Plain English Summary
Background and study aims
Gestational diabetes mellitus (GDM) is high blood sugar in response to carbohydrate intake which is first detected during pregnancy. It is estimated that 16% of live births in 2015 were affected by high blood sugar with 85% due to GDM. Good control of blood sugar in GDM reduces the risk of adverse pregnancy outcomes. Self-monitoring of blood glucose (SMBG) with a personal glucose meter using pin prick blood from a finger is recommended for women with diabetes during pregnancy. There is a lack of data on the needed frequency for SMBG in GDM. A study that compared daily 4-point SMBG (blood glucose tests before meals and before bed) with weekly single-point fasting office-based testing finds a reduction in the incidence of big baby (birth weight of 4 kg or more), large for gestational age infants and less maternal weight gain with the 4-point every day SMBG. The Malaysian Ministry of Health Perinatal Care Manual recommends SMBG 4 points per day as infrequently as one day out of every 4 weeks for GDM patients on diet and lifestyle control only and only one day out of every 2 weekly if on insulin. With diet and lifestyle advice, GDM cases can be adequately controlled with only about 20% needing drug treatment. Hence many women with GDM have normal blood sugar profiles through pregnancy, bringing into question the need for frequent blood testing on a daily basis. On the other hand, the discipline, positive feedback and validation from more frequent SMBG that are within normal range may contribute to a stronger adherence to good diet and lifestyle choice, resulting in lower glucose levels through pregnancy. The glycated haemoglobin (HbA1c) level typically reflects average blood glucose level over the preceding 2-3 months. Higher HbA1c toward the end of pregnancy is associated with adverse pregnancy outcomes. The aim of this study is to compare 4-point SMBG on three days per week compared to one day per week, to see whether it reduces the patients’ HbA1c levels.
Who can participate?
Women aged 18 to 45 with a single pregnancy and confirmed GDM
What does the study involve?
Participants are randomly allocated to SMBG using a personal blood glucose monitor at 4 timepoints per day (i.e. when still fasted before breakfast, and 2 hours after breakfast, lunch and dinner) for either: 3 days per week (on 2 week days and 1 weekend day each week) or 1 day per week (on a week day or a weekend day on alternate weeks). Participants are followed up until delivery. HbA1c levels are measured using a blood sample at the start of the study and at 36 weeks.
What are the possible benefits and risks of participating?
Participants should not expect any benefit as it is not proven whether more frequent monitoring than on a weekly basis leads to better glucose levels or pregnancy outcomes. The possible disadvantages are the participants allocated to 3 days per week SMBG will need to prick their fingers 12 times a week compared with 4 times a week for the other group. More intensive monitoring can result in intervention which may prove to be unnecessary.
Where is the study run from?
University Malaya Medical Centre (Malaysia)
When is the study starting and how long is it expected to run for?
January 2018 to December 2018
Who is funding the study?
Department of Obstetrics and Gynaecology Support for Research Funding (Malaysia)
Who is the main contact?
Dr Ahmad Firdzaus Mohd Noor
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2017104-5626
Study information
Scientific title
Self-monitoring of blood glucose of three days compared to one day per week in mild gestational diabetes: a randomised trial
Acronym
SMBG-GDM
Study hypothesis
Three days vs one day per week (4-point per day) of self monitoring of blood glucose in mild gestational diabetes will lower HbA1c level by 0.2% by 36 weeks gestation.
Ethics approval
Medical Research Ethics Committee, University Malaya Medical Centre, 29/11/2017, ref: MREC ID NO: 2017104-5626
Study design
Open-label randomised trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet
Condition
Gestational diabetes
Intervention
Randomisation sequence will be generated in random blocks of 4 or 8 using a random number generator by a co-investigator who is not involved in recruitment. Participants will be randomised to self-monitoring of blood glucose using a personal blood glucose monitor 4 time points per day (i.e. when still fasted before breakfast, 2 hours after breakfast, lunch and dinner) for either:
1. 3 days per week (on 2 week days and 1 weekend day each week)
2. 1 day per week (on a week day or a weekend day on alternate weeks)
Patients will be under intervention and follow up from recruitment and until delivery.
Intervention type
Device
Phase
Drug names
Primary outcome measures
HbA1c level, measured using blood sample taken and sent to haematology labarotory in UMMC at recruitment and at 36 weeks
Secondary outcome measures
1. Drug treatment (e.g. metformin, insulin) during follow up
2. Pregnancy induced hypertension (BP ≥ 140 sys or 90 diastolic on 2 occasions prior to labour > 6 hours apart) during follow up
3. Gestational age at delivery
4. Induction of labor with indication
5. Epidural analgesia in labour
6. Mode of delivery:
6.1. Spontaneous vertex delivery
6.2. Instrumental delivery
6.3. Caesarean section with indication
7. Delivery estimated blood loss (major primary postpartum hemorrhage > 1000 ml)
8. Third/fourth degree tear
9. Placenta weight
10. Birth weight
11. Umbilical cord arterial pH at birth
12. Apgar score at 1st and 5th minutes
13. Special care nursery/neonatal intensive care unit admission during birth admission, indications of admission
3 to 13: the outcomes will be measured after delivery
Overall trial start date
01/01/2018
Overall trial end date
31/12/2018
Reason abandoned
Eligibility
Participant inclusion criteria
1. Aged 18 to 45
2. Singleton pregnancy
3. Gestational age at recruitment 20-30 weeks
4. Confirmed GDM: Fasting plasma glucose ≥ 5.1 mmol/L and/or the 2-hour ≥ 7.8 mmol/L by 75g OGTT ≥ 16 weeks of pregnancy
5. Normal 4-point blood sugar profile (BSP) in the preceding 2 weeks: fasting/pre-prandial ≤ 5.3, post prandial 1 hour of ≤ 7.8 or post prandial 2 hours of ≤ 6.7 mmol/L
6. Not on any hypoglycaemic drug treatment
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
106
Participant exclusion criteria
1. History of prepregnant hyperglycaemia (type 2 diabetes, impaired glucose tolerance or fasting glycaemia)
2. Fasting plasma glucose ≥ 7.0 and/or the 2-hour level ≥ 11.1 mmol/L by 75g OGTT
3. Haemoglobin level of < 8
4. Medical condition likely to result in delivery before 36 weeks gestation
5. Planning to deliver in different hospital from UMMC
Recruitment start date
01/01/2018
Recruitment end date
31/12/2018
Locations
Countries of recruitment
Malaysia
Trial participating centre
University Malaya Medical Centre
Lembah Pantai
Kuala Lumpur
59100
Malaysia
Funders
Funder type
Hospital/treatment centre
Funder name
Department of Obstetrics and Gynaecology Support for Research Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study protocol and statistical analysis plan are available on request. Planned publication of the study results in a peer reviewed journal.
IPD sharing statement
The datasets generated during and/or analysed during the current study are/will be available upon request from Professor Dr Tan Peng Chiong (pctan@um.edu.my). The data will become available after 2 years and it is subject to the approval of the ethics committee.
Intention to publish date
31/12/2019
Participant level data
Available on request
Results - basic reporting
Publication summary