Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT03061851
Status:
UNKNOWN
Last Update Posted:
2017-02-23
First Post:
2017-02-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Individualized Behavioral Intervention of Smartphone App in the Treatment of Type 2 Diabetes Mellitus
Sponsor:
Qingdao Zhixin Health Technology Co., Ltd.
Organization:
Study Overview
Official Title:
A Multicenter, Prospective, Randomized, Controlled Clinical Trial of the Individualized Behavioral Intervention of Smartphone App in the Treatment of Type 2 Diabetes Mellitus
Status:
UNKNOWN
Status Verified Date:
2017-02
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The patients with type 2 diabetes who underwent routine hypoglycemic agents and insulin therapy were evaluated for 48 weeks with maltose software.
Detailed Description:
This study enrolled 400 patients with type 2 diabetes in five centers in Shandong Province, China. Patients with type 2 diabetes who met the inclusion / exclusion criteria were randomly assigned to the trial group (conventional treatment + maltose app) or the control group (conventional treatment) in a 1: 1 ratio.
The control group: given conventional hypoglycemic drug treatment, the treatment plan by the investigators according to the patient's condition may be, this study does not interfere.
The trial group: the patients were treated with conventional hypoglycemic drugs. The treatment plan was decided by the researcher according to the patient's condition. The intervention was not done in this study.
Interventions include:
1. Weekly diabetes-related science articles.
2. Patients reported hypoglycemia or other adverse reactions, the competent physician to deal with.
3. Questionnaires published out the hospital (2 weeks 1), the feedback for the problem.
4. monitoring of abnormal blood glucose data or the presence of related discomfort, can communicate with the competent physician online.
5. Personalize the development of diet, exercise program.
6. different insulin and oral hypoglycemic drug medication time to remind.
7. hypoglycemic drug side effects query.
The control group: given conventional hypoglycemic drug treatment, the treatment plan by the investigators according to the patient's condition may be, this study does not interfere.
The trial group: the patients were treated with conventional hypoglycemic drugs. The treatment plan was decided by the researcher according to the patient's condition. The intervention was not done in this study.
Interventions include:
1. Weekly diabetes-related science articles.
2. Patients reported hypoglycemia or other adverse reactions, the competent physician to deal with.
3. Questionnaires published out the hospital (2 weeks 1), the feedback for the problem.
4. monitoring of abnormal blood glucose data or the presence of related discomfort, can communicate with the competent physician online.
5. Personalize the development of diet, exercise program.
6. different insulin and oral hypoglycemic drug medication time to remind.
7. hypoglycemic drug side effects query.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: