4 vs 7 Points Blood Glucose Monitoring in Gestational Diabetes on Dietary Modification

November 7, 2023 updated by: Rahana Abd Rahman, National University of Malaysia

4 Versus 7 Points Self-monitoring Blood Glucose in Gestational Diabetes on Diet Modification-A Randomised Control Trial

This study aims to compare between 4 and 7 points blood glucose monitoring in women with gestational diabetes on diet modification.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

All women with gestational diabetes on diet modification will be recruited and randomised to 4 versus 7 points self monitoring blood glucose. They will be followed up 4 weekly and the pregnancy outcomes will be evaluated.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Malaysia
    • Kuala Lumpur
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • National University of Malaysia
      • Cheras, Kuala Lumpur, Malaysia, 56000
        • Antenatal clinic, UKM Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Aged 18-45 years old
  • Pregnant women with gestational diabetes mellitus on diet modification
  • Confirmed gestational diabetes mellitus using National Institute for Health and Care Excellence guideline by 75g oral glucose tolerance test after 14 weeks
  • Gestational age at recruitment 20-34 week

Exclusion Criteria:

  • bad obstetrics history.
  • Women with underlying medical disorders such as hypertension, autoimmune diseases on steroids
  • fetal anomaly.
  • Women planning to deliver in other centres
  • Women who refuse to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: 4 points blood glucose monitoring
4 points of self monitoring blood glucose which comprises of fasting, 1 hour post breakfast, 1 hour post lunch and 1 hour post dinner
Dietary supplement: diabetic diet
Patients with gestational diabetes will be seen by the dietitian to be taught diet modification
Other: 7 points blood glucose monitoring
7 points of self monitoring blood glucose which comprises of fasting,1 hour post breakfast, 1 hour pre and post lunch, 1 hour pre and post dinner, pre bed at 10 pm
Dietary supplement: diabetic diet
Patients with gestational diabetes will be seen by the dietitian to be taught diet modification

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pregnancy outcome of participants
Time Frame: From date of randomisation up to 40 weeks gestation
Mean gestational age at delivery in weeks
From date of randomisation up to 40 weeks gestation
Pregnancy outcome of participants
Time Frame: From date of randomisation up to 40 weeks gestation and participants are diagnosed in established labour
Rate of spontaneous or induced labour in percentage
From date of randomisation up to 40 weeks gestation and participants are diagnosed in established labour
Pregnancy outcome of participants
Time Frame: From date of randomisation up to 40 weeks gestation when the participants had given birth to the newborn
Rate of vaginal, instrumental or caesarean delivery in percentage
From date of randomisation up to 40 weeks gestation when the participants had given birth to the newborn
Pregnancy outcome of participants
Time Frame: From date of randomisation up to 40 weeks gestation during progress of labour up to 24 hours post delivery
Rate of intrapartum complications such as postpartum haemorrhage, shoulder dystocia and third or fourth degree tear in percentage
From date of randomisation up to 40 weeks gestation during progress of labour up to 24 hours post delivery
Pregnancy outcome of participants
Time Frame: At the point of birth of the neonate
Mean neonatal birth weight in kilogram
At the point of birth of the neonate
Pregnancy outcome of participants
Time Frame: At the point of birth of the neonate
Rate of neonates born with Apgar score at five minutes of less than 7 in percentage
At the point of birth of the neonate
Pregnancy outcome of participants
Time Frame: At the point of birth of the neonate
Rate of neonatal intensive care unit admission in percentage
At the point of birth of the neonate
Pregnancy outcome of participants
Time Frame: From date of randomisation up to 7 days after birth of the neonate
Rate of neonatal complications such as intrauterine fetal demise, neonatal death, neonatal hypoglycaemia, neonatal jaundice, neonatal respiratory distress syndrome and neonatal sepsis in percentage
From date of randomisation up to 7 days after birth of the neonate
Demographic data of participants
Time Frame: On the date of randomisation
Mean age of participants in years
On the date of randomisation
Demographic data of participants
Time Frame: On the date of randomisation
Rate of each different races such as Malay, Chinese and Indian in percentage
On the date of randomisation
Demographic data of participants
Time Frame: On the date of randomisation
Rate of parity such as nulliparous or multiparous in percentage
On the date of randomisation
Demographic data of participants
Time Frame: On the date of randomisation up to 40 weeks gestation based on the first trimester weight documented in the antenatal record
Mean prepregnancy body mass index in kg/m^2
On the date of randomisation up to 40 weeks gestation based on the first trimester weight documented in the antenatal record
Demographic data of participants
Time Frame: On the date of randomisation till 40 weeks gestation
Mean total weight gain in kilogram
On the date of randomisation till 40 weeks gestation
Demographic data of participants
Time Frame: On the date of randomisation up to 40 weeks gestation
Rate of positive family history of diabetes mellitus in percentage
On the date of randomisation up to 40 weeks gestation
Demographic data of participants
Time Frame: On the date of randomisation up to 40 weeks gestation
Rate of previous pregnancy affected by gestational diabetes mellitus in percentage
On the date of randomisation up to 40 weeks gestation
Demographic data of participants
Time Frame: On the date of randomisation up to 40 weeks gestation
Rate of previous pregnancy complicated by fetal macrosomia in percentage
On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants
Time Frame: On the date of randomisation up to 40 weeks gestation
Mean gestational age gestational diabetes mellitus is diagnosed in weeks
On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants
Time Frame: On the date of randomisation up to 40 weeks gestation
Mean fasting glucose level from the modified glucose tolerance test in mmol/l
On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants
Time Frame: On the date of randomisation up to 40 weeks gestation
Mean two hours post 75 gram glucose load from the modified glucose tolerance test in mmol/l
On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants
Time Frame: At the point of randomisation till 40 weeks gestation
Rate of antenatal complications such as preeclampsia, threatened preterm labour, preterm prelabour rupture of membranes, anaemia,
At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants
Time Frame: At the point of randomisation till 40 weeks gestation
Mean level of glycosylated haemoglobin in percentage
At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants
Time Frame: At the point of randomisation till 40 weeks gestation
Mean level of serum fructosamine in percentage
At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants
Time Frame: At the point of randomisation till 40 weeks gestation
Mean level of fasting blood glucose in self monitoring blood glucose in mmol/l
At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants
Time Frame: At the point of randomisation till 40 weeks gestation
Mean level of pre-meal blood glucose in self monitoring blood glucose in mmol/l
At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants
Time Frame: At the point of randomisation till 40 weeks gestation
Mean level of one hour post-meal blood glucose in self monitoring blood glucose in mmol/l
At the point of randomisation till 40 weeks gestation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Requirement of treatment in participants
Time Frame: From the date of randomisation up to 40 weeks gestation
Mean gestational age that the participants are detected to require added treatment in weeks
From the date of randomisation up to 40 weeks gestation
Requirement of treatment in participants
Time Frame: From point of randomisation till 40 weeks gestation
Rate of type of treatment needed such as oral hypoglycaemic agent only, combination of insulin and oral hypoglycaemic agent
From point of randomisation till 40 weeks gestation
Participants' compliance
Time Frame: From point of randomisation till 40 weeks gestation
Rate of frequency of four weekly self blood glucose monitoring in percentage
From point of randomisation till 40 weeks gestation
Participants' satisfaction
Time Frame: From point of randomisation till 40 weeks gestation
Rate of participants' satisfaction whether satisfied, neutral or not satisfied in percentage
From point of randomisation till 40 weeks gestation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
National University of Malaysia

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Noor Dalila Berohan, National University of Malaysia
  • Study Director: Norasyikin Abd Wahab, National University of Malaysia
  • Study Chair: Shuhaila Ahmad, National University of Malaysia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 25, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 24, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FF-2019-351

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The IPD will only be shared upon request. The data that can be shared will be the blood glucose levels and pregnancy outcomes.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gestational Diabetes Mellitus in Pregnancy

Clinical Trials on diabetic diet

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings