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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
Must not have
Unable to tolerate oral glucose tolerance test (i.e. history of gastric bypass surgery)
Diagnosis of pregestational diabetes
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

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.
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.
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
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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I cannot undergo an oral glucose tolerance test due to past gastric bypass surgery.
Select...
I was diagnosed with diabetes before becoming pregnant.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Interventional procedure
Secondary study objectives
Glycosylated hemoglobin A

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

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)

Find a Location

Who is running the clinical trial?

Tufts Medical CenterLead Sponsor
263 Previous Clinical Trials
264,308 Total Patients Enrolled
Alyssa Trochtenberg, MDStudy DirectorTufts Medical Center
Sebastian Z Ramos, MDStudy DirectorTufts Medical Center
1 Previous Clinical Trials
156 Total Patients Enrolled
Erika Werner, MD, MSPrincipal InvestigatorTufts Medical Center

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
~0 spots leftby Jan 2025
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