Gestational DiabetesNCT03769701
Efficacy of Two Schemes of Self-monitoring Capillary Glucose in Gestational Diabetes
A study testing self-monitoring capillary glucose (SMCG) in people with Gestational Diabetes, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
Trial summary
Gestational diabetes mellitus (GDM) affects 10 % of women who receive prenatal care at Instituto Nacional de Perinatología (Mexico, City). Currently, there is clear evidence on the utility of self- monitoring of capillary glucose (SMGC) to evaluate the efficacy of medical-nutrition therapy on glycemic control. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes
- What is being tested?
- self-monitoring capillary glucose (SMCG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteMexico
- Study dates
- 7 Dec 2018to 30 Jul 2022
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- GDM diagnosis, defined by 2 or more altered values during oral glucose tolerance test (75g-2h): Fasting ≥ 95 mg/dl, 1 hour ≥ 180 mg/dl and 2 hours ≥ 155 mg/dl.
- Singleton pregnancy between 12-32 weeks of gestation at GDM diagnosis.
Who cannot join
- Multiple pregnancy.
- Pregestational diabetes.
- Fasting glucose > 126 mg/dl or random glucose > 200 mg/dl before 12 weeks of gestation.
- Active pathology: systemic lupus erythematosus, rheumatoid arthritis, congenital or acquired cardiopathy, uterine leiomyoma > 10cm, renal insufficiency and chronic hypertension.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
National Institute of Perinatology
México, 11000
Enrique Reyes-Muñoz, MD, 52 (55)55209900 ext. 299, dr.enriquereyes@gmail.com
Carlos Orega-Gonzalez, MD, 52 (55) 55209900 ext. 307, ortegagonzalez@hotmail.com
About this study
Official title: Efficacy of Two Schemes of Self-monitoring Capillary Glucose to Monitor Glycemic Control in Mexican Women With GDM
Gestational diabetes mellitus (GDM) affects 10 % of women who receive prenatal care at Instituto Nacional de Perinatología (Mexico, City). Currently, there is clear evidence on the utility of self- monitoring of capillary glucose (SMGC) to evaluate the efficacy of medical-nutrition therapy on glycemic control. However, the reports regarding the best pattern of SMGC in terms of frequency and number of determinations per day are limited. The objective of this study is to evaluate the efficacy of two SMGC schemes for monitoring glycemic control in Mexican women with GDM.
Read the detailed description
Currently, the evidence from randomized clinical trials about the most appropriate scheme of SMGC for monitoring the glycemic control among women with GDM is limited. This study was designed to evaluate the efficacy of two different schemes of SMGC in GDM Mexican population, it is an open-label randomized clinical trial including 2 groups: group 1 (SMGC 4 times/day) measured in fasting and 1 hour postprandial of breakfast, lunch and dinner; group 2 (SMGC 2 times/day), measured preprandial and 1 hour postprandial, of breakfast, lunch or dinner, alternating the meal each day, from GDM diagnosis until the resolution of pregnancy. Additionally, determinations of insulin, lipids and glycosylated hemoglobin (HbA1c) will be determinate at enrollment, and between the 30-32 and 36-38 of gestation week. The primary outcome: To compare the proportion of women who achieve glycemic control using SMGC 4 times/day versus SMGC 2 times/day.
Secondary outcome: To compare the risk of new-born large for gestational age, gestational hypertension, preeclampsia, preterm birth, cesarean section, new-born weight, neonatal hypoglycemia, neonatal hyperbilirubinemia and entry to neonatal intensive care between groups. An analysis for intention of treatment will be made according to the recommendations of the CONSORT guidelines.
- Conditions
- Gestational Diabetes
- Being tested
- self-monitoring capillary glucose (SMCG)
- Medical subject headings
- Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self-monitoring capillary glucose (SMCG)Procedure or surgery
To measure the capillary glucose with a glucometer according to the assigned group.
| Study group | Role | What they receive |
|---|---|---|
| Group 1, SMGC four times/day | Active comparator | Women with GDM and SMGC 4 times/day; fasting and 1-hour post-prandial of breakfast, lunch and dinner Receives: Procedure: self-monitoring capillary glucose (SMCG) |
| SMGC two times/day | Experimental | Women with GDM and SMGC 2 times/day; pre-prandial and 1-hour post-prandial of breakfast, lunch or dinner alternating the meal each day. Receives: Procedure: self-monitoring capillary glucose (SMCG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of women who achieve glycemic control.
Proportion of women with more than 80% of capillary glucose determination into the following goals: preprandial; 70 to 95 mg/dl and 1 hour post-prandial ≤ 140 mg/dl.
Measured: from GDM diagnosis to delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2018
- Study start7 Dec 2018
- Primary completion30 Apr 2022 (estimated)
- Study completion30 Jul 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.
- 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
- Sponsor type
- Other government
- Responsible party
- Principal investigator, ENRIQUE REYES-Munoz MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03769701
- Sponsor's protocol ID
- 2017-1-53
- Status last verified
- Dec 2021
- First submitted
- 6 Dec 2018
- Last updated
- 28 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Two Schemes of Self-monitoring Capillary Glucose to Monitor Glycemic Control in Mexican Women With GDM
- ClinicalTrials.gov ID
- NCT03769701
- Acronym / sponsor ID
- 2017-1-53
- Conditions
- Gestational Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Instituto Nacional de Perinatologia Isidro Espinosa de los ReyesOther government
- Study start
- 7 Dec 2018 (actual)
- Primary completion
- 30 Apr 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 7 Dec 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.
Gestational diabetes mellitus (GDM) affects 10 % of women who receive prenatal care at Instituto Nacional de Perinatología (Mexico, City). Currently, there is clear evidence on the utility of self- monitoring of capillary glucose (SMGC) to evaluate the efficacy of medical-nutrition therapy on glycemic control. However, the reports regarding the best pattern of SMGC in terms of frequency and number of determinations per day are limited. The objective of this study is to evaluate the efficacy of two SMGC schemes for monitoring glycemic control in Mexican women with GDM.
Detailed description
Currently, the evidence from randomized clinical trials about the most appropriate scheme of SMGC for monitoring the glycemic control among women with GDM is limited. This study was designed to evaluate the efficacy of two different schemes of SMGC in GDM Mexican population, it is an open-label randomized clinical trial including 2 groups: group 1 (SMGC 4 times/day) measured in fasting and 1 hour postprandial of breakfast, lunch and dinner; group 2 (SMGC 2 times/day), measured preprandial and 1 hour postprandial, of breakfast, lunch or dinner, alternating the meal each day, from GDM diagnosis until the resolution of pregnancy. Additionally, determinations of insulin, lipids and glycosylated hemoglobin (HbA1c) will be determinate at enrollment, and between the 30-32 and 36-38 of gestation week. The primary outcome: To compare the proportion of women who achieve glycemic control using SMGC 4 times/day versus SMGC 2 times/day.
Secondary outcome: To compare the risk of new-born large for gestational age, gestational hypertension, preeclampsia, preterm birth, cesarean section, new-born weight, neonatal hypoglycemia, neonatal hyperbilirubinemia and entry to neonatal intensive care between groups. An analysis for intention of treatment will be made according to the recommendations of the CONSORT guidelines.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1, SMGC four times/day | Active comparator | Procedure: self-monitoring capillary glucose (SMCG)Women with GDM and SMGC 4 times/day; fasting and 1-hour post-prandial of breakfast, lunch and dinner |
| SMGC two times/day | Experimental | Procedure: self-monitoring capillary glucose (SMCG)Women with GDM and SMGC 2 times/day; pre-prandial and 1-hour post-prandial of breakfast, lunch or dinner alternating the meal each day. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- GDM diagnosis, defined by 2 or more altered values during oral glucose tolerance test (75g-2h): Fasting ≥ 95 mg/dl, 1 hour ≥ 180 mg/dl and 2 hours ≥ 155 mg/dl.
- Singleton pregnancy between 12-32 weeks of gestation at GDM diagnosis.
Key exclusion criteria (4 listed)
- Multiple pregnancy.
- Pregestational diabetes.
- Fasting glucose > 126 mg/dl or random glucose > 200 mg/dl before 12 weeks of gestation.
- Active pathology: systemic lupus erythematosus, rheumatoid arthritis, congenital or acquired cardiopathy, uterine leiomyoma > 10cm, renal insufficiency and chronic hypertension.
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 |
|---|---|---|
| self-monitoring capillary glucose (SMCG)To measure the capillary glucose with a glucometer according to the assigned group. | Procedure or surgery | Group 1, SMGC four times/day, SMGC two times/day |
Primary outcome
Proportion of women who achieve glycemic control.
Time frame: from GDM diagnosis to delivery.
Proportion of women with more than 80% of capillary glucose determination into the following goals: preprandial; 70 to 95 mg/dl and 1 hour post-prandial ≤ 140 mg/dl.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2021.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing self-monitoring capillary glucose (SMCG) in people with Gestational Diabetes, run by Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes at 1 site in Mexico.
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 2 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: status not confirmed, as of the sponsor's last update on 28 Dec 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Enrique Reyes-Muñoz, PhD (+521 5555209900 ext. 307, dr.enriquereyes@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of women who achieve glycemic control. (time frame: from GDM diagnosis to delivery.). 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 28 Dec 2021.