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NCT Number: NCT06005987

Mobile App Logging for Diabetes in Pregnancy

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year–100 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

OneTouch Reveal application

Behavioral

Evaluate if compliance with glucose logging and percentage of in range glucoses changes with use of a mobile application instead of paper logging

Primary outcomes

  1. Compliance

    Time frame: 4 weeks

    percentage of actual blood glucose values logged compared to expected.

Secondary outcomes

  1. Percentage of in-range blood glucose levels

    Time frame: 4 weeks

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

Study contacts

Contact information is provided by the study sponsor or research team.

Carolyn M Zahler-Miller, MD

CONTACT

[email protected]

7067212543

Rebecca Keipper, MD

CONTACT

[email protected]

7067212541

Sponsors and collaborators

Lead sponsor

Carolyn Zahler-Miller

Other

Registry information

Official study title

Effect of a Mobile Application on Blood Sugar Testing Compliance in Pregnant Women With Diabetes

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 23, 2023
Registry last updated
Jan 31, 2025

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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