Development of a self-efficacy questionnaire, 'Insulin Therapy Self-efficacy Scale (ITSS)', for insulin users in Japanese: The Self-Efficacy-Q study.

AIMS/INTRODUCTION: Although patient self-efficacy is known to affect adherence to therapy, no available tool measures self-efficacy of insulin therapy administration while addressing the entire therapeutic process and management. In light of this, we developed the 'Insulin Therapy Self-efficacy Scale (ITSS).' MATERIALS AND METHODS: Development of the ITSS involved three phases: (i) item generation and creation of a questionnaire draft; (ii) testing and correcting the items through interviews with patients; and (iii) a multicenter, single-arm study to validate the questionnaire. RESULTS: A factor analysis and Cronbach's α both confirmed good internal consistency in the patients' confidence regarding the following four factors: the insulin injection procedure, insulin titration, glycemic control and ability to cope with hypoglycemia. Reproducibility was confirmed using weighted κ statistics and intraclass correlations. Good concurrent validity was confirmed with two other questionnaires. The ITSS score was also found to correlate with several patient characteristics and clinical parameters, as well as with a better adherence to injected insulin therapy 6 months later, suggesting the predictive validity of this scale. CONCLUSIONS: The ITSS is a reliable and valid tool for assessing and quantifying patients' self-efficacy. The ITSS estimation of self-efficacy can predict a patient's glycemic control and future adherence to insulin therapy. These characteristics will ensure the usefulness of the ITSS in ensuring a successful therapeutic process for patients and physicians.

Real-life glycemic control in patients with type 2 diabetes treated with insulin therapy: A prospective, longitudinal cohort study (Diabetes Distress and Care Registry at Tenri [DDCRT 9]).

AIMS/INTRODUCTION: We investigated the association between four insulin regimens, and increase in glycated hemoglobin (HbA1c) and insulin dose in a real-life clinical setting because there are no data about them among insulin regimens. MATERIALS AND METHODS: Participants included 757 patients with type 2 diabetes having been treated with insulin therapy for more than 1 year. The four insulin regimens were regimen 1 (long-acting insulin, once daily), regimen 2 (biphasic insulin, twice daily), regimen 3 (biphasic insulin, three times daily) and regimen 4 (basal-bolus therapy). Main outcomes were increases in HbA1c levels >0.5% and increases in daily insulin units after 1 year. We carried out multivariable analyses to examine differences in glycemic control and insulin dose with adjustment for possible confounders. RESULTS: Mean HbA1c level and duration of insulin therapy were 7.8% and 11.3 years, respectively. HbA1c levels increased by >0.5% at follow up in 22.8, 24.9, 20.7, and 29.3% of participants using regimen 1, 2, 3 and 4, respectively, with no significant differences between groups. Daily insulin doses increased in 62.3, 68.8, 65.3 and 38.6% of patients, respectively (P < 0.001). Multivariable regression analysis showed that patients who received regimen 4 had significantly lower odds of requiring future insulin dose increases than those who had received regimen 2 (adjusted odds ratio 0.24, 95% confidence interval 0.14-0.41; P < 0.001). CONCLUSIONS: Many patients receiving insulin therapy showed increases in HbA1c levels and insulin doses 1 year later. The smallest increase in insulin dose was observed in the basal-bolus therapy group compared with other regimens.

Association between dipstick hematuria and decline in estimated glomerular filtration rate among Japanese patients with type 2 diabetes: A prospective cohort study [Diabetes Distress and Care Registry at Tenri (DDCRT 14)].

AIMS: To assess the association between dipstick hematuria and estimated glomerular filtration rate (eGFR) decline in Japanese patients with type 2 diabetes. METHODS: Longitudinal data were obtained from 3068 Japanese patients with type 2 diabetes. To assess the independent association between dipstick hematuria and eGFR decline, we used Cox proportional hazard model adjusted for potential confounders. RESULTS: Median follow-up period was 699.7days. Mean age, body mass index (BMI), and HbA1c level were 65.7years, 24.6kg/m2, and 7.5% (58.1mmol/mol), respectively. Positive dipstick hematuria was significantly associated with baseline eGFR and severity of albuminuria (p<0.001). The multivariable-adjusted hazard ratio for eGFR decline in patients with dipstick hematuria compared with those without dipstick hematuria was 2.19 [95% confidence interval (CI): 1.22-3.91]; this association remained significant even after the exclusion of patients who did not have diabetic retinopathy (hazard ratio: 2.39; 95% CI: 1.13-5.04). CONCLUSION: Positive dipstick hematuria was associated with severity of albuminuria and renal function. A significant association was found between dipstick hematuria and increased risk of eGFR decline among patients with type 2 diabetes. Therefore, our results suggest that dipstick hematuria is perhaps indicative of more severe diabetic nephropathy.

Diabetes treatment-related quality of life is associated with levels of self-care activities in insulin injection among Japanese patients with type 2 diabetes: Diabetes Distress and Care Registry at Tenri (DDCRT 8).

AIMS: We investigated the association between diabetes treatment-related quality of life (QOL) and levels of self-care activities in insulin injection among Japanese patients with type 2 diabetes. METHODS: Data from 1394 patients with type 2 diabetes on insulin therapy were obtained from a diabetes registry in Japan. We used the Diabetes Therapy-Related QOL (DTR-QOL) questionnaire and relative risk regression analysis to assess the independent association of high levels of self-care activities in insulin injection and DTR-QOL scores while adjusting for possible confounders. RESULTS: The mean age, BMI and HbA1c level were 65.8 years, 24.8 kg/m(2) and 62 mmol/mol (7.8 %), respectively. The frequency of insulin injection omission was associated with DTR-QOL scores. In the multivariable-adjusted model, the relative risks for high levels of self-care activities in insulin injection was 1.15 (95 % confidence interval, 1.05-1.26) in the highest quintile compared with those in the lowest quintile of DTR-QOL scores. Subgroup analysis confirmed this association in patients <65 years. CONCLUSIONS: DTR-QOL was associated with self-reported levels of self-care activities in insulin injection, particularly among Japanese patients <65 years with type 2 diabetes. DTR-QOL might be a useful tool to identify patients who consequently omit insulin. For patients with low DTR-QOL score, healthcare providers should discuss their treatment-related problems to prevent insulin injection omission.

Fear of hypoglycemia and its determinants in insulin-treated patients with type 2 diabetes mellitus.

The aim of the present study was to investigate the prevalence of fear of hypoglycemia, in association with severe hypoglycemia and social factors, in insulin-treated patients with type 2 diabetes mellitus. A questionnaire survey on hypoglycemia and patient-physician communication was carried out in 355 patients with insulin-treated type 2 diabetes mellitus patients at 16 hospitals and clinics. A fear of hypoglycemia was reported by 27.7% of patients. A stepwise logistic regression analysis found that severe hypoglycemia during the past 1 year was a significant determinant of fear of hypoglycemia (odds ratio 2.16, 95% confidence interval 1.06-4.41; P = 0.034), and age (odds ratio 1.02, 95% confidence interval 1.00-1.05, P = 0.038) and living alone (odds ratio 1.93, 95% confidence interval 1.00-3.73, P < 0.05) were significantly higher in patients with fear of hypoglycemia than in those without it.

Switching from insulin to liraglutide improved glycemic control and the quality of life scores in a case of type 2 diabetes and active Crohn's disease.

A 44-year-old man with type 2 diabetes of five years' duration was admitted for the management of poor glycemic control despite the administration of insulin therapy. On admission, he received vigorous treatment for a 28-year history of Crohn's disease and a 14-year history of a psychiatric disorder. His glycosylated hemoglobin A1c (HbA1c) level was 11.3%, his fasting blood glucose level was 567 mg/dL and his C-peptide level was 1.0 ng/mL. His quality of life (QOL) was severely impaired as a result of frequent episodes of hyperglycemia and hypoglycemia. Treatment with liraglutide was commenced in place of insulin, which improved the patient's glycemic control to an HbA1c level of 5.5% and markedly increased his QOL score with no hypoglycemia.

Patient-reported adherence to insulin regimen is associated with glycemic control among Japanese patients with type 2 diabetes: Diabetes Distress and Care Registry at Tenri (DDCRT 3).

AIMS: We investigated the association between self-reported adherence to an insulin regimen and glycemic control in Japanese patients with type 2 diabetes. METHODS: Data from 1441 patients with type 2 diabetes who were treated with insulin were obtained from a diabetes registry in Japan. We obtained information on self-reported adherence to an insulin regimen. Relative risk regression analysis was employed to assess the independent association of various demographic factors with good glycemic control (HbA1c<7.0% [53 mmol/mol]) while adjusting for possible confounders. RESULTS: The mean age, body mass index, and number of daily insulin injections of participants were 65.4 years, 24.7 kg/m(2), and 2.3, respectively. Of all patients, 70.6% reported high adherence to their insulin regimen. Compared with participants with higher adherence, the crude relative risk of good glycemic control was 0.82 (95% CI, 0.67-1.00) for those with middle adherence and 0.64 (95% CI, 0.31-1.31) for those with lower adherence (P=0.029 for trend). Subgroup analysis confirmed this association in patients below 65 years old, but not in those 65 years old and over. CONCLUSIONS: A higher adherence to a daily insulin regimen was associated with a greater likelihood of good glycemic control in Japanese type 2 diabetes patients. This association was not seen in patients of 65 years old or over. Self-reported adherence to an insulin regimen may prove useful in titrating insulin dose in patients in the younger age group, but requires further investigation.

Glucagon underutilized among type 1 diabetes mellitus patients in Japan.

AIM: Glucagon is recommended to treat severe hypoglycemia in nonhospital environments, when a patient with type 1 diabetes mellitus (T1DM) is unconscious and unable to eat or drink. However, the actual possession rate of glucagon in Japan has not been investigated. SUBJECTS AND METHODS: We recruited 208 T1DM patients older than 15 years of age. The patients were treated at 16 hospitals and clinics in different regions of Japan. Answers were obtained using a self-administered questionnaire about the possession, the experience of usage, and the preference to possess glucagon after reading what is glucagon and when it is used. A stepwise logistic regression analysis was performed to assess the influence of various factors on the possession of glucagon. RESULTS: The possession rate of glucagon was 15.9%, and the rate of those who had experience of using glucagon to treat severe hypoglycemia was 6.0%. The rate of preference to possess glucagon at home after reading the description of glucagon was 39.0%. The possession of glucagon was significantly associated with results of the Glucagon Knowledge Test (odds ratio=24.1; 95% confidence interval, 3.2-183.3; P=0.002) and the history of severe hypoglycemia within 1 year (odds ratio=4.8; 95% confidence interval, 2.0-12.0; P=0.001). CONCLUSIONS: Glucagon as a measure to treat severe hypoglycemia was underutilized among T1DM patients in Japan.

Predictor variables and an equation for estimating HbA1c attainable by initiation of basal supported oral therapy.

UNLABELLED: Aims/Introduction: A method of estimating HbA1c attained after initiation of basal supported oral therapy (BOT) has not been reported previously. The aim of the present study was to determine which characteristics of patients could influence the effectiveness of BOT introduction, and to obtain an equation to estimate HbA1c after BOT initiation. MATERIALS AND METHODS: Sixty consecutive insulin-naive type 2 diabetic patients with poor glycemic control (HbA1c ≥7.5%) started once-daily injections of insulin glargine. Simple correlations were calculated between parameters such as HbA1c at baseline, HbA1c at week 24, reduction rate of HbA1c over 24 weeks (calculated as: [HbA1c level at baseline - HbA1c level at week 24]/HbA1c level at baseline), duration of diabetes, and the number of classes of coadministered oral antidiabetic drugs. Using multiple linear regression models, the independent effects of these parameters on HbA1c at week 24 were evaluated separately. RESULTS: Multiple linear regression analysis revealed that duration of diabetes (ß = 0.561; P < 0.001) and HbA1c at baseline (ß = 0.284; P = 0.006) were significant predictors of HbA1c at week 24. The best fitting multiple regression equation was: HbA1c at week 24 = 0.078 × duration of diabetes + 0.218 × HbA1c at baseline + 4.628 (r (2) = 0.437). CONCLUSIONS: The equation based on the multiple linear regression models indicates necessary conditions for type 2 diabetic patients to achieve target HbA1c. The present findings emphasize the principle that early initiation of BOT in type 2 diabetes effectively achieves good glycemic control. (J Diabetes Invest, doi: 10.1111/j.2040-1124.2011.00164.x, 2011).