Gestational DiabetesNCT05326204
1 Versus 2 Hours Post Meal Glucose Monitoring in Gestational Diabetes on Treatment
An observational study of Gestational Diabetes and Treatment Adherence, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
A study to compare between 1 and 2 hours post meal blood glucose monitoring in patients with Gestational Diabetes Mellitus requiring treatment. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Diabetes, Treatment Adherence
- What is being tested?
- Home blood glucose monitoring
- How many people
- 2,954 participants
- Where
- 1 siteMalaysia
- Study dates
- 30 Dec 2021to 29 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult
Study population: All women with gestational diabetes on treatment attending the antenatal clinic in our centre
Who may be able to join
- Gestational diabetes diagnosed based on National Institute for Health and Care Excellence guideline
- requiring treatment either with metformin alone or combined with insulin
Who cannot join
- type 1 and 2 diabetes
- bad obstetrics history
- underlying medical disorders such as Systemic Lupus Erythematosus
- fetal anomaly
- delivery elsewhere
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site, 1 recruiting
- Recruiting
UKM Medical Center
Kuala Lumpur, W.Persekutuan, 56000
Rahana Abd Rahman, +60122719985, drrahana@ppukm.ukm.edu.my
About this study
Official title: 1 Versus 2 Hours Post Meal Self Monitoring Blood Glucose in Gestational Diabetes Mellitus on Treatment-A Prospective Randomised Controlled Trial
A study to compare between 1 and 2 hours post meal blood glucose monitoring in patients with Gestational Diabetes Mellitus requiring treatment.
Read the detailed description
This study involves all pregnant women who attended our antenatal clinic with Gestational Diabetes Mellitus requiring treatment. They will be randomised to either 1 or 2 hours post meal self blood glucose monitoring. The blood sugar profile is a staggered 7 points. They are followed up in the research clinic until delivery.
- Conditions
- Gestational Diabetes, Treatment Adherence
- Being tested
- Home blood glucose monitoring
- Keywords
- Gestational diabetes, treatment, glucose monitoring
- Medical subject headings
- Diabetes, Gestational, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home blood glucose monitoringOther
Self monitoring of capillary blood glucose
| Study group | Role | What they receive |
|---|---|---|
| 1 hour | Blood glucose monitoring comprises of 1 hour post meal Receives: Other: Home blood glucose monitoring | |
| 2 hours | Blood glucose monitoring comprises of 2 hours post meal Receives: Other: Home blood glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of delivery
route
Measured: from point of randomization to birth of the neonate
Gestational age
in weeks
Measured: from point of randomization to birth of the neonate
Fetal weight
in gram
Measured: from point of randomization to birth of the neonate
Secondary outcomes (2)
Maternal complications
postpartum haemorrhage, perineal tear
Measured: from point of randomization to birth of the neonate
perinatal complications
intrauterine death, macrosomia, admission to neonatal intensive care unit
Measured: from point of randomization to birth of the neonate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start30 Dec 2021
- Primary completion29 Dec 2025 (estimated)
- Study completion29 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 2,954 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rahana Abd Rahman, Principal investigator, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05326204
- Sponsor's protocol ID
- FF-2022-002
- Status last verified
- Jun 2025
- First submitted
- 6 Apr 2022
- Last updated
- 12 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 1 Versus 2 Hours Post Meal Self Monitoring Blood Glucose in Gestational Diabetes Mellitus on Treatment-A Prospective Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05326204
- Acronym / sponsor ID
- FF-2022-002
- Conditions
- Gestational Diabetes, Treatment Adherence
- Keywords
- Gestational diabetes, treatment, glucose monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,954 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 30 Dec 2021 (actual)
- Primary completion
- 29 Dec 2025 (estimated)
- Study completion
- 29 Dec 2025 (estimated)
- First posted
- 13 Apr 2022 (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.
A study to compare between 1 and 2 hours post meal blood glucose monitoring in patients with Gestational Diabetes Mellitus requiring treatment.
Detailed description
This study involves all pregnant women who attended our antenatal clinic with Gestational Diabetes Mellitus requiring treatment. They will be randomised to either 1 or 2 hours post meal self blood glucose monitoring. The blood sugar profile is a staggered 7 points. They are followed up in the research clinic until delivery.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 hour | – | Other: Home blood glucose monitoringBlood glucose monitoring comprises of 1 hour post meal |
| 2 hours | – | Other: Home blood glucose monitoringBlood glucose monitoring comprises of 2 hours post meal |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All women with gestational diabetes on treatment attending the antenatal clinic in our centre
Key inclusion criteria (2 listed)
- Gestational diabetes diagnosed based on National Institute for Health and Care Excellence guideline
- requiring treatment either with metformin alone or combined with insulin
Key exclusion criteria (5 listed)
- type 1 and 2 diabetes
- bad obstetrics history
- underlying medical disorders such as Systemic Lupus Erythematosus
- fetal anomaly
- delivery elsewhere
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 |
|---|---|---|
| Home blood glucose monitoringSelf monitoring of capillary blood glucose | Other | 1 hour, 2 hours |
Primary outcome
Mode of delivery
Time frame: from point of randomization to birth of the neonate
route
Gestational age
Time frame: from point of randomization to birth of the neonate
in weeks
Fetal weight
Time frame: from point of randomization to birth of the neonate
in gram
2 secondary outcomes
Maternal complications
Time frame: from point of randomization to birth of the neonate
perinatal complications
Time frame: from point of randomization to birth of the neonate
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Individual participant dataSharing planned: No
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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.
Rahana Abd Rahman principal investigator
National University of Malaysia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and Treatment Adherence, run by National University of Malaysia at 1 site 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 2 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: looking for participants now, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahana Abd Rahman (+60122719985, drrahana@ppukm.ukm.edu.my), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mode of delivery (time frame: from point of randomization to birth of the neonate). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jun 2025.