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

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ClinicalTrials.gov Identifier: NCT03769701
Recruitment Status : Recruiting
First Posted : December 7, 2018
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
ENRIQUE REYES-Munoz MD, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

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) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 6, 2018
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : July 30, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Dextrose

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.




Primary Outcome Measures :
  1. Proportion of women who achieve glycemic control. [ Time Frame: 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.



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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03769701


Contacts
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Contact: Enrique Reyes-Muñoz, PhD +521 5555209900 ext 307 dr.enriquereyes@gmail.com
Contact: Lidia Arce-Sánchez, MD +521 5555209900 ext 299 li_arce@yahoo.com.mx

Locations
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Mexico
National Institute of Perinatology Recruiting
Mexico, Mexico, 11000
Contact: Enrique Reyes-Muñoz, MD    52 (55)55209900 ext 299    dr.enriquereyes@gmail.com   
Contact: Carlos Orega-Gonzalez, MD    52 (55) 55209900 ext 307    ortegagonzalez@hotmail.com   
Sponsors and Collaborators
Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes

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Responsible Party: ENRIQUE REYES-Munoz MD, Medical Science Researcher, Instituto Nacional de Perinatologia Isidro Espinosa de los Reyes
ClinicalTrials.gov Identifier: NCT03769701     History of Changes
Other Study ID Numbers: 2017-1-53
First Posted: December 7, 2018    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases