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Prediabetes Management

Primary Purpose

PreDiabetes, Metabolic Management Center, Continuous Glucose Monitoring

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fu Lishan instant sense hospital dynamic glucose monitoring system
Sponsored by
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for PreDiabetes focused on measuring prediabetes, continuous glucose monitoring, metabolic management center

Eligibility Criteria

20 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • IConforms to the pre diabetes in the diagnostic criteria of type 2 diabetes in the Chinese guidelines for the prevention and treatment of type 2 diabetes (version 2020) (only use plasma glucose at 0 minutes in OGTT and 120 minutes after taking glucose);

    • Initial screening and diagnosis; ③ without other serious basic diseases; ④ Have complete cognition, reading and writing ability, have a smart phone, can use simple functions, and know how to use wechat; ⑤ Those who voluntarily participate in this study are willing to sign the informed consent form.

Exclusion Criteria:

  • Those who have been diagnosed with diabetes;

    • Patients with severe heart, lung, liver and kidney dysfunction;

      • Those with mental disorder, language disorder or senile dementia; ④ Those who can't take care of themselves, are bedridden or have mobility problems; ⑤ Lactating or pregnant women; ⑥ Patients with recent history of surgery, trauma, cardio cerebral and other acute large vessel complications and infectious diseases.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Fu Lishan instant sense hospital dynamic glucose monitoring system

    Arm Description

    Using CGM Technology (dynamic glucose monitoring system for Fu Lishan instant sense hospital), on the basis of the original eating habits of patients, according to the guidelines and the training of MMC center, patients are guided to adjust the diet model according to the glucose map monitored by the dynamic glucose monitoring system and the log recorded, so as to implement therapeutic monitoring, control the blood glucose level within the target range as far as possible, and record the amount of various foods accordingly, After that, the eating method and amount remained basically unchanged.

    Outcomes

    Primary Outcome Measures

    Incidence of diabetes
    Incidence rate of patients with pre diabetes turning into diabetes after one year of standardized management

    Secondary Outcome Measures

    HbA1c increased by 0.5%
    HbA1c increased by 0.5%

    Full Information

    First Posted
    September 4, 2022
    Last Updated
    September 4, 2022
    Sponsor
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05531838
    Brief Title
    Prediabetes Management
    Official Title
    A Community Controlled Study of MMC Mode Combined With CGM Therapeutic Monitoring Technology in the Management of Patients With Prediabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 17, 2022 (Anticipated)
    Primary Completion Date
    October 30, 2023 (Anticipated)
    Study Completion Date
    December 31, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Systematically screen the high-risk population of diabetes in Xinqiao district to understand the characteristics of early glucose metabolism changes and pancreatic islet function changes in patients with pre diabetes. Relying on MMC platform and combined with CGM therapeutic monitoring technology to standardize the management of patients with prediabetes, it is expected that the annual conversion rate of diabetes in patients with prediabetes will be 8% (according to the literature, if the pre diabetes population is not intervened, the annual conversion rate of diabetes will be about 14%), which will move forward the management of diabetes and create a new mode of pre diabetes management.
    Detailed Description
    Part I: Establish the first standardized study cohort of prediabetes patients in Songjiang On the basis of previous studies, we will continue to carry out early screening of diabetes high-risk groups. It is planned to complete 500 high-risk screening cases in Xinqiao area, and all screened patients will have their medical history and relevant laboratory examinations, and will be followed up regularly. The standard OGTT method was used for screening. The screening contents included: fasting blood glucose and insulin, blood glucose and insulin levels 2 hours after 75g glucose load, and glycosylated hemoglobin levels. In addition to glucose metabolism, other metabolic related diseases such as hematuria routine, liver and kidney function, uric acid, blood lipids, thyroid function, and urine protein / creatinine were also screened. The establishment of the high-quality high-risk screening project in Xinqiao community will establish the first standardized research cohort of diabetes high-risk and pre diabetes patients in Songjiang area, which has very important strategic significance. Part II: Standardized management and follow-up based on MMC mode combined with CGM therapeutic monitoring technology For patients with pre diabetes diagnosed by screening, we will rely on MMC mode and CGM technology for standardized management and follow-up. The management mode is mainly embodied in the following forms: ① using CGM Technology (dynamic glucose monitoring system for auxiliary Lishan instant sense hospital), on the basis of the original eating habits of patients, according to the guidelines and the training of MMC center, patients are guided to adjust their eating mode according to the glucose map monitored by the dynamic glucose monitoring system and the log recorded, so as to implement therapeutic monitoring, so as to control the blood glucose level within the target range as far as possible, And record the amount of various foods accordingly, and then maintain the eating mode and amount basically unchanged. ② Offline management. Patient education at least twice a year and hospital follow-up once a year; ③ Issue health instruction manuals, blood glucose monitoring diaries, etc; ④ A full-time wechat management group is established, and full-time intelligent assistants push diet, sports and other guidance every day. Taking the cases of diabetes patients screened in the previous study of the research group as the control, the annual conversion rate of diabetes was observed one year later.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    PreDiabetes, Metabolic Management Center, Continuous Glucose Monitoring
    Keywords
    prediabetes, continuous glucose monitoring, metabolic management center

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Sequential Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    190 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Fu Lishan instant sense hospital dynamic glucose monitoring system
    Arm Type
    Other
    Arm Description
    Using CGM Technology (dynamic glucose monitoring system for Fu Lishan instant sense hospital), on the basis of the original eating habits of patients, according to the guidelines and the training of MMC center, patients are guided to adjust the diet model according to the glucose map monitored by the dynamic glucose monitoring system and the log recorded, so as to implement therapeutic monitoring, control the blood glucose level within the target range as far as possible, and record the amount of various foods accordingly, After that, the eating method and amount remained basically unchanged.
    Intervention Type
    Device
    Intervention Name(s)
    Fu Lishan instant sense hospital dynamic glucose monitoring system
    Intervention Description
    Using CGM Technology (dynamic glucose monitoring system used in Fu Lishan instant sense hospital), on the basis of patients' original eating habits, according to the guidelines and the training of MMC center, patients are guided to adjust their eating patterns according to the glucose map monitored by the dynamic glucose monitoring system.
    Primary Outcome Measure Information:
    Title
    Incidence of diabetes
    Description
    Incidence rate of patients with pre diabetes turning into diabetes after one year of standardized management
    Time Frame
    one year
    Secondary Outcome Measure Information:
    Title
    HbA1c increased by 0.5%
    Description
    HbA1c increased by 0.5%
    Time Frame
    one year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    79 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: IConforms to the pre diabetes in the diagnostic criteria of type 2 diabetes in the Chinese guidelines for the prevention and treatment of type 2 diabetes (version 2020) (only use plasma glucose at 0 minutes in OGTT and 120 minutes after taking glucose); Initial screening and diagnosis; ③ without other serious basic diseases; ④ Have complete cognition, reading and writing ability, have a smart phone, can use simple functions, and know how to use wechat; ⑤ Those who voluntarily participate in this study are willing to sign the informed consent form. Exclusion Criteria: Those who have been diagnosed with diabetes; Patients with severe heart, lung, liver and kidney dysfunction; Those with mental disorder, language disorder or senile dementia; ④ Those who can't take care of themselves, are bedridden or have mobility problems; ⑤ Lactating or pregnant women; ⑥ Patients with recent history of surgery, trauma, cardio cerebral and other acute large vessel complications and infectious diseases.

    12. IPD Sharing Statement

    Learn more about this trial

    Prediabetes Management

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