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

Gestational Diabetes Clinical Trial

Official title:

Efficacy of Two Schemes of Self-monitoring Capillary Glucose to Monitor Glycemic Control in Mexican Women With GDM

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03769701
• Other study ID #: 2017-1-53
• Status: Recruiting
• Phase: N/A
• Start date: December 7, 2018
• Est. completion date: July 30, 2022

Study information

• Verified date: December 2021
• Source: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
• Contact: Enrique Reyes-Muñoz, PhD
• Phone: +521 5555209900
• Email: dr.enriquereyes[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: July 30, 2022
• Est. primary completion date: April 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes, Gestational
• Gestational Diabetes

Intervention

Procedure:
• self-monitoring capillary glucose (SMCG)
To measure the capillary glucose with a glucometer according to the assigned group.

Locations

Country	Name	City	State
Mexico	National Institute of Perinatology	Mexico

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	from GDM diagnosis to delivery.