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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetes Mellitus
• Intervention / Treatment: Behavioral: Mobile APP management; Behavioral: Traditional mode of management

• Study Type: Interventional
• Enrollment (Anticipated): 1200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Glycated hemoglobin at 12 months	Changes of glycated hemoglobin （percentage）before and after management	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Blood pressure at 12 months	Changes of blood pressure（mmHg） before and after management	Month 12
Change from Baseline blood lipid at 12 months	Changes of blood lipid （mmol/L）before and after management	Month 12
Change from Baseline Diabetic nephropathy at 12 months	Changes of Diabetic nephropathy（ratio） before and after management	Month 12

Collaborators and Investigators

• Sponsor: Chongqing Renji Hospital, University of Chinese Academy of Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): August 25, 2021
• Primary Completion (Anticipated): December 31, 2021
• Study Completion (Anticipated): June 24, 2022

Study Registration Dates

• First Submitted: July 19, 2021
• First Submitted That Met QC Criteria: August 9, 2021
• First Posted (Actual): August 11, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 9, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Diabetes Mellitus; Mobile app; Manage
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2021CQSDWRMYYEC-004

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No