Pregnancy, Type 1 Diabetes, Type 2 Diabetes
Conditions
Keywords
insulin pump, CSII, multiple daily injections, MDI, type 1 diabetes, type 2 diabetes, pregnancy
Brief summary
This study is investigating whether insulin treatment with the insulin pump or with multiple daily injections (MDI) gives better outcomes for mother and baby in pregnant women with pregestational diabetes. Participants will be randomized to use either the insulin pump or MDI.
Detailed description
Primary outcome is a composite of Cesarian section, instrumental delivery, maternal hypertension, LGA infant, neonatal hypoglycemia or SCN admission.
Interventions
DEVICEinsulin pump
subjects in the experimental arm will administer insulin using a pump
Subjects will continue with usual insulin injections
Sponsors
University of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* subjects are attending the Diabetes Pregnancy Clinic at participating hospitals * have had type 1 or type 2 diabetes for at least one year * are in the first trimester or are actively attempting pregnancy * have a singleton pregnancy * are receiving intensive insulin therapy * are judged by clinic staff to be capable of using an insulin pump * are age 19 or older * are willing to adhere to the study protocol including monitoring blood glucose levels * are willing to take folic acid before pregnancy and during the first trimester * are willing to discontinue any medication contraindicated in pregnancy prior to conception * weigh less than 100 kg (220 lb) prior to becoming pregnant * use less than 100 units of insulin per day
Exclusion criteria
* current or previous use of an insulin pump * use of fertility treatments * have a multiple pregnancy * have had children born with major birth defects * have experienced stillbirth or multiple early pregnancy losses * have significant diabetes complications or a serious medical issue
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite obstetrical/perinatal endpoint consisting of specific elements (see description) | Up to 42 weeks | Composite obstetrical/perinatal endpoint consisting of one or more of pre-eclampsia, primary caesarian section, pre-term delivery, spontaneous abortion, termination for congenital anomaly or chromosomal abnormality, perinatal mortality, large-for-gestational age, shoulder dystocia, birth injury, major congenital anomaly, neonatal hypoglycemia, jaundice requiring phototherapy, or admission to neonatal intensive care nursery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean maternal HbA1c during pregnancy | up to 42 weeks | HbA1c will be measured at least every three months to provide information about overall glycemic control |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of episodes of severe hypoglycemia | up to 42 weeks | Severe hypoglycemia is defined as capillary glucose \< 3.3 mmol/L requiring the assistance of another person for treatment. |
Countries
Canada
Outcome results
None listed