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Completed

NCT Number: NCT03504592

Smartphone Utilization for Glucose Monitoring and Antenatal Reporting

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.

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Key information

Conditions

Gestational Diabetes Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pregestational Diabetes Pregnancy Complications Urogenital Diseases

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UR Medicine Obstetrics and Gynecology

Rochester, New York, 14620, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Completion of Glucose logs

Behavioral

Glucose logs will be assessed by provider for completeness and accuracy

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

Utilizing mHealth to Improve Diabetes in an Obstetric Population

Acronym: SUGAR

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Apr 20, 2018
Registry last updated
Feb 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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