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Smartphone Utilization for Glucose Monitoring and Antenatal Reporting (SUGAR)

Primary Purpose

Gestational Diabetes, Pregestational Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Completion of Glucose logs
Sponsored by
University of Rochester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • UR Medicine Obstetrics and Gynecology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glooko App

Traditional Care

Arm Description

Glooko application and meter compatibility device (if required)

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Patient Satisfaction
Responses to patient satisfaction survey
Glucose values at goal
% of glucose values at goal during the study period
% Change in Hemoglobin A1C
% of change in values of HbA1C during the study period
Clinic visits
Number of clinic visits during the study period
Unscheduled health care access episodes
Number of unanticipated or unscheduled health care visits during the study period

Full Information

First Posted
March 9, 2018
Last Updated
February 11, 2020
Sponsor
University of Rochester
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1. Study Identification

Unique Protocol Identification Number
NCT03504592
Brief Title
Smartphone Utilization for Glucose Monitoring and Antenatal Reporting
Acronym
SUGAR
Official Title
Utilizing mHealth to Improve Diabetes in an Obstetric Population
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, Pregestational Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glooko App
Arm Type
Experimental
Arm Description
Glooko application and meter compatibility device (if required)
Arm Title
Traditional Care
Arm Type
Active Comparator
Arm Description
Traditional clinic reporting system: paper/MyChart/emailed glucose logs
Intervention Type
Behavioral
Intervention Name(s)
Completion of Glucose logs
Intervention Description
Glucose logs will be assessed by provider for completeness and accuracy
Primary Outcome Measure Information:
Title
Completeness and accuracy of blood glucose record
Description
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.
Time Frame
Every 2 weeks through study completion, up to 42 weeks
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
Responses to patient satisfaction survey
Time Frame
Once prior to exiting the study, an average of 42 weeks
Title
Glucose values at goal
Description
% of glucose values at goal during the study period
Time Frame
Every 2 weeks through study completion, up to 42 weeks
Title
% Change in Hemoglobin A1C
Description
% of change in values of HbA1C during the study period
Time Frame
Once prior to exiting the study, up to 42 weeks
Title
Clinic visits
Description
Number of clinic visits during the study period
Time Frame
through study completion, up to 42 weeks
Title
Unscheduled health care access episodes
Description
Number of unanticipated or unscheduled health care visits during the study period
Time Frame
through study completion, up to 42 weeks

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Patients must be pregnant to be enrolled in this study
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
UR Medicine Obstetrics and Gynecology
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Smartphone Utilization for Glucose Monitoring and Antenatal Reporting

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