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Malama App for Gestational Diabetes

N/A

Recruiting

Led By Erika Werner, MD, MS

Research Sponsored by Tufts Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

>= 18 years of age

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial tests a smartphone app to improve antenatal glucose control to reduce postpartum glucose intolerance & long-term diabetes risk in women with GDM.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Since this intervention involves using an app rather than medication or medical procedures, there are no direct side effects associated with its use. However, participants may experience stress or anxiety related to monitoring their health through the app.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Interventional procedure

Secondary outcome measures

Glycosylated hemoglobin A

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Malama ArmExperimental Treatment1 Intervention

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

Group II: ControlActive Control1 Intervention

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

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor

256 Previous Clinical Trials

255,707 Total Patients Enrolled

Alyssa Trochtenberg, MDStudy DirectorTufts Medical Center

Sebastian Z Ramos, MDStudy DirectorTufts Medical Center

1 Previous Clinical Trials

156 Total Patients Enrolled

Media Library

Malama App Clinical Trial Eligibility Overview. Trial Name: NCT05597943 — N/A

Gestational Diabetes Research Study Groups: Malama Arm, Control

Gestational Diabetes Clinical Trial 2023: Malama App Highlights & Side Effects. Trial Name: NCT05597943 — N/A

Malama App 2023 Treatment Timeline for Medical Study. Trial Name: NCT05597943 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the opportunity to participate in this research endeavor still available for individuals?

"Based on the information available, it appears this clinical trial is not actively enrolling at this juncture. It was posted to ClinicalTrials.gov on December 1st 2022 and last updated October 25th 2022; however, there are currently 409 other trials that require potential participants."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM

2023. "mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05597943.