ClinicalTrials.gov
ClinicalTrials.gov Menu

Digital Glucose Monitoring in Gestational Diabetes

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: NCT02783612
Recruitment Status : Unknown
Verified May 2016 by Wolfson Medical Center.
Recruitment status was:  Recruiting
First Posted : May 26, 2016
Last Update Posted : May 26, 2016
Sponsor:
Information provided by (Responsible Party):
Wolfson Medical Center

Brief Summary:

Assessing blood glucose control in women with gestational diabetes can be challenging. The standard of care remains visual inspection of blood glucose paper diaries of self-performed capillary monitoring during regular meeting in High Risk pregnancy clinics.

The researchers are interested in preforming a randomized control trial comparing women with the diagnosis of gestational diabetes with regular High-Risk clinic surveillance to digital monitoring using an application in a Smart-phone and submitting those values via email in addition to the regular clinic appointments.

The Primary outcome of the trial is to assess the compliance of the research group as compared to the control group.


Condition or disease Intervention/treatment Phase
Gestational Diabetes Other: glucose buddy application Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Official Title: Improvement of Compliance by Digital Blood Glucose Monitoring of Women With Gestational Diabetes
Study Start Date : March 2016
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: glucose application
Regular high risk pregnancy clinic surveillance in addition to a Smart phone application for registering the Blood glucose levels and submitting via email every 3-5 days to the High risk Doctor involved in the trial.
Other: glucose buddy application
No Intervention: Regular monitoring
Regular high risk pregnancy clinic surveillance



Primary Outcome Measures :
  1. Assessing the compliance of the research group compared to the control group. [ Time Frame: 18 month ]
    By calculating the amount of daily glucose measurements in the research group compared to the number of glucose measurements in the control group



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.


Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • gestational diabetes

Exclusion Criteria:

  • pre-gestational diabetes

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): NCT02783612


Contacts
Contact: Hadas Miremberg, MD 972526741740 dasile2@gmail.com

Locations
Israel
Wolfson medical center Recruiting
Holon, Israel
Contact: Hadas Miremberg, MD    972526741740    dasile2@gmail.com   
Sponsors and Collaborators
Wolfson Medical Center

Responsible Party: Wolfson Medical Center
ClinicalTrials.gov Identifier: NCT02783612     History of Changes
Other Study ID Numbers: GDMAPP
First Posted: May 26, 2016    Key Record Dates
Last Update Posted: May 26, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications