mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM
Primary Purpose
Gestational Diabetes, PreDiabetes, Pregnancy Related
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Malama App
Sponsored by
About this trial
This is an interventional prevention trial for Gestational Diabetes
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Tufts Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Malama Arm
Control
Arm Description
Participants enrolled in this arm will agree to using the Malama app to track glycemic management.
Participants enrolled in this arm agree to standard management (FS log on phone, notebook, etc)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Postpartum hemoglobin A1c level
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05597943
Brief Title
mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM
Official Title
Randomized Control Trial to Investigate the Effect of a Smartphone Application for Gestational Diabetes Management on Postpartum Glucose Intolerance
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 1, 2023 (Actual)
Primary Completion Date
November 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes, PreDiabetes, Pregnancy Related, Pregnancy, High Risk
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Malama Arm
Arm Type
Experimental
Arm Description
Participants enrolled in this arm will agree to using the Malama app to track glycemic management.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants enrolled in this arm agree to standard management (FS log on phone, notebook, etc)
Intervention Type
Behavioral
Intervention Name(s)
Malama App
Intervention Description
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.
Primary Outcome Measure Information:
Title
Malama app as intervention
Description
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.
Time Frame
8-26 weeks
Secondary Outcome Measure Information:
Title
Postpartum hemoglobin A1c level
Description
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).
Time Frame
6 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alysa St. Charles, MA
Phone
617-636-9897
Email
astcharles1@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name or Official Title & Degree
Sebastian Z Ramos, MD
Email
sebastian.ramos@tuftsmedicine.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sebastian Z Ramos, MD
Organizational Affiliation
Tufts Medical Center
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Erika Werner, MD, MS
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alysa St. Charles, MA
Phone
617-636-9897
Email
astcharles1@tuftsmedicalcenter.org
First Name & Middle Initial & Last Name & Degree
Alyssa Trochtenberg, MD
First Name & Middle Initial & Last Name & Degree
Erika Werner, MD, MS
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
mHealth Smartphone App and Postpartum Glucose Intolerance for Patients With GDM
We'll reach out to this number within 24 hrs