Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Smartphone Application for the Management of Gestational Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03838380
Recruitment Status : Completed
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Information provided by (Responsible Party):
Cheol-Young Park, Kangbuk Samsung Hospital

Brief Summary:
The prevalence of gestational diabetes mellitus (GDM) has been progressively increasing. It is important to recognize and treat GDM to minimize the risk of maternal and neonatal complications. Multifaceted professional interventions are effective in the management of GDM and mobile healthcare can be an effective approach. The purpose of the current study was to develop and evaluate a model for prevention and management of GDM using mobile healthcare. Subjects with no previous history of diabetes, who were diagnosed with GDM during 24-28 weeks of gestation, were randomly divided into a conventional management group and a mobile management group. The conventional mangement group received conventional GDM management and could freely use the mobile healthcare application. The mobile management group received mobile healthcare services including tailored mobile coaching. The effectiveness of the management using the application were evaluated through the result values of the laboratory tests, anthropometric measurement performed during the study period and perinatal outcomes.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Mellitus in Pregnancy Other: Smartphone application Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Peripartum Management of Gestational Diabetes Using a Digital Healthcare Service: a Pilot, Randomized Controlled Study
Actual Study Start Date : February 1, 2017
Actual Primary Completion Date : August 31, 2017
Actual Study Completion Date : October 31, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: conventional management group
The conventional management group received standard GDM management and could freely use the smartphone healthcare application.
Experimental: mobile management group
The mobile management group received mobile healthcare services through smartphone application specifically developed for this trial including tailored mobile coaching.
Other: Smartphone application
Mobile management group participants were given monitoring system devices including a glucometer with Bluetooth connectivity and an accelerometer to detect physical activity level. The mobile phone application specifically designed for this study was installed at enrollment for the mobile management group to collect clinical data and messages from the patients. The application consisted of four sections: clinical data, nutrition and diet, medication, and messaging system and information. Patients allocated to the mobile management group recorded their blood glucose level and diet via the smartphone application, and health care providers regularly scanned clinical data and messages from patients and sent return messages with tailored medical and nutritional guidance.




Primary Outcome Measures :
  1. hemoglobin A1c levels [ Time Frame: up to 4 to 12weeks after delivery ]
    serum glycated hemoglobin levels


Secondary Outcome Measures :
  1. body weight [ Time Frame: up to 4 to 12weeks after delivery ]
    the changes in body weight

  2. body mass index [ Time Frame: up to 4 to 12weeks after delivery ]
    the changes in body mass index

  3. percent body fat [ Time Frame: up to 4 to 12weeks after delivery ]
    the changes in percent body fat

  4. HOMA IR(homeostatic model assessment insulin resistance) [ Time Frame: up to 4 to 12weeks after delivery ]
    the changes in insulin resistance

  5. HOMA-ß (homeostatic model assessment ß-cell dysfunction ) [ Time Frame: up to 4 to 12weeks after delivery ]
    the changes in ß-cell dysfunction

  6. Neonate large for gestational age [ Time Frame: at the day of delivery ]
    Birth weight of neonates of GDM patients

  7. Mode of delivery [ Time Frame: at the day of delivery ]
    Rate of cesarean section



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnant women diagnosed as GDM at 24 to 28 weeks of gestation were included.

Exclusion Criteria:

  • Patients after 30th week of gestation and patients with pregestational diabetes were excluded from participating in the study. Patients who were unable to understand Korean, were unfamiliar with mobile phones, who did not have access to a mobile phone, or who were already receiving services from another mobile healthcare agency were also excluded.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03838380


Locations
Layout table for location information
Korea, Republic of
Kangbuk Samsung hospital
Seoul, Korea, Republic of
Sponsors and Collaborators
Kangbuk Samsung Hospital

Layout table for additonal information
Responsible Party: Cheol-Young Park, Professor, Division of Endocrionology and metabolism, Department of Internal medicine, Kangbuk Samsung Hospital
ClinicalTrials.gov Identifier: NCT03838380     History of Changes
Other Study ID Numbers: KBSMC2016-11-049
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes, Gestational
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications