None listed
Conditions
Brief summary
Insulin therapy is recommended in gestational diabetes when dietary changes have not adequately controlled blood glucose levels. The purpose of this study is to compare the effectiveness of two different types of insulin that we use in treating gestational diabetes, Optisulin® and Novomix30®, in managing fasting blood glucose levels.
Interventions
Novomix30 (30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamine) by subcutaneous injection before dinner for insulin requiring gestational diabetes, from diagnosis to delivery (childbirth).
Initial dose: 14 units with dinner daily, adjusted to response (i.e. Fasting hyperglycaemia of BGL greater than or equal to 5.3 mmol/L for 2 days and no fasting or post-dinner hypoglycaemia
• If NovoMix 30 dose is less than 20 units, increase by 2 units
• If NovoMix 30 do
Novomix30 (30% soluble insulin aspart (rys) and 70% insulin aspart (rys) crystallised with protamine) by subcutaneous injection before dinner for insulin requiring gestational diabetes, from diagnosis to delivery (childbirth). Initial dose: 14 units with dinner daily, adjusted to response (i.e. Fasting hyperglycaemia of BGL greater than or equal to 5.3 mmol/L for 2 days and no fasting or post-dinner hypoglycaemia • If NovoMix 30 dose is less than 20 units, increase by 2 units • If NovoMix 30 dose is greater than or equal to 20 units, increase by 4 units) Participant diary of insulin doses administered and blood glucose levels as recorded on glucometer.
Sponsors
Canberra Hospital Department of Endocrinology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Pregnant women aged 18 years old and older 2. Diagnosed with Gestational Diabetes Mellitus using one or more of the following criteria: - Fasting plasma glucose 5.3 – 6.9 mmol/L - 75g oral glucose tolerance test: 1 hour plasma glucose greater or equal to 10.6 mmol/L or 2 hour plasma glucose 9.0 – 11.0 mmol/L Or diagnosed with overt diabetes in pregnancy using one or more of the following criteria: - Fasting plasma glucose greater or equal to 7.0 mmol/L - 2 hour plasma glucose greater or equal to 11.1 mmol/L following a 75g 2 hour pregnancy oral glucose tolerance test - HbA1c greater or equal to 6.5% 3. Insulin requiring GDM – i.e. GDM inadequately controlled on dietary and lifestyle interventions
Exclusion criteria
- Multiple pregnancy (twins, triplets or more) - Diagnosed with Type 1 Diabetes Mellitus, Type 3c Diabetes Mellitus, Cystic Fibrosis Related Diabetes - Diagnosed with Type 2 Diabetes Mellitus prior to pregnancy - Ongoing concurrent metformin use (while in study) - Steroid induced hyperglycaemia
Outcome results
None listed