Smartphone Utilization for Glucose Monitoring and Antenatal Reporting

NCT ID: NCT03504592

Last Updated: 2020-02-13

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

COMPLETED

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2019-05-31

Brief Summary

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This project will utilize MHealth technology to address the barriers providers and obstetric patients experience when reporting blood glucose results. Half of the participants will record their blood glucose values with the assistance of a smartphone device, the other half will continue in the traditional care method of the clinic.

Detailed Description

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This will be a prospective single center randomized trial piloting the use of mHealth applications in an obstetric population with diabetes. Participants will be enrolled in the study after the diagnosis of diabetes is made in pregnancy for those with gestational diabetes, or for patients with preexisting diabetes they will be enrolled upon initiation of prenatal care. Participants will be randomized to traditional care or mHealth intervention. Outcomes will include completeness and accuracy of the participant glucose log, unscheduled health care access episodes in the pregnancy, patient satisfaction, percentage of glucose values at goal and percent change in Hemoglobin A1C.

Conditions

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Gestational Diabetes Pregestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Glooko App

Glooko application and meter compatibility device (if required)

Group Type EXPERIMENTAL

Completion of Glucose logs

Intervention Type BEHAVIORAL

Glucose logs will be assessed by provider for completeness and accuracy

Traditional Care

Traditional clinic reporting system: paper/MyChart/emailed glucose logs

Group Type ACTIVE_COMPARATOR

Completion of Glucose logs

Intervention Type BEHAVIORAL

Glucose logs will be assessed by provider for completeness and accuracy

Interventions

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Completion of Glucose logs

Glucose logs will be assessed by provider for completeness and accuracy

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Pregnant, English speaking, Diagnosed with diabetes during pregnancy or with known preexisting diabetes, has smartphone, sees URMC OBGYN for obstetric care in pregnancy.

Exclusion Criteria

* Not English speaking, does not have smartphone, unable to consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University of Rochester

OTHER

Sponsor Role lead

Responsible Party

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Lisa Gray

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UR Medicine Obstetrics and Gynecology

Rochester, New York, United States

Site Status

Countries

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United States

Other Identifiers

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RSRB00068149

Identifier Type: -

Identifier Source: org_study_id

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