NCT03588000

Brief Summary

To investigate whether strengthen community diabetes patients self-monitoring of blood glucose can improve the patient's blood glucose control under Chinese guidelines for the prevention and treatment of diabetes (CDS 2017) and whether this intervention produces health and economic benefits.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
498

participants targeted

Target at P75+ for not_applicable diabetes-mellitus-type-2

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable diabetes-mellitus-type-2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 7, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

November 23, 2018

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 16, 2021

Completed
Last Updated

September 21, 2021

Status Verified

September 1, 2021

Enrollment Period

2.3 years

First QC Date

June 7, 2018

Last Update Submit

September 20, 2021

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

  • absolute change in % HbA1c from baseline to 12 months

    absolute change in glycemic control (% HbA1c) from baseline to 12 months

    baseline to 12 months

Secondary Outcomes (5)

  • absolute change in % HbA1c from baseline to 6 months

    baseline to 6 months

  • absolute change in % HbA1c from baseline at 24 months

    baseline to 24 months

  • change in blood glucose from baseline to 6 month

    baseline to 6 months

  • change in blood glucose from baseline to 12 month

    baseline to 12 months

  • change in blood glucose from baseline to 24 month

    baseline to 24 months

Other Outcomes (8)

  • mean difference in Health-related Quality of Life Scores from baseline to 12 months

    baseline to 12 months

  • mean difference in Health-related Quality of Life Scores from baseline to 24 months

    baseline to 24 months

  • change in urinary albumin-to-creatinine ratio (UACR) from baseline to 12 months

    baseline to 12 months

  • +5 more other outcomes

Study Arms (2)

Strength group

EXPERIMENTAL

Strengthen self-monitoring of blood glucose by Internet mobile terminal (APP)

Other: Strengthen self-monitoring of blood glucose

Control group

NO INTERVENTION

Voluntary self-monitoring of blood glucose

Interventions

Strengthen self-monitoring of blood glucoseOTHER

Strengthen self-monitoring of blood glucose by Internet mobile terminal（APP）.

Strength group

Eligibility Criteria

Age18 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of type 2 Diabetes
  • Between 18 and 79 years old
  • %\<HbA1c ≤ 9.5%
  • Routinely uses a smart phone
  • Capability of operating the designated APP
  • Long-time residents in Jiading District, Shanghai, China
  • Subordinated to Shanghai medical insurance
  • Contracted residents of community in Jiading District, Shanghai, China
  • Being cognitively able to participate
  • Provision of written informed consent

You may not qualify if:

  • Type 1 diabetes, gestational diabetes mellitus or other types of diabetes mellitus
  • Currently pregnant or contemplating pregnancy within the next 24 months
  • Lactating women
  • Was not able to insist until the end (24 months)
  • Cognitive impairment
  • Migrant population

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin Hospital North

Shanghai, 201801, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 7, 2018

First Posted

July 17, 2018

Study Start

November 23, 2018

Primary Completion

February 28, 2021

Study Completion

April 16, 2021

Last Updated

September 21, 2021

Record last verified: 2021-09

Locations

CN(1)