scholarly journals Comparable efficacy and safety between LY2963016 insulin glargine and insulin glargine (Lantus®) in Chinese patients with type 1 diabetes: a phase III , randomized, controlled trial

2021 ◽  
Author(s):  
Xiang Yan ◽  
Shan Jiang ◽  
Ying Lou ◽  
Zhiguang Zhou
Keyword(s):  
Randomized Controlled Trial ◽  
Type 1 Diabetes ◽  
Insulin Glargine ◽  
Controlled Trial ◽  
Phase Iii ◽  
Chinese Patients ◽  
Comparable Efficacy ◽  
Efficacy And Safety ◽  
Randomized Controlled

scholarly journals An automated structured education intervention based on a smartphone app in Chinese patients with type 1 diabetes: a protocol for a single-blinded randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Fansu Huang ◽  
Xinyin Wu ◽  
Yuting Xie ◽  
Fang Liu ◽  
Juan Li ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Randomized Controlled Trial ◽  
Type 1 Diabetes ◽  
Controlled Trial ◽  
Routine Care ◽  
Chinese Patients ◽  
Smartphone App ◽  
Structured Education ◽  
Randomized Controlled

Abstract Background Although evidence had demonstrated the effectiveness of smartphone apps in diabetes care, the majority of apps had been developed for type 2 diabetes mellitus (T2DM) patients and targeted at populations outside of China. The effects of applying a smartphone app with structured education on glycemic control in type 1 diabetes mellitus (T1DM) are unclear. A digital, culturally tailored structured education program was developed in a smartphone app (Yi tang yun qiao) to provide an automated, individualized education program aimed at improving self-management skills in patients with T1DM in China. This trial aims to investigate the effectiveness of this smartphone app among Chinese T1DM patients. Methods and analysis This single-blinded, 24-week, parallel-group randomized controlled trial of a smartphone app versus routine care will be conducted in Changsha, China. We plan to recruit 138 patients with T1DM who will be randomly allocated into the intervention group (automated, individualized education through an app) or routine care group. The intervention will last for 24 weeks. The primary outcome will be the change in glycated hemoglobin (HbA1c) from baseline to week 24. The secondary outcomes will include time in range, fasting blood glucose, levels of serum triglycerides and cholesterol, blood pressure, body mass index, quality of life, diabetes self-care activities, diabetes self-efficacy, depression, anxiety, and patient satisfaction. Adverse events will be formally documented. Data analysis will be conducted using the intention-to-treat principle with appropriate univariate and multivariate methods. Missing data will be imputed with a multiple imputation method under the “missing at random” assumption. Discussion This trial will investigate the effectiveness of an app-based automated structured education intervention for Chinese patients with T1DM. If the intervention is effective, this study will provide a strategy that satisfies the need for effective lifelong diabetes care to reduce the disease burden and related complications resulting from T1DM. Trial registration ClinicalTrials.gov NCT04016987. Registered on 29 October 2019.

Two-Year Efficacy and Safety of AIR Inhaled Insulin in Patients with Type 1 Diabetes: An Open-Label Randomized Controlled Trial

2009 ◽  
Vol 11 (s2) ◽  
pp. S-5-S-16 ◽  
Author(s):  
Satish K. Garg ◽  
Chantal Mathieu ◽  
Nadeem Rais ◽  
Haitao Gao ◽  
Janet A. Tobian ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Type 1 Diabetes ◽  
Controlled Trial ◽  
Efficacy And Safety ◽  
Open Label ◽  
Inhaled Insulin ◽  
Randomized Controlled
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