Mobile App Logging for Diabetes in Pregnancy

Carolyn Zahler-Miller

Status: Enrolling

Conditions: Gestational Diabetes Mellitus in Pregnancy; Type 2 Diabetes

Treatments: Behavioral: OneTouch Reveal application

Study type: Interventional

Funder types: Other

Identifiers

NCT06005987

1992519

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Mobile App arm

Experimental group

Description:

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

Treatment:

Behavioral: OneTouch Reveal application

Paper Log Arm

No Intervention group

Description:

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