Gestational Diabetes Mellitus in PregnancyNCT06005987
Mobile App Logging for Diabetes in Pregnancy
A study testing OneTouch Reveal application in people with Gestational Diabetes Mellitus in Pregnancy and Type 2 Diabetes, run by Carolyn Zahler-Miller at 1 site in United States.
Trial summary
To determine the effect of using a mobile app versus paper logs on compliance and percentage in range blood sugars in monitoring blood sugar in pregnant women with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 100 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy, Type 2 Diabetes
- What is being tested?
- OneTouch Reveal application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2024to 1 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 100 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years and older
- Verified intrauterine pregnancy
- At least 12 weeks gestation
- Diagnosed with either type 2 diabetes mellitus or gestational diabetes mellitus.
Who cannot join
- Patients with less than 4 weeks anticipated to be remaining in pregnancy
- Pre-existing use of a continuous glucose monitor or other mobile application for glucose tracking
- Type 1 diabetes mellitus
- Non-English speaking patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Augusta University
Augusta, Georgia, 30912
Carolyn M Zahler-Miller, 706-721-2542, czahlermiller@augusta.edu
Rebecca Keipper, 7067212541, rkeipper@augusta.edu
About this study
Official title: Effect of a Mobile Application on Blood Sugar Testing Compliance in Pregnant Women With Diabetes
To determine the effect of using a mobile app versus paper logs on compliance and percentage in range blood sugars in monitoring blood sugar in pregnant women with diabetes.
Read the detailed description
Women with type 2 and gestational diabetes have to keep strict logs of their blood sugar and record blood sugar values 4 times per day (fasting and 2 hours after every meal). This is often the first time they've had to keep such strict logs. Patients are provided with paper logs to record their blood sugars, however these can be lost or damaged and often they are not brought back to clinic. Mobile apps can be used to record blood sugar as well. This study will be comparing compliance with recording blood sugar values as prescribed with paper logs versus a mobile app. Subjects will be recruited from the Augusta University downtown location obstetric clinics.
Qualifying subjects must be at least 18 years of age with a verified intrauterine pregnancy of at least 12 weeks gestation and must have preexisting type 2 diabetes or gestational diabetes diagnosed by 1h glucose tolerance test (GTT) > 200mg/dL or 3h GTT with 2 or more abnormal values. Exclusion criteria includes patients with less than 2 weeks expected to be remaining in pregnancy, Preexisting use of a continuous glucose monitor (CGM) or application to track blood sugar readings, and type 1 diabetes.
- Being tested
- OneTouch Reveal application
- Keywords
- technology in medicine, mobile applications, blood glucose monitoring, diabetes in pregnancy
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OneTouch Reveal applicationBehavioural
Evaluate if compliance with glucose logging and percentage of in range glucoses changes with use of a mobile application instead of paper logging
| Study group | Role | What they receive |
|---|---|---|
| Mobile App arm | Experimental | Patient will input their daily blood glucose levels (fasting and 2 hours after breakfast, lunch and dinner) into the OneTouch Reveal app Receives: Behavioral: OneTouch Reveal application |
| Paper Log Arm | No intervention | Patients will input their daily blood glucose levels onto paper logs which is the current process in the prenatal clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compliance
percentage of actual blood glucose values logged compared to expected.
Measured: 4 weeks
Secondary outcomes (1)
Percentage of in-range blood glucose levels
Percentage of blood glucose levels in pregnancy appropriate range out of total blood glucose levels logged.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2023
- Study start1 Jun 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized to two arms. First is traditional logging of blood glucoses with standard paper form in the clinic. The second arm will log their blood glucoses with the OneTouch Reveal smart phone application.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carolyn Zahler-Miller
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Carolyn Zahler-Miller, Augusta University
- Investigators
- Rebecca Keipper, MD, Principal investigator, Augusta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06005987
- Sponsor's protocol ID
- 1992519
- Status last verified
- Jan 2025
- First submitted
- 16 Aug 2023
- Last updated
- 31 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Mobile Application on Blood Sugar Testing Compliance in Pregnant Women With Diabetes
- ClinicalTrials.gov ID
- NCT06005987
- Acronym / sponsor ID
- 1992519
- Keywords
- technology in medicine, mobile applications, blood glucose monitoring, diabetes in pregnancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Carolyn Zahler-MillerUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 23 Aug 2023 (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.
To determine the effect of using a mobile app versus paper logs on compliance and percentage in range blood sugars in monitoring blood sugar in pregnant women with diabetes.
Detailed description
Women with type 2 and gestational diabetes have to keep strict logs of their blood sugar and record blood sugar values 4 times per day (fasting and 2 hours after every meal). This is often the first time they've had to keep such strict logs. Patients are provided with paper logs to record their blood sugars, however these can be lost or damaged and often they are not brought back to clinic. Mobile apps can be used to record blood sugar as well. This study will be comparing compliance with recording blood sugar values as prescribed with paper logs versus a mobile app. Subjects will be recruited from the Augusta University downtown location obstetric clinics.
Qualifying subjects must be at least 18 years of age with a verified intrauterine pregnancy of at least 12 weeks gestation and must have preexisting type 2 diabetes or gestational diabetes diagnosed by 1h glucose tolerance test (GTT) > 200mg/dL or 3h GTT with 2 or more abnormal values. Exclusion criteria includes patients with less than 2 weeks expected to be remaining in pregnancy, Preexisting use of a continuous glucose monitor (CGM) or application to track blood sugar readings, and type 1 diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Patients will be randomized to two arms. First is traditional logging of blood glucoses with standard paper form in the clinic. The second arm will log their blood glucoses with the OneTouch Reveal smart phone application.
| Arm | Type | Receives |
|---|---|---|
| Mobile App arm | Experimental | Behavioral: OneTouch Reveal applicationPatient will input their daily blood glucose levels (fasting and 2 hours after breakfast, lunch and dinner) into the OneTouch Reveal app |
| Paper Log Arm | No intervention | –Patients will input their daily blood glucose levels onto paper logs which is the current process in the prenatal clinic. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years and older
- Verified intrauterine pregnancy
- At least 12 weeks gestation
- Diagnosed with either type 2 diabetes mellitus or gestational diabetes mellitus.
Key exclusion criteria (4 listed)
- Patients with less than 4 weeks anticipated to be remaining in pregnancy
- Pre-existing use of a continuous glucose monitor or other mobile application for glucose tracking
- Type 1 diabetes mellitus
- Non-English speaking patients
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 |
|---|---|---|
| OneTouch Reveal applicationEvaluate if compliance with glucose logging and percentage of in range glucoses changes with use of a mobile application instead of paper logging | Behavioural | Mobile App arm |
Primary outcome
Compliance
Time frame: 4 weeks
percentage of actual blood glucose values logged compared to expected.
1 secondary outcome
Percentage of in-range blood glucose levels
Time frame: 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2025.
- Individual participant dataSharing planned: Yes
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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.
Rebecca Keipper, MD principal investigator
Augusta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OneTouch Reveal application in people with Gestational Diabetes Mellitus in Pregnancy and Type 2 Diabetes, run by Carolyn Zahler-Miller 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 4 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 31 Jan 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rebecca Keipper, MD (7067212541, rkeipper@augusta.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance (time frame: 4 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 31 Jan 2025.