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Efficacy of Two Schemes of Self-monitoring Capillary Glucose in Gestational Diabetes

NCT ID: NCT03769701

Last Updated: 2021-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-07

Study Completion Date

2022-07-30

Brief Summary

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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

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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

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Gestational Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Group 1, SMGC four times/day

Women with GDM and SMGC 4 times/day; fasting and 1-hour post-prandial of breakfast, lunch and dinner

Group Type ACTIVE_COMPARATOR

self-monitoring capillary glucose (SMCG)

Intervention Type PROCEDURE

To measure the capillary glucose with a glucometer according to the assigned group.

SMGC two times/day

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.

Group Type EXPERIMENTAL

self-monitoring capillary glucose (SMCG)

Intervention Type PROCEDURE

To measure the capillary glucose with a glucometer according to the assigned group.

Interventions

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self-monitoring capillary glucose (SMCG)

To measure the capillary glucose with a glucometer according to the assigned group.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

1. Multiple pregnancy.
2. Pregestational diabetes.
3. Fasting glucose \> 126 mg/dl or random glucose \> 200 mg/dl before 12 weeks of gestation.
4. Active pathology: systemic lupus erythematosus, rheumatoid arthritis, congenital or acquired cardiopathy, uterine leiomyoma \> 10cm, renal insufficiency and chronic hypertension.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

OTHER_GOV

Sponsor Role lead

Responsible Party

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ENRIQUE REYES-Munoz MD

Medical Science Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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National Institute of Perinatology

México, , Mexico

Site Status RECRUITING

Countries

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Mexico

Central Contacts

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Enrique Reyes-Muñoz, PhD

Role: CONTACT

Phone: +521 5555209900

Email: [email protected]

Lidia Arce-Sánchez, MD

Role: CONTACT

Phone: +521 5555209900

Email: [email protected]

Facility Contacts

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Enrique Reyes-Muñoz, MD

Role: primary

Carlos Orega-Gonzalez, MD

Role: backup

Other Identifiers

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2017-1-53

Identifier Type: -

Identifier Source: org_study_id