Diabetes Symptom Checklist-Revised Research Articles

Prevalence and burden of diabetes mellitus-related symptoms in patients with type 2 diabetes mellitus: A cross-sectional study.

Type 2 diabetes mellitus (T2DM) is a significant non-communicable disease in Malaysia, with a prevalence of 18.1%, per the National Health and Morbidity Survey. This study aimed to determine the prevalence and burden of diabetes mellitus-related symptoms and whether these symptoms were addressed by primary care doctors. This 1-month cross-sectional study was conducted at an urban hospital-based primary care clinic in Malaysia. Patients with T2DM were recruited using systematic random sampling. Participants answered a self-administered questionnaire adapted from the Diabetes Symptom Checklist-Revised, which evaluated the sociodemographic characteristics, burden of diabetes mellitus-related symptoms in the past month and post-consultation feedback about symptoms. Data were analysed using SPSS. Four hundred eighteen participants were included, yielding a response rate of 97.7%. Hyperglycaemia was the most prevalent symptom, with 48.1% of the participants reporting a frequent need to empty their bladder. Most participants experienced a low symptom burden, so 56.7% did not report their symptoms to their doctors. The participants who reported their symptoms had a higher symptom burden. Among them, 97.5% indicated that their doctors addressed their symptoms. Approximately 78% reported satisfaction and good coping skills when their symptoms were addressed. Hyperglycaemia was the most prevalent diabetes mellitus-related symptom among the patients with T2DM. The symptom burden was generally low, so most patients did not report their symptoms to their doctors. Those who reported their symptoms had a higher symptom burden. Further studies must explore why patients do not report their symptoms and how doctors address patients' symptoms.

SYMPTOMS CONTRIBUTING TO SLEEP PROBLEMS IN OLDER ADULTS WITH TYPE 2 DIABETES

Abstract Sleep problems are common in older adults. Those with diabetes are more vulnerable to sleep disorders since diabetes-specific symptoms can interfere with sleep quality. Yet little is known which diabetes symptoms most strongly affect sleep in older adults. This study aimed to examine the associations between diabetes symptoms and sleep and to identity the symptoms that most strongly disrupt sleep in older adults in the United States. Diabetes symptoms were assessed using the Diabetes Symptom Checklist-Revised. Sleep impairment and sleep disturbance were self-reported using The Patient-Reported Outcomes Measurement Information System. Demographic (age, sex, race/ethnicity) and other variables (body mass index, depressive symptoms, diabetes duration, glycemic control) were also assessed. Multivariate regression analyses were used with standardized coefficients. A total of 82 adults aged ≥ 60 years were included (mean age = 68.32 ± 5.29 years, White 76.83%, female 56.1%). After controlling for demographic and other variables, increased hypoglycemia (β = .35), hyperglycemia (β = .38), fatigue (β = .65), cognitive (β = .48), and ophthalmologic (β = .25) symptoms and neurological pain (β = .42) significantly increased sleep impairment. Of these, fatigue was the strongest contributor to sleep impairment. Similarly, increased hyperglycemia symptoms (β = .30), fatigue (β = .34), and neurological pain (β = .37) significantly increased sleep disturbance while neurological pain was the strongest contributor. To improve sleep quality of older adults with diabetes, their diabetes symptoms should be comprehensively assessed, and potential contributor to poor sleep such as increased fatigue and neurological pain should be addressed.

Plant Extracts as Add-On Therapeutics in Homeopathy: An Open-Label, Randomized Trial Using Mother Tinctures in Prediabetes.

Objectives: Prediabetes is a major public health concern. Different plant extracts are used in homeopathy as mother tinctures (MTs) for the treatment of prediabetes as an adjunct to individualized homeopathic medicines (IHMs); however, their effectiveness remains under-researched. Design: Open-label, randomized (1:1), active-controlled, pragmatic, exploratory trial. Setting: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Subjects: Eighty-nine patients with prediabetes. Interventions: Group 1 (n = 45; IHMs plus any one of the following MTs: Cephalandra indica, Gymnema sylvestre, and Syzygium jambolanum; experimental/verum) versus Group 2 (n = 44; IHMs only; control). Outcome measures: Blood parameters, including-the fasting blood sugar (FBS) level, blood sugar level 2 h after ingestion of 75 g of glucose (oral glucose tolerance test [OGTT] result), and glycosylated hemoglobin percentage (HbA1c%), and symptoms, including the Diabetes Symptom Checklist-Revised (DSC-R) score; all of them were measured at baseline and after 3 and 6 months. Results: Although recruitment of 140 patients was initially planned, the target sample size could not be achieved because of coronavirus disease pandemic-related restrictions. Only 89 patients could be enrolled, and the trial had to be terminated prematurely owing to the time constraints of the project. The data of 82 patients (Group 1, n = 40; Group 2, n = 42) were analyzed using a modified intention-to-treat approach. Improvements in all outcomes were greater in Group 1 than in Group 2, but without a significant difference: FBS level (F1, 80 = 4.095, p = 0.046), OGTT result (F1, 80 = 2.399, p = 0.125), HbA1c% (F1, 80 = 1.612, p = 0.208), and DSC-R score (F1, 80 = 0.023, p = 0.880). Conclusions: A promising but nonsignificant trend favored the combination of MTs and IHMs compared with IHMs alone among the patients with prediabetes, especially in FBS. Therefore, further studies are required. Clinical Trial Registration Number: CTRI/2018/08/015319; secondary identifier (UTN): U1111-1218-6016.

Objective Sleep-Wake Characteristics Are Associated With Diabetes Symptoms in Young Adults With Type 1 Diabetes.

The primary purpose of this descriptive cross-sectional study was to examine the associations between sleep-wake characteristics (total sleep time, sleep variability, sleep onset latency, and sleep efficiency), distress symptoms (general and diabetes), and diabetes physical symptoms in young adults ages 18 to 30 years with type 1 diabetes (T1D). The secondary purpose was to determine whether biological sex, body mass index (BMI), and T1D duration (covariates) influence the relationships among the study variables. Forty-six young adults with T1D, recruited from diabetes clinics from December 2018 to February 2020, wore a wrist actigraph and continuous glucose monitor concurrently for 6 to 14 days and completed the PROMIS Emotional Distress Scale, Diabetes Distress Scale, and Diabetes Symptom Checklist-Revised. Shorter total sleep time and poorer sleep efficiency were associated with higher diabetes emotional distress symptoms. Higher sleep variability was associated with higher neurological pain symptoms. A longer sleep onset latency was associated with higher symptoms of diabetes distress, including psychological, cognitive, hyperglycemia, and a higher total symptom burden. Associations remained statistically significant after adjusting for biological sex and BMI, with the exception of sleep onset latency and total symptom burden. Poorer objective sleep-wake characteristics were associated with higher diabetes symptoms even after considering biological sex and BMI among young adults with T1D.

643 Rest Activity Rhythms, Symptom Burden, and Glucose Variability in Young Adults with Type 1 Diabetes

Abstract Introduction Circadian alignment is an important element in individual health, and one behavioral marker, rest-activity rhythm (RAR), may influence disease management in young adults with type 1 diabetes (T1D). Thus, in this descriptive study, we examined whether circadian rhythm is correlated with symptoms (emotional and diabetes distress, and diabetes physical symptom burden) and glucose variability in young adults with T1D. Methods Using convenience sampling, young adults with T1D underwent concurrent actigraphy and continuous glucose monitoring for 6–14 days to generate the following RAR parameters: (MESOR, amplitude, acrophase, and circadian quotient) and glucose variability indices (coefficient of variation and time in range). Participants completed the 8-item Epworth Sleepiness Scale, 8-item PROMIS v1.0 Emotional Distress Scale, 17-item Diabetes Distress Scale, and 34-item Diabetes Symptom Checklist-Revised. Cosinor analysis was used to compute the RAR parameters and linear regression modeling procedures were performed to determine the associations among the study variables. Results The sample included 46 young adults (mean age 22.3±3.2; 32.6% male; 84.8% non-Hispanic White, A1C mean 7.2±1.1%, BMI 27.0±4.4 kg/m2). A more robust rhythm (higher amplitude) was associated with a lower diabetes symptom burden (ß=-0.31, p=.035). A higher circadian quotient was associated with less daytime sleepiness (ß=-0.41, p=.004). All associations between the RAR parameters and symptom measures remained statistically significant (p<.05) after adjustment for sex and BMI. The associations between the RAR parameters and glucose variability indices were not significant. Conclusion RAR was associated with daytime sleepiness, as well as symptom burden in young adults with T1D even after consideration of sex and BMI. Future investigators should clarify the causality of these associations and the potential for improving the strength and stability of RAR in the mitigation of daytime sleepiness and symptoms. Support (if any) This research is or was partially supported by grants from the American Academy of Sleep Medicine (220-BS-19), National Institute of Nursing Research (K99NR018886 & T32NR0008346), Sigma Theta Tau International, and Dexcom provided continuous glucose monitors (G4) free of charge for participants who did not have a device.

Subjective cognitive decline in diabetes: Associations with psychological, sleep, and diabetes-related factors.

To determine whether psychological, sleep, and diabetes-related factors were associated with subjective cognitive decline (SCD) in adults with type 2 diabetes (T2D). A secondary analysis with a cross-sectional, correlational design. Data from two parent studies were combined. A total of 105 adults with diabetes were recruited from a Midwestern city in the United States from September 2013-March 2014 and September 2016-September 2017. Subjective cognitive decline was measured with the psychological-cognitive symptom subscale of the Diabetes Symptom Checklist-Revised. Psychological factors (diabetes distress, fatigue, and depressive symptoms) and sleep were measured using the Diabetes Distress Scale and Patient-Reported Outcomes Measurement Information System. Diabetes-related factors were measured with body mass index and glycaemia control. Quantile regression was used to examine the associations. The mean age of the participants was 58.10 (SD 7.92) years and 58.1% were women. The participants' mean psychological-cognitive symptom score was 1.41 (SD 1.13). After controlling for age and gender, sleep disturbance, sleep-related impairment, and body mass index were associated with SCD in lower cognitive symptom quantile groups (5th to 30th percentiles). In contrast, fatigue and depressive symptoms were more strongly associated with SCD in higher quantile groups (70th to 95th percentiles). In adults with T2D, SCD was differentially associated with psychological, sleep, and diabetes-related factors depending on cognitive symptom percentiles. Adults with T2D require regular screening for SCD. If they complain of cognitive symptoms at clinical visits, different underlying factors should be assessed according to their symptom severity. Findings from this study provided evidence for early identification of SCD and its influencing factors, which may help to develop nursing interventions to recognize and/or delay the onset of cognitive impairment in adults with T2D.

766-P: Factors Related to Subjective Cognitive Symptoms in People with Type 2 Diabetes: A Quantile Regression Analysis

Objectives: Early cognitive impairment is common in people with type 2 diabetes (T2DM). Subjective cognitive symptoms (SCS) have been associated with higher risks for early dementia and mild cognitive impairment and may be an early indication of further cognitive decline. Our goal was to identify factors related to SCS in people with T2DM to facilitate early screening for cognitive impairment in this population. Methods: A convenience sample of 115 adults with T2D was included. The cognitive symptom subscale of the Diabetes Symptom Checklist-Revised was used. Potential factors were measured using the Patient-Reported Outcomes Measurement Information System including depression, fatigue, and sleep. Data were analyzed using quantile regression which accounts for non-normal distribution of the dependent variable. Quantile regression was useful to examine the relationships along the continuum of SCS severity that may be missed in traditional linear regression. Results: The mean age of the participants was 58.64 (SD 8.64), and 53.9% were females. The mean score of the cognitive symptom subscale was 1.45 (SD 1.14, range 0 to 5). Using quantile regression, we found that increased sleep impairment (r = .02), sleep disruption (r = .02 to .05), and body mass index (r = .02) were significantly associated with increased SCS when the participants’ cognitive symptoms were in the lower quantiles (from .05 to .30). In contrast, increased depressive symptoms (r = .05 to .07) and fatigue (r = .04 to .06) were significantly associated with increased SCS in the higher quantiles of cognitive symptoms (from .70 to .95). Conclusions: In adults with T2DM, the level of SCS is differentially associated with common diabetes factors and should be considered when screening and intervening for cognitive impairment. Sleep and weight should be considered for patients reporting fewer cognitive symptoms, whereas depression and fatigue should be considered for patients reporting more cognitive symptoms. Disclosure M. Kim: None. C.G. Park: None. B. Zhu: None. C. Fritschi: None. Funding National Institute for Nursing Research (K99R00NR012219); University of Illinois at Chicago College of Nursing

Improving interpretability of individual Diabetes Symptom Checklist-Revised (DSC-R) scores: the role of patient characteristics

IntroductionThe Diabetes Symptom Checklist-Revised (DSC-R) is a well-validated patient-reported outcome designed to assess symptom burden in persons with type 2 diabetes mellitus (T2DM) across eight domains. The DSC-R has so...

Patient-reported outcomes in elderly patients with type 2 diabetes mellitus treated with dual oral therapy: a multicenter, observational study from Italy

Objective To assess patient-reported outcomes after two years of use of dual oral anti-diabetes drug (OAD) therapy in elderly people (≥65 years) with type 2 diabetes mellitus (T2DM) from Italy under real-life settings. Methods 3-AGE was a prospective, non-interventional study in elderly people with T2DM inadequately controlled on metformin monotherapy (defined as glycated hemoglobin [HbA1c] 7.0–9.0%), in whom a second OAD was prescribed. Primary endpoint was to assess the physical and psychological symptoms associated with T2DM from baseline to 24 months using the Diabetes Symptom Check List revised (DSC-R) questionnaire. Patient’s quality of life and health status, treatment satisfaction, consumption of healthcare resources, and physician satisfaction with treatment were also assessed (secondary endpoints) using validated questionnaires. Additionally, safety and clinical characteristics were also evaluated. Results The mean age of the study population (N = 860) was 71.5 ± 5.2 years. Addition of a second OAD significantly (p < .0001) reduced the DSC-R score from baseline (0.73 ± 0.68) to both Months 12 and 24 (0.63 ± 0.59 and 0.61 ± 0.56), and HbA1c from baseline (7.72% ± 0.54%) to Month 12 (6.95% ± 0.82%). Adding a second OAD improved quality of life and health status (baseline, 71.31 ± 15.16 to Month 12, 74.49 ± 13.64; p < .0001), patient’s treatment satisfaction (p < .0001), and consumption of healthcare resources per patient. Physicians expressed good satisfaction with patients’ treatment (across efficacy, tolerability and compliance domains) at Month 12. Overall, 32 adverse reactions (in 24 patients) and four hypoglycemic episodes were reported during the 24 months. Conclusion Addition of a second OAD improved physical and psychological symptoms associated with T2DM and was well tolerated in elderly people under real-life settings.

Does hypoglycaemia affect the improvement in QoL after the transition to insulin in people with type 2 diabetes?

PurposeQuality of Life (QoL) of insulin-naïve people with type 2 diabetes mellitus (T2DM) improves after transition to insulin. Little is known about the role of hypoglycaemia in this context. Secondary analyses of the Study of the Psychological Impact in Real care of Initiating insulin glargine Treatment (SPIRIT) aimed to investigate the relationship between hypoglycaemia and QoL when transitioning to insulin.MethodsInsulin-naïve Dutch people with T2DM in suboptimal glycaemic control (HbA1c >53 mmol/mol; 7.0%) on maximum dose of oral glucose-lowering medications were included from 363 primary care practices (n = 911). Participants started insulin glargine and completed QoL-questionnaires (WHO-5 Well-being Index (WHO-5; emotional well-being), Hypoglycaemia Fear Survey-worry scale (HFS-w; hypoglycaemia fear) and Diabetes Symptom Checklist-revised (DSC-r; diabetes symptom distress) at baseline, 3 and 6 months follow-up. Linear GEE analyses were used to investigate the association between symptomatic, nocturnal, severe hypoglycaemia (number of episodes during 3 months prior to visit) and QoL over time.Results52.5% men participated, mean age 62.2 years (SD ± 10.92), and median HbA1c 67 mmol/mol (range 61–77) (8.3%). More symptomatic hypoglycaemic episodes were associated with higher HFS-w and DSC-r scores (P < 0.01). Experiencing multiple nocturnal or severe episodes was related to higher symptom distress as well, when compared to no episodes. These associations did not change significantly over time.ConclusionsHypoglycaemia is associated with lower QoL in terms of hypoglycaemia fear and diabetes symptom distress. The transition to insulin does not affect this relationship, suggesting hypoglycaemia in itself has a detrimental effect on diabetes-related QoL independent of treatment regimen.

Psychometric evaluation of the Diabetes Symptom Checklist-Revised in patients with type 2 diabetes in Turkey.

To evaluate the psychometric properties of the Diabetes Symptoms Checklist-Revised (DSC-R), as measures of diabetes-related symptoms, in patients with type 2 diabetes in Turkey. This research was carried out on 340 patients diagnosed with type 2 diabetes in the Department of Endocrinology and Metabolic Diseases of a university hospital in Turkey, between 25 January 2011 and 1 April 2011. Personal information forms developed by the researchers and the DSC-R were used as the data tools. All data were collected by authors during face-to-face interviews. According to the results of the research, the patients had a mean ± standard deviation age 55.9 ± 7.54 years (range, 20-65) and included most patients who were female (64.1%), married (87.1%), housewives (50.3%), and had completed primary education (47.4%). Cronbach's alpha found reliability for the total scale to be 0.92 and subscale alpha coefficients ranged 0.76-0.85. Confirmatory factor analysis resulted in a six factor structure: (i) neurology; (ii) psychology/fatigue; (iii) cardiology; (iv) ophthalmology; (v) psychology/cognition; and (vi) hyperglycemia. The Turkish version of the DSC-R was found to be a reliable and valid means to measure the level in effect on symptoms in patients with type 2 diabetes.

Psychometric evaluation of the Korean version of the Diabetes Symptom Checklist-Revised (DSC-R) for patients with type 2 diabetes.

BackgroundThis study was to elucidate the psychometric properties of the Korean version of the Diabetes Symptom Checklist-Revised (K-DSC-R), which is a patient-reported outcome measure of diabetes symptom burden.MethodsA sample of 432 Korean patients with diabetes was recruited from university hospitals. The data were analyzed using exploratory factor analysis (EFA), confirmatory factor analysis (CFA), multitrait/multi-item correlation, Pearson’s correlation, t-test, ANOVA, and Cronbach’s alpha for construct, item-convergent/discriminant, concurrent, and known-groups validity, and internal consistency reliability.ResultsEFA extracted a total of 29 items clustered into 7 subscales from the K-DSC-R. The construct of the seven-subscales was supported by CFA. The scaling success rates of item-convergent validity were 100% for all subscales, and those of item-discriminant validity ranged from 83.3% to 100%. Patients in more-depressed groups and in the HbA1c-uncontrolled group had higher K-DSC-R scores, satisfying the known-groups validity. The subscales of the K-DSC-R were moderately correlated with health-related quality of life, indicative of the established concurrent validity. The Cronbach’s alpha of the K-DSC-R was 0.92.ConclusionsThe psychometric properties of the K-DSC-R have been established. It is thus appropriate for use with respect to reliability and validity in practice and clinical trials for Korean patients with type 2 diabetes.

Toward Defining a Cutoff Score for Elevated Fear of Hypoglycemia on the Hypoglycemia Fear Survey Worry Subscale in Patients With Type 2 Diabetes

OBJECTIVE To determine a cutoff score for clinically meaningful fear of hypoglycemia (FoH) on the Hypoglycemia Fear Survey Worry subscale (HFS-W). RESEARCH DESIGN AND METHODS Data on the HFS-W, history of hypoglycemia, emotional well-being (World Health Organization-5 well-being index), and distress about diabetes symptoms (Diabetes Symptom Checklist-Revised) were available from Dutch patients with type 2 diabetes who were treated with oral medication or insulin (n = 1,530). Four criteria were applied to define a threshold for clinically meaningful FoH: 1) modal score distribution (MD criterion), 2) scores 2 SDs above the mean (SD criterion), 3) concurrent validity with severe hypoglycemia and suboptimal well-being (CV criterion), and 4) an elevated score (≥3) on more than one HFS-W item (elevated item endorsement [EI criterion]). Associations between the outcomes of these approaches and a history of severe hypoglycemia and suboptimal well-being were studied. RESULTS Of the 1,530 patients, 19% had a HFS-W score of 0 (MD criterion), and 5% reported elevated FoH (HFS-W ≥ mean + 2 SD; SD criterion). Patients with severe hypoglycemia reported higher HFS-W scores than those without (25 ± 20 vs. 15 ± 17; P < 0.001). Patients with suboptimal well-being reported higher HFS-W scores than those with satisfactory well-being (20 ± 18 vs. 13 ± 15; P < 0.001, CV criterion). Elevated FoH (defined by the EI criterion) was seen in 26% of patients. The SD and EI criteria were the strongest associated with history of severe hypoglycemia. The EI criterion was the strongest associated with suboptimal well-being. CONCLUSIONS Although no definite cutoff score has been determined, the EI criterion may be most indicative of clinically relevant FoH in this exploratory study. Further testing of the clinical relevance of this criterion is needed.

The longitudinal association between glycaemic control and health-related quality of life following insulin therapy optimisation in type 2 diabetes patients. A prospective observational study in secondary care

PurposeTo test whether improvement in glycosylated haemoglobin (HbA1c) as a marker of glycaemic control, following intensifying insulin therapy, is associated with improvements in HRQoL.MethodsDutch sub-optimally controlled (HbA1c > 7%) type 2 diabetes patients (N = 447, mean age 59 ± 11) initiated insulin glargine therapy. Data were collected at baseline, 3 and 6 months, and included HbA1c and measures of HRQoL: diabetes symptom distress (Diabetes Symptom Checklist-revised; DSC-r), fear of hypoglycaemia (Hypoglycaemia Fear Survey; HFS-w) and emotional well-being (WHO-5 wellbeing index).ResultsHbA1c decreased from 8.8 ± 1.4% to 8.0 ± 1.2% and 7.7 ± 1.3% at 3 and 6 months follow-up, respectively (P < 0.001), DSC-r score improved from 17.7 ± 14.7 to 14.3 ± 13.3 and 13.6 ± 13.3 (P < 0.001). HFS-w score did not significantly change. WHO-5 score increased from 56 ± 23 to 62 ± 23 and 65 ± 22 P < 0.001). A modest, significant association was found between HbA1c and WHO-5 score (B = −1.8, 95% CI: −2.7 to −0.8) and HbA1c and DSC-r score (B = 1.0, 95% CI: 0.4 to 1.6). No such association was found for HFS-w score.ConclusionsAn association between improvement in HbA1c by means of optimising insulin therapy and improvement in HRQoL in type 2 diabetes patients has been observed. A weak, yet significant longitudinal association was found between improved HbA1c and emotional well-being and diabetes symptom distress.

Initiation of insulin glargine in patients with Type 2 diabetes in suboptimal glycaemic control positively impacts health‐related quality of life. A prospective cohort study in primary care

To study prospectively the impact of initiating insulin glargine in suboptimally controlled insulin-naïve patients with Type 2 diabetes on health-related quality of life in relation to glycaemic control. Insulin-naïve Dutch patients with Type 2 diabetes in suboptimal glycaemic control (HbA(1c) > 53 mmol/mol; 7%) on maximum dose of oral glucose-lowering medications were included from 363 primary care practices (n = 911). Patients started insulin glargine and were followed up for 6 months. At baseline (start insulin therapy), 3 and 6 months, HbA(1c) was measured and patients completed self-report health-related quality of life measures, including emotional well-being (World Health Organization-5 well-being index), fear of hypoglycaemia (Hypoglycaemia Fear Survey) and diabetes symptom distress (Diabetes Symptom Checklist-revised). Data were analysed using generalized estimating equations analysis. HbA(1c) (mmol/mol; %) decreased from 69 ± 16; 8.5 ± 1.7 to 60 ± 11; 7.6 ± 1.0 and 57 ± 11; 7.3 ± 1.0 at 3 and 6 months, respectively (P < 0.001). Pre-insulin BMI (kg/m(2) ) was 30 ± 5.7, which remained stable at 3 months (30 ± 5.8) and increased to 31 ± 5.9 at 6 months (P = 0.004); no significant changes in self-reported symptomatic and severe hypoglycaemia were observed, while nocturnal hypoglycaemia slightly decreased. The Hypoglycaemia Fear Survey score decreased from 14.6 ± 16.2 to 12.1 ± 15.2 and 10.8 ± 14.4 at 3 and 6 months, respectively (P < 0.001). The Diabetes Symptom Checklist-revised score decreased from 15 ± 14 to 10 ± 12 and 10 ± 13 (P < 0.001), with most pronounced reductions in hyperglycaemic symptoms and fatigue. The World Health Organization-5 score increased from 57 ± 25.3 to 65 ± 21.6 at 3-month follow-up and 67 ± 21.8 at 6-month follow-up (P < 0.001). Results of this observational study demonstrate combined glycaemic and health-related quality of life benefits of initiating insulin glargine in patients with Type 2 diabetes in routine primary care.

Associations Between Improved Glucose Control and Patient-Reported Outcomes After Initiation of Insulin Pump Therapy in Patients with Type 2 Diabetes Mellitus

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

Health-related quality of life and self-related health in patients with type 2 diabetes: Effects of group-based rehabilitation versus individual counselling

BackgroundType 2 diabetes can seriously affect patients' health-related quality of life and their self-rated health. Most often, evaluation of diabetes interventions assess effects on glycemic control with little consideration of quality of life. The aim of the current study was to study the effectiveness of group-based rehabilitation versus individual counselling on health-related quality of life (HRQOL) and self-rated health in type 2 diabetes patients.MethodsWe randomised 143 type 2 diabetes patients to either a six-month multidisciplinary group-based rehabilitation programme including patient education, supervised exercise and a cooking-course or a six-month individual counselling programme. HRQOL was measured by Medical Outcomes Study Short Form 36-item Health Survey (SF-36) and self-rated health was measured by Diabetes Symptom Checklist - Revised (DCS-R).ResultsIn both groups, the lowest estimated mean scores of the SF36 questionnaire at baseline were "vitality" and "general health". There were no significant differences in the change of any item between the two groups after the six-month intervention period. However, vitality-score increased 5.2 points (p = 0.12) within the rehabilitation group and 5.6 points (p = 0.03) points among individual counselling participants.In both groups, the highest estimated mean scores of the DSC-R questionnaire at baseline were "Fatigue" and "Hyperglycaemia". Hyperglycaemic and hypoglycaemic distress decreased significantly after individual counselling than after group-based rehabilitation (difference -0.3 points, p = 0.04). No between-group differences occurred for any other items. However, fatigue distress decreased 0.40 points within the rehabilitation group (p = 0.01) and 0.34 points within the individual counselling group (p < 0.01). In the rehabilitation group cardiovascular distress decreased 0.25 points (p = 0.01).ConclusionsA group-based rehabilitation programme did not improve health-related quality of life and self-rated health more than an individual counselling programme. In fact, the individual group experienced a significant relief in hyper- and hypoglycaemic distress compared with the rehabilitation group.However, the positive findings of several items in both groups indicate that lifestyle intervention is an important part of the management of type 2 diabetes patients.

Patient-Reported Outcomes from a 16-Week Open-Label, Multicenter Study of Insulin Pump Therapy in Patients with Type 2 Diabetes Mellitus

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

The Contribution of Pretreatment Expectations and Expectation-Perception Difference to Change in Treatment Satisfaction and End Point Treatment Satisfaction in the Context of Initiation of Inhaled Insulin Therapy in Patients with Type 2 Diabetes

This study explored relationships among pretreatment expectations, treatment perceptions, expectation-perception difference, change in diabetes treatment satisfaction, and end point diabetes treatment satisfaction in individuals with type 2 diabetes. Multivariate models were used to evaluate clinical and patient-reported outcomes (PRO) data from a randomized clinical trial comparing treatment algorithms for an inhaled insulin. PRO measures--Diabetes Symptom Checklist-Revised subscales, Well-Being Questionnaire 12, Diabetes Treatment Satisfaction Questionnaire, and Self-Efficacy Scale--were administered at baseline and end point. Expectations about Insulin Therapy (EITQ) and Perceptions of Insulin Therapy Questionnaires (PITQ) were administered at baseline and end point, respectively. Change scores for hemoglobin A1C (A1C), PRO (i.e., during-trial effects), and expectation-perception change were calculated. Perceptions, expectation-perception difference, and change in and end point treatment satisfaction served as dependent variables for statistical models. Complete EITQ and PITQ data were available for 240 insulin-naive individuals with type 2 diabetes (mean age, 58 years; 61% male; 78% white; mean baseline A1C, 8.4%). Treatment perceptions were significantly (P < 0.01) more positive than expectations. After controlling for baseline patient assessments and during-trial effects, regression analyses showed that pretreatment expectations independently contributed to perceptions (beta = 0.18, P = 0.001) and expectation-perception change (beta = -0.71, P < 0.001). Acting as a suppressor variable, pretreatment expectations enhanced the ability of expectation-perception difference to predict both change in (beta = 0.39, P < 0.001) and end point (beta = 0.57, P < 0.001) diabetes treatment satisfaction. Pretreatment expectations and expectation-perception difference play an important role in the amount of change that occurs in satisfaction with new treatment as compared to that of previous treatment, as well as satisfaction with new treatment.

A psychometric evaluation of the Diabetes Symptom Checklist-Revised (DSC-R) cognitive distress, fatigue, hyperglycemia, and hypoglycemia subscales in patients with type 1 and type 2 diabetes

A psychometric evaluation of the Diabetes Symptom Checklist-Revised (DSC-R) cognitive distress, fatigue, hyperglycemia, and hypoglycemia subscales in patients with type 1 and type 2 diabetes April N Naegeli1, Timothy E Stump2, Risa P Hayes11Global Health Outcomes, Eli Lilly and Company, Indianapolis, IN, USA; 2Consultant, Indianapolis, IN, USAObjective: To explore the use of Diabetes Symptom Checklist-Revised (DSC-R) Cognitive Distress, Fatigue, Hyperglycemia, and Hypoglycemia subscales as measures of acute diabetesassociated symptoms in patients with both type 1 and 2 diabetes.Research design and methods: Our study was conducted in context of two international, multicenter, randomized clinical trials for inhaled insulin. Confirmatory factor analyses and assessments of reliability and construct validity were performed.Results: Study participants were 371 patients with type 2 (56% male; mean age, 57 years) and 481 with type 1 diabetes (57% male, mean age, 40 years). In both populations a four-factor model was the best fit. Cronbach&rsquo;s &alpha; &ge; 0.79 and intraclass correlation coefficient &ge;0.63; subscales correlated (P &le; 0.05) with measures of well-being and satisfaction (0.12 &le; r &le; 0.71). In patients with type 1 diabetes, three subscales correlated (P &lt; 0.05) with A1C.Conclusions: The psychometric properties of the DSC-R Cognitive Distress, Fatigue, Hyperglycemia, and Hypoglycemia suggest they may be utilized in clinical trials as reliable and valid measures of acute symptoms of diabetes.Keywords: Diabetes Symptom Checklist-Revised, DSC-R, type 1 diabetes, type 2 diabetes, psychometric validation