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Completed

NCT Number: NCT04192409

Glycemic Control Using Mobile-based Intervention in Patients With Diabetes Undergoing Coronary Artery Bypass to Promote Self-management

The study is a two-arm parallel, randomized clinical trial. The purpose of the study is to evaluate the effectiveness and feasibility of using high-quality medication reminder smartphone application as a tool for secondary prevention in patients undergone CABG with DM, including the change in quality of life, medication adherence improvement and clinical outcome. The participants will be randomized into intervention and control groups in a 1:1 ratio. The intervention group will receive information of secondary prevention of CHD and medication alarm using a specific smartphone application, while the control group will receive usual care.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chinese Academy of Medical Science,Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

About this study

Objective: this study designed to evaluate the effectiveness and feasibility of using high-quality medication reminder smartphone application as a tool for secondary prevention in patients undergone CABG with DM, including the change in quality of life, medication adherence improvement and clinical outcome.

Study design: the study is a two-arm, parallel, randomized clinical trial. Patients will be eligible if they have undergone CABG at this admission, have a history of diabetes mellitus, have the capability of reading and using smartphone application, and are able to provide informed consent. Patients will be excluded if they do not have smartphone. The eligible participants will be allocated into intervention and control groups in a 1:1 ratio randomly. The intervention group will receive intervention of smartphone application in addition to usual care, while the control group will receive usual care. All the participants will be followed up for 6 months.

Study intervention: participants in the intervention group will install a specific costume smartphone application, which will send health education information, medication alarm and risk factor questionnaire at a fixed frequency to aid patients' self-evaluation, recording patients' recent fast plasma glucose value in addition to usual care.

Outcome measures: The primary endpoint is the change in glycemic hemoglobin (HbA1C). Secondary endpoints include MACCE, medication adherence, quality of life and status of graft vessel.

Statistical analysis: Evaluation will be carried out on an intention-to-treat basis. Values of analyzed endpoints between intervention group and control group will be compared according to the analysis plan. We'll follow a prespecified analysis plan and subgroup analysis will be conducted accordingly.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnose with type 2 diabetes before this administration;
  • Postoperative patients undergoing CABG in this hospitalization;

Exclusion criteria

  • Die before discharge;
  • Disability of reading, vision or hearing which leads to disability of using smartphone;
  • Cognitive communication impairments or communication disorder;
  • Unable to use smartphone.

Treatment and study plan

Smartphone Application

Behavioral

Patients will use a smartphone application contain the following functions: providing health education information about DM and CAD, reminding patients to take medicine on time by alarm, recording patients' recent fast plasma glucose value.

Primary outcomes

  1. Change in glucose level measured by HbA1C level

    Time frame: Baseline; 6 months

    We will measured the change in glucose level from baseline to 6 months.

Secondary outcomes

  1. The incidence of all-cause death

    Time frame: 6 months

    We will measure the incidence of all-cause death at 6 months.

  2. The incidence of major adverse cardiovascular events(MACE)

    Time frame: 6 months

    We will measure the incidence of major adverse cardiovascular events(MACE) at 6 months.

  3. EQ-5D

    Time frame: 6 months

    We will measure the change in EQ-5D health survey 6 months postoperatively.

  4. Medication adherence

    Time frame: 6 months

    Medication adherence is collected by a self-reported questionnaire including two questions: 1) have you ever forget to take your medication? If so, how often will you describe? 2) have you ceased to take any medication? If so, does it ceased as prescribed by doctor? Question 1 has four option if patients choose yes: 1) I hardly forget to take my medicine; 2) I forget to take my medicine monthly; 3) I forget to take my medicine every week; 4) I hardly take any medicine.

  5. Status of the graft vessels

    Time frame: 6 months

    We will measure the status of the graft vessels by coronary CT angiography at 6 months.

  6. blood pressure

    Time frame: 6 months

    We will document blood pressure at 6 months postoperatively.

  7. blood glucose

    Time frame: 6 months

    We will document blood glucose at 6 months postoperatively.

  8. low density lipoprotein

    Time frame: 6 months

    We will document low density lipoprotein at 6 months postoperatively.

Sponsors and collaborators

Lead sponsor

China National Center for Cardiovascular Diseases

Other Gov

Collaborators

  • Chinese Academy of Medical Sciences, Fuwai Hospital

Registry information

Acronym: GUIDEME

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 10, 2019
Registry last updated
Jan 19, 2023

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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