The Effect of Remote SMBG Combined With the Application of APP on the Improvement of T2DM Management in the Community

The Effect of Remote Self-monitoring of Blood Glucose (SMBG) Combined With the Promotion and Application of Internet Mobile Terminal (APP) on the Improvement of the Staged Type 2 Diabetes Mellitus (T2DM) Management and the Success Rate of Blood Glucose in the Community

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Other: Strengthen self-monitoring of blood glucose

Detailed Description

This project is a cohort intervention study for randomized controlled trials. Community health service centers are the main body of implementing treatment and community diabetes patients are the objects of intervention. 498 T2DM patients with poor blood glucose control (7%<HbA1c≤9.5%) from 4 different community health service centers will be randomized into two groups (strengthen group and control group). Strengthen self-monitoring of blood glucose by APP is the intervention and its duration is 12 months. Follow-up time of this study is 24 months (12 months after the intervention stopped). The diabetes treatment of patients from both groups follows Chinese guidelines (CDS 2017).

• Study Type: Interventional
• Enrollment (Actual): 498
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China, 201801
    • Ruijin Hospital North

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosis of type 2 Diabetes
• Between 18 and 79 years old
• 7.0%<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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Strength group; Strengthen self-monitoring of blood glucose by Internet mobile terminal (APP)	Other: Strengthen self-monitoring of blood glucose; Strengthen self-monitoring of blood glucose by Internet mobile terminal（APP）.
No Intervention: Control group; Voluntary self-monitoring of blood glucose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
absolute change in % HbA1c from baseline to 6 months	absolute change in glycemic control (% HbA1c) from baseline to 6 months	baseline to 6 months
absolute change in % HbA1c from baseline at 24 months	absolute change in glycemic control (% HbA1c) from baseline to 24 months	baseline to 24 months
change in blood glucose from baseline to 6 month	change in fasting and postprandial blood glucose from baseline to 6 month	baseline to 6 months
change in blood glucose from baseline to 12 month	change in fasting and postprandial blood glucose from baseline to 12 month	baseline to 12 months
change in blood glucose from baseline to 24 month	change in fasting and postprandial blood glucose from baseline to 24 month	baseline to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean difference in Health-related Quality of Life Scores from baseline to 12 months	change in Short Form-36 (SF-36) subscale scores (Physical and Mental subscales) from baseline to 52 weeks. The SF-36 is a widely used measure of health-related quality of life.	baseline to 12 months
mean difference in Health-related Quality of Life Scores from baseline to 24 months	change in Short Form-36 (SF-36) subscale scores (Physical and Mental subscales) from baseline to 52 weeks. The SF-36 is a widely used measure of health-related quality of life.	baseline to 24 months
change in urinary albumin-to-creatinine ratio (UACR) from baseline to 12 months	change in urinary albumin-to-creatinine ratio (UACR) from baseline to 12 months	baseline to 12 months
change in urinary albumin-to-creatinine ratio (UACR) from baseline to 24 months	change in urinary albumin-to-creatinine ratio (UACR) from baseline to 24 months	baseline to 24 months
number of participants on specified Diabetes medications at baseline and follow-up	number of participants taking each of the following medications at baseline and follow-up: insulin, metformin, sulfonylurea, glinides, α-glucosidase inhibitor, glucagon-like peptide-1 (GLP-1), Thiazolidinediones (TZD), dipeptidyl peptidase IV (DPP-IV) and sodium glucose cotransporter-2 (SGLT-2).	baseline to 12 months
number of participants on specified Diabetes medications at baseline and follow-up	number of participants taking each of the following medications at baseline and follow-up: insulin, metformin, sulfonylurea, glinides, α-glucosidase inhibitor, glucagon-like peptide-1 (GLP-1), Thiazolidinediones (TZD), dipeptidyl peptidase IV (DPP-IV) and sodium glucose cotransporter-2 (SGLT-2).	baseline to 24 months
change in health economics indexes from baseline to 12 months	health economics indexes assessed by the number of participants taking each of the following medications at baseline and follow-up: insulin, metformin, sulfonylurea, glinides, α-glucosidase inhibitor, glucagon-like peptide-1 (GLP-1), Thiazolidinediones (TZD), dipeptidyl peptidase IV (DPP-IV) and sodium glucose cotransporter-2 (SGLT-2).	baseline to 12 months
change in health economics indexes from baseline to 24 months	health economics indexes assessed by the number of participants taking each of the following medications at baseline and follow-up: insulin, metformin, sulfonylurea, glinides, α-glucosidase inhibitor, glucagon-like peptide-1 (GLP-1), Thiazolidinediones (TZD), dipeptidyl peptidase IV (DPP-IV) and sodium glucose cotransporter-2 (SGLT-2).	baseline to 24 months

Collaborators and Investigators

• Sponsor: Yuwen Zhang

Study record dates

Study Major Dates

• Study Start (Actual): November 23, 2018
• Primary Completion (Actual): February 28, 2021
• Study Completion (Actual): April 16, 2021

Study Registration Dates

• First Submitted: June 7, 2018
• First Submitted That Met QC Criteria: July 2, 2018
• First Posted (Actual): July 17, 2018

Study Record Updates

• Last Update Posted (Actual): September 21, 2021
• Last Update Submitted That Met QC Criteria: September 20, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 16CR4020A

Drug and device information, study documents

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