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Smartphone Utilization for Glucose Monitoring and Antenatal Reporting (SUGAR)

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ClinicalTrials.gov Identifier: NCT03504592
Recruitment Status : Recruiting
First Posted : April 20, 2018
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
University of Rochester

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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes Pregestational Diabetes Behavioral: Completion of Glucose logs Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Utilizing mHealth to Improve Diabetes in an Obstetric Population
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : May 2019
Estimated Study Completion Date : June 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Glooko App
Glooko application and meter compatibility device (if required)
Behavioral: Completion of Glucose logs
Glucose logs will be assessed by provider for completeness and accuracy

Active Comparator: Traditional Care
Traditional clinic reporting system: paper/MyChart/emailed glucose logs
Behavioral: Completion of Glucose logs
Glucose logs will be assessed by provider for completeness and accuracy




Primary Outcome Measures :
  1. Completeness and accuracy of blood glucose record [ Time Frame: Every 2 weeks through study completion, up to 42 weeks ]
    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 :
  1. Patient Satisfaction [ Time Frame: Once prior to exiting the study, an average of 42 weeks ]
    Responses to patient satisfaction survey

  2. Glucose values at goal [ Time Frame: Every 2 weeks through study completion, up to 42 weeks ]
    % of glucose values at goal during the study period

  3. % Change in Hemoglobin A1C [ Time Frame: Once prior to exiting the study, up to 42 weeks ]
    % of change in values of HbA1C during the study period

  4. Clinic visits [ Time Frame: through study completion, up to 42 weeks ]
    Number of clinic visits during the study period

  5. Unscheduled health care access episodes [ Time Frame: through study completion, up to 42 weeks ]
    Number of unanticipated or unscheduled health care visits during the study period



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Patients must be pregnant to be enrolled in this study
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504592


Contacts
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Contact: Heather Link, MD/MPH 585-275-7480 heather_link@urmc.rochester.edu
Contact: Lisa Gray, MD 585-275-7480 lisa_gray@urmc.rochester.edu

Locations
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United States, New York
UR Medicine Obstetrics and Gynecology Recruiting
Rochester, New York, United States, 14620
Contact: Heather Link, MD/MPH    585-273-3608    Heather_Link@URMC.rochester.edu   
Contact: Lisa Gray, MD    585-275-7408    Lisa_Gray@URMC.rochester.edu   
Sponsors and Collaborators
University of Rochester

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Responsible Party: University of Rochester
ClinicalTrials.gov Identifier: NCT03504592     History of Changes
Other Study ID Numbers: RSRB00068149
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications