Mobile App Logging for Diabetes in Pregnancy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes; Gestational Diabetes Mellitus in Pregnancy
• Intervention / Treatment: Behavioral: OneTouch Reveal application

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rebecca Keipper, MD; Phone Number: 7067212541; Email: rkeipper@augusta.edu
• Study Contact Backup: Name: Carolyn M Zahler-Miller, MD; Phone Number: 7067212543; Email: czahlermiller@augusta.edu

Study Locations

• United States
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Recruiting
      • Augusta University
      • Contact: Carolyn M Zahler-Miller; Phone Number: 706-721-2542; Email: czahlermiller@augusta.edu
      • Contact: Rebecca Keipper; Phone Number: 7067212541; Email: rkeipper@augusta.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile App arm; Patient will input their daily blood glucose levels (fasting and 2 hours after breakfast, lunch and dinner) into the OneTouch Reveal app	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
No Intervention: Paper Log Arm; Patients will input their daily blood glucose levels onto paper logs which is the current process in the prenatal clinic.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance	percentage of actual blood glucose values logged compared to expected.	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Carolyn Zahler-Miller
• Investigators: Principal Investigator: Rebecca Keipper, MD, Augusta University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: August 16, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 23, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 29, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: mobile applications; diabetes in pregnancy; technology in medicine; blood glucose monitoring
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes, Gestational; Diabetes Mellitus; Pregnancy in Diabetics
• Other Study ID Numbers: 1992519

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After study completion and for 2 years afterwards
• IPD Sharing Access Criteria: contact study PI
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No