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

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes
• Intervention / Treatment: Procedure: self-monitoring capillary glucose (SMCG)

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 Type: Interventional
• Enrollment (Anticipated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Enrique Reyes-Muñoz, PhD; Phone Number: 307 +521 5555209900; Email: dr.enriquereyes@gmail.com
• Study Contact Backup: Name: Lidia Arce-Sánchez, MD; Phone Number: 299 +521 5555209900; Email: li_arce@yahoo.com.mx

Study Locations

• Mexico
  • Mexico, Mexico, 11000
    • Recruiting
    • National Institute of Perinatology
    • Contact: Enrique Reyes-Muñoz, MD; Phone Number: 299 52 (55)55209900; Email: dr.enriquereyes@gmail.com
    • Contact: Carlos Orega-Gonzalez, MD; Phone Number: 307 52 (55) 55209900; Email: ortegagonzalez@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: self-monitoring capillary glucose (SMCG); To measure the capillary glucose with a glucometer according to the assigned group.
Experimental: 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.	Procedure: self-monitoring capillary glucose (SMCG); To measure the capillary glucose with a glucometer according to the assigned group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2018
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): July 30, 2022

Study Registration Dates

• First Submitted: December 6, 2018
• First Submitted That Met QC Criteria: December 6, 2018
• First Posted (Actual): December 7, 2018

Study Record Updates

• Last Update Posted (Actual): December 28, 2021
• Last Update Submitted That Met QC Criteria: December 24, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Diabetes, Gestational
• Other Study ID Numbers: 2017-1-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No