Gestational DiabetesiGlucoseNCT04206748
iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes
A study testing iGlucose Smart Meter System and Routine Care-RX meter in people with Gestational Diabetes and Type2 Diabetes, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The purpose of this study is to investigate whether automation of glucose monitoring data to facilitate the total number of recommended and completed SMBG checks improve clinical outcomes for women living with gestational and type 2 diabetes during pregnancy? This is a RCT 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, Type2 Diabetes, Pregnancy in Diabetic
- What is being tested?
- iGlucose Smart Meter System and Routine Care-RX meter
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2019to 1 Nov 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- All patients >/= women 18 years of age with gestational diabetes or type 2 diabetes during pregnancy and identified by the research team and consented before 30.6 weeks.
- Non-anomalous singletons
- Ability to provide informed consent
Who cannot join
- Patients with Type 1 diabetes
- Patients with fetal major congenital abnormalities
- Patients identified/referred after 30.6 weeks
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
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
Joycelyn Cornthwaite, RD, 832-325-7205, joycelyn.a.cornthwaite@uth.tmc.edu
Sunbola Ashimi, PhD, 713-500-6410, sunbola.s.ashimi@uth.tmc.edu
About this study
Official title: iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes: a Pilot Randomized, Controlled Trial
The purpose of this study is to investigate whether automation of glucose monitoring data to facilitate the total number of recommended and completed SMBG checks improve clinical outcomes for women living with gestational and type 2 diabetes during pregnancy? This is a RCT
- Conditions
- Gestational Diabetes, Type2 Diabetes, Pregnancy in Diabetic
- Being tested
- iGlucose Smart Meter System, Routine Care-RX meter
- Medical subject headings
- Diabetes, Gestational, Pregnancy in Diabetics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iGlucose Smart Meter SystemDevice
Subjects will have routine care enhanced by use of theThe iGlucose Smart meter system. This is an example of integration of a SMBG system with internet-based technology; including cell phone notifications for reminders, feedback, and communication with clinicians
Routine Care-RX meterDevice
Subjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary.
| Study group | Role | What they receive |
|---|---|---|
| iGlucose Smart Meter | Experimental | Not described Receives: Device: iGlucose Smart Meter System |
| Rx glucose meter | Placebo comparator | Not described Receives: Device: Routine Care-RX meter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal morbidity
Measured: at the time of discharge (about 2-7 days after birth)
Neonatal gestational age at delivery
Measured: at delivery
# of neonates who where Small for gestational age (SGA)
Measured: at delivery
Neonatal intensive care unit (NICU) length of stay
Measured: delivery to discharge (2-7 days)
# of Neonates with hyperbilirubinemia-requiring therapy.
Measured: delivery to discharge (2-7 days)
Secondary outcomes (10)
Average Neonatal Weight
To evaluate the relationship of change in average neonatal weight to two skill sets of Self-monitoring of blood glucose (SMBG), operational and interpretive, as demonstrated by patient-perceived self-efficacy and adherence to self-care behaviors
Measured: at the time of discharge (about 2-7 days after birth)
Maternal Mean fasting glucose
Measured: perinatal to postpartum (32 weeks)
Maternal Mean post prandial glucose
Measured: perinatal to postpartum (32 weeks)
Maternal # of Hypoglycemia events (<60 mg/dl)
Measured: perinatal to postpartum (32 weeks)
Maternal weight gain during pregnancy
Measured: perinatal to postpartum (32 weeks)
Maternal Gestational hypertension
Measured: perinatal to postpartum (32 weeks)
Maternal Preeclampsia
Measured: perinatal to postpartum (32 weeks)
Maternal Cesarean delivery
Measured: at delivery
Maternal Operative vaginal delivery
Measured: at delivery
Effect of SMBG checks on pregnancy
To evaluate relationship between percent of total achieved SMBG checks, diabetes distress, and maternal and neonatal outcomes, for women living with GDM and T2DM during pregnancy.
Measured: perinatal to postpartum (32 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start12 Nov 2019
- Primary completion12 Nov 2021 (estimated)
- Study completion1 Nov 2022 (estimated)
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 The University of Texas Health Science Center, HoustonThe 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Smart Meter Corporation
- Responsible party
- Principal investigator, Joycelyn Ashby Cornthwaite, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206748
- Sponsor's protocol ID
- HSC-MS-19-0402
- Acronym
- iGlucose
- Status last verified
- Sep 2021
- First submitted
- 15 Nov 2019
- Last updated
- 2 Sep 2021
- 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 2 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- iGlucose® Remote Patient Monitoring Device as an Adjunct to Routine Glucose Meter Devices for Glycemic Management and Control in Gestational Diabetes: a Pilot Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT04206748
- Acronym / sponsor ID
- iGlucose / HSC-MS-19-0402
- Conditions
- Gestational Diabetes, Type2 Diabetes, Pregnancy in Diabetic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Smart Meter Corporation
- Study start
- 12 Nov 2019 (actual)
- Primary completion
- 12 Nov 2021 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 20 Dec 2019 (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.
The purpose of this study is to investigate whether automation of glucose monitoring data to facilitate the total number of recommended and completed SMBG checks improve clinical outcomes for women living with gestational and type 2 diabetes during pregnancy? This is a RCT
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iGlucose Smart Meter | Experimental | Device: iGlucose Smart Meter System |
| Rx glucose meter | Placebo comparator | Device: Routine Care-RX meter |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- All patients >/= women 18 years of age with gestational diabetes or type 2 diabetes during pregnancy and identified by the research team and consented before 30.6 weeks.
- Non-anomalous singletons
- Ability to provide informed consent
Key exclusion criteria (3 listed)
- Patients with Type 1 diabetes
- Patients with fetal major congenital abnormalities
- Patients identified/referred after 30.6 weeks
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 |
|---|---|---|
| iGlucose Smart Meter SystemSubjects will have routine care enhanced by use of theThe iGlucose Smart meter system. This is an example of integration of a SMBG system with internet-based technology; including cell phone notifications for reminders, feedback, and communication with clinicians | Device | iGlucose Smart Meter |
| Routine Care-RX meterSubjects will receive routine care with the insurance prescribed glucose meter. They will self manage with traditional diabetes diary. | Device | Rx glucose meter |
Primary outcome
Neonatal morbidity
Time frame: at the time of discharge (about 2-7 days after birth)
Neonatal gestational age at delivery
Time frame: at delivery
# of neonates who where Small for gestational age (SGA)
Time frame: at delivery
Neonatal intensive care unit (NICU) length of stay
Time frame: delivery to discharge (2-7 days)
# of Neonates with hyperbilirubinemia-requiring therapy.
Time frame: delivery to discharge (2-7 days)
10 secondary outcomes
Average Neonatal Weight
Time frame: at the time of discharge (about 2-7 days after birth)
Maternal Mean fasting glucose
Time frame: perinatal to postpartum (32 weeks)
Maternal Mean post prandial glucose
Time frame: perinatal to postpartum (32 weeks)
Maternal # of Hypoglycemia events (<60 mg/dl)
Time frame: perinatal to postpartum (32 weeks)
Maternal weight gain during pregnancy
Time frame: perinatal to postpartum (32 weeks)
Maternal Gestational hypertension
Time frame: perinatal to postpartum (32 weeks)
Maternal Preeclampsia
Time frame: perinatal to postpartum (32 weeks)
Maternal Cesarean delivery
Time frame: at delivery
Maternal Operative vaginal delivery
Time frame: at delivery
Effect of SMBG checks on pregnancy
Time frame: perinatal to postpartum (32 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 2 Sep 2021.
- Individual participant dataSharing planned: No
Related trials for Gestational Diabetes
Active, not recruiting
Effect of Probiotics on Insulin Sensitivity in Overweight and Obese Pregnancy
Obesity & Overweight, Gestational Diabetes Mellitus (GDM)
Not yet recruitingObservational study
Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
Gestational Diabetes Mellitus (GDM), Obstetric Anesthesia
Active, not recruitingPhase 2
Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
Weight Loss, Gestational Diabetes Mellitus in Pregnancy
Not yet recruiting
STRONG: SMART Trial
Gestational Diabetes Mellitus (GDM)
Not yet recruiting
A Study to Lower Blood Pressure One Year After Childbirth in Women Who Had Preeclampsia
Adverse Pregnancy Outcomes, Cardiovascular Diseases
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iGlucose Smart Meter System and Routine Care-RX meter in people with Gestational Diabetes and Type2 Diabetes, run by The University of Texas Health Science Center, Houston 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 3 inclusion and 3 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 2 Sep 2021. 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?
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 Joycelyn Corthwaite, RD (832-325-7205, joycelyn.a.cornthwaite@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neonatal morbidity (time frame: at the time of discharge (about 2-7 days after birth)). The study lists 5 primary outcomes in all. 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 2 Sep 2021.