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mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM

NCT05597943 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-04-23

No results posted yet for this study

Summary

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.

Conditions

  • Gestational Diabetes
  • PreDiabetes
  • Pregnancy Related
  • Pregnancy, High Risk

Interventions

BEHAVIORAL

Malama App

The Malama smartphone application is a gestational diabetes management app that syncs directly with commercially-available glucometers via Bluetooth, enabling both automatic blood glucose logging and providing interactive diet management/diet education tools. We aim to perform a pilot study assessing the impact of the Malama smartphone application on perinatal and postpartum outcomes in patients with GDM.

Sponsors & Collaborators

  • Tufts Medical Center

    lead OTHER

Principal Investigators

  • Sebastian Z Ramos, MD · Tufts Medical Center

  • Erika Werner, MD, MS · Tufts Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2025-02-01
Completion
2025-02-01

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05597943 on ClinicalTrials.gov