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mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM

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ClinicalTrials.gov Identifier: NCT05597943
Recruitment Status : Recruiting
First Posted : October 28, 2022
Last Update Posted : February 2, 2024
Sponsor:
Information provided by (Responsible Party):
Tufts Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gestational Diabetes PreDiabetes Pregnancy Related Pregnancy, High Risk Behavioral: Malama App Not Applicable

Detailed Description:

The effect of smartphone applications for gestational diabetes management on risk of postpartum glucose intolerance, antenatal glycemic control, and other perinatal outcomes is unknown.

This study is a randomized control trial in which patients diagnosed with gestational diabetes will be randomized to use of the Malama app vs. standard care as described above.

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.

Secondary outcomes that will be investigated include several markers of maternal and neonatal perinatal morbidity. Maternal outcomes that will be investigated include postpartum hemoglobin A1c level, interval pregnancy weight gain, incidence of hypertensive disorders of pregnancy, cesarean delivery, operative delivery, postpartum hemorrhage, and advanced perineal lacerations. Neonatal secondary outcomes include gestational age at delivery, birthweight and incidence of large for gestational age infants, shoulder dystocia, NICU admission, length of NICU stay, neonatal blood glucose nadir, and need for neonatal IV glucose support.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Randomized Control Trial to Investigate the Effect of a Smartphone Application for Gestational Diabetes Management on Postpartum Glucose Intolerance
Actual Study Start Date : May 1, 2023
Estimated Primary Completion Date : May 1, 2024
Estimated Study Completion Date : December 1, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Malama Arm
Participants enrolled in this arm will agree to using the Malama app to track glycemic management.
 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.
No Intervention: Control
Participants enrolled in this arm agree to standard management (FS log on phone, notebook, etc)


Outcome Measures
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Primary Outcome Measures :
  1. Malama app as intervention [ Time Frame: 8-26 weeks ]
    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.


Secondary Outcome Measures :
  1. Postpartum hemoglobin A1c level [ Time Frame: 6 months ]
    We will be measuring the postpartum A1c level to capture whether the mobile health app influences blood glucose levels based on glycemic control log method (app for intervention arm, pen-and-paper log for control).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pregnant women receiving prenatal, delivery, and postpartum care at Tufts Medical Center
  2. 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
  3. >= 18 years of age
  4. Literate in English or Spanish (?additional languages pending app translation)
  5. Access to or ownership of a smartphone compatible with Malama
  6. Willing and able to sign the informed consent

Exclusion Criteria:

  1. Unable to tolerate oral glucose tolerance test (i.e. history of gastric bypass surgery)
  2. Diagnosis of pregestational diabetes
  3. Prescribed medications for chronic disease that affect glucose metabolism (e.g., long term oral steroids)
  4. Does not own smartphone compatible with Malama application
  5. Severe life-limiting fetal anomaly
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05597943


Contacts
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Contact: Alysa St. Charles, MA 617-636-9897 astcharles1@tuftsmedicalcenter.org
Contact: Sebastian Z Ramos, MD sebastian.ramos@tuftsmedicine.org

Locations
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United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Alysa St. Charles, MA    617-636-9897    astcharles1@tuftsmedicalcenter.org   
Principal Investigator: Alyssa Trochtenberg, MD         
Sub-Investigator: Erika Werner, MD, MS         
Sponsors and Collaborators
Tufts Medical Center
Investigators
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Study Director: Sebastian Z Ramos, MD Tufts Medical Center
Principal Investigator: Erika Werner, MD, MS Tufts Medical Center
More Information
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Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT05597943    
Other Study ID Numbers: STUDY00003186
First Posted: October 28, 2022    Key Record Dates
Last Update Posted: February 2, 2024
Last Verified: January 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes, Gestational
Glucose Intolerance
Pregnancy Complications
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
 Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperglycemia