Digital Glucose Monitoring in Gestational Diabetes

NCT ID: NCT02783612

Last Updated: 2016-05-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

glucose buddy application

Intervention Type OTHER

Regular monitoring

Regular high risk pregnancy clinic surveillance

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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glucose buddy application

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* gestational diabetes

Exclusion Criteria

* pre-gestational diabetes
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Wolfson Medical Center

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Wolfson medical center

Holon, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Hadas Miremberg, MD

Role: CONTACT

972526741740

Facility Contacts

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Hadas Miremberg, MD

Role: primary

972526741740

Other Identifiers

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GDMAPP

Identifier Type: -

Identifier Source: org_study_id

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