Puhong Zhang

Observational Registry of Basal Insulin Treatment (ORBIT) in patients with type 2 diabetes uncontrolled with oral antihyperglycaemic drugs: Real-life use of basal insulin in China.

To examine treatment patterns following basal insulin (BI) introduction in type 2 diabetes mellitus (T2DM) patients under real‐world conditions across China.

Observational Registry of Basal Insulin Treatment (ORBIT) in Patients with Type 2 Diabetes Uncontrolled by Oral Hypoglycemic Agents in China--Study Design and Baseline Characteristics.

BACKGROUND Efficacy of basal insulin (BI) has been well studied by randomized controlled trials, but the impact of BI on glycemic control in the real world has not been well documented. The Observational Registry for BI Treatment (ORBIT) study is designed to evaluate the real-life outcomes of BI in China. MATERIALS AND METHODS Participants with type 2 diabetes (n=19,894), from December 2011 to June 2013, inadequately controlled on oral hypoglycemic agents (OHAs) were initiated on BI treatment from 209 hospitals in all the eight regions in Mainland China. Data for each patient on use of OHAs and insulin (type and dose), glycemic control, hypoglycemic episodes, body weight, quality of life, and costs were collected at baseline and 3 and 6 months. RESULTS For the 18,995 participants who were eligible for baseline analysis, mean±SD age was 55.4±10.4 years, with 52.5% males. The mean duration of diabetes was 6.4±5.3 years and was positively associated with the economic level of eight regions. Before initiation of BI, patients had a mean hemoglobin A1c level of 9.6±2.0% with a fasting plasma glucose level of 11.7±4.0 mmol/L. Of the patients, 35.5% had some diabetes complications. Metformin, sulfonylureas, and α-glycosidase inhibitors were the most commonly used OHAs. The proportions of patients using one, two, or more than two OHAs before BI initiation were 48.4%, 42.7%, and 8.9%, respectively. CONCLUSIONS To the best of our knowledge, the ORBIT study is the largest registry study to evaluate glycemic outcomes and safety of BI in real-world China. Baseline data indicate delays in initiation of BI in the majority of patients with type 2 diabetes in China.

Association of Diabetic Microvascular Complications and Parameters of Obstructive Sleep Apnea in Patients with Type 2 Diabetes

BACKGROUND Obstructive sleep apnea (OSA) is prevalent in patients with type 2 diabetes, but the influence of OSA on diabetes complications is not clear. We aimed to investigate the association of OSA with chronic diabetes complications in Chinese patients with type 2 diabetes. SUBJECTS AND METHODS In total, 880 hospitalized patients were enrolled in a multicenter, cross-sectional study that involved 12 hospitals from six cities in the Peoples Republic of China. Overnight sleep monitoring with a portable monitor was used to record respiratory parameters, including the apnea-hypopnea index (AHI), the oxygen desaturation index (ODI), the oxygen saturation (SPO2), and the cumulative time of SPO2 below 90% or 85% (CT90% and CT85%, respectively). Chronic diabetes complications were recorded from medical charts. RESULTS CT90% was independently associated with diabetic nephropathy (DN) after adjusting for age, sex, diabetes duration, glycosylated hemoglobin, body mass index, hypertension, and the use of angiotensin converting enzyme inhibitor/angiotensin receptor blocker drugs within 1 week. The associated parameters increased from two (the average SPO2 and CT90%) to three (ODI, the lowest SPO2, and CT85%) when the severity of DN increased from microalbuminuria to renal insufficiency. The estimated glomerular filtration rate was independently correlated with ODI (β = -0.172, P = 0.029) and the lowest SPO2 (β = 0.354, P = 0.004) after adjustments. The lowest SPO2 was associated with proliferative diabetic retinopathy by univariate logistic regression but was not significant in multivariate regression after adjustment. CONCLUSIONS Parameters of nocturnal hypoxemia are associated with DN and renal function of patients with type 2 diabetes. The parameters of hypoxemia may more sensitively reflect the association of OSA and diabetic microvascular complications than AHI.

Comparative effectiveness and safety of different basal insulins in a real-world setting.

To compare glucose control and safety of different basal insulin therapies (BI, including Insulin NPH, glargine and detemir) in real‐world clinical settings based on a large‐scale registry study.

Type 1 diabetes mellitus care and education in China: The 3C study of coverage, cost, and care in Beijing and Shantou.

AIMS The paucity of data on Type 1 diabetes in China hinders progress in care and policy-making. This study compares Type 1 diabetes care and clinical outcomes in Beijing and Shantou with current clinical guidelines. METHODS The 3C Study was a cross-sectional study of the clinical practices and outcomes of people with Type 1 diabetes. The study sequentially enrolled 849 participants from hospital records, inpatient wards, and outpatient clinics. Data were collected via face-to-face interviews with patients and health professionals, the Summary of Diabetes Self-Care Activities, medical records, and venous blood samples. Care was audited using ISPAD/IDF indicators. Data underwent descriptive analysis and tests for association. RESULTS The median age was 22years (IQR=13-34years), and 48.4% of the sample had diabetes less than six years. The median HbA1c was 8.5% (69mmol/mol) (IQR 7.2-10.5%), with significant regional variance (p=0.002). Insulin treatment was predominantly two injections/day (45% of patients). The highest incidence of diabetic ketoacidosis was 14.4 events/100 patient years among adolescents. Of the 57.3% of patients with LDL-C>2.6mmol/L, only 11.2% received treatment. Of the 10.6% considered hypertensive, 47.1% received treatment. Rates of documented screening for retinopathy, nephropathy, and peripheral neuropathy were 35.2%, 42.3%, and 25.0%, respectively. The median number of days of self-monitoring/week was 3.0 (IQR=1.0-7.0). There were significant differences in care practices across regions. CONCLUSIONS The study documented an overall deficit in care with significant regional differences noted compared to practice guidelines. Modifications to treatment modalities and the structure of care may improve outcomes.

Mobile Device–Based Electronic Data Capture System Used in a Clinical Randomized Controlled Trial: Advantages and Challenges

Background Electronic data capture (EDC) systems have been widely used in clinical research, but mobile device–based electronic data capture (mEDC) system has not been well evaluated. Objective The aim of our study was to evaluate the feasibility, advantages, and challenges of mEDC in data collection, project management, and telemonitoring in a randomized controlled trial (RCT). Methods We developed an mEDC to support an RCT called “Telmisartan and Hydrochlorothiazide Antihypertensive Treatment (THAT)” study, which was a multicenter, double-blinded, RCT, with the purpose of comparing the efficacy of telmisartan and hydrochlorothiazide (HCTZ) monotherapy in high-sodium-intake patients with mild to moderate hypertension during a 60 days follow-up. Semistructured interviews were conducted during and after the trial to evaluate the feasibility, advantage, and challenge of mEDC. Nvivo version 9.0 (QSR International) was used to analyze records of interviews, and a thematic framework method was used to obtain outcomes. Results The mEDC was successfully used to support the data collection and project management in all the 14 study hospitals. A total of 1333 patients were recruited with support of mEDC, of whom 1037 successfully completed all 4 visits. Across all visits, the average time needed for 141 questions per patient was 53 min, which were acceptable to both doctors and patients. All the interviewees, including 24 doctors, 53 patients, 1 clinical research associate (CRA), 1 project manager (PM), and 1 data manager (DM), expressed their satisfaction to nearly all the functions of the innovative mEDC in randomization, data collection, project management, quality control, and remote monitoring in real time. The average satisfaction score was 9.2 (scale, 0-10). The biggest challenge came from the stability of the mobile or Wi-Fi signal although it was not a problem in THAT study. Conclusions The innovative mEDC has many merits and is well acceptable in supporting data collection and project management in a timely manner in clinical trial.

Dose titration model and correlative factors analysis in Chinese patients with type-2 diabetes on basal insulin — results from an Observational Registry of Basal Insulin Treatment study

INTRODUCTION This study evaluates an insulin dose titration model and factors that impact insulin dose adjustment in Chinese adults with type-2 diabetes, who receive basal insulin in real-world settings. MATERIAL AND METHODS A total of 19,894 patients from the ORBIT study were included. These patients were divided into four groups, according to the type of insulin dose adjustment: no insulin titration (group A), self-titration (group B), physician-led insulin titration (group C), and combined physician and patient-led insulin titration (group D). Data were collected and compared at baseline and after six months of treatment. RESULTS A total of 12,865 patients completed the visits and were included in the analysis. Among these patients, 3187 (24.8%), 1971 (15.3%), 5165 (40.1%), and 2542 (19.8%) patients were included in groups A, B, C, and D, respectively. The multivariate logistic regression analysis revealed that the duration of diabetes, body mass index, microvascular complications, inpatient days, HbA1C level, and self-monitoring of blood glucose (SMBG) were positively correlated with insulin titration in group B, C, and D, compared with group A. The number of inpatient days and outpatient visits were positively correlated with dose adjustment for physician-led titration, while this was negatively correlated for self-titration. Self-titration encouraged by physicians and home blood glucose monitoring were positively correlated with self-titration and the combined physician and patient-led titration. CONCLUSIONS High HbA1C level, SMBG, long disease duration, microvascular complications, and the encouragement of physicians while initiating insulin use prompt patients to perform dose adjustments in real-world settings.

Clinical characteristics of type 2 diabetes patients with discordance between HbA1c and fasting plasma glucose in the real world: An analysis of the ORBIT study

We aimed to determine the clinical characteristics of type 2 diabetes patients on basal insulin therapy with inadequate glucose control due to discordance between glycated haemoglobin (HbA1c) and fasting plasma glucose (FPG) in the real world.

OS 26-03 mobile device based electronic data capture system in pharmaceutical clinical trial: a feasibility study

Objective: To evaluate the feasibility and acceptability of a mobile device based electronical data capture (mEDC) system applied in one randomized clinical trial (RCT). Design and Method: The mEDC, an android smartphone-based application, was developed to support real-time data capture, project management and quality control in a multicenter randomized double-blinded parallel controlled pharmaceutical trial. Four user interfaces are shown in Figure 1. The RCT is to evaluate the efficacy of telmisartan (40mg) and hydrochlorothiazide (25mg) monotherapy in high sodium intake patients with mild to moderate hypertension in 14 hospitals, including one baseline survey and three follow-ups. A designated qualitative study was conducted to evaluate its feasibility and acceptability during implementation of project. Fifteen investigators, including fourteen doctors and one nurse in local hospitals, two clinical research associates (CRA) and one senior data manager were interviewed by personal depth, face-to-face interview. Nvivo 9.0 was applied to analyze the records and theme framework method was used to obtain outcomes. Results: With support of mEDC, 1333 patients were recruited, and 1037 patients of them successfully completed all visits during 2 months. The average time was needed around 53 minutes for 141 questions of all visits per patient. Nearly all the interviewees were satisfied with the features of smooth manipulation, user-friendly interface, real-time data transfer, procedure control, patient screening, central randomization, blinded drug allocation, visit organization, automatic data check and real-time remote monitoring. The average satisfaction score was 9.2 (10 as full mark). All the investigators and CRAs expressed their expectation of using the app again in the future. The senior data manager evaluated the mEDC and found it safe in data transferring and storage. Very rare occasion of unstable wireless internet access was complained by investigators. Conclusions: mEDC was a feasible and acceptable tool to support RCT. High quality research may benefit from mEDCs real-time and multi-user features. Figure. No caption available.

OS 03-08 EFFICACY OF TELMISARTAN 40 MG (T40) AND HYDROCHLOROTHIAZIDE 25 MG (H25) MONOTHERAPY IN HIGH SODIUM INTAKE PATIENTS WITH MILD TO MODERATE HYPERTENSION (THAT STUDY): A MULTICENTER RANDOMIZED DOUBLE-BLINDED PARALLEL CONTROLLED TRIAL.

Objective: To compare the BP lowering effect of ARBs and thiazide diuretics in high sodium intake patients with mild to moderate hypertension. Design and Method: This research was a multicenter randomized double-blinded parallel controlled trial. Eligible participants were randomly divided into T40 and H25 groups, with 3 follow-ups, scheduled on the 15th, 30th and 60th day to compare the difference of average BP decrease, blood pressure control rates, FBG (fast blood glucose), hypokalemia and other adverse events between two groups after intervention. Results: 1333 participants were enrolled from 14 county hospitals in high-salt-intake area of China in 2014, with average sodium intake of 5893 mg per day. Baseline characteristics were well balanced between groups. In general, SBP/DBP reduction in T40 group was 12.5/8.0, 14.3/9.1 and 12.8/7.2 mmHg at 15 days, 30 days and 60 days of follow-up, respectively, while the counterparts in H25 group was 11.0/5.8, 13.6/7.1 and 11.5/5.3 mmHg, respectively. BP reduction in T40 group was greater than that in H25 group at 3 follow-up visits, but with only statistical significance for DBP. When controlled by gender, age, body mass index and baseline BP, subgroup analysis showed that DBP reduction was still higher in T40 group than that in H25 group (P < 0.001) regardless of the amount of urine sodium excretion and pulse pressure (PP). SBP reduction was positively related to increasing urine sodium and PP level for patients in both groups, but increased faster with increasing PP in H25 group than that in T40 group (P = 0.0238 for group*PP). Compared with T40, patients in H25 group showed more hypokalemia (T:0.4% vs H:4.5%, P < 0.001). Conclusions: Telmisartan 40 mg showed better DBP lowering effect and less hypokalemia than HCTZ 25 mg among high sodium intake patients with mild to moderate hypertension. Effect superiority of HCTZ among patients with large pulse pressure might exist and needs further test. Figure. No caption available.