self; Boehringer Ingelheim GmbH. Research Support; Self; Mitsubishi Tanabe Pharma Corporation. Speaker's Bureau; Self; Mitsubishi Tanabe Pharma Corporation. Advisory Panel; Self; Mitsubishi Tanabe Pharma Corporation. Research Support; Self; Daiichi Sankyo Company, Limited. Speaker's Bureau; Self; Daiichi Sankyo Company, Limited. Advisory Panel; Self; Daiichi Sankyo Company, Limited. Research Support; Self; Sanwa Kagaku Kenkyusho Co., Ltd.. Speaker's Bureau; Self; Sanwa Kagaku Kenkyusho Co., Ltd.. Research Support; Self; Novo Nordisk Inc.. Speaker's Bureau; Self; Novo Nordisk Inc.. Advisory Panel; Self; Novo Nordisk Inc.. Research Support; Self; Eli Lilly and Company. Speaker's Bureau; Self; Eli Lilly and Company. Advisory Panel; Self; Eli Lilly and Company. Research Support; Self; Sanofi. Speaker's Bureau; Self; Sanofi. Advisory Panel; Self; Sanofi. Research Support; Self; Sumitomo Dainippon Pharma Co., Ltd.. Speaker's Bureau; Self; Sumitomo Dainippon Pharma Co., Ltd.. Research Support; Self; Shionogi &amp; Co., Ltd.. Speaker's Bureau; Self; Shionogi &amp; Co., Ltd., Bayer Yakuhin, Ltd., Astellas Pharma US, Inc., AstraZeneca. Advisory Panel; Self; AstraZeneca, Teijin Pharma Limited.

Impact of Diabetes-Related Distress on Predicted Cardiovascular Complications in Patients with Type 2 Diabetes

Objective: To evaluate the impact of diabetes-related distress along with other cardiovascular risk factors on the predicted 10-year cardiovascular complication risks in patients with type 2 diabetes Methods: This cross-sectional study involved Problem Areas in Diabetes (PAID) questionnaire and UK Prospective Diabetes Study (UKPDS) Risk Engine 2.0, surveying a population with lower socioeconomic status and type 2 diabetes. Statistical analyses incorporated multiple linear regression models, comprising of the predicted cardiovascular risks, PAID scores, tobacco use, gender, age, LDL levels, clinically documented depression status, BMI, and systolic blood pressure. Results: Results are organized by statistical models (driven by risk factors for cardiovascular conditions) and the predicted, individual 10-year cardiovascular complication risks vs. PAID scores. Conclusion: This study found an association between psychosocial status and cardiovascular disease risk management in lower socioeconomic patients with type 2 diabetes. Within all the multiple linear regression models, the levels of diabetes-related distress have been shown to impact the predicted fatal coronary heart disease risks, thus allowing this distress to predict such cardiovascular risk after including certain risk factors. Coefficientp-value95% CIDepression Status, Tobacco Use, LDL Levels, Gender, AgePredicted Coronary Heart Disease Risks vs. PAID Scores0.0770.039(0.0039 – 0.15)Predicted Fatal Coronary Heart Disease Risks vs. PAID Scores0.0700.014(0.014 – 0.13)Predicted Stroke Risks vs. PAID Scores0.0160.38(-0.020 – 0.053)Predicted Fatal Stroke Risks vs. PAID Scores0.00170.62(-0.0050 – 0.0084)Systolic Blood Pressure, Tobacco Use, LDL Levels, Gender, AgePredicted Coronary Heart Disease Risks vs. PAID Scores0.0680.069(-0.0054 – 0.14)Predicted Fatal Coronary Heart Disease Risks vs. PAID Scores0.0630.029(0.0066 – 0.12)Predicted Stroke Risks vs. PAID Scores0.0150.388(-0.019 – 0.049)Predicted Fatal Stroke Risks vs. PAID Scores0.00190.495(-0.0036 – 0.0075)BMI, Tobacco Use, LDL Levels, Gender, AgePredicted Coronary Heart Disease Risks vs. PAID Scores0.0660.072(-0.0061 – 0.14)Predicted Fatal Coronary Heart Disease Risks vs. PAID Scores0.0610.032(0.0053 – 0.12)Predicted Stroke Risks vs. PAID Scores0.0110.52(-0.024 – 0.047)Predicted Fatal Stroke Risks vs. PAID Scores0.000880.79(-0.0056 – 0.0073) Disclosure C. Young: None. J.A. Dugan: None. A.J. Ray: None. J.H. Shubrook: Advisory Panel; Self; Eli Lilly and Company, Novo Nordisk Inc., Intarcia Therapeutics, Inc..