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the Effect of Mobile Medical Used for the Standardized Management of Gestational Diabetes

Primary Purpose

GDM, Blood Glucose, Compliance, Patient

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
m-health management
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for GDM focused on measuring GDM, CGM, m-health, diet modification, blood glucose, compliance

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged between 18 and 45 years.
  • With singleton pregnancy
  • Diagnosed as GDM by 75g oral glucose tolerance test (OGTT) and insulin treatment is not required assessed by multi-disciplinary consultation.
  • Be able to use smart phone for chatting, read and write basic Chinese.
  • Volunteer for research.

Exclusion Criteria:

  • Pregnancies with diagnosed chronic disease
  • Pregnancies with other pregnancy complications except GDM
  • Pregnancies had recent trauma and treatment of glucocorticoids

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    Standard Clinic Prenatal Care (Control Group)

    m-health group (Intervention Group)

    Arm Description

    pregnancy's prenatal care appointment would be changed to once every two weeks when diagnosed with GDM. Doctors generally ask GDM women record their daily diet, exercise, weight, BG and blood pressure for at least three days between two visits and give lifestyle guidance according to the records. If they fail to show diaries, doctors would ask them come back with record next week. If BG control is poor, medicine intervention would be considered.

    participants were managed continuously through WeChat group chat.

    Outcomes

    Primary Outcome Measures

    glycemic qualification rate
    Glycemic qualification rate was calculated by the number of BG within the control range /30*100%. BG control range were fasting BG (fasting and before-sleep BG)<95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)<120 mg/dL (6.7 mmol/L)

    Secondary Outcome Measures

    pregnancy outcome
    delivery mode, premature rupture of the membranes, preterm birth, birthweight and postpartum hemorrhage

    Full Information

    First Posted
    June 5, 2020
    Last Updated
    June 13, 2020
    Sponsor
    Peking Union Medical College Hospital
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04424238
    Brief Title
    the Effect of Mobile Medical Used for the Standardized Management of Gestational Diabetes
    Official Title
    Clinical Research on Mobile Medical Used for the Standardized Management of Gestational Diabetes: a Randomized Control Trail
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 15, 2016 (Actual)
    Primary Completion Date
    June 15, 2020 (Anticipated)
    Study Completion Date
    June 30, 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Peking Union Medical College Hospital

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    A multicenter, randomized controlled trial was conducted to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM.
    Detailed Description
    Most gestational diabetes mellitus (GDM) can be well controlled by health education and life style management, expecting a better pregnancy outcome. But standard clinic prenatal care which consist of clinic visit every two weeks may not give full play to the effects of GDM management. Telemedicine shows its potential to fill this gap. A multicenter, randomized controlled trial was designed to investigate whether health education and life style management through WeChat group chat was more effective in controlling blood glucose (BG) than standard clinic prenatal care in women with GDM. Women with GDM diagnosed by oral glucose tolerance test between 23-30+6 gestational weeks were randomized to a WeChat group chat-based blood glucose management group or routine clinic prenatal care. In PUMCH, investigators also equip CGM for m-health group allowing a more detailed BG information. The primary outcome was change of glycemic qualification rate during follow up period in both groups. The second outcome was pregnancy outcomes. Also, a case-control study is designed to compare the glucose control status between rice-richen meal and wheaten-richen meal, and all other macronutrients and micronutrients are all calculated and same between two groups, which may provide more clues for type of carbohydrate recommendation for Chinese women with GDM.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    GDM, Blood Glucose, Compliance, Patient, Diet Habit
    Keywords
    GDM, CGM, m-health, diet modification, blood glucose, compliance

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    400 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Standard Clinic Prenatal Care (Control Group)
    Arm Type
    No Intervention
    Arm Description
    pregnancy's prenatal care appointment would be changed to once every two weeks when diagnosed with GDM. Doctors generally ask GDM women record their daily diet, exercise, weight, BG and blood pressure for at least three days between two visits and give lifestyle guidance according to the records. If they fail to show diaries, doctors would ask them come back with record next week. If BG control is poor, medicine intervention would be considered.
    Arm Title
    m-health group (Intervention Group)
    Arm Type
    Experimental
    Arm Description
    participants were managed continuously through WeChat group chat.
    Intervention Type
    Behavioral
    Intervention Name(s)
    m-health management
    Intervention Description
    Patients in intervention group received additional WeChat group management when conducted standard clinic prenatal care.
    Primary Outcome Measure Information:
    Title
    glycemic qualification rate
    Description
    Glycemic qualification rate was calculated by the number of BG within the control range /30*100%. BG control range were fasting BG (fasting and before-sleep BG)<95 mg/dL (5.3 mmol/L) and two-hour postprandial BG (post-breakfast, post-lunch, post-dinner BG)<120 mg/dL (6.7 mmol/L)
    Time Frame
    From enrollment to 42 days postpartum
    Secondary Outcome Measure Information:
    Title
    pregnancy outcome
    Description
    delivery mode, premature rupture of the membranes, preterm birth, birthweight and postpartum hemorrhage
    Time Frame
    delivery

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged between 18 and 45 years. With singleton pregnancy Diagnosed as GDM by 75g oral glucose tolerance test (OGTT) and insulin treatment is not required assessed by multi-disciplinary consultation. Be able to use smart phone for chatting, read and write basic Chinese. Volunteer for research. Exclusion Criteria: Pregnancies with diagnosed chronic disease Pregnancies with other pregnancy complications except GDM Pregnancies had recent trauma and treatment of glucocorticoids
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Liangkun Ma
    Organizational Affiliation
    Chinese Academy of Medical Science & Peking Union Medical College Hospital
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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