Study of blood glucose control in patients with steroid-induced diabetes mellitus
| ISRCTN | ISRCTN23135945 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN23135945 |
| Secondary identifying numbers | SXYHP1001 |
- Submission date
- 04/11/2024
- Registration date
- 05/11/2024
- Last edited
- 28/04/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
Mobile healthcare (mHealthcare) has been widely used to manage diabetes in developed countries, but it's still new in China. This study explores how internet-based health management can help patients record their health data using mobile devices, while healthcare providers monitor this data using big data platforms.
Who can participate?
Patients with nephrotic syndrome (NS) complicated by steroid-induced diabetes mellitus (SDM) can participate. The experimental group includes 15 men and 13 women, with an average age of about 69 years. The control group includes 14 men and 14 women, with an average age of about 65 years.
What does the study involve?
The control group receives routine health management through group education sessions during hospitalization. This includes group discussions and large classroom lectures about preventing and treating SDM. Education is provided once a week, with each session lasting about 1 to 1.5 hours. They do not use mobile educational platforms.
The experimental group uses a mobile educational platform for individualized health management. A team of healthcare professionals provides one-on-one guidance on weight control, diet, exercise, blood glucose monitoring, and self-management skills. Online education materials, such as videos and images, are also available on the platform.
What are the possible benefits and risks of participating?
Participants may benefit from improved self-management skills and better control of their condition. However, there may be risks associated with the new approach, and the effectiveness of the mobile platform is still being studied.
Where is the study run from?
The study is conducted at Shanxi People’s Hospital in China.
When is the study starting and how long is it expected to run for?
January 2019 to June 2021
Who is funding the study?
The study is funded by the Shanxi Province "136" Medical Engineering Research Project.
Who is the main contact?
For more information, you can contact Zhimin Yang at Zhimin_yang9@126.com
Contact information
Public, Scientific, Principal Investigator
No. 359 Heping North Road, Jiancaoping District
Taiyuan City
030000
China
 ORCID ID |
0009-0009-7549-3456 |
|---|---|
| Phone | +86 13834601227 |
| Zhimin_yang9@126.com |
Study information
| Study design | Single-center interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Positive impact of mobile educational platforms on blood glucose control in patients with nephrotic syndrome (NS) and steroid-induced diabetes mellitus (SDM): a randomized controlled study |
| Study objectives | The central hypothesis of this study is that a mobile educational platforms significantly resulted in better glycemic control and treatment adherence in the patients with NS and SDM compared with standard care. |
| Ethics approval(s) |
Approved 13/10/2021, The Ethics Committee of Shanxi Provincial People's Hospital (No. 359 Heping North Road, Jiancaoping District, Taiyuan City, 030000, China; +86 03154961105; qinzhicheng9@hotmail.com), ref: (2021) Provincial Medical Department Ethical Review No. (272) |
| Health condition(s) or problem(s) studied | Nephrotic syndrome and steroid-induced diabetes mellitus |
| Intervention | The control group received routine health management (group education), where nurses provided collective health education orally and through manuals during hospitalisation, including group education and large classroom-based education. In the group education, patients in the control group were divided into two groups for separate instruction. Common issues among multiple patients were addressed through communication and guidance, with each educational session lasting around 1 h. Large classroom-based education was conducted in the form of lectures without grouping, where nurses explained knowledge related to the prevention and treatment of SDM to patients. Education was provided once a week, with each session lasting around 1.5 h. No access to mobile educational platforms was provided to this group, ensuring a clear comparison with the intervention group. This approach controlled for any influence that patient education might have on blood glucose management, allowing for isolating the effect of the mobile platform. In contrast, a mobile educational platform was utilised to construct individualised health management (individual education) in the experimental group. First, a 6-member health management team was established on the mobile educational platform, consisting of 1 information liaison officer, 1 health manager, 2 responsible nurses and 2 doctors, all with work experience of >5 years. For offline education, nurses conducted one-on-one communication and guidance with the patients, with the education content including weight control, balanced diet, moderate exercise, blood glucose monitoring and guidance on self-management skills. Additionally, emphasis was placed on the participation of patients when setting health education goals. During the implementation of the programme, the goals for behaviour changes were refined, and feedback from patients was taken onboard to adjust the programme as needed. Regarding online education, relevant courseware, videos, images, etc. were created and subsequently uploaded to the mobile educational platform, with the content including routine information about NS, risk factors leading to SDM, clinical manifestations, preventive measures, treatment and care. Moreover, remote education was conducted via mobile applications and online platforms to promote the self-management knowledge of patients with NS after using GCs and to enhance their self-management skills. |
| Intervention type | Behavioural |
| Primary outcome measure | 1. Blood glucose levels (fasting glucose and postprandial blood glucose) measured using blood test at baseline and 3 months 2. Self-management efficacy measured using Diabetes Self-Management Attitude Scale, Diabetes Self-Management Behavior Scale and Diabetes Self-Efficacy Scale (DSES) scores, pre-intervention and 3 months after intervention |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 01/01/2019 |
| Completion date | 30/06/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 81 Years |
| Sex | Both |
| Target number of participants | 56 |
| Total final enrolment | 56 |
| Key inclusion criteria | Sure, here is the revised numbering format: 1. Patients with a confirmed diagnosis of NS and SDM for at least 3 months prior to enrollment. 1.1. NS was diagnosed based on nephrotic-range proteinuria (urinary protein excretion >3.5 g/day), hypoalbuminemia (serum albumin <3.0 g/dL), and clinical evidence of edema. 1.2. SDM was diagnosed using the American Diabetes Association criteria, requiring fasting plasma glucose ≥126 mg/dL, 2-hour plasma glucose ≥200 mg/dL during an oral glucose tolerance test, or haemoglobin A1c (HbA1c) levels ≥6.5%. 2. Aged >18 years. 3. Patients who were able to use smartphones or computers. 4. With outpatient follow-up for 3 months or above to ensure treatment adherence and stability. 5. Patients whose initial dose of GCs ≥40 mg/d (prednisone dose). |
| Key exclusion criteria | 1. History of diabetes or impaired glucose tolerance before GC use 2. Severe infection, stress response and other factors caused by significantly elevated blood glucose |
| Date of first enrolment | 01/04/2019 |
| Date of final enrolment | 31/12/2020 |
Locations
Countries of recruitment
- China
Study participating centre
Taiyuan City
030000
China
Sponsor information
Hospital/treatment centre
No. 359 Heping North Road, Jiancaoping District
Taiyuan City
030000
China
| Phone | +86-03514961105 |
|---|---|
| LLxininmm@21cn.com | |
| Website | http://wjw.shanxi.gov.cn/ |
Funders
Funder type
Government
No information available
Results and Publications
| Intention to publish date | 01/12/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a peer-reviewed journal. |
| IPD sharing plan | The datasets generated during and /or analysed during the current study will be available upon request from Dr Zhimin Yang, Zhimin_yang9@126.com |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 27/04/2025 | 28/04/2025 | Yes | No |
Editorial Notes
28/04/2025: Publication reference added.
04/11/2024: Trial's existence confirmed by The Ethics Committee of Shanxi Provincial People's Hospital.
