Gestational DiabetesGLIMPSENCT01818557
Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes
A study testing Blood glucose testing in people with Gestational Diabetes, run by The University of Texas Health Science Center, Houston at 3 sites in United States.
Trial summary
The incidence of gestational diabetes mellitus (GDM) is increasing. GDM requires patients to test their blood glucose at least four times daily. The investigators propose to prospectively evaluate blood glucose testing done every day compared to every other day. Read more about this study
- Who is it for?
- Ages 18 to 55 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- Blood glucose testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 293 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2013to Oct 2016
- 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 55 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Gestational age between 20 weeks 0 days and 32 weeks 0 days of gestation.
- Singleton pregnancies
- Maternal age over 18 years
- Patients able to read and write in English or Spanish,
- Diagnosis of gestational diabetes mellitus using criteria supported by the American College of Obstetrics and Gynecology (ACOG).
- Patients identified as not requiring medical therapy (insulin or glyburide) after the first week of initial blood glucose monitoring.
Who cannot join
- Diagnosis of GDM made by any method or criteria other than the one outlined above
- Women with pre-existing diabetes mellitus
- Patients under the age of 18 years
- Patients known to be carrying a fetus with a fetal anomaly that requires either prenatal or postnatal surgery, requires early delivery or is at risk for intrauterine growth restriction (IUGR)
- Patients carrying multiple gestations
- Patients with past history of gastric bypass
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- Patients with poorly controlled asthma, defined as the need for oral/inhaled corticosteroids to control symptoms
- Patients with chronic hypertension requiring medical therapy
- Patients currently on methadone/suboxone therapy
- Patients currently on any steroid therapy, regardless of the dose or route of administration
- Patients demonstrating poor compliance during the first week of initial blood glucose monitoring, defined as <20% of expected values actually recorded during the one-week period of initial monitoring
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Geisinger Health System
Danville, Pennsylvania, 17822
The University of Texas Health Science Center, Houston
Houston, Texas, 77030
Women & Infants Hospital
Providence, Rhode Island, 02905
About this study
Official title: Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes: A Randomized, Non-Inferiority Pilot Study
The incidence of gestational diabetes mellitus (GDM) is increasing. GDM requires patients to test their blood glucose at least four times daily. The investigators propose to prospectively evaluate blood glucose testing done every day compared to every other day. The primary goal is to establish the most cost-effective modality while still being able to detect patients who require therapy in a timely fashion. The investigators plan to evaluate this new management scheme utilizing a non-inferiority trial design.
The investigators primary research question is the following: When managing patients with GDM, is every other day blood glucose testing non-inferior compared to every day blood glucose testing, as measured by the difference of less than 5% in birth weight?
Read the detailed description
This study is a prospective randomized, non-inferiority clinical trial of pregnant women diagnosed with gestational diabetes. Patients with GDM diagnosed between 20 weeks 0 days and 32 weeks 0 days of gestation will be recruited. Diagnosis of GDM will be based on Carpenter and Coustan criteria for an abnormal 3-hr 100 gram oral glucose tolerance test, as currently supported by the American College of Obstetricians and Gynecologists (ACOG). Patients whose 1-hr, 50 gram oral glucose challenge test exceeds 200 mg/dl will not require a 3-hr oral glucose tolerance test (OGTT). If the patient meets the inclusion and exclusion criteria listed below, she will be offered participation in the trial and randomized to every day blood glucose testing or every other day blood glucose testing for the remainder of her pregnancy.
After the diagnosis of GDM, and before recruitment to the study, all patients will be provided counseling and education and will attempt adequate blood glucose control with medical nutritional therapy alone for one week. During this period, all patients will test their blood glucose values daily. Only after this week is completed will a subject be approached for participation.
- Conditions
- Gestational Diabetes
- Being tested
- Blood glucose testing
- Keywords
- glucose monitoring, gestational diabetes
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood glucose testingBehavioural
Patients will be assigned either to blood glucose monitoring done every day (during a fasting state and 2 hours after breakfast, lunch and dinner) continued throughout gestation or to blood glucose monitoring done every other day with the same timeframes outlined above.
| Study group | Role | What they receive |
|---|---|---|
| Every day blood glucose testing | No intervention | Patients will test their blood glucose values 4 times every day |
| Every other day blood glucose testing | Experimental | Patients will test their blood glucose 4 times every other day Receives: Behavioral: Blood glucose testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neonatal weight
In patients with GDM, every other day blood glucose testing is non-inferior to every day blood glucose testing, as measured by the difference of less than 5% in birth weight
Measured: At birth
Secondary outcomes (1)
Macrosomia
To determine if every other day testing is associated with a greater rate of macrosomia, defined as birth weight > 4,000 grams, than every day blood glucose testing
Measured: At birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMay 2013
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 293 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island, Geisinger Clinic
- Responsible party
- Sponsor
- Investigators
- Hector Mendez-Figueroa, M.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818557
- Sponsor's protocol ID
- HSC-MS-13-0719
- Acronym
- GLIMPSE
- Status last verified
- Jun 2018
- First submitted
- 21 Mar 2013
- Last updated
- 2 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Mendez-Figueroa H, Schuster M, Maggio L, Pedroza C, Chauhan SP, Paglia MJ. Gestational Diabetes Mellitus and Frequency of Blood Glucose Monitoring: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):163-170. doi: 10.1097/AOG.0000000000002101.
PubMed 28594772
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Blood Glucose Monitoring in Patients With Gestational Diabetes: A Randomized, Non-Inferiority Pilot Study
- ClinicalTrials.gov ID
- NCT01818557
- Acronym / sponsor ID
- GLIMPSE / HSC-MS-13-0719
- Conditions
- Gestational Diabetes
- Keywords
- glucose monitoring, gestational diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 293 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Women and Infants Hospital of Rhode Island, Geisinger Clinic
- Study start
- May 2013
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 26 Mar 2013 (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.
The incidence of gestational diabetes mellitus (GDM) is increasing. GDM requires patients to test their blood glucose at least four times daily. The investigators propose to prospectively evaluate blood glucose testing done every day compared to every other day. The primary goal is to establish the most cost-effective modality while still being able to detect patients who require therapy in a timely fashion. The investigators plan to evaluate this new management scheme utilizing a non-inferiority trial design.
The investigators primary research question is the following: When managing patients with GDM, is every other day blood glucose testing non-inferior compared to every day blood glucose testing, as measured by the difference of less than 5% in birth weight?
Detailed description
This study is a prospective randomized, non-inferiority clinical trial of pregnant women diagnosed with gestational diabetes. Patients with GDM diagnosed between 20 weeks 0 days and 32 weeks 0 days of gestation will be recruited. Diagnosis of GDM will be based on Carpenter and Coustan criteria for an abnormal 3-hr 100 gram oral glucose tolerance test, as currently supported by the American College of Obstetricians and Gynecologists (ACOG). Patients whose 1-hr, 50 gram oral glucose challenge test exceeds 200 mg/dl will not require a 3-hr oral glucose tolerance test (OGTT). If the patient meets the inclusion and exclusion criteria listed below, she will be offered participation in the trial and randomized to every day blood glucose testing or every other day blood glucose testing for the remainder of her pregnancy.
After the diagnosis of GDM, and before recruitment to the study, all patients will be provided counseling and education and will attempt adequate blood glucose control with medical nutritional therapy alone for one week. During this period, all patients will test their blood glucose values daily. Only after this week is completed will a subject be approached for participation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Every day blood glucose testing | No intervention | –Patients will test their blood glucose values 4 times every day |
| Every other day blood glucose testing | Experimental | Behavioral: Blood glucose testingPatients will test their blood glucose 4 times every other day |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Gestational age between 20 weeks 0 days and 32 weeks 0 days of gestation.
- Singleton pregnancies
- Maternal age over 18 years
- Patients able to read and write in English or Spanish,
- Diagnosis of gestational diabetes mellitus using criteria supported by the American College of Obstetrics and Gynecology (ACOG).
Key exclusion criteria (11 listed)
- Diagnosis of GDM made by any method or criteria other than the one outlined above
- Women with pre-existing diabetes mellitus
- Patients under the age of 18 years
- Patients known to be carrying a fetus with a fetal anomaly that requires either prenatal or postnatal surgery, requires early delivery or is at risk for intrauterine growth restriction (IUGR)
- Patients carrying multiple gestations
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 |
|---|---|---|
| Blood glucose testingPatients will be assigned either to blood glucose monitoring done every day (during a fasting state and 2 hours after breakfast, lunch and dinner) continued throughout gestation or to blood glucose monitoring done every other day with the same timeframes outlined above. | Behavioural | Every other day blood glucose testing |
Primary outcome
Neonatal weight
Time frame: At birth
In patients with GDM, every other day blood glucose testing is non-inferior to every day blood glucose testing, as measured by the difference of less than 5% in birth weight
1 secondary outcome
Macrosomia
Time frame: At birth
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 2 Jul 2018.
- Derived from this study: PubMed 28594772Mendez-Figueroa H, Schuster M, Maggio L, Pedroza C, Chauhan SP, Paglia MJ. Gestational Diabetes Mellitus and Frequency of Blood Glucose Monitoring: A Randomized Controlled Trial. Obstet Gynecol. 2017 Jul;130(1):163-170. doi: 10.1097/AOG.0000000000002101.
Related trials for Gestational Diabetes
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Effectiveness Study of a Lifestyle Intervention Versus Metformin in Mothers With Recent Gestational Diabetes
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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.
Hector Mendez-Figueroa, M.D. principal investigator
The University of Texas Health Science Center, Houston
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood glucose testing in people with Gestational Diabetes, run by The University of Texas Health Science Center, Houston at 3 sites 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 11 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 2 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
Neonatal weight (time frame: At birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01818557, which also lists 1 linked publication.
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 Jul 2018.