Comparison of Insulin Pump and MDI for Pregestational Diabetes During Pregnancy

Study Overview
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Brief Summary
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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
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Primary outcome is a composite of Cesarian section, instrumental delivery, maternal hypertension, LGA infant, neonatal hypoglycemia or SCN admission.

Official Title
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Comparison of Continuous Subcutaneous Insulin Infusion (CSII) With Multiple Daily Injections (MDI) for the Treatment of Pregestational Diabetes During Pregnancy

Conditions
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Type 1 Diabetes, Type 2 Diabetes, Pregnancy

Intervention / Treatment
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* Device: insulin pump
* Other: multiple daily insulin injection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: insulin pump<br>subjects will use an insulin pump for the duration of the pregnancy. The intervention is that they will control their diabetes using an insulin pump | Device: insulin pump<br>* subjects in the experimental arm will administer insulin using a pump<br>|
| Active Comparator: Multiple Daily Insulin injections<br>subjects will continue their usual insulin treatment with multiple daily injections of sc insulin | Other: multiple daily insulin injection<br>* Subjects will continue with usual insulin injections<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite obstetrical/perinatal endpoint consisting of specific elements (see description) | 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. | Up to 42 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean maternal HbA1c during pregnancy | HbA1c will be measured at least every three months to provide information about overall glycemic control | up to 42 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pregnancy, insulin pump, CSII, multiple daily injections, MDI, type 1 diabetes, type 2 diabetes