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NCT02783612 Clinical Trial

Digital Glucose Monitoring in Gestational Diabetes

Gestational Diabetes Clinical Trial

Official title:
Improvement of Compliance by Digital Blood Glucose Monitoring of Women With Gestational Diabetes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02783612
Other study ID # GDMAPP
Secondary ID
Status Recruiting
Phase N/A
First received April 12, 2016
Last updated May 25, 2016
Start date March 2016
Est. completion date July 2018

Study information
Verified date May 2016
Source Wolfson Medical Center
Contact Hadas Miremberg, MD
Phone 972526741740
Email dasile2@gmail.com
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 2018
Est. primary completion date July 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 45 Years
Eligibility Inclusion Criteria:

- gestational diabetes

Exclusion Criteria:

- pre-gestational diabetes

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Related Conditions & MeSH terms

Intervention

Other:
• glucose buddy application

Locations
Country Name City State
Israel Wolfson medical center Holon

Sponsors (1)
Lead Sponsor Collaborator
Wolfson Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Assessing the compliance of the research group compared to the control group. 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 No
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