NCT04999722

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,200

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Aug 2021

Shorter than P25 for not_applicable diabetes-mellitus

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 19, 2021

Completed
23 days until next milestone

First Posted

Study publicly available on registry

August 11, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

August 25, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 24, 2022

Completed
Last Updated

August 11, 2021

Status Verified

July 1, 2021

Enrollment Period

4 months

First QC Date

July 19, 2021

Last Update Submit

August 9, 2021

Conditions

Diabetes Mellitus

Keywords

Diabetes MellitusManageMobile app

Outcome Measures

Primary Outcomes (1)

  • Change from Baseline Glycated hemoglobin at 12 months

    Changes of glycated hemoglobin （percentage）before and after management

    Month 12

Secondary Outcomes (3)

  • Change from Baseline Blood pressure at 12 months

    Month 12

  • Change from Baseline blood lipid at 12 months

    Month 12

  • Change from Baseline Diabetic nephropathy at 12 months

    Month 12

Study Arms (2)

APP group

ACTIVE COMPARATOR

Participants with diabetes who had access to a mobile APP

Behavioral: Mobile APP management

Control Group

PLACEBO COMPARATOR

Diabetes participants who accepted the traditional management model

Behavioral: Traditional mode of management

Interventions

Traditional mode of managementBEHAVIORAL

Traditional model management of Diabetes Mellitus patients

Control Group
Mobile APP managementBEHAVIORAL

Management of diabetic patients with mobile phone APP

APP group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of type 2 diabetes.
  • Aged 18-70;
  • HbA1c ≥ 8.0%

You may not qualify if:

  • Pregnancy;
  • Chronic kidney disease (CKD stage 5);
  • Senile dementia patients;
  • With malignant tumor;
  • Moderate and severe anemia;
  • Severe liver dysfunction;
  • Hemolytic anemia, aplastic anemia, massive blood loss or transfusion, chronic malaria;
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Mobile app was used for follow-up
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 19, 2021

First Posted

August 11, 2021

Study Start

August 25, 2021

Primary Completion

December 31, 2021

Study Completion

June 24, 2022

Last Updated

August 11, 2021

Record last verified: 2021-07