Efficacy of Two Schemes of Self-monitoring Capillary Glucose in Gestational Diabetes
Primary Purpose
Gestational Diabetes
Status
Recruiting
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
self-monitoring capillary glucose (SMCG)
Sponsored by
About this trial
This is an interventional other trial for Gestational Diabetes
Eligibility Criteria
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.
Sites / Locations
- National Institute of PerinatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group 1, SMGC four times/day
SMGC two times/day
Arm Description
Women with GDM and SMGC 4 times/day; fasting and 1-hour post-prandial of breakfast, lunch and dinner
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03769701
First Posted
December 6, 2018
Last Updated
December 24, 2021
Sponsor
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
1. Study Identification
Unique Protocol Identification Number
NCT03769701
Brief Title
Efficacy of Two Schemes of Self-monitoring Capillary Glucose in Gestational Diabetes
Official Title
Efficacy of Two Schemes of Self-monitoring Capillary Glucose to Monitor Glycemic Control in Mexican Women With GDM
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 7, 2018 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
July 30, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group 1, SMGC four times/day
Arm Type
Active Comparator
Arm Description
Women with GDM and SMGC 4 times/day; fasting and 1-hour post-prandial of breakfast, lunch and dinner
Arm Title
SMGC two times/day
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
self-monitoring capillary glucose (SMCG)
Intervention Description
To measure the capillary glucose with a glucometer according to the assigned group.
Primary Outcome Measure Information:
Title
Proportion of women who achieve glycemic control.
Description
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.
Time Frame
from GDM diagnosis to delivery.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Enrique Reyes-Muñoz, PhD
Phone
+521 5555209900
Ext
307
Email
dr.enriquereyes@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Lidia Arce-Sánchez, MD
Phone
+521 5555209900
Ext
299
Email
li_arce@yahoo.com.mx
Facility Information:
Facility Name
National Institute of Perinatology
City
Mexico
ZIP/Postal Code
11000
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Enrique Reyes-Muñoz, MD
Phone
52 (55)55209900
Ext
299
Email
dr.enriquereyes@gmail.com
First Name & Middle Initial & Last Name & Degree
Carlos Orega-Gonzalez, MD
Phone
52 (55) 55209900
Ext
307
Email
ortegagonzalez@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of Two Schemes of Self-monitoring Capillary Glucose in Gestational Diabetes
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