NCT02783612

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2018

Completed
Last Updated

May 26, 2016

Status Verified

May 1, 2016

Enrollment Period

2.3 years

First QC Date

April 12, 2016

Last Update Submit

May 25, 2016

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

glucose application

EXPERIMENTAL

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

Regular monitoring

NO INTERVENTION

Regular high risk pregnancy clinic surveillance

Interventions

glucose buddy applicationOTHER
glucose application

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • gestational diabetes

You may not qualify if:

  • pre-gestational diabetes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Wolfson medical center

Holon, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Central Study Contacts

Hadas Miremberg, MD

CONTACT

972526741740dasile2@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 12, 2016

First Posted

May 26, 2016

Study Start

March 1, 2016

Primary Completion

July 1, 2018

Study Completion

July 1, 2018

Last Updated

May 26, 2016

Record last verified: 2016-05

Locations

IL(1)