Gestational Diabetes Mellitus in PregnancyNCT04101396
4 vs 7 Points Blood Glucose Monitoring in Gestational Diabetes on Dietary Modification
A study testing diabetic diet in people with Gestational Diabetes Mellitus in Pregnancy, run by National University of Malaysia at 2 sites in Malaysia.
Trial summary
This study aims to compare between 4 and 7 points blood glucose monitoring in women with gestational diabetes on diet modification. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Gestational Diabetes Mellitus in Pregnancy
- What is being tested?
- diabetic diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesMalaysia
- Study dates
- 25 Oct 2019to 30 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Malaysia2 sites
Antenatal clinic, UKM Medical Centre
Cheras, Kuala Lumpur, 56000
National University of Malaysia
Cheras, Kuala Lumpur, 56000
About this study
Official title: 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.
Read the 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.
- Being tested
- diabetic diet
- Keywords
- diet modification, 4 and 7 points monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diabetic dietDietary supplement
Patients with gestational diabetes will be seen by the dietitian to be taught diet modification
| Study group | Role | What they receive |
|---|---|---|
| 4 points blood glucose monitoring | Other | 4 points of self monitoring blood glucose which comprises of fasting, 1 hour post breakfast, 1 hour post lunch and 1 hour post dinner Receives: Dietary Supplement: diabetic diet |
| 7 points blood glucose monitoring | Other | 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 Receives: Dietary Supplement: diabetic diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy outcome of participants
Mean gestational age at delivery in weeks
Measured: From date of randomisation up to 40 weeks gestation
Pregnancy outcome of participants
Rate of spontaneous or induced labour in percentage
Measured: From date of randomisation up to 40 weeks gestation and participants are diagnosed in established labour
Pregnancy outcome of participants
Rate of vaginal, instrumental or caesarean delivery in percentage
Measured: From date of randomisation up to 40 weeks gestation when the participants had given birth to the newborn
Pregnancy outcome of participants
Rate of intrapartum complications such as postpartum haemorrhage, shoulder dystocia and third or fourth degree tear in percentage
Measured: From date of randomisation up to 40 weeks gestation during progress of labour up to 24 hours post delivery
Pregnancy outcome of participants
Mean neonatal birth weight in kilogram
Measured: At the point of birth of the neonate
Pregnancy outcome of participants
Rate of neonates born with Apgar score at five minutes of less than 7 in percentage
Measured: At the point of birth of the neonate
Pregnancy outcome of participants
Rate of neonatal intensive care unit admission in percentage
Measured: At the point of birth of the neonate
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
Measured: From date of randomisation up to 7 days after birth of the neonate
Demographic data of participants
Mean age of participants in years
Measured: On the date of randomisation
Demographic data of participants
Rate of each different races such as Malay, Chinese and Indian in percentage
Measured: On the date of randomisation
Demographic data of participants
Rate of parity such as nulliparous or multiparous in percentage
Measured: On the date of randomisation
Demographic data of participants
Mean prepregnancy body mass index in kg/m^2
Measured: 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
Mean total weight gain in kilogram
Measured: On the date of randomisation till 40 weeks gestation
Demographic data of participants
Rate of positive family history of diabetes mellitus in percentage
Measured: On the date of randomisation up to 40 weeks gestation
Demographic data of participants
Rate of previous pregnancy affected by gestational diabetes mellitus in percentage
Measured: On the date of randomisation up to 40 weeks gestation
Demographic data of participants
Rate of previous pregnancy complicated by fetal macrosomia in percentage
Measured: On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants
Mean gestational age gestational diabetes mellitus is diagnosed in weeks
Measured: On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants
Mean fasting glucose level from the modified glucose tolerance test in mmol/l
Measured: On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants
Mean two hours post 75 gram glucose load from the modified glucose tolerance test in mmol/l
Measured: On the date of randomisation up to 40 weeks gestation
Clinical characteristics of participants
Rate of antenatal complications such as preeclampsia, threatened preterm labour, preterm prelabour rupture of membranes, anaemia,
Measured: At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants
Mean level of glycosylated haemoglobin in percentage
Measured: At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants
Mean level of serum fructosamine in percentage
Measured: At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants
Mean level of fasting blood glucose in self monitoring blood glucose in mmol/l
Measured: At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants
Mean level of pre-meal blood glucose in self monitoring blood glucose in mmol/l
Measured: At the point of randomisation till 40 weeks gestation
Clinical characteristics of participants
Mean level of one hour post-meal blood glucose in self monitoring blood glucose in mmol/l
Measured: At the point of randomisation till 40 weeks gestation
Secondary outcomes (4)
Requirement of treatment in participants
Mean gestational age that the participants are detected to require added treatment in weeks
Measured: From the date of randomisation up to 40 weeks gestation
Requirement of treatment in participants
Rate of type of treatment needed such as oral hypoglycaemic agent only, combination of insulin and oral hypoglycaemic agent
Measured: From point of randomisation till 40 weeks gestation
Participants' compliance
Rate of frequency of four weekly self blood glucose monitoring in percentage
Measured: From point of randomisation till 40 weeks gestation
Participants' satisfaction
Rate of participants' satisfaction whether satisfied, neutral or not satisfied in percentage
Measured: From point of randomisation till 40 weeks gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2019
- Study start25 Oct 2019
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gestational Diabetes Mellitus in PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All women with gestational diabetes are randomised to 4 or 7 points of self monitoring blood glucose.
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahana Abd Rahman, National University of Malaysia
- Investigators
- Noor Dalila Berohan, Principal investigator, National University of MalaysiaNorasyikin Abd Wahab, Study director, National University of MalaysiaShuhaila Ahmad, Study chair, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04101396
- Sponsor's protocol ID
- FF-2019-351
- Status last verified
- Nov 2023
- First submitted
- 17 Sep 2019
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The IPD will only be shared upon request. The data that can be shared will be the blood glucose levels and pregnancy outcomes.
Publications
Berohan ND, Alias H, Ishak S, Mohammed Nawi A, Azman N, Sohaimi D, Kamisan Atan I, Abd Wahab N, Kalok AH, Mohamad AS, Abd Rahman R. 4 vs 7 points self-monitoring blood glucose in gestational diabetes mellitus on diet modification: randomised clinical trial in a single tertiary centre in Malaysia. Arch Gynecol Obstet. 2024 Oct;310(4):1959-1965. doi: 10.1007/s00404-024-07661-5. Epub 2024 Aug 7.
PubMed 39110209
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 4 Versus 7 Points Self-monitoring Blood Glucose in Gestational Diabetes on Diet Modification-A Randomised Control Trial
- ClinicalTrials.gov ID
- NCT04101396
- Acronym / sponsor ID
- FF-2019-351
- Keywords
- diet modification, 4 and 7 points monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 25 Oct 2019 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 24 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- All women with gestational diabetes are randomised to 4 or 7 points of self monitoring blood glucose.
| Arm | Type | Receives |
|---|---|---|
| 4 points blood glucose monitoring | Other | Dietary Supplement: diabetic diet4 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 blood glucose monitoring | Other | Dietary Supplement: diabetic diet7 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 |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diabetic dietPatients with gestational diabetes will be seen by the dietitian to be taught diet modification | Dietary supplement | 4 points blood glucose monitoring, 7 points blood glucose monitoring |
Primary outcome
Pregnancy outcome of participants
Time frame: From date of randomisation up to 40 weeks gestation
Mean gestational age at delivery in weeks
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
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
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
Pregnancy outcome of participants
Time frame: At the point of birth of the neonate
Mean neonatal birth weight in kilogram
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
Pregnancy outcome of participants
Time frame: At the point of birth of the neonate
Rate of neonatal intensive care unit admission in percentage
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
Demographic data of participants
Time frame: On the date of randomisation
Mean age of participants in years
Demographic data of participants
Time frame: On the date of randomisation
Rate of each different races such as Malay, Chinese and Indian in percentage
Demographic data of participants
Time frame: On the date of randomisation
Rate of parity such as nulliparous or multiparous in percentage
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
Demographic data of participants
Time frame: On the date of randomisation till 40 weeks gestation
Mean total weight gain in kilogram
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
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
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
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
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
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
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,
Clinical characteristics of participants
Time frame: At the point of randomisation till 40 weeks gestation
Mean level of glycosylated haemoglobin in percentage
Clinical characteristics of participants
Time frame: At the point of randomisation till 40 weeks gestation
Mean level of serum fructosamine in percentage
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
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
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
4 secondary outcomes
Requirement of treatment in participants
Time frame: 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
Participants' compliance
Time frame: From point of randomisation till 40 weeks gestation
Participants' satisfaction
Time frame: From point of randomisation till 40 weeks gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2023.
- Derived from this study: PubMed 39110209Berohan ND, Alias H, Ishak S, Mohammed Nawi A, Azman N, Sohaimi D, Kamisan Atan I, Abd Wahab N, Kalok AH, Mohamad AS, Abd Rahman R. 4 vs 7 points self-monitoring blood glucose in gestational diabetes mellitus on diet modification: randomised clinical trial in a single tertiary centre in Malaysia. Arch Gynecol Obstet. 2024 Oct;310(4):1959-1965. doi: 10.1007/s00404-024-07661-5. Epub 2024 Aug 7.
- Individual participant dataSharing planned: No. The IPD will only be shared upon request. The data that can be shared will be the blood glucose levels and pregnancy outcomes.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noor Dalila Berohan principal investigator
National University of Malaysia
Norasyikin Abd Wahab study director
National University of Malaysia
Shuhaila Ahmad study chair
National University of Malaysia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing diabetic diet in people with Gestational Diabetes Mellitus in Pregnancy, run by National University of Malaysia at 2 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy outcome of participants (time frame: From date of randomisation up to 40 weeks gestation). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04101396, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2023.