Gestational Diabetes MellitusNCT03340311
Evaluating the Feasibility of Using M-Health to Improve Serum Glucose Logs
A study testing iHealth Wireless Smart Gluco- Monitoring System (BG5) in people with Gestational Diabetes Mellitus, run by Leslie Balcazar De Martinez at 1 site in United States.
Trial summary
Gestational diabetes mellitus (GDM) can cause adverse outcomes for the mother and fetus due to hyperglycemia. The purpose of this study is to evaluate the feasibility of improving pregnant women's glucose logs using a Bluetooth enabled glucose monitor and associated mobile health application and to assess their… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus
- What is being tested?
- iHealth Wireless Smart Gluco- Monitoring System (BG5)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2017to 28 Apr 2018
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old
- Willing and able to give informed consent
- Diagnosis of gestational diabetes
- Speak English and/or Spanish
- Have ownership of a smartphone capable of running the mobile health application
- Willing to download the iGluco mobile phone application
Who cannot join
- Have knowledge that their delivery will occur prior to completion of the required eight weeks of glucose logs
- Possess a Bluetooth enabled glucometer
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Maternal Fetal Medicine Clinic
Charlottesville, Virginia, 22901
About this study
Official title: Evaluating the Feasibility of Using M-Health to Improve Serum Glucose Logs of Women With Gestational Diabetes
Gestational diabetes mellitus (GDM) can cause adverse outcomes for the mother and fetus due to hyperglycemia. The purpose of this study is to evaluate the feasibility of improving pregnant women's glucose logs using a Bluetooth enabled glucose monitor and associated mobile health application and to assess their satisfaction with using mobile health technology.
Read the detailed description
Study Question: Does use of a Bluetooth enabled serum glucose monitor in conjunction with a mobile health application improve pregnant women's glucose log completion? This pilot study proposes that the use of Bluetooth glucometers and mobile health applications will be feasible and well accepted by the target population.
Methods: This project utilizes a quasi-experimental pre-post design with up to 25 participants. Over the course of eight weeks, participants will collect serum glucose logs (SGL) for four weeks using usual care followed by SGLs for four weeks using Bluetooth-enabled glucometers and the iGluco application. Measures will include a demographic sheet and completed SGL. Descriptive statistics of the appropriate level will be used to summarize the data collected. Glucose log completeness will be calculated using the total number of entries required for the period between visits divided by the number of actual entries. For example, if the participant has had 14 days between appointments, 56 entries would be expected, if the patient only records 40 results the completeness score would be 0.71. Raw data will be reported in the final manuscript under results. The data anticipated from this study include the number of women who consented to participate, average education level, primary languages, age range with mean age, the number of women on medication or diet only control, average completion score for usual care phase, and average completion score for the intervention phase. Data will also be generated and reported for the number of patients that did not bring their logs but brought their smartphones or glucometer for transcription and the number of patients that dropped out of the study before completion of eight weeks of glucose logs, and a mean satisfaction score calculated. Eligibility for this study includes women who are at least 18 years old, competent for consent, have gestational diabetes, speak English, have ownership of a smartphone capable of running the mobile health application and are willing to download the application.
Implications: This study has the potential to demonstrate the feasibility of improved Self-management of GDM and provide the groundwork for future studies. The use of Bluetooth enabled glucose monitors with mobile health applications to aid in efficient and complete SMBG management may translate to a decrease in adverse outcomes.
- Conditions
- Gestational Diabetes Mellitus
- Being tested
- iHealth Wireless Smart Gluco- Monitoring System (BG5)
- Keywords
- M-Health, GDM, Bluetooth, SMBG
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iHealth Wireless Smart Gluco- Monitoring System (BG5)Device
Over the course of 8 weeks, participants collected serum glucose logs (SGL) for 4 weeks using usual care followed by SGL's log for 4 weeks using Bluetooth-enabled glucometers and the iGluco application.
| Study group | Role | What they receive |
|---|---|---|
| Pre-Post | Other | (Phase one): Each participant will receive usual care (four weeks). Four weeks of glucose logs will be collected at patient's provider visits and completeness recorded.
(Phase two): Each participant will receive a BG5 wireless glucose meter with supplies enough for four weeks. Each participant will download the iGluco application to their smartphone. Education will be given on the monitor and iGluco application use. Four weeks of glucose logs will be collected at patient's provider visits and completeness recorded.
At the conclusion of phase 2, the participants will be asked to complete a satisfaction survey about the care received and their preference of monitors. Receives: Device: iHealth Wireless Smart Gluco- Monitoring System (BG5) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glucose log completeness
Glucose log completeness will be calculated using the total number of entries required for the period between visits divided by the number of actual entries. For example, if the participant has had 14 days between appointments, 56 entries would be expected, if the patient only records 40 results the completeness score would be 0.71.
Measured: 8 weeks
Secondary outcomes (1)
Patient satisfaction
Adapted from the PSQ-18 with a question added to determine patients device preference.
Measured: 1 day at the end of the study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2017
- Study start1 Nov 2017
- Primary completion28 Apr 2018
- Study completion28 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes MellitusStudies 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
- Other
- Intervention model
- Sequential
- Model description
- Quasi-experimental pre-post design
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Leslie Balcazar De Martinez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Leslie Balcazar De Martinez, University of Virginia
- Investigators
- Emily Drake, RN, Ph.D, Study chair, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03340311
- Sponsor's protocol ID
- 20100
- Status last verified
- Apr 2018
- First submitted
- 20 Oct 2017
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility of Using M-Health to Improve Serum Glucose Logs of Women With Gestational Diabetes
- ClinicalTrials.gov ID
- NCT03340311
- Acronym / sponsor ID
- 20100
- Conditions
- Gestational Diabetes Mellitus
- Keywords
- M-Health, GDM, Bluetooth, SMBG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Leslie Balcazar De MartinezUniversity, hospital or other
- Study start
- 1 Nov 2017 (actual)
- Primary completion
- 28 Apr 2018 (actual)
- Study completion
- 28 Apr 2018 (actual)
- First posted
- 13 Nov 2017 (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.
Gestational diabetes mellitus (GDM) can cause adverse outcomes for the mother and fetus due to hyperglycemia. The purpose of this study is to evaluate the feasibility of improving pregnant women's glucose logs using a Bluetooth enabled glucose monitor and associated mobile health application and to assess their satisfaction with using mobile health technology.
Detailed description
Study Question: Does use of a Bluetooth enabled serum glucose monitor in conjunction with a mobile health application improve pregnant women's glucose log completion? This pilot study proposes that the use of Bluetooth glucometers and mobile health applications will be feasible and well accepted by the target population.
Methods: This project utilizes a quasi-experimental pre-post design with up to 25 participants. Over the course of eight weeks, participants will collect serum glucose logs (SGL) for four weeks using usual care followed by SGLs for four weeks using Bluetooth-enabled glucometers and the iGluco application. Measures will include a demographic sheet and completed SGL. Descriptive statistics of the appropriate level will be used to summarize the data collected. Glucose log completeness will be calculated using the total number of entries required for the period between visits divided by the number of actual entries. For example, if the participant has had 14 days between appointments, 56 entries would be expected, if the patient only records 40 results the completeness score would be 0.71. Raw data will be reported in the final manuscript under results. The data anticipated from this study include the number of women who consented to participate, average education level, primary languages, age range with mean age, the number of women on medication or diet only control, average completion score for usual care phase, and average completion score for the intervention phase. Data will also be generated and reported for the number of patients that did not bring their logs but brought their smartphones or glucometer for transcription and the number of patients that dropped out of the study before completion of eight weeks of glucose logs, and a mean satisfaction score calculated. Eligibility for this study includes women who are at least 18 years old, competent for consent, have gestational diabetes, speak English, have ownership of a smartphone capable of running the mobile health application and are willing to download the application.
Implications: This study has the potential to demonstrate the feasibility of improved Self-management of GDM and provide the groundwork for future studies. The use of Bluetooth enabled glucose monitors with mobile health applications to aid in efficient and complete SMBG management may translate to a decrease in adverse outcomes.
Study design
- Primary purpose
- Other
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Quasi-experimental pre-post design
| Arm | Type | Receives |
|---|---|---|
| Pre-Post | Other | Device: iHealth Wireless Smart Gluco- Monitoring System (BG5)(Phase one): Each participant will receive usual care (four weeks). Four weeks of glucose logs will be collected at patient's provider visits and completeness recorded. (Phase two): Each participant will receive a BG5 wireless glucose meter with supplies enough for four weeks. Each participant will download the iGluco application to their smartphone. Education will be given on the monitor and iGluco application use. Four weeks of glucose logs will be collected at patient's provider visits and completeness recorded. At the conclusion of phase 2, the participants will be asked to complete a satisfaction survey about the care received and their preference of monitors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- At least 18 years old
- Willing and able to give informed consent
- Diagnosis of gestational diabetes
- Speak English and/or Spanish
- Have ownership of a smartphone capable of running the mobile health application
Key exclusion criteria (2 listed)
- Have knowledge that their delivery will occur prior to completion of the required eight weeks of glucose logs
- Possess a Bluetooth enabled glucometer
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 |
|---|---|---|
| iHealth Wireless Smart Gluco- Monitoring System (BG5)Over the course of 8 weeks, participants collected serum glucose logs (SGL) for 4 weeks using usual care followed by SGL's log for 4 weeks using Bluetooth-enabled glucometers and the iGluco application. | Device | Pre-Post |
Primary outcome
Glucose log completeness
Time frame: 8 weeks
Glucose log completeness will be calculated using the total number of entries required for the period between visits divided by the number of actual entries. For example, if the participant has had 14 days between appointments, 56 entries would be expected, if the patient only records 40 results the completeness score would be 0.71.
1 secondary outcome
Patient satisfaction
Time frame: 1 day at the end of the study.
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 1 May 2018.
- Individual participant dataSharing planned: No
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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.
Emily Drake, RN, Ph.D study chair
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iHealth Wireless Smart Gluco- Monitoring System (BG5) in people with Gestational Diabetes Mellitus, run by Leslie Balcazar De Martinez 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 6 inclusion and 2 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 1 May 2018. 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?
Glucose log completeness (time frame: 8 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 1 May 2018.