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Clinical Trials/NCT06005987
NCT06005987
Recruiting
Not Applicable

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

Carolyn Zahler-Miller1 site in 1 country40 target enrollmentJune 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Gestational Diabetes Mellitus in Pregnancy
Sponsor
Carolyn Zahler-Miller
Enrollment
40
Locations
1
Primary Endpoint
Compliance
Status
Recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 1, 2024
End Date
January 1, 2027
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Carolyn Zahler-Miller
Responsible Party
Sponsor Investigator
Principal Investigator

Carolyn Zahler-Miller

Associate Professor

Augusta University

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

Outcomes

Primary Outcomes

Compliance

Time Frame: 4 weeks

percentage of actual blood glucose values logged compared to expected.

Secondary Outcomes

  • Percentage of in-range blood glucose levels(4 weeks)

Study Sites (1)

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