Mobile App Logging for Diabetes in Pregnancy

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06005987
• Other study ID #: 1992519
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: August 2023
• Source: Augusta University
• Contact: Rebecca Keipper, MD
• Phone: 7067212541
• Email: rkeipper[@]augusta.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational
• Gestational Diabetes Mellitus in Pregnancy
• Pregnancy in Diabetics
• Type 2 Diabetes

Intervention

Behavioral:
• OneTouch Reveal application
Evaluate if compliance with glucose logging and percentage of in range glucoses changes with use of a mobile application instead of paper logging

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Carolyn Zahler-Miller

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compliance	percentage of actual blood glucose values logged compared to expected.	4 weeks
Secondary	Percentage of in-range blood glucose levels	Percentage of blood glucose levels in pregnancy appropriate range out of total blood glucose levels logged.	4 weeks