Mobile App Logging for Diabetes in Pregnancy

Not Applicable

Recruiting

• Conditions: Type 2 Diabetes; Gestational Diabetes Mellitus in Pregnancy

• Registration Number: NCT06005987
• Lead Sponsor: Carolyn Zahler-Miller

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.

Study Timeline

• Study First Submitted: 2023-08-16
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-23
• Study Start: 2024-06-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-29
• Last Update Posted: 2025-01-31
• Primary Completion: 2027-01-01
• Study Completion: 2027-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Compliance	4 weeks	percentage of actual blood glucose values logged compared to expected.

Secondary Outcome Measures

Name	Time	Method
Percentage of in-range blood glucose levels	4 weeks	Percentage of blood glucose levels in pregnancy appropriate range out of total blood glucose levels logged.

Trial Locations

Locations (1)

Augusta University; 🇺🇸 Augusta, Georgia, United States