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

NCT ID: NCT04999722

Last Updated: 2021-08-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

1200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-25

Study Completion Date

2022-06-24

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Mobile app was used for follow-up
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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APP group

Participants with diabetes who had access to a mobile APP

Group Type ACTIVE_COMPARATOR

Mobile APP management

Intervention Type BEHAVIORAL

Management of diabetic patients with mobile phone APP

Control Group

Diabetes participants who accepted the traditional management model

Group Type PLACEBO_COMPARATOR

Traditional mode of management

Intervention Type BEHAVIORAL

Traditional model management of Diabetes Mellitus patients

Interventions

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Traditional mode of management

Traditional model management of Diabetes Mellitus patients

Intervention Type BEHAVIORAL

Mobile APP management

Management of diabetic patients with mobile phone APP

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chongqing Renji Hospital, University of Chinese Academy of Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2021CQSDWRMYYEC-004

Identifier Type: -

Identifier Source: org_study_id

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