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Mobile App Logging for Diabetes in Pregnancy

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy, Type 2 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
OneTouch Reveal application
Sponsored by
Carolyn Zahler-Miller
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gestational Diabetes Mellitus in Pregnancy focused on measuring technology in medicine, mobile applications, blood glucose monitoring, diabetes in pregnancy

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 18 years and older Verified intrauterine pregnancy At least 12 weeks gestation Diagnosed with either type 2 diabetes mellitus or gestational diabetes mellitus. Exclusion Criteria: Patients with less than 4 weeks anticipated to be remaining in pregnancy Pre-existing use of a continuous glucose monitor or other mobile application for glucose tracking Type 1 diabetes mellitus Non-English speaking patients

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Mobile App arm

    Paper Log Arm

    Arm Description

    Patient will input their daily blood glucose levels (fasting and 2 hours after breakfast, lunch and dinner) into the OneTouch Reveal app

    Patients will input their daily blood glucose levels onto paper logs which is the current process in the prenatal clinic.

    Outcomes

    Primary Outcome Measures

    Compliance
    percentage of actual blood glucose values logged compared to expected.

    Secondary Outcome Measures

    Percentage of in-range blood glucose levels
    Percentage of blood glucose levels in pregnancy appropriate range out of total blood glucose levels logged.

    Full Information

    First Posted
    August 16, 2023
    Last Updated
    August 16, 2023
    Sponsor
    Carolyn Zahler-Miller
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06005987
    Brief Title
    Mobile App Logging for Diabetes in Pregnancy
    Official Title
    Effect of a Mobile Application on Blood Sugar Testing Compliance in Pregnant Women With Diabetes
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    November 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2024 (Anticipated)
    Study Completion Date
    July 1, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Carolyn Zahler-Miller

    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
    To determine the effect of using a mobile app versus paper logs on compliance and percentage in range blood sugars in monitoring blood sugar in pregnant women with diabetes.
    Detailed Description
    Women with type 2 and gestational diabetes have to keep strict logs of their blood sugar and record blood sugar values 4 times per day (fasting and 2 hours after every meal). This is often the first time they've had to keep such strict logs. Patients are provided with paper logs to record their blood sugars, however these can be lost or damaged and often they are not brought back to clinic. Mobile apps can be used to record blood sugar as well. This study will be comparing compliance with recording blood sugar values as prescribed with paper logs versus a mobile app. Subjects will be recruited from the Augusta University downtown location obstetric clinics. Qualifying subjects must be at least 18 years of age with a verified intrauterine pregnancy of at least 12 weeks gestation and must have preexisting type 2 diabetes or gestational diabetes diagnosed by 1h glucose tolerance test (GTT) > 200mg/dL or 3h GTT with 2 or more abnormal values. Exclusion criteria includes patients with less than 2 weeks expected to be remaining in pregnancy, Preexisting use of a continuous glucose monitor (CGM) or application to track blood sugar readings, and type 1 diabetes.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Gestational Diabetes Mellitus in Pregnancy, Type 2 Diabetes
    Keywords
    technology in medicine, mobile applications, blood glucose monitoring, diabetes in pregnancy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Patients will be randomized to two arms. First is traditional logging of blood glucoses with standard paper form in the clinic. The second arm will log their blood glucoses with the OneTouch Reveal smart phone application.
    Masking
    Outcomes Assessor
    Masking Description
    Cannot mask participant who needs to use the mobile application, or their care provider, or the investigator who will need to teach the patient how to use the application.
    Allocation
    Randomized
    Enrollment
    40 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Mobile App arm
    Arm Type
    Experimental
    Arm Description
    Patient will input their daily blood glucose levels (fasting and 2 hours after breakfast, lunch and dinner) into the OneTouch Reveal app
    Arm Title
    Paper Log Arm
    Arm Type
    No Intervention
    Arm Description
    Patients will input their daily blood glucose levels onto paper logs which is the current process in the prenatal clinic.
    Intervention Type
    Behavioral
    Intervention Name(s)
    OneTouch Reveal application
    Intervention Description
    Evaluate if compliance with glucose logging and percentage of in range glucoses changes with use of a mobile application instead of paper logging
    Primary Outcome Measure Information:
    Title
    Compliance
    Description
    percentage of actual blood glucose values logged compared to expected.
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    Percentage of in-range blood glucose levels
    Description
    Percentage of blood glucose levels in pregnancy appropriate range out of total blood glucose levels logged.
    Time Frame
    4 weeks

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Gender Eligibility Description
    Patients must be pregnant.
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    100 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 18 years and older Verified intrauterine pregnancy At least 12 weeks gestation Diagnosed with either type 2 diabetes mellitus or gestational diabetes mellitus. Exclusion Criteria: Patients with less than 4 weeks anticipated to be remaining in pregnancy Pre-existing use of a continuous glucose monitor or other mobile application for glucose tracking Type 1 diabetes mellitus Non-English speaking patients
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Rebecca Keipper, MD
    Phone
    7067212541
    Email
    rkeipper@augusta.edu
    First Name & Middle Initial & Last Name or Official Title & Degree
    Carolyn M Zahler-Miller, MD
    Phone
    7067212543
    Email
    czahlermiller@augusta.edu
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rebecca Keipper, MD
    Organizational Affiliation
    Augusta University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes
    IPD Sharing Time Frame
    After study completion and for 2 years afterwards
    IPD Sharing Access Criteria
    contact study PI

    Learn more about this trial

    Mobile App Logging for Diabetes in Pregnancy

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