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

Sponsor

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes (Other)

Overall Status

Recruiting

CT.gov ID

NCT03769701

Collaborator

(none)

110

Enrollment

Location

Arms

43.7

Anticipated Duration (Months)

2.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gestational Diabetes	Procedure: self-monitoring capillary glucose (SMCG)	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

110 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Dec 7, 2018

Anticipated Primary Completion Date :

Apr 30, 2022

Anticipated Study Completion Date :

Jul 30, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Proportion of women who achieve glycemic control. [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institute of Perinatology	Mexico		Mexico	11000

Sponsors and Collaborators

Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

ENRIQUE REYES-Munoz MD, Medical Science Researcher, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

ClinicalTrials.gov Identifier:

NCT03769701

Other Study ID Numbers:

2017-1-53

First Posted:

Dec 7, 2018

Last Update Posted:

Dec 28, 2021

Last Verified:

Dec 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes, Gestational

Study Results

No Results Posted as of Dec 28, 2021