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Completed

NCT Number: NCT03588000

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

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ruijin Hospital North

Shanghai, 201801, China

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Strengthen self-monitoring of blood glucose

Other

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

Primary outcomes

  1. absolute change in % HbA1c from baseline to 12 months

    Time frame: baseline to 12 months

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

Secondary outcomes

  1. absolute change in % HbA1c from baseline to 6 months

    Time frame: baseline to 6 months

    absolute change in glycemic control (% HbA1c) from baseline to 6 months

  2. absolute change in % HbA1c from baseline at 24 months

    Time frame: baseline to 24 months

    absolute change in glycemic control (% HbA1c) from baseline to 24 months

  3. change in blood glucose from baseline to 6 month

    Time frame: baseline to 6 months

    change in fasting and postprandial blood glucose from baseline to 6 month

  4. change in blood glucose from baseline to 12 month

    Time frame: baseline to 12 months

    change in fasting and postprandial blood glucose from baseline to 12 month

  5. change in blood glucose from baseline to 24 month

    Time frame: baseline to 24 months

    change in fasting and postprandial blood glucose from baseline to 24 month

Other outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: baseline to 12 months

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

  4. change in urinary albumin-to-creatinine ratio (UACR) from baseline to 24 months

    Time frame: baseline to 24 months

    change in urinary albumin-to-creatinine ratio (UACR) from baseline to 24 months

  5. number of participants on specified Diabetes medications at baseline and follow-up

    Time frame: baseline to 12 months

    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).

  6. number of participants on specified Diabetes medications at baseline and follow-up

    Time frame: baseline to 24 months

    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).

  7. change in health economics indexes from baseline to 12 months

    Time frame: 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).

  8. change in health economics indexes from baseline to 24 months

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Yuwen Zhang

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 17, 2018
Registry last updated
Sep 21, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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