Establishment and Preliminary Evaluation of Digital Three Level Linkage Whole Process Diabetes Management System

• Sponsor: Chongqing Renji Hospital, University of Chinese Academy of Sciences (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT04999722
• Collaborator: (none)
• Enrollment: 1,200
• Arms: 2
• Anticipated Duration (Months): 10

Study Details

Study Description

Brief Summary

This study used Nan'an District of Chongqing, China as a pilot project to improve the comprehensive compliance rate of diabetic patients in China, and reduce the physical and economic harm caused by complications.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Behavioral: Traditional mode of management; Behavioral: Mobile APP management	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 1200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Mobile app was used for follow-upMobile app was used for follow-up
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Establishment and Preliminary Evaluation of Digital Three Level Linkage Whole Process Diabetes Management System
• Anticipated Study Start Date: Aug 25, 2021
• Anticipated Primary Completion Date: Dec 31, 2021
• Anticipated Study Completion Date: Jun 24, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: APP group Participants with diabetes who had access to a mobile APP	Behavioral: Mobile APP management; Management of diabetic patients with mobile phone APP
Placebo Comparator: Control Group Diabetes participants who accepted the traditional management model	Behavioral: Traditional mode of management; Traditional model management of Diabetes Mellitus patients

Outcome Measures

Primary Outcome Measures

1. Change from Baseline Glycated hemoglobin at 12 months [Month 12]

   Changes of glycated hemoglobin （percentage）before and after management

Secondary Outcome Measures

1. Change from Baseline Blood pressure at 12 months [Month 12]

   Changes of blood pressure（mmHg） before and after management

2. Change from Baseline blood lipid at 12 months [Month 12]

   Changes of blood lipid （mmol/L）before and after management

3. Change from Baseline Diabetic nephropathy at 12 months [Month 12]

   Changes of Diabetic nephropathy（ratio） before and after management

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Clinical diagnosis of type 2 diabetes.

2. Aged 18-70;

3. HbA1c ≥ 8.0%

Exclusion Criteria:

1. Pregnancy;

2. Chronic kidney disease (CKD stage 5);

3. Senile dementia patients;

4. With malignant tumor;

5. Moderate and severe anemia;

6. Severe liver dysfunction;

7. Hemolytic anemia, aplastic anemia, massive blood loss or transfusion, chronic malaria;

8. In the recent one week, large doses of salicylate, erythropoietin, antiretroviral drugs, ribavirin and other drugs that have an impact on the detection of glycosylated hemoglobin were used

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Chongqing Renji Hospital, University of Chinese Academy of Sciences

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Chongqing Renji Hospital, University of Chinese Academy of Sciences
• ClinicalTrials.gov Identifier: NCT04999722
• Other Study ID Numbers: 2021CQSDWRMYYEC-004
• First Posted: Aug 11, 2021
• Last Update Posted: Aug 11, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Chongqing Renji Hospital, University of Chinese Academy of Sciences: Diabetes Mellitus; Manage; Mobile app
• Additional relevant MeSH terms: Diabetes Mellitus

Study Results

No Results Posted as of Aug 11, 2021