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

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

Detailed Description
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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.

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

Conditions
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Gestational Diabetes Mellitus in Pregnancy

Intervention / Treatment
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* Dietary Supplement: diabetic diet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: All women with gestational diabetes are randomised to 4 or 7 points of self monitoring blood glucose.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 4 points blood glucose monitoring<br>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<br>* Patients with gestational diabetes will be seen by the dietitian to be taught diet modification<br>|
| Other: 7 points blood glucose monitoring<br>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<br>* Patients with gestational diabetes will be seen by the dietitian to be taught diet modification<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pregnancy outcome of participants | Mean gestational age at delivery in weeks | From date of randomisation up to 40 weeks gestation | 
| Pregnancy outcome of participants | 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 | 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 | 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 | Mean neonatal birth weight in kilogram | 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 | At the point of birth of the neonate | 
| Pregnancy outcome of participants | Rate of neonatal intensive care unit admission in percentage | 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 | From date of randomisation up to 7 days after birth of the neonate | 
| Demographic data of participants | Mean age of participants in years | On the date of randomisation | 
| Demographic data of participants | Rate of each different races such as Malay, Chinese and Indian in percentage | On the date of randomisation | 
| Demographic data of participants | Rate of parity such as nulliparous or multiparous in percentage | On the date of randomisation | 
| Demographic data of participants | 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 | Mean total weight gain in kilogram | On the date of randomisation till 40 weeks gestation | 
| Demographic data of participants | Rate of positive family history of diabetes mellitus in percentage | 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 | On the date of randomisation up to 40 weeks gestation | 
| Demographic data of participants | Rate of previous pregnancy complicated by fetal macrosomia in percentage | On the date of randomisation up to 40 weeks gestation | 
| Clinical characteristics of participants | Mean gestational age gestational diabetes mellitus is diagnosed in weeks | 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 | 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 | 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, | At the point of randomisation till 40 weeks gestation | 
| Clinical characteristics of participants | Mean level of glycosylated haemoglobin in percentage | At the point of randomisation till 40 weeks gestation | 
| Clinical characteristics of participants | Mean level of serum fructosamine in percentage | 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 | 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 | 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 | At the point of randomisation till 40 weeks gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Requirement of treatment in participants | 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 | 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 | Rate of frequency of four weekly self blood glucose monitoring in percentage | From point of randomisation till 40 weeks gestation | 
| Participants' satisfaction | Rate of participants' satisfaction whether satisfied, neutral or not satisfied in percentage | From point of randomisation till 40 weeks gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diet modification, 4 and 7 points monitoring