- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02783612
Digital Glucose Monitoring in Gestational Diabetes
Improvement of Compliance by Digital Blood Glucose Monitoring of Women With Gestational Diabetes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Hadas Miremberg, MD
- Phone Number: 972526741740
- Email: dasile2@gmail.com
Study Locations
-
-
-
Holon, Israel
- Recruiting
- Wolfson Medical Center
-
Contact:
- Hadas Miremberg, MD
- Phone Number: 972526741740
- Email: dasile2@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- gestational diabetes
Exclusion Criteria:
- pre-gestational diabetes
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
|
No Intervention: Regular monitoring
Regular high risk pregnancy clinic surveillance
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
18 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GDMAPP
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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