Gestational DiabetesSUGARNCT03504592
Smartphone Utilization for Glucose Monitoring and Antenatal Reporting
A study testing Completion of Glucose logs in people with Gestational Diabetes and Pregestational Diabetes, run by University of Rochester at 1 site in United States.
Trial summary
This project will utilize MHealth technology to address the barriers providers and obstetric patients experience when reporting blood glucose results. Half of the participants will record their blood glucose values with the assistance of a smartphone device, the other half will continue in the traditional care method… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Gestational Diabetes, Pregestational Diabetes
- What is being tested?
- Completion of Glucose logs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2018to 31 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 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pregnant, English speaking, Diagnosed with diabetes during pregnancy or with known preexisting diabetes, has smartphone, sees URMC OBGYN for obstetric care in pregnancy.
Who cannot join
- Not English speaking, does not have smartphone, unable to consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
UR Medicine Obstetrics and Gynecology
Rochester, New York, 14620
About this study
Official title: Utilizing mHealth to Improve Diabetes in an Obstetric Population
This project will utilize MHealth technology to address the barriers providers and obstetric patients experience when reporting blood glucose results. Half of the participants will record their blood glucose values with the assistance of a smartphone device, the other half will continue in the traditional care method of the clinic.
Read the detailed description
This will be a prospective single center randomized trial piloting the use of mHealth applications in an obstetric population with diabetes. Participants will be enrolled in the study after the diagnosis of diabetes is made in pregnancy for those with gestational diabetes, or for patients with preexisting diabetes they will be enrolled upon initiation of prenatal care. Participants will be randomized to traditional care or mHealth intervention. Outcomes will include completeness and accuracy of the participant glucose log, unscheduled health care access episodes in the pregnancy, patient satisfaction, percentage of glucose values at goal and percent change in Hemoglobin A1C.
- Conditions
- Gestational Diabetes, Pregestational Diabetes
- Being tested
- Completion of Glucose logs
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Completion of Glucose logsBehavioural
Glucose logs will be assessed by provider for completeness and accuracy
| Study group | Role | What they receive |
|---|---|---|
| Glooko App | Experimental | Glooko application and meter compatibility device (if required) Receives: Behavioral: Completion of Glucose logs |
| Traditional Care | Active comparator | Traditional clinic reporting system: paper/MyChart/emailed glucose logs Receives: Behavioral: Completion of Glucose logs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completeness and accuracy of blood glucose record
The number of values reported to the provider out of the number that should have been collected during the time period, expressed as a percent, as well as the number of values reported that were verified accurate by the meter out of the total number of values reported in the time frame expressed as a percent.
Measured: Every 2 weeks through study completion, up to 42 weeks
Secondary outcomes (5)
Patient Satisfaction
Responses to patient satisfaction survey
Measured: Once prior to exiting the study, an average of 42 weeks
Glucose values at goal
% of glucose values at goal during the study period
Measured: Every 2 weeks through study completion, up to 42 weeks
% Change in Hemoglobin A1C
% of change in values of HbA1C during the study period
Measured: Once prior to exiting the study, up to 42 weeks
Clinic visits
Number of clinic visits during the study period
Measured: through study completion, up to 42 weeks
Unscheduled health care access episodes
Number of unanticipated or unscheduled health care visits during the study period
Measured: through study completion, up to 42 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2018
- Study start1 May 2018
- Primary completion31 May 2019
- Study completion31 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.
- More trials run by University of RochesterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa Gray, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03504592
- Sponsor's protocol ID
- RSRB00068149
- Acronym
- SUGAR
- Status last verified
- Feb 2020
- First submitted
- 9 Mar 2018
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilizing mHealth to Improve Diabetes in an Obstetric Population
- ClinicalTrials.gov ID
- NCT03504592
- Acronym / sponsor ID
- SUGAR / RSRB00068149
- Conditions
- Gestational Diabetes, Pregestational Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- 1 May 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 20 Apr 2018 (actual)
- 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.
This project will utilize MHealth technology to address the barriers providers and obstetric patients experience when reporting blood glucose results. Half of the participants will record their blood glucose values with the assistance of a smartphone device, the other half will continue in the traditional care method of the clinic.
Detailed description
This will be a prospective single center randomized trial piloting the use of mHealth applications in an obstetric population with diabetes. Participants will be enrolled in the study after the diagnosis of diabetes is made in pregnancy for those with gestational diabetes, or for patients with preexisting diabetes they will be enrolled upon initiation of prenatal care. Participants will be randomized to traditional care or mHealth intervention. Outcomes will include completeness and accuracy of the participant glucose log, unscheduled health care access episodes in the pregnancy, patient satisfaction, percentage of glucose values at goal and percent change in Hemoglobin A1C.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Glooko App | Experimental | Behavioral: Completion of Glucose logsGlooko application and meter compatibility device (if required) |
| Traditional Care | Active comparator | Behavioral: Completion of Glucose logsTraditional clinic reporting system: paper/MyChart/emailed glucose logs |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Pregnant, English speaking, Diagnosed with diabetes during pregnancy or with known preexisting diabetes, has smartphone, sees URMC OBGYN for obstetric care in pregnancy.
Key exclusion criteria (1 listed)
- Not English speaking, does not have smartphone, unable to consent.
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 |
|---|---|---|
| Completion of Glucose logsGlucose logs will be assessed by provider for completeness and accuracy | Behavioural | Glooko App, Traditional Care |
Primary outcome
Completeness and accuracy of blood glucose record
Time frame: Every 2 weeks through study completion, up to 42 weeks
The number of values reported to the provider out of the number that should have been collected during the time period, expressed as a percent, as well as the number of values reported that were verified accurate by the meter out of the total number of values reported in the time frame expressed as a percent.
5 secondary outcomes
Patient Satisfaction
Time frame: Once prior to exiting the study, an average of 42 weeks
Glucose values at goal
Time frame: Every 2 weeks through study completion, up to 42 weeks
% Change in Hemoglobin A1C
Time frame: Once prior to exiting the study, up to 42 weeks
Clinic visits
Time frame: through study completion, up to 42 weeks
Unscheduled health care access episodes
Time frame: through study completion, up to 42 weeks
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 13 Feb 2020.
- Individual participant dataSharing planned: Undecided
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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 Completion of Glucose logs in people with Gestational Diabetes and Pregestational Diabetes, run by University of Rochester 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 1 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 13 Feb 2020. 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. 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?
Completeness and accuracy of blood glucose record (time frame: Every 2 weeks through study completion, up to 42 weeks). 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 13 Feb 2020.