Malama App for Gestational Diabetes

Overseen By Sebastian Z Ramos, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Tufts Medical Center

Must not be taking: Oral steroids

Disqualifiers: Pregestational diabetes, Gastric bypass, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 8-26 weeks

30 Participants Needed

Trial Summary

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications, but you cannot participate if you are on medications for chronic diseases that affect glucose metabolism.

What data supports the idea that Malama App for Gestational Diabetes is an effective treatment?

The available research shows that mobile health apps, like the Malama App, can help manage gestational diabetes by improving blood sugar control. In a study comparing traditional management to mobile health management, the group using mobile health apps had a higher rate of blood sugar control. However, there were no significant differences in other pregnancy outcomes like birth weight or preterm birth. This suggests that while the Malama App can help with managing blood sugar levels, its impact on other pregnancy outcomes needs more research. ^{1 2 3 4 5}

What safety data exists for the Malama App for gestational diabetes?

The provided research does not mention specific safety data for the Malama App or its variants. It discusses the general benefits of mobile apps for gestational diabetes management, such as improved self-management and compliance, but does not provide safety evaluations for the Malama App specifically. ^{1 5 6 7 8}

Is the Malama App a promising treatment for gestational diabetes?

Yes, the Malama App is a promising treatment for gestational diabetes. Mobile health apps like Malama can help manage gestational diabetes by offering personalized health care, improving self-management, and encouraging regular blood glucose monitoring. They can also provide lifestyle and professional support, which can prevent or reduce the risk of gestational diabetes and related health issues. ^{1 2 5 8 9}

What is the purpose of this trial?

Without intervention, approximately 70% of women diagnosed with GDM will develop type 2 diabetes mellitus in their lifetime. Abnormal results of a 2 hour oral glucose tolerance test (OGTT) performed as early as 2 days postpartum are predictive of impaired glucose tolerance 1 year postpartum. The investigators hypothesize that use of the Malama smartphone application to optimize antenatal glycemic control will result in lower incidence of postpartum glucose intolerance, which may decrease long term risk of progression to diabetes mellitus.

Research Team

Sebastian Z Ramos, MD

Principal Investigator

Tufts Medical Center

Erika Werner, MD, MS

Principal Investigator

Tufts Medical Center

Eligibility Criteria

This trial is for pregnant women over 18 with gestational diabetes diagnosed between weeks 14 and 32 of pregnancy, who get care at Tufts Medical Center. They must read English or Spanish, have a smartphone that works with the Malama app, and be able to consent. It's not for those intolerant to glucose tests, without a compatible smartphone, with pregestational diabetes, on long-term steroids affecting glucose metabolism or carrying a fetus with severe anomalies.

Inclusion Criteria

Willing and able to sign the informed consent

Literate in English or Spanish (?additional languages pending app translation)

Access to or ownership of a smartphone compatible with Malama

Exclusion Criteria

I cannot undergo an oral glucose tolerance test due to past gastric bypass surgery.

I was diagnosed with diabetes before becoming pregnant.

I am on long-term medication that affects my blood sugar levels.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Malama app for gestational diabetes management or receive standard care

8-26 weeks

Regular app usage or standard care monitoring

Follow-up

Participants are monitored for postpartum glucose intolerance and other maternal and neonatal outcomes

6 months

Postpartum visits for outcome assessments

Treatment Details

Interventions

• Malama App

Trial Overview The trial is testing if the Malama smartphone app can help control blood sugar levels during pregnancy and reduce postpartum glucose intolerance in women who had gestational diabetes. This could potentially lower their risk of developing type 2 diabetes later on.

Participant Groups

Group I: Malama Arm Experimental Treatment 1 Intervention

Participants enrolled in this arm will agree to using the Malama app to track glycemic management.

Group II: Control Active Control 1 Intervention

Participants enrolled in this arm agree to standard management (FS log on phone, notebook, etc)

Malama App is already approved in United States for the following indications:

Approved in United States as Malama App for:

• Gestational Diabetes Management
• Postpartum Glucose Intolerance Prevention

Who Is Running the Clinical Trial?

Tufts Medical Center

Lead Sponsor

Trials

264

Recruited

264,000+

Findings from Research

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]

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 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]

In a study of 295 pregnant women with gestational diabetes, the use of a mobile health platform significantly improved glycemic control rates compared to traditional management (67.22% vs. 60.69%).

However, the mobile health intervention did not lead to significant differences in pregnancy outcomes such as low birth weight or preterm birth, indicating that while it helps manage blood sugar levels, its impact on overall pregnancy results needs further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of Mobile Health for Standardized Management on Women with Gestational Diabetes Mellitus]. Huang, FL., Hu, HY., Zhang, SH., et al.[2021]

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]

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]

This randomized controlled trial will involve 230 pregnant women with gestational diabetes mellitus (GDM) to assess whether using the Pregnant+ app alongside standard care improves blood glucose levels compared to standard care alone.

The main outcome will be glucose levels measured at a 2-hour oral glucose tolerance test (OGTT) three months postpartum, with secondary outcomes including changes in health behavior, quality of life, and maternal and child complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial. Borgen, I., Garnweidner-Holme, LM., Jacobsen, AF., et al.[2019]

A review of mobile applications for managing gestational diabetes mellitus (GDM) found that only five out of 102 identified apps were analyzed, indicating a limited selection available for users.

The highest-rated app, 'Pregnant with Diabetes', scored 3.10 out of 5 on the Mobile App Rating Scale (MARS), highlighting that while some apps exist, the overall quality of GDM management apps is generally poor and needs improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quality Evaluation of English Mobile Applications for Gestational Diabetes: App Review using Mobile Application Rating Scale (MARS). Kalhori, SRN., Hemmat, M., Noori, T., et al.[2021]

A review of 12 articles on mobile phone apps for managing gestational diabetes mellitus (GDM) found that these apps can offer personalized and cost-effective interventions, although research on their effectiveness is still limited.

Health literacy was considered in some app developments, highlighting the need for better integration of health literacy features to enhance user engagement and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Functionality, Implementation, Impact, and the Role of Health Literacy in Mobile Phone Apps for Gestational Diabetes: Scoping Review. Chen, Q., Carbone, ET.[2020]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Mobile Phone Applications for Gestational Diabetes Mellitus: Appraisal and Perspectives. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Effectivness of specific mobile health applications (mHealth-apps) in gestational diabtetes mellitus: a systematic review. [2022]

3. England pubmed.ncbi.nlm.nih.gov

mHealth apps for gestational diabetes mellitus that provide clinical decision support or artificial intelligence: A scoping review. [2022]

4. China pubmed.ncbi.nlm.nih.gov

[Effect of Mobile Health for Standardized Management on Women with Gestational Diabetes Mellitus]. [2021]

5. Canada 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. [2022]

6. Scotland 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. [2018]

7. England pubmed.ncbi.nlm.nih.gov

Smartphone application for women with gestational diabetes mellitus: a study protocol for a multicentre randomised controlled trial. [2019]

8. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Quality Evaluation of English Mobile Applications for Gestational Diabetes: App Review using Mobile Application Rating Scale (MARS). [2021]

9. Canada pubmed.ncbi.nlm.nih.gov

Functionality, Implementation, Impact, and the Role of Health Literacy in Mobile Phone Apps for Gestational Diabetes: Scoping Review. [2020]