Comparison of Sensor Augmented Insulin Pump (with Smartguard technology) (SAP) with Non Augmented Pump Therapy (CSII) and Multiple daily injections (MDI) on Maternal and Neonatal Outcomes in Pregnancy in Women with Type 1 Diabetes.

Dr Sophie Poulter0 个研究点目标入组 78 人开始时间: 2017年3月8日最近更新: 2020年2月10日

适应症

试验速览

暂无简介。

•1. Women with Type 1 diabetes who are preconception (planning pregnancy but not yet pregnant) or in early pregnancy (less than 12 weeks gestation) who currently administer insulin.
•2. Criteria for intervention:
•i. Inability to achieve target HbA1c (<6.5%) or having significant hypoglycaemia using conventional treatment with multiple daily injections;
•ii. Women who can demonstrate willingness and ability to carbohydrate count and undertake the required education to use insulin pump therapy;
•iii. Women who are willing to enter into an agreement/contract outlining: a) that they will be responsible for the insulin pump consumables (cannulae, infusion sets and reservoirs) for the duration of the pump loan (approx. $30/month); b) that there will be a 3 month trial period where they will need to meet criteria (including appropriate education, ability to use the pump, improvement in predefined glycaemic parameters) for ongoing use of a loan pump; c) that the pump will be loaned until up to 4 weeks postdelivery, after which the pump will be returned to the department.

•1. Women not planning pregnancy.
•2. Women presenting after 12 weeks gestation.
•3. Exclusion from intervention includes women not demonstrating willingness to undertake appropriate education or accept conditions of loan of pump.

发起方

Dr Sophie Poulter