Gestational DiabetesNCT03026218
Group and Mobile Care for Gestational Diabetes
A study testing GlucoseMama application with blood sugar monitoring and carb monitoring. and Group prenatal care for GDM. in people with Gestational Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
A critical variation in the provision of prenatal care to women with GDM is the need to keep patients engaged with their care between visits by tracking glucose levels using finger sticks and making dietary and other lifestyle modifications to keep these levels at or close to normal. Read more about this study
- Who is it for?
- Ages 18 to 51 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- GlucoseMama application with blood sugar monitoring and carb monitoring. and Group prenatal care for GDM.
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2017to 15 May 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 51 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Gestational Diabetes
- Planning on delivering at home institution
Who cannot join
- Unwilling to participate.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
A critical variation in the provision of prenatal care to women with GDM is the need to keep patients engaged with their care between visits by tracking glucose levels using finger sticks and making dietary and other lifestyle modifications to keep these levels at or close to normal. Multiple studies have demonstrated that the use of mobile devices can improve medical outcomes. In order to keep patients engaged between appointments and improve self-care/lifestyle, we will study the use of a glucose monitoring system with nutrition therapy called GlucoseMama(GM). GM is a mobile app on the iOS system that individuals with GDM will use to tract blood sugars and number of carbs consumed. In addition, it will give the user positive feedback and rewards for using the system. This model of group care with mobile phone monitoring and reminders for women with GDM has not been previously studied. A randomized control trial is purposed to determine if this approach improves patient care. The investigators hypothesize that group prenatal care along with inter-session mobile therapy will increase dietary compliance and therefore reduce the number of individuals requiring pharmacologic therapy and improve neonatal outcomes during pregnancy. Group prenatal care (GPC) will provide a community foundation to improve learning and increase the motivation of patients to learn and change. This motivation will be further strengthened by the use of the GlucoseMama monitoring system which will provide each patient with glucose tracking and individualized nutritional support.
- Conditions
- Gestational Diabetes
- Being tested
- GlucoseMama application with blood sugar monitoring and carb monitoring., Group prenatal care for GDM.
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucoseMama application with blood sugar monitoring and carb monitoring.Other
We will use the Glucosemama application to review glucose and carb logs on a weekly basis. This will be reviewed with the patient in order to adjust dietary and medicals.
Group prenatal care for GDM.Other
group prenatal care is a group based intervention where individuals with GDM will meet together to learn about pregnancy and diabetes.
| Study group | Role | What they receive |
|---|---|---|
| Group and Glucose Mama | Experimental | Enrolled subjects with have GlucoseMama application and group care. Receives: Other: GlucoseMama application with blood sugar monitoring and carb monitoring.; Other: Group prenatal care for GDM. |
| Group and No Glucose Mama | Placebo comparator | Enrolled participants will be enrolled in group care but will not have access to GlucoseMama application. Receives: Other: Group prenatal care for GDM. |
| Traditional and glucoseMama | Experimental | Enrolled subjects will have traditional care and glucoseMama Receives: Other: GlucoseMama application with blood sugar monitoring and carb monitoring. |
| Traditional and no GlucoseMama | No intervention | enrolled subjects will not have access to group care or GlucoseMama. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes
Measured: 2 years
Secondary outcomes (3)
Reduction in the number of neonates born large for gestational age.
Measured: 2 years
Increased number of individuals who are screened in the postpartum period for type 2 diabetes.
Measured: 2 years
Reduction in the number of infants with neonatal hypoglycemia.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2017 (estimated)
- Study start15 Apr 2017
- Primary completion15 Oct 2018
- Study completion15 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Crimmins, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03026218
- Sponsor's protocol ID
- HP-00071275
- Status last verified
- Mar 2022
- First submitted
- 11 Jan 2017
- Last updated
- 22 Mar 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group and Mobile Care for Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03026218
- Acronym / sponsor ID
- HP-00071275
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 15 Apr 2017 (actual)
- Primary completion
- 15 Oct 2018 (actual)
- Study completion
- 15 May 2019 (actual)
- First posted
- 20 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A critical variation in the provision of prenatal care to women with GDM is the need to keep patients engaged with their care between visits by tracking glucose levels using finger sticks and making dietary and other lifestyle modifications to keep these levels at or close to normal. Multiple studies have demonstrated that the use of mobile devices can improve medical outcomes. In order to keep patients engaged between appointments and improve self-care/lifestyle, we will study the use of a glucose monitoring system with nutrition therapy called GlucoseMama(GM). GM is a mobile app on the iOS system that individuals with GDM will use to tract blood sugars and number of carbs consumed. In addition, it will give the user positive feedback and rewards for using the system. This model of group care with mobile phone monitoring and reminders for women with GDM has not been previously studied. A randomized control trial is purposed to determine if this approach improves patient care. The investigators hypothesize that group prenatal care along with inter-session mobile therapy will increase dietary compliance and therefore reduce the number of individuals requiring pharmacologic therapy and improve neonatal outcomes during pregnancy. Group prenatal care (GPC) will provide a community foundation to improve learning and increase the motivation of patients to learn and change. This motivation will be further strengthened by the use of the GlucoseMama monitoring system which will provide each patient with glucose tracking and individualized nutritional support.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group and Glucose Mama | Experimental | Other: GlucoseMama application with blood sugar monitoring and carb monitoring., Other: Group prenatal care for GDM.Enrolled subjects with have GlucoseMama application and group care. |
| Group and No Glucose Mama | Placebo comparator | Other: Group prenatal care for GDM.Enrolled participants will be enrolled in group care but will not have access to GlucoseMama application. |
| Traditional and glucoseMama | Experimental | Other: GlucoseMama application with blood sugar monitoring and carb monitoring.Enrolled subjects will have traditional care and glucoseMama |
| Traditional and no GlucoseMama | No intervention | –enrolled subjects will not have access to group care or GlucoseMama. |
Who may qualify
- Ages
- 18 to 51 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Diagnosis of Gestational Diabetes
- Planning on delivering at home institution
Key exclusion criteria (1 listed)
- Unwilling to participate.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GlucoseMama application with blood sugar monitoring and carb monitoring.We will use the Glucosemama application to review glucose and carb logs on a weekly basis. This will be reviewed with the patient in order to adjust dietary and medicals. | Other | Group and Glucose Mama, Traditional and glucoseMama |
| Group prenatal care for GDM.group prenatal care is a group based intervention where individuals with GDM will meet together to learn about pregnancy and diabetes. | Other | Group and Glucose Mama, Group and No Glucose Mama |
Primary outcome
Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes
Time frame: 2 years
3 secondary outcomes
Reduction in the number of neonates born large for gestational age.
Time frame: 2 years
Increased number of individuals who are screened in the postpartum period for type 2 diabetes.
Time frame: 2 years
Reduction in the number of infants with neonatal hypoglycemia.
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GlucoseMama application with blood sugar monitoring and carb monitoring. and Group prenatal care for GDM. in people with Gestational Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in the number of individuals requiring pharmacotherapy for treatment of gestational diabetes (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022; AzTrials last refreshed its copy on 1 Nov 2026.