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

NCT03769701 | Unknown DMC

• 1 other identifier: 2017-1-53
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gestational Diabetes

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

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

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.

Procedure: self-monitoring capillary glucose (SMCG)

Interventions

self-monitoring capillary glucose (SMCG) PROCEDURE

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

Group 1, SMGC four times/day; SMGC two times/day

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

National Institute of Perinatology

México, 11000, Mexico

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Enrique Reyes-Muñoz, PhD

CONTACT

+521 5555209900; dr.enriquereyes@gmail.com

Lidia Arce-Sánchez, MD

CONTACT

+521 5555209900; li_arce@yahoo.com.mx

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Science Researcher

Study Record Dates

• First Submitted: December 6, 2018
• First Posted: December 7, 2018
• Study Start: December 7, 2018
• Primary Completion: April 30, 2022
• Study Completion: July 30, 2022
• Last Updated: December 28, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)