NCT03504592

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

March 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 20, 2018

Completed
11 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2019

Completed
Last Updated

February 13, 2020

Status Verified

February 1, 2020

Enrollment Period

1.1 years

First QC Date

March 9, 2018

Last Update Submit

February 11, 2020

Conditions

Gestational DiabetesPregestational Diabetes

Outcome Measures

Primary Outcomes (1)

  • Completeness and accuracy of blood glucose record

    The number of values reported to the provider out of the number that should have been collected during the time period, expressed as a percent, as well as the number of values reported that were verified accurate by the meter out of the total number of values reported in the time frame expressed as a percent.

    Every 2 weeks through study completion, up to 42 weeks

Secondary Outcomes (5)

  • Patient Satisfaction

    Once prior to exiting the study, an average of 42 weeks

  • Glucose values at goal

    Every 2 weeks through study completion, up to 42 weeks

  • % Change in Hemoglobin A1C

    Once prior to exiting the study, up to 42 weeks

  • Clinic visits

    through study completion, up to 42 weeks

  • Unscheduled health care access episodes

    through study completion, up to 42 weeks

Study Arms (2)

Glooko App

EXPERIMENTAL

Glooko application and meter compatibility device (if required)

Behavioral: Completion of Glucose logs

Traditional Care

ACTIVE COMPARATOR

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

Behavioral: Completion of Glucose logs

Interventions

Completion of Glucose logsBEHAVIORAL

Glucose logs will be assessed by provider for completeness and accuracy

Glooko AppTraditional Care

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsPatients must be pregnant to be enrolled in this study
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Not English speaking, does not have smartphone, unable to consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UR Medicine Obstetrics and Gynecology

Rochester, New York, 14620, United States

Location

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 9, 2018

First Posted

April 20, 2018

Study Start

May 1, 2018

Primary Completion

May 31, 2019

Study Completion

May 31, 2019

Last Updated

February 13, 2020

Record last verified: 2020-02

Locations

US(1)