Mobile App for Gestational Diabetes

Overseen By Carolyn M Zahler-Miller, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Carolyn Zahler-Miller

Disqualifiers: Type 1 diabetes, Non-English, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile app can help pregnant women with diabetes manage their blood sugar more effectively than traditional paper logs. Participants will track their blood sugar levels using either the OneTouch Reveal app, a mobile application for diabetes management, or paper logs. The trial seeks pregnant women who are at least 12 weeks along and have been diagnosed with type 2 or gestational diabetes. As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance diabetes management for pregnant women.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the OneTouch Reveal application is safe for monitoring blood sugar in pregnant women with diabetes?

Research shows that the OneTouch Reveal app helps track blood sugar levels and insulin doses. Healthcare professionals and people with diabetes use this app to monitor glucose data. Studies have found that apps like this are generally safe and improve diabetes management.

No reports of negative effects from using the OneTouch Reveal app suggest that users tolerate it well. The app primarily logs and shares blood sugar readings, aiding in the management of gestational diabetes. Overall, the app appears to be a safe tool for tracking blood sugar levels. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of the OneTouch Reveal mobile app for managing gestational diabetes because it offers a modern twist on tracking blood glucose levels. Unlike the traditional method of recording glucose readings on paper logs, this app allows patients to input their data digitally, making it easier to track and manage their health. The app could improve patient engagement by providing immediate feedback and potentially more accurate, real-time data analysis. This convenience and potential for better data accuracy are what make this approach stand out from the standard paper-based logging method.

What evidence suggests that the OneTouch Reveal app is effective for monitoring blood sugar in pregnant women with diabetes?

Research has shown that the OneTouch Reveal app, available to participants in this trial, can aid in managing gestational diabetes. One study found that the app simplifies blood sugar control by enabling users to track their glucose levels. By connecting with glucose meters, the app helps users identify patterns in their blood sugar, leading to better management. Other studies have also found that people using the app experienced improved A1C levels, a measure of average blood sugar. These findings suggest that the app can help maintain blood sugar control during pregnancy. ^{3 6 7 8 9}

Who Is on the Research Team?

Rebecca Keipper, MD

Principal Investigator

Augusta University

Are You a Good Fit for This Trial?

This trial is for pregnant women who are at least 12 weeks along, with a confirmed intrauterine pregnancy, aged 18 or older. Participants must be diagnosed with either type 2 diabetes mellitus or gestational diabetes.

Inclusion Criteria

You are at least 12 weeks pregnant.

You have been confirmed to be pregnant within the uterus.

I have been diagnosed with type 2 or gestational diabetes.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants record their daily blood glucose levels using either a mobile app or paper logs for comparison of compliance

4 weeks

Regular clinic visits for monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• OneTouch Reveal application

Trial Overview The study is examining the impact of using the OneTouch Reveal mobile app versus traditional paper logs to track blood sugar levels in pregnant women with diabetes and how it affects their compliance and control over blood sugar.

How Is the Trial Designed?

Group I: Mobile App arm Experimental Treatment 1 Intervention

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

Group II: Paper Log Arm Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Carolyn Zahler-Miller

Lead Sponsor

Trials

1

Recruited

40+

Published Research Related to This Trial

Identifying and managing Gestational Diabetes Mellitus (GDM) through tight blood glucose control is crucial for reducing risks to both mothers and newborns, as highlighted by the review of clinical studies.

Mobile phone applications like MobiGuide, Pregnant+, and GDm-Health have been shown to enhance patient care and self-management for GDM, improving compliance with blood glucose monitoring and treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile Phone Applications for Gestational Diabetes Mellitus: Appraisal and Perspectives. Nikolopoulos, M., Karampela, I., Antonakos, G., et al.[2019]

The smartphone-based NET-Health application for monitoring blood glucose levels in women with gestational diabetes showed high patient satisfaction and did not negatively impact maternal or neonatal outcomes when compared to historical controls.

This intervention also led to a significant reduction in healthcare resource utilization, saving approximately AUD$68 per woman in clinician time, indicating a potential financial benefit of using this technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of a smartphone-based, interactive blood glucose management system in women with gestational diabetes mellitus: A pilot study. Poulter, SE., Meloncelli, N., Mack, M.[2022]

The M♡THer mHealth platform, designed for managing gestational diabetes mellitus (GDM), was well-received by both clinicians and patients, indicating high satisfaction and ease of use among the 40 participants involved in the study.

Using the M♡THer app led to increased blood glucose monitoring and more antenatal contacts compared to a historical sample, suggesting it effectively enhances care coordination for women with GDM, especially during the challenges posed by the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

M♡THer, an mHealth System to Support Women with Gestational Diabetes Mellitus: Feasibility and Acceptability Study. Varnfield, M., Redd, C., Stoney, RM., et al.[2021]

Remote monitoring technologies, including various glucometers and mobile applications, have been shown to improve glycemic control in pregnant women with gestational diabetes mellitus (GDM), leading to lower postprandial glucose levels compared to control groups.

The use of these technologies not only enhances maternal confidence and satisfaction but also optimizes healthcare team efficiency, suggesting a promising approach to managing GDM and reducing associated risks during pregnancy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Remote Monitoring Technologies for Assisting Patients With Gestational Diabetes Mellitus: A Systematic Review. Bertini, A., Gárate, B., Pardo, F., et al.[2022]

Women with gestational diabetes mellitus (GDM) reported that using the Pregnant+ smartphone app helped increase their confidence and motivation in managing their blood glucose levels, driven by their desire to care for their unborn babies.

Despite the app's benefits, some women experienced frustration and faced technological issues, highlighting the need for better support from healthcare professionals to enhance the effectiveness of mobile health technologies in managing GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Women's experiences with using a smartphone app (the Pregnant+ app) to manage gestational diabetes mellitus in a randomised controlled trial. Skar, JB., Garnweidner-Holme, LM., Lukasse, M., et al.[2018]

A review identified 11 mobile health (mHealth) apps for managing gestational diabetes (GDM), but only 3 were sufficiently developed, with just one currently used in clinical practice.

Most apps provided useful feedback for patient self-care but failed to cover the entire GDM clinical pathway from diagnosis to postpartum, highlighting a need for more comprehensive and AI-integrated solutions to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth apps for gestational diabetes mellitus that provide clinical decision support or artificial intelligence: A scoping review. Daley, BJ., Ni'Man, M., Neves, MR., et al.[2022]

Pregnant women at high risk for gestational diabetes mellitus (GDM) expressed a strong desire for user-friendly mobile health apps that offer personalized features, accurate information, and interactive designs to help prevent GDM.

The study identified key app functionalities that could support healthy living habits, including professional and peer support, practical tools, and effective reminder systems, which are essential for improving user engagement and app effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the Views and Needs of People at High Risk of Gestational Diabetes Mellitus for the Development of Mobile Health Apps: Descriptive Qualitative Study. Duan, B., Liu, Z., Liu, W., et al.[2022]

The review analyzed 11 studies involving smartphone applications for managing gestational diabetes mellitus (GDM), highlighting their potential to improve patient care and compliance in blood glucose monitoring.

Mobile apps like MobiGuide, pregnant +, and GDm health offer personalized health services that can enhance the management of GDM, ultimately benefiting both mothers and infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application of Mobile Technology for Disease and Treatment Monitoring of Gestational Diabetes Mellitus Among Pregnant Women: A Systematic Review. Garg, N., Arunan, SK., Arora, S., et al.[2022]

Mobile health applications (mHealth-Apps) have the potential to improve glycemic control in women with gestational diabetes mellitus (GDM), as indicated by trends in fasting and postprandial blood glucose levels in a review of 6 studies involving 813 participants.

The use of mHealth-Apps was associated with more vaginal deliveries and fewer emergency caesarean sections, suggesting that these tools may positively influence delivery outcomes for mothers with GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectivness of specific mobile health applications (mHealth-apps) in gestational diabtetes mellitus: a systematic review. Eberle, C., Loehnert, M., Stichling, S.[2022]

A mobile application was successfully used to provide nutritional intervention for patients with gestational diabetes mellitus (GDM), helping to control carbohydrate intake.

The intervention led to improvements in blood glucose levels among GDM patients, highlighting the effectiveness of mobile healthcare services in managing this condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a Mobile-based Nutritional Intervention Application Improves Glycemic Control but Reduces the Intake of Some Nutrients in Patients with Gestational Diabetes Mellitus: A Case Series Study. Seo, Y., Kim, EM., Choi, JS., et al.[2020]

This study is a randomized controlled trial involving 200 pregnant women with gestational diabetes, aiming to assess the impact of the eMOM GDM mobile app on glucose levels and other maternal and neonatal outcomes.

The intervention group will use the app alongside standard care, tracking glucose and activity, with the primary outcome being the change in fasting plasma glucose from baseline to gestational weeks 35-37, which could provide insights into effective management of GDM.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive self-tracking of blood glucose and lifestyle with a mobile application in the management of gestational diabetes: a study protocol for a randomised controlled trial (eMOM GDM study). Kytö, M., Markussen, LT., Marttinen, P., et al.[2022]

Gestational diabetes affects up to 18% of pregnant women and can lead to serious complications if blood glucose levels are not managed properly, highlighting the need for effective monitoring and control.

The BabySTEPS portal aims to improve glucose management in pregnant women by providing personalized feedback and electronic access to their health data, potentially reducing complications during delivery and long-term health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

BabySTEPS: a sugar tracking electronic portal system for gestational diabetes. Arnold, CW., Nguyen, T., Janzen, C.[2013]

Citations

1. hrb.ie hrb.ie/grant-approved/the-clinical-efficacy-of-the-onetouch-app-in-patients-with-gestational-diabetes/

The clinical efficacy of the OneTouch app in patients with ... This study seeks to appraise the clinical effectiveness of the OneTouch application in the management of diabetes during pregnancy.

2. explorationpub.com explorationpub.com/Journals/eemd/Article/101414

Glycemic trends, app engagement and achievement of ... We evaluated glycemic trends and guideline-recommended glycemic targets achieved in PwGDM using a diabetes app with a family of Bluetooth ® connected BGMs.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10065322/

Efficacy of a glucose meter connected to a mobile app on ... The OneTouch Reveal app used in the present study improved both A1C levels and DSMP scores in patients with T1DM or LADA compared with standard treatment (CSII) ...

4. withpower.com withpower.com/trial/mobile-app-for-gestational-diabetes-95263

Mobile App for Gestational Diabetes The OneTouch Reveal app is unique because it uses mobile technology to help manage gestational diabetes by providing personalized health care services, ...

5. adces.org adces.org/education/danatech/apps-dtx/find-apps-tools/product-detail/onetouch-reveal-mobile-and-web-app

Diabetes Apps & Digital Therapeutics l OneTouch Reveal ... The OneTouch Reveal smartphone app logs blood glucose readings from compatible OneTouch meters. Users can review glucose data in the app and easily share it ...

6. onetouch.com onetouch.com/sites/onetouch_us/files/2022-10/usermanualprofessional-en-us.pdf

OneTouch Reveal® Web Application User Manual for ... The application is designed to assist healthcare professionals and people with diabetes track glucose levels and insulin doses. The OneTouch Reveal® web ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2405844023097128

Efficacy and safety of a telemedicine system in subjects ... This study aimed to evaluate the efficacy of telemedicine in GDM patients, focusing on patient satisfaction and health economic indicators.

8. clinicaltrials.gov clinicaltrials.gov/study/NCT06005987

Mobile App Logging for Diabetes in Pregnancy Also called a data safety and monitoring board, or DSMB. ... The second arm will log their blood glucoses with the OneTouch Reveal smart phone application.

9. onetouch.com onetouch.com/about-diabetes/starting-your-journey/gestational-diabetes

Gestational Diabetes | Getting Started | OneTouch® Risks associated with gestational diabetes include: An increased chance of delivering a large baby weighing 9 pounds (4 kg) or more, a condition known as ...