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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04999722

Enrollment

1200

Registered

2021-08-11

Start date

2021-08-25

Completion date

2022-06-24

Last updated

2021-08-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus, Manage, Mobile app

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.

Interventions

BEHAVIORALTraditional mode of management

Traditional model management of Diabetes Mellitus patients

BEHAVIORALMobile APP management

Management of diabetic patients with mobile phone APP

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

SINGLE (Outcomes Assessor)

Intervention model description

Mobile app was used for follow-up

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026