mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM

NCT05597943 | Completed

• 1 other identifier: STUDY00003186
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Malama app as intervention

  The primary aim of the study is to investigate if the incidence of postpartum glucose intolerance is lower in patients using the Malama app for gestational diabetes management compared to patients receiving standard care.

  8-26 weeks

Secondary Outcomes (1)

• Postpartum hemoglobin A1c level

  6 months

Study Arms (2)

Malama Arm

EXPERIMENTAL

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

Behavioral: Malama App

Control

NO INTERVENTION

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

Interventions

Malama App BEHAVIORAL

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.

Malama Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women receiving prenatal, delivery, and postpartum care at Tufts Medical Center
• Gestational diabetes diagnosed between 14 0/7 and 31 6/7 weeks gestation on basis of 1-hour glucose challenge test result of \>=200 mg/dL or Carpenter-Coustan criteria
• \>= 18 years of age
• Literate in English or Spanish (?additional languages pending app translation)
• Access to or ownership of a smartphone compatible with Malama
• Willing and able to sign the informed consent

You may not qualify if:

• Unable to tolerate oral glucose tolerance test (i.e. history of gastric bypass surgery)
• Diagnosis of pregestational diabetes
• Prescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids)
• Does not own smartphone compatible with Malama application
• Severe life-limiting fetal anomaly

Sponsors & Collaborators

• Tufts Medical Center: lead

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

MeSH Terms

Conditions

Diabetes, Gestational; Prediabetic State

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Sebastian Z Ramos, MD

  Tufts Medical Center

  STUDY DIRECTOR

• Erika Werner, MD, MS

  Tufts Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 28, 2022
• Study Start: May 1, 2023
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: April 23, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)