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

Primary Purpose

Gestational Diabetes Mellitus in Pregnancy

Status
Recruiting
Phase
Not Applicable
Locations
Malaysia
Study Type
Interventional
Intervention
diabetic diet
Sponsored by
National University of Malaysia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gestational Diabetes Mellitus in Pregnancy focused on measuring diet modification, 4 and 7 points monitoring

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Antenatal clinic, UKM Medical CentreRecruiting
  • National University of Malaysia

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

4 points blood glucose monitoring

7 points blood glucose monitoring

Arm Description

4 points of self monitoring blood glucose which comprises of fasting, 1 hour post breakfast, 1 hour post lunch and 1 hour post dinner

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

Outcomes

Primary Outcome Measures

Pregnancy outcome of participants
Mean gestational age at delivery in weeks
Pregnancy outcome of participants
Rate of spontaneous or induced labour in percentage
Pregnancy outcome of participants
Rate of vaginal, instrumental or caesarean delivery in percentage
Pregnancy outcome of participants
Rate of intrapartum complications such as postpartum haemorrhage, shoulder dystocia and third or fourth degree tear in percentage
Pregnancy outcome of participants
Mean neonatal birth weight in kilogram
Pregnancy outcome of participants
Rate of neonates born with Apgar score at five minutes of less than 7 in percentage
Pregnancy outcome of participants
Rate of neonatal intensive care unit admission in percentage
Pregnancy outcome of participants
Rate of neonatal complications such as intrauterine fetal demise, neonatal death, neonatal hypoglycaemia, neonatal jaundice, neonatal respiratory distress syndrome and neonatal sepsis in percentage
Demographic data of participants
Mean age of participants in years
Demographic data of participants
Rate of each different races such as Malay, Chinese and Indian in percentage
Demographic data of participants
Rate of parity such as nulliparous or multiparous in percentage
Demographic data of participants
Mean prepregnancy body mass index in kg/m^2
Demographic data of participants
Mean total weight gain in kilogram
Demographic data of participants
Rate of positive family history of diabetes mellitus in percentage
Demographic data of participants
Rate of previous pregnancy affected by gestational diabetes mellitus in percentage
Demographic data of participants
Rate of previous pregnancy complicated by fetal macrosomia in percentage
Clinical characteristics of participants
Mean gestational age gestational diabetes mellitus is diagnosed in weeks
Clinical characteristics of participants
Mean fasting glucose level from the modified glucose tolerance test in mmol/l
Clinical characteristics of participants
Mean two hours post 75 gram glucose load from the modified glucose tolerance test in mmol/l
Clinical characteristics of participants
Rate of antenatal complications such as preeclampsia, threatened preterm labour, preterm prelabour rupture of membranes, anaemia,
Clinical characteristics of participants
Mean level of glycosylated haemoglobin in percentage
Clinical characteristics of participants
Mean level of serum fructosamine in percentage
Clinical characteristics of participants
Mean level of fasting blood glucose in self monitoring blood glucose in mmol/l
Clinical characteristics of participants
Mean level of pre-meal blood glucose in self monitoring blood glucose in mmol/l
Clinical characteristics of participants
Mean level of one hour post-meal blood glucose in self monitoring blood glucose in mmol/l

Secondary Outcome Measures

Requirement of treatment in participants
Mean gestational age that the participants are detected to require added treatment in weeks
Requirement of treatment in participants
Rate of type of treatment needed such as oral hypoglycaemic agent only, combination of insulin and oral hypoglycaemic agent
Participants' compliance
Rate of frequency of four weekly self blood glucose monitoring in percentage
Participants' satisfaction
Rate of participants' satisfaction whether satisfied, neutral or not satisfied in percentage

Full Information

First Posted
September 17, 2019
Last Updated
March 25, 2022
Sponsor
National University of Malaysia
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1. Study Identification

Unique Protocol Identification Number
NCT04101396
Brief Title
4 vs 7 Points Blood Glucose Monitoring in Gestational Diabetes on Dietary Modification
Official Title
4 Versus 7 Points Self-monitoring Blood Glucose in Gestational Diabetes on Diet Modification-A Randomised Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 25, 2019 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
June 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University of Malaysia

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus in Pregnancy
Keywords
diet modification, 4 and 7 points monitoring

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
All women with gestational diabetes are randomised to 4 or 7 points of self monitoring blood glucose.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
4 points blood glucose monitoring
Arm Type
Other
Arm Description
4 points of self monitoring blood glucose which comprises of fasting, 1 hour post breakfast, 1 hour post lunch and 1 hour post dinner
Arm Title
7 points blood glucose monitoring
Arm Type
Other
Arm Description
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
Intervention Type
Dietary Supplement
Intervention Name(s)
diabetic diet
Intervention Description
Patients with gestational diabetes will be seen by the dietitian to be taught diet modification
Primary Outcome Measure Information:
Title
Pregnancy outcome of participants
Description
Mean gestational age at delivery in weeks
Time Frame
From date of randomisation up to 40 weeks gestation
Title
Pregnancy outcome of participants
Description
Rate of spontaneous or induced labour in percentage
Time Frame
From date of randomisation up to 40 weeks gestation and participants are diagnosed in established labour
Title
Pregnancy outcome of participants
Description
Rate of vaginal, instrumental or caesarean delivery in percentage
Time Frame
From date of randomisation up to 40 weeks gestation when the participants had given birth to the newborn
Title
Pregnancy outcome of participants
Description
Rate of intrapartum complications such as postpartum haemorrhage, shoulder dystocia and third or fourth degree tear in percentage
Time Frame
From date of randomisation up to 40 weeks gestation during progress of labour up to 24 hours post delivery
Title
Pregnancy outcome of participants
Description
Mean neonatal birth weight in kilogram
Time Frame
At the point of birth of the neonate
Title
Pregnancy outcome of participants
Description
Rate of neonates born with Apgar score at five minutes of less than 7 in percentage
Time Frame
At the point of birth of the neonate
Title
Pregnancy outcome of participants
Description
Rate of neonatal intensive care unit admission in percentage
Time Frame
At the point of birth of the neonate
Title
Pregnancy outcome of participants
Description
Rate of neonatal complications such as intrauterine fetal demise, neonatal death, neonatal hypoglycaemia, neonatal jaundice, neonatal respiratory distress syndrome and neonatal sepsis in percentage
Time Frame
From date of randomisation up to 7 days after birth of the neonate
Title
Demographic data of participants
Description
Mean age of participants in years
Time Frame
On the date of randomisation
Title
Demographic data of participants
Description
Rate of each different races such as Malay, Chinese and Indian in percentage
Time Frame
On the date of randomisation
Title
Demographic data of participants
Description
Rate of parity such as nulliparous or multiparous in percentage
Time Frame
On the date of randomisation
Title
Demographic data of participants
Description
Mean prepregnancy body mass index in kg/m^2
Time Frame
On the date of randomisation up to 40 weeks gestation based on the first trimester weight documented in the antenatal record
Title
Demographic data of participants
Description
Mean total weight gain in kilogram
Time Frame
On the date of randomisation till 40 weeks gestation
Title
Demographic data of participants
Description
Rate of positive family history of diabetes mellitus in percentage
Time Frame
On the date of randomisation up to 40 weeks gestation
Title
Demographic data of participants
Description
Rate of previous pregnancy affected by gestational diabetes mellitus in percentage
Time Frame
On the date of randomisation up to 40 weeks gestation
Title
Demographic data of participants
Description
Rate of previous pregnancy complicated by fetal macrosomia in percentage
Time Frame
On the date of randomisation up to 40 weeks gestation
Title
Clinical characteristics of participants
Description
Mean gestational age gestational diabetes mellitus is diagnosed in weeks
Time Frame
On the date of randomisation up to 40 weeks gestation
Title
Clinical characteristics of participants
Description
Mean fasting glucose level from the modified glucose tolerance test in mmol/l
Time Frame
On the date of randomisation up to 40 weeks gestation
Title
Clinical characteristics of participants
Description
Mean two hours post 75 gram glucose load from the modified glucose tolerance test in mmol/l
Time Frame
On the date of randomisation up to 40 weeks gestation
Title
Clinical characteristics of participants
Description
Rate of antenatal complications such as preeclampsia, threatened preterm labour, preterm prelabour rupture of membranes, anaemia,
Time Frame
At the point of randomisation till 40 weeks gestation
Title
Clinical characteristics of participants
Description
Mean level of glycosylated haemoglobin in percentage
Time Frame
At the point of randomisation till 40 weeks gestation
Title
Clinical characteristics of participants
Description
Mean level of serum fructosamine in percentage
Time Frame
At the point of randomisation till 40 weeks gestation
Title
Clinical characteristics of participants
Description
Mean level of fasting blood glucose in self monitoring blood glucose in mmol/l
Time Frame
At the point of randomisation till 40 weeks gestation
Title
Clinical characteristics of participants
Description
Mean level of pre-meal blood glucose in self monitoring blood glucose in mmol/l
Time Frame
At the point of randomisation till 40 weeks gestation
Title
Clinical characteristics of participants
Description
Mean level of one hour post-meal blood glucose in self monitoring blood glucose in mmol/l
Time Frame
At the point of randomisation till 40 weeks gestation
Secondary Outcome Measure Information:
Title
Requirement of treatment in participants
Description
Mean gestational age that the participants are detected to require added treatment in weeks
Time Frame
From the date of randomisation up to 40 weeks gestation
Title
Requirement of treatment in participants
Description
Rate of type of treatment needed such as oral hypoglycaemic agent only, combination of insulin and oral hypoglycaemic agent
Time Frame
From point of randomisation till 40 weeks gestation
Title
Participants' compliance
Description
Rate of frequency of four weekly self blood glucose monitoring in percentage
Time Frame
From point of randomisation till 40 weeks gestation
Title
Participants' satisfaction
Description
Rate of participants' satisfaction whether satisfied, neutral or not satisfied in percentage
Time Frame
From point of randomisation till 40 weeks gestation

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: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rahana Abd Rahman
Phone
+60122719985
Email
drrahana@ppukm.ukm.edu.my
First Name & Middle Initial & Last Name or Official Title & Degree
Nor Azlin Mohamed Ismail
Phone
+60193122255
Email
azlinm@ppukm.ukm.edu.my
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Noor Dalila Berohan
Organizational Affiliation
National University of Malaysia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Norasyikin Abd Wahab
Organizational Affiliation
National University of Malaysia
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Shuhaila Ahmad
Organizational Affiliation
National University of Malaysia
Official's Role
Study Chair
Facility Information:
Facility Name
Antenatal clinic, UKM Medical Centre
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahana Abd Rahman
Facility Name
National University of Malaysia
City
Cheras
State/Province
Kuala Lumpur
ZIP/Postal Code
56000
Country
Malaysia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rahana Abd Rahman
Phone
+60122719985
Email
drrahana@ppukm.ukm.edu.my
First Name & Middle Initial & Last Name & Degree
Nor Azlin Mohamed Ismail
Phone
+60193122255
Email
azlinm@ppukm.ukm.edu.my

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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.

Learn more about this trial

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

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